Brief Digital Interventions to Support the Psychological Well-being of NHS Staff During the COVID-19 Pandemic: 3-Arm Pilot Randomized Controlled Trial

Background Health and social care staff are at high risk of experiencing adverse mental health (MH) outcomes during the COVID-19 pandemic. Hence, there is a need to prioritize and identify ways to effectively support their psychological well-being (PWB). Compared to traditional psychological interventions, digital psychological interventions are cost-effective treatment options that allow for large-scale dissemination and transcend social distancing, overcome rurality, and minimize clinician time. Objective This study reports MH outcomes of a Consolidated Standards of Reporting Trials (CONSORT)-compliant parallel-arm pilot randomized controlled trial (RCT) examining the potential usefulness of an existing and a novel digital psychological intervention aimed at supporting psychological health among National Health Service (NHS) staff working through the COVID-19 pandemic. Methods NHS Highland (NHSH) frontline staff volunteers (N=169) were randomly assigned to the newly developed NHSH Staff Wellbeing Project (NHSWBP), an established digital intervention (My Possible Self [MPS]), or a waitlist (WL) group for 4 weeks. Attempts were made to blind participants to which digital intervention they were allocated. The interventions were fully automated, without any human input or guidance. We measured 5 self-reported psychological outcomes over 3 time points: before (baseline), in the middle of (after 2 weeks), and after treatment (4 weeks). The primary outcomes were anxiety (7-item General Anxiety Disorder), depression (Patient Health Questionnaire), and mental well-being (Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes included mental toughness (Mental Toughness Index) and gratitude (Gratitude Questionnaire-6). Results Retention rates mid- and postintervention were 77% (n=130) and 63.3% (n=107), respectively. Postintervention, small differences were noted between the WL and the 2 treatment groups on anxiety (vs MPS: Cohen d=0.07, 95% CI –0.20 to 0.33; vs NHSWBP: Cohen d=0.06, 95% CI –0.19 to 0.31), depression (vs MPS: Cohen d=0.37, 95% CI 0.07-0.66; vs NHSWBP: Cohen d=0.18, 95% CI –0.11 to 0.46), and mental well-being (vs MPS: Cohen d=–0.04, 95% CI –0.62 to –0.08; vs NHSWBP: Cohen d=–0.15, 95% CI –0.41 to 0.10). A similar pattern of between-group differences was found for the secondary outcomes. The NHSWBP group generally had larger within-group effects than the other groups and displayed a greater rate of change compared to the other groups on all outcomes, except for gratitude, where the rate of change was greatest for the MPS group. Conclusions Our analyses provided encouraging results for the use of brief digital psychological interventions in improving PWB among health and social care workers. Future multisite RCTs, with power to reliably detect differences, are needed to determine the efficacy of contextualized interventions relative to existing digital treatments. Trial Registration ISRCTN Registry (ISRCTN) ISRCTN18107122; https://www.isrctn.com/ISRCTN18107122


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Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Methods: NHS Highland (NHSH) frontline staff volunteers (N = 169) were randomly assigned to the newly developed NHSH Staff Wellbeing Project (NHSWBP), an established digital intervention (My Possible Self; MPS), or to a waitlist (WL) condition for four weeks. Attempts were made to blind participants to which digital intervention they were allocated. The interventions were fully automated, without any human input or guidance. We measured five self-reported psychological outcomes over three time points: before (baseline), middle (after 2 weeks) and after treatment (4 weeks). The primary outcomes were anxiety (GAD-7), depression (PHQ-9) and mental well-being (Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes included mental toughness (Mental Toughness Index) and gratitude (the Gratitude Questionnaire)." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes : "The interventions were fully automated, without any human input or guidance. " 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study yes: "Methods: NHS Highland (NHSH) frontline staff volunteers (N = 169) were randomly assigned to the newly developed NHSH Staff Wellbeing Project (NHSWBP), an established digital intervention (My Possible Self; MPS), or to a waitlist (WL) condition for four weeks. Attempts were made to blind participants to which digital intervention they were allocated. The interventions were fully automated, without any human input or guidance. We measured five self-reported psychological outcomes over three time points: before (baseline), middle (after 2 weeks) and after treatment (4 weeks). The primary outcomes were anxiety (GAD-7), depression (PHQ-9) and mental well-being (Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes included mental toughness (Mental Toughness Index) and gratitude (the Gratitude Questionnaire)" 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Results: Retention rates at middle and post-intervention were 77% (n = 130) and 63.3% (n = 107), respectively. At postintervention, small differences were noted between the WL condition and the two treatment conditions on anxiety ( Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5)

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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Mental health (MH) has been deteriorating both globally and across the UK during the coronavirus disease 2019  pandemic, with large scale population studies reporting increased prevalence of depression and anxiety [1]. There are concerns that the public health crisis has disproportionately impacted the wellbeing of specialized populations, including health and social care workers (HSCWs) who provide valuable healthcare services. HSCWs exhibited high levels of pre-existing mental health problems before the COVID-19 pandemic [2] [3][4][5], and recent evidence suggests that this group is at increased risk of experiencing worsening MH outcomes as a direct result of the COVID-19 pandemic [6, 7] [8, 9]. "Interventions designed to improve MH and psychological well-being (PWB) could help to mitigate the adverse effects of the COVID-19 pandemic on the well-being of HSCWs [8]. Digital psychological interventions overcome social distancing, rurality and already overburdened clinician time constraints. Furthermore, digital interventions have a low cost relative to traditional psychological interventions, they have already been widely used [14], are generally popular with users and can be accessed anonymously at the user's convenience. Evidence based and rigorously tested digital interventions could allow for a rapid, economical, and large-scale dissemination of urgently needed psychological support for frontline staff working through the COVID-19 pandemic and its aftermath." 2a-ii) Scientific background, rationale: What is known about the (type of) system

METHODS
Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "The current study This study aims to provide preliminary evidence on the use of digital psychological interventions to support frontline staff psychological health in the context of the COVID-19 pandemic. In a pilot randomised controlled trial (RCT), we evaluated the use of two smartphone apps designed to support PWB against a control condition (waitlist): 1) My Possible Self (MPS) [19], which is a well-established validated app with a track record of showing significant improvements in depression, anxiety and stress in users over a short period of time [19], together with good user satisfaction rates; 2) the NHS Highland Wellbeing Project (NHSWBP), which is a PPI-informed, brief, fully automated, context (COVID-19 pandemic) and population-specific (frontline staff) digital psychological intervention built on the MPS model and wireframe to promote psychological well-being among HSCWs. We predicted that symptoms of depression and anxiety would decline among users randomly allocated to receive digital psychological interventions, whilst mental well-being would increase, relative to the WL condition. Two positive psychology concepts shown to mitigate the negative effects of depression and anxiety and promote positive adaptation in the face of adversity (such as what frontline staff are facing while working through a pandemic), that are amenable to change, are mental toughness (MT) [20] and gratitude [21]. We also predicted that use of digital psychological interventions would increase MT and gratitude. Although we predicted both digital interventions to yield improvements relative to the WL condition, we expected that NHSWBP would show greater rates of improvements because it is designed specifically for the COVID-19 context. To our knowledge, this is the first trial to examine fully automated, brief digital psychological interventions aimed to support the psychological health of frontline staff working through the COVID-19 pandemic." 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "parallel-arm pilot randomised controlled trial (RCT)" (see also abstract) Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No changes were needed in this pilot study once the trail commenced 3b-i) Bug fixes, Downtimes, Content Changes Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
Clear selection 4a) Eligibility criteria for participants subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No changes were needed in this pilot study once the trail commenced Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Eligibility criteria Participants were required to meet the following criteria: UK resident; aged 18 and over; working in NHSH as a health or social care worker during the COVID-19 pandemic; and own an internet enabled mobile phone. Both "clinical" (doctors, nurses, allied health professionals) and "non-clinical" (such as administrators) staff were eligible".

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.

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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Participants were required to meet the following criteria: UK resident; aged 18 and over; working in NHSH as a health or social care worker during the COVID-19 pandemic; and own an internet enabled mobile phone." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.

Clear selection
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Participants were recruited locally and online between July 2020 and September 2020. Data collection took place at the beginning, middle and end of the pilot RCT intervention phase, which ran from September 2020 to October 2020. Recruitment was conducted digitally by NHSH Human Resources, which included emails and electronic newsletters. Further recruitment was conducted via GP practice managers, as well as heads of departments in primary and secondary care. A secondary level of recruitment was conducted on social media; a page for the study was made on Twitter, Facebook and LinkedIn. Paid advertisements were also used on Facebook and LinkedIn to promote the study. Across all recruitment routes, interested individuals were directed to a secure data collection website via a weblink where they first reviewed information about the study and gave electronic consent to participate.
"Randomisation A research assistant not involved in the RCT randomised participants after baseline using computerised Simple randomization. Allocation was either to the MPS, NHSWBP, or WL condition. Participants received advice of their group assignment by email. Participants were blinded to which intervention they received by styling the two interventions, and communications to participants similarly. Participants downloaded the same app from the iTunes/Appstore/Playstore and a code was sent back to them to initiate the intervention that they received. " subitem not at all important 1 2 3 4 5 essential 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Clear selection 4b) Settings and locations where the data were collected Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Randomisation A research assistant not involved in the RCT randomised participants after baseline using computerised Simple randomization. Allocation was either to the MPS, NHSWBP, or WL condition. Participants received advice of their group assignment by email. Participants were blinded to which intervention they received by styling the two interventions, and communications to participants similarly. Participants downloaded the same app from the iTunes/Appstore/Playstore and a code was sent back to them to initiate the intervention that they received." "Recruitment was conducted digitally by NHSH Human Resources, which included emails and electronic newsletters. Further recruitment was conducted via GP practice managers, as well as heads of departments in primary and secondary care. A secondary level of recruitment was conducted on social media; a page for the study was made on Twitter, Facebook and LinkedIn. Paid advertisements were also used on Facebook and LinkedIn to promote the study. Across all recruitment routes, interested individuals were directed to a secure data collection website via a weblink where they first reviewed information about the study and gave electronic consent to participate. Eligible participants then completed a baseline survey, after which they were randomized to a condition. All participants were asked to complete follow-up surveys after the first two weeks of the intervention (middle) and four weeks after baseline following completion of the intervention period. At each assessment point, participants accessed the survey via a weblink sent to them in an email message" subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes "Across all recruitment routes, interested individuals were directed to a secure data collection website via a weblink where they first reviewed information about the study and gave electronic consent to participate. Eligible participants then completed a baseline survey, after which they were randomized to a condition. All participants were asked to complete follow-up surveys after the first two weeks of the intervention (middle) and four weeks after baseline following completion of the intervention period. At each assessment point, participants accessed the survey via a weblink sent to them in an email message.
" This study was a part of the Scottish Government's Rapid Research into COVID-19 and time restrictions limited recruitment activities; it was not possible to extend recruitment activities or product development beyond the grant's funding timeframe. Written informed consent was provided by all participants. The RCT was approved by the NHS Health Research Authority (20/SW/0098) and registered at ISRCTN18107122. The intervention phase ran from September 7 to October 5 2020, during the start of the second wave of the COVID-19 pandemic in Scotland." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

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subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "All participants were asked to complete follow-up surveys after the first two weeks of the intervention (middle) and four weeks after baseline following completion of the intervention period. At each assessment point, participants accessed the survey via a weblink sent to them in an email message." 4b-ii) Report how institutional affiliations are displayed

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Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Clear selection
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study not applicable to our study

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

Clear selection
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "NHS Highland Staff Wellbeing Project (NHSWBP) The NHSWBP is a PPI-informed, brief, fully automated, context-(COVID-19) and populationspecific (NHSH frontline staff) digital psychological intervention (smartphone app) based on MPS. It utilises the tried and tested cognitive behavioural therapeutic (CBT) and positive psychological techniques delivered via the MPS [19] smartphone app's modules. There were a number of ways in which the NHSWBP app differed from the MPS app. First, the NHSWBP was presented as a coherent narrative with a fictional character, a Scottish nurse named Iona, who guided participants through the linear narrative of the app and its interventions. Participants also received automated text messages from Iona to engage them in the overall narrative and to motivate continued engagement with the intervention. Second, the NHSWBP was designed following PPI feedback, which included input about which MPS modules were most relevant, the duration of the modules, and the coherence and flow of the presentation format. Third, the NHSWBP provided links to local and national 24-hour support services. Similarly to MPS, participants were able to monitor and record their mood and levels of distress or well-being, add notes, and identify and record triggers for low mood and anxiety. The intervention lasted for four weeks and consisted of two parts: Part 1 (duration two weeks) focused on increasing participants' happiness, resilience and well-being; and Part 2 (duration two weeks) focused on managing low mood and anxiety effectively. The NHSWBP was co-designed by the University of the Highlands and Islands (UHI), NHSH and the software and technical team that supports the MPS app. The NHSWBP was designed using the MPS app platform and participant communication system, owing to its established track record and NHS approval. " subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Clear selection
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No -this was a pilot study for a pilot project that only had 1 version.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

Clear selection
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, in the primary and secondary outcomes section we provide a rationale for using assessments that are seen as the most widely standards for each construct.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

Clear selection
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This was a pilot study and we aim to due provide source code, screen shots etc in the fullscale RCT

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Clear selection
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This was a pilot study intervention is no longer available for download and as closed only to participants.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).

Clear selection
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Eligible participants then completed a baseline survey, after which they were randomized to a condition. All participants were asked to complete follow-up surveys after the first two weeks of the intervention (middle) and four weeks after baseline following completion of the intervention period. At each assessment point, participants accessed the survey via a weblink sent to them in an email message." "Allocation was either to the MPS, NHSWBP, or WL condition. Participants received advice of their group assignment by email. Participants were blinded to which intervention they received by styling the two interventions, and communications to participants similarly. Participants downloaded the same app from the iTunes/Appstore/Playstore and a code was sent back to them to initiate the intervention that they received".
subitem not at all important 1 2 3 4 5 essential 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework

Clear selection
Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Interventions My Possible Self (MPS) MPS is a tried and tested, NHS approved [22] smartphone well-being app with a validated track record of showing significant improvements in depression, anxiety and stress in its users over a short period of time [19]. It is fully automated and freely available to NHS staff. This intervention has modules that cover a variety of topics and can be accessed in any order, including coping effectively with depression and anxiety, enhancing happiness, improving sleep quality and practicing mindfulness.

NHS Highland Staff Wellbeing Project (NHSWBP)
The NHSWBP is a PPI-informed, brief, fully automated, context-(COVID-19) and populationspecific (NHSH frontline staff) digital psychological intervention (smartphone app) based on MPS. It utilises the tried and tested cognitive behavioural therapeutic (CBT) and positive psychological techniques delivered via the MPS [19] smartphone app's modules. There were a number of ways in which the NHSWBP app differed from the MPS app. First, the NHSWBP was presented as a coherent narrative with a fictional character, a Scottish nurse named Iona, who guided participants through the linear narrative of the app and its interventions. Participants also received automated text messages from Iona to engage them in the overall narrative and to motivate continued engagement with the intervention. Second, the NHSWBP was designed following PPI feedback, which included input about which MPS modules were most relevant, the duration of the modules, and the coherence and flow of the presentation format. Third, the NHSWBP provided links to local and national 24-hour support services. Similarly to MPS, participants were able to monitor and record their mood and levels of distress or well-being, add notes, and identify and record triggers for low mood and anxiety. The intervention lasted for four weeks and consisted of two parts: Part 1 (duration two weeks) focused on increasing participants' happiness, resilience and well-being; and Part 2 (duration two weeks) focused on managing low mood and anxiety effectively. The NHSWBP was co-designed by the University of the Highlands and Islands (UHI), NHSH and the software and technical team that supports the MPS app. The NHSWBP was designed using the MPS app platform and participant communication system, owing to its established track record and NHS approval.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.

Clear selection
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: NHS Highland Staff Wellbeing Project (NHSWBP) The NHSWBP is a PPI-informed, brief, fully automated, context-(COVID-19) and populationspecific (NHSH frontline staff) digital psychological intervention (smartphone app) based on MPS. It utilises the tried and tested cognitive behavioural therapeutic (CBT) and positive psychological techniques delivered via the MPS [19] smartphone app's modules. There were a number of ways in which the NHSWBP app differed from the MPS app. First, the NHSWBP was presented as a coherent narrative with a fictional character, a Scottish nurse named Iona, who guided participants through the linear narrative of the app and its interventions. Participants also received automated text messages from Iona to engage them in the overall narrative and to motivate continued engagement with the intervention. Second, the NHSWBP was designed following PPI feedback, which included input about which MPS modules were most relevant, the duration of the modules, and the coherence and flow of the presentation format. Third, the NHSWBP provided links to local and national 24-hour support services. Similarly to MPS, participants were able to monitor and record their mood and levels of distress or well-being, add notes, and identify and record triggers for low mood and anxiety. The intervention lasted for four weeks and consisted of two parts: Part 1 (duration two weeks) focused on increasing participants' happiness, resilience and well-being; and Part 2 (duration two weeks) focused on managing low mood and anxiety effectively. The NHSWBP was co-designed by the University of the Highlands and Islands (UHI), NHSH and the software and technical team that supports the MPS app. The NHSWBP was designed using the MPS app platform and participant communication system, owing to its established track record and NHS approval.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Clear selection
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "The interventions were fully automated, without any human input or guidance."

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Clear selection
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Yes: NHS Highland Staff Wellbeing Project (NHSWBP) The NHSWBP is a PPI-informed, brief, fully automated, context-(COVID-19) and populationspecific (NHSH frontline staff) digital psychological intervention (smartphone app) based on MPS. It utilises the tried and tested cognitive behavioural therapeutic (CBT) and positive psychological techniques delivered via the MPS [19] smartphone app's modules. There were a number of ways in which the NHSWBP app differed from the MPS app. First, the NHSWBP was presented as a coherent narrative with a fictional character, a Scottish nurse named Iona, who guided participants through the linear narrative of the app and its interventions. Participants also received automated text messages from Iona to engage them in the overall narrative and to motivate continued engagement with the intervention. Second, the NHSWBP was designed following PPI feedback, which included input about which MPS modules were most relevant, the duration of the modules, and the coherence and flow of the presentation format. Third, the NHSWBP provided links to local and national 24-hour support services. Similarly to MPS, participants were able to monitor and record their mood and levels of distress or well-being, add notes, and identify and record triggers for low mood and anxiety. The intervention lasted for four weeks and consisted of two parts: Part 1 (duration two weeks) focused on increasing participants' happiness, resilience and well-being; and Part 2 (duration two weeks) focused on managing low mood and anxiety effectively. The NHSWBP was co-designed by the University of the Highlands and Islands (UHI), NHSH and the software and technical team that supports the MPS app. The NHSWBP was designed using the MPS app platform and participant communication system, owing to its established track record and NHS approval. " subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.

Clear selection
Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No ancillary training/support were used in this pilot study Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: " All participants were asked to complete follow-up surveys after the first two weeks of the intervention (middle) and four weeks after baseline following completion of the intervention period. At each assessment point, participants accessed the survey via a weblink sent to them in an email message." Furthermore a full description of the Primary and secondary outcomes are provided, including their online use during the COVID-19 pandemic.
subitem not at all important 1 2 3 4 5 essential 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].

Clear selection
Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text Yes: A full a full description of the Primary and secondary outcomes are provided, including their online use during the COVID-19 pandemic. "Primary outcomes Post-intervention was the primary timepoint for all outcomes.
Depression. The Patient Health Questionnaire (PHQ-9)[23] was used to measure depression. The 9 items ask participants to consider how bothered they have been over the past two weeks according to each statement (e.g., "feeling tired or having little energy"). The questionnaire score ranges from 0-27; each question is given a four-point response ("Not at all" = 0, "Nearly every day" = 3 scale was used to measure anxiety. Similar to the PHQ-9, each item asks the respondent to consider the statement based on how much they have been bothered over a two-week period (e.g., "Feeling nervous anxious or on edge"). Each item is scaled from 0 ("Not at all") to 3 ("Nearly every day") with a total score range of 0-21. A number of studies during the COVID-19 pandemic have used the GAD-7 to measure levels of anxiety in various UK and international population settings, including in frontline staff working through this pandemic [8,24]. Mental Well-being. Mental well-being was measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) [27]. The scale consists of 14-items used to measure subjective well-being and psychological functioning. The wording of each item is positive and aimed to address positive aspects of MH.
Responses are completed using a 5point scale (1 = "None of the time", 5 = "All of the time"); the total score ranges from 14- Qualitative feedback was not a part of this study. We did however design this with public involvement and had specific test-groups providing us with qualitative feedback outside of this study.
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No changes were required in this pilot project 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Clear selection 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Given that this was a pilot trial being done in a limited time, the sample size targets were based on pragmatic factors rather than an expectation of having the power to enable detection of the expected effect sizes" "Post-hoc power calculation Instead of using the observed effect size to calculate post-hoc study power (which could introduce bias)[45], we used the observed sample size and a fixed threshold for power and significance, and calculated the smallest effect size that could be reliably detected with our sample size. By using this approach, together with our study design, we found that our study could detect an effect size of at least f = 0.27 at 80% power" Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: We explain that this is a limited pilot study that lasted 4 weeks only 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Randomisation A research assistant not involved in the RCT randomised participants after baseline using computerised Simple randomization. " Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Randomisation A research assistant not involved in the RCT randomised participants after baseline using computerised Simple randomization. " 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Randomisation A research assistant not involved in the RCT randomised participants after baseline using computerised Simple randomization. Allocation was either to the MPS, NHSWBP, or WL condition. Participants received advice of their group assignment by email. Participants were blinded to which intervention they received by styling the two interventions, and communications to participants similarly. Participants downloaded the same app from the iTunes/Appstore/Playstore and a code was sent back to them to initiate the intervention that they received. " Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: Yes: "Randomisation A research assistant not involved in the RCT randomised participants after baseline using computerised Simple randomization. Allocation was either to the MPS, NHSWBP, or WL condition. Participants received advice of their group assignment by email. Participants were blinded to which intervention they received by styling the two interventions, and communications to participants similarly. Participants downloaded the same app from the iTunes/Appstore/Playstore and a code was sent back to them to initiate the intervention that they received. " subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

Clear selection
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: Yes: "Randomisation A research assistant not involved in the RCT randomised participants after baseline using computerised Simple randomization. Allocation was either to the MPS, NHSWBP, or WL condition. Participants received advice of their group assignment by email. Participants were blinded to which intervention they received by styling the two interventions, and communications to participants similarly. Participants downloaded the same app from the iTunes/Appstore/Playstore and a code was sent back to them to initiate the intervention that they received. " 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Clear selection 11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: Yes: "Randomisation A research assistant not involved in the RCT randomised participants after baseline using computerised Simple randomization. Allocation was either to the MPS, NHSWBP, or WL condition. Participants received advice of their group assignment by email. Participants were blinded to which intervention they received by styling the two interventions, and communications to participants similarly. Participants downloaded the same app from the iTunes/Appstore/Playstore and a code was sent back to them to initiate the intervention that they received. " Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: Under the intervention heading we describe this in detail: "Interventions My Possible Self (MPS) MPS is a tried and tested, NHS approved [22] smartphone well-being app with a validated track record of showing significant improvements in depression, anxiety and stress in its users over a short period of time [19]. It is fully automated and freely available to NHS staff. This intervention has modules that cover a variety of topics and can be accessed in any order, including coping effectively with depression and anxiety, enhancing happiness, improving sleep quality and practicing mindfulness.

NHS Highland Staff Wellbeing Project (NHSWBP)
The NHSWBP is a PPI-informed, brief, fully automated, context-(COVID-19) and populationspecific (NHSH frontline staff) digital psychological intervention (smartphone app) based on MPS. It utilises the tried and tested cognitive behavioural therapeutic (CBT) and positive psychological techniques delivered via the MPS [19] smartphone app's modules. There were a number of ways in which the NHSWBP app differed from the MPS app. First, the NHSWBP was presented as a coherent narrative with a fictional character, a Scottish nurse named Iona, who guided participants through the linear narrative of the app and its interventions. Participants also received automated text messages from Iona to engage them in the overall narrative and to motivate continued engagement with the intervention. Second, the NHSWBP was designed following PPI feedback, which included input about which MPS modules were most relevant, the duration of the modules, and the coherence and flow of the presentation format. Third, the NHSWBP provided links to local and national 24-hour support services. Similarly to MPS, participants were able to monitor and record their mood and levels of distress or well-being, add notes, and identify and record triggers for low mood and anxiety. The intervention lasted for four weeks and consisted of two parts: Part 1 (duration two weeks) focused on increasing participants' happiness, resilience and well-being; and Part 2 (duration two weeks) focused on managing low mood and anxiety effectively. The NHSWBP was co-designed by the University of the Highlands and Islands (UHI), NHSH and the software and technical team that supports the MPS app. The NHSWBP was designed using the MPS app platform and participant communication system, owing to its established track record and NHS approval." 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Statistical analyses Statistical analyses and data manipulations were implemented with R[37]. Baseline characteristics of participants randomly allocated to the three intervention groups were compared using chi square. The effects of the MPS and NHSWBP interventions on psychological measures were examined using intention-to-treat (ITT) analyses that included data from all participants who completed the baseline assessment and any follow-up assessment. No imputation was used for missing data. Standard regression models assume independent observations. To adequately account for the dependencies in the data, we adopted the linear mixed modelling (LMM) approach [38] for the analyses of the data. This approach is appropriate for studying the relationships and sources of variation in the dataset. It uses all available data and efficiently handles missing data, thereby avoiding listwise deletion. LMM models all sources of variation in the data and avoids the need for data imputation. Each psychological outcome was modelled as a function of time, treatment group, and their interaction and adjusting for random effects due to individual differences and repeated observations from each participant. The models allow for each participant to have a different trajectory. Model parameters were estimated using restricted maximum likelihood. The best model was selected using likelihood ratio test.
Based on the chosen model, marginal means were estimated and multiple comparison of group by time interaction tests conducted using sets of Tukey adjusted interaction contrasts [39]; degrees of freedom was calculated using Kenward-Roger [40] . The effects were tested at a significance level of 0.05, adjusted depending on the number of contrasts in multiple tests. Cohen's d was calculated by standardising the mean difference of within and between groups using the square root of the sum of all the variance components from the mixed models. This is to adequately represent the study design and account for all sources of variation in data [41,42]. Linear regression slopes of each psychological measure were modelled as a function of time, treatment and timetreatment interaction. Pairs of the slopes were then compared using the lsmean approach of Lenth (2016) to determine the intervention that brought about higher rate of change in the mean of the psychological measures [43]. This analysis used data for the three-time period and models the average trend for each of the measured outcomes. A second analysis adjusted for the baseline by entering the baseline values of the outcome of interest as a covariate in the mixed effect model that also included group by time intervention as fixed effect." subitem not at all important 1 2 3 4 5 essential 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).

Clear selection
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Statistical analyses Statistical analyses and data manipulations were implemented with R[37]. Baseline characteristics of participants randomly allocated to the three intervention groups were compared using chi square. The effects of the MPS and NHSWBP interventions on psychological measures were examined using intention-to-treat (ITT) analyses that included data from all participants who completed the baseline assessment and any follow-up assessment. No imputation was used for missing data. Standard regression models assume independent observations. To adequately account for the dependencies in the data, we adopted the linear mixed modelling (LMM) approach [38] for the analyses of the data. This approach is appropriate for studying the relationships and sources of variation in the dataset. It uses all available data and efficiently handles missing data, thereby avoiding listwise deletion. LMM models all sources of variation in the data and avoids the need for data imputation. Each psychological outcome was modelled as a function of time, treatment group, and their interaction and adjusting for random effects due to individual differences and repeated observations from each participant. The models allow for each participant to have a different trajectory. Model parameters were estimated using restricted maximum likelihood. The best model was selected using likelihood ratio test.
Based on the chosen model, marginal means were estimated and multiple comparison of group by time interaction tests conducted using sets of Tukey adjusted interaction contrasts [39]; degrees of freedom was calculated using Kenward-Roger [40] . The effects were tested at a significance level of 0.05, adjusted depending on the number of contrasts in multiple tests. Cohen's d was calculated by standardising the mean difference of within and between groups using the square root of the sum of all the variance components from the mixed models. This is to adequately represent the study design and account for all sources of variation in data [41,42]. Linear regression slopes of each psychological measure were modelled as a function of time, treatment and timetreatment interaction. Pairs of the slopes were then compared using the lsmean approach of Lenth (2016) to determine the intervention that brought about higher rate of change in the mean of the psychological measures [43]. This analysis used data for the three-time period and models the average trend for each of the measured outcomes. A second analysis adjusted for the baseline by entering the baseline values of the outcome of interest as a covariate in the mixed effect model that also included group by time intervention as fixed effect." 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Statistical analyses Statistical analyses and data manipulations were implemented with R[37]. Baseline characteristics of participants randomly allocated to the three intervention groups were compared using chi square. The effects of the MPS and NHSWBP interventions on psychological measures were examined using intention-to-treat (ITT) analyses that included data from all participants who completed the baseline assessment and any follow-up assessment. No imputation was used for missing data. Standard regression models assume independent observations. To adequately account for the dependencies in the data, we adopted the linear mixed modelling (LMM) approach [38] for the analyses of the data. This approach is appropriate for studying the relationships and sources of variation in the dataset. It uses all available data and efficiently handles missing data, thereby avoiding listwise deletion. LMM models all sources of variation in the data and avoids the need for data imputation. Each psychological outcome was modelled as a function of time, treatment group, and their interaction and adjusting for random effects due to individual differences and repeated observations from each participant. The models allow for each participant to have a different trajectory. Model parameters were estimated using restricted maximum likelihood. The best model was selected using likelihood ratio test.
Based on the chosen model, marginal means were estimated and multiple comparison of group by time interaction tests conducted using sets of Tukey adjusted interaction contrasts [39]; degrees of freedom was calculated using Kenward-Roger [40] . The effects were tested at a significance level of 0.05, adjusted depending on the number of contrasts in multiple tests. Cohen's d was calculated by standardising the mean difference of within and between groups using the square root of the sum of all the variance components from the mixed models. This is to adequately represent the study design and account for all sources of variation in data [41,42]. Linear regression slopes of each psychological measure were modelled as a function of time, treatment and timetreatment interaction. Pairs of the slopes were then compared using the lsmean approach of Lenth (2016)

Clear selection
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "The RCT was approved by the NHS Health Research Authority (20/SW/0098) and registered at ISRCTN18107122. "

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Clear selection
subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Across all recruitment routes, interested individuals were directed to a secure data collection website via a weblink where they first reviewed information about the study and gave electronic consent to participate."

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)

Clear selection
Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "the NHSWBP provided links to local and national 24-hour support services." 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Details of enrolment into the trial, organised according to the CONSORT guidelines [44], are shown in Figure 1. Of the 225 people who expressed an interest in the study, completed eligibility screening information and provided consent to participate, 54 (24%) did not complete the pre-intervention questionnaire and 2 declined to participate (1%). These 56 individuals were excluded from the analyses, leaving a study sample of N = 169 participants. The distribution of participant characteristics at baseline and post-intervention are reported in Table 1." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Details of enrolment into the trial, organised according to the CONSORT guidelines [44], are shown in Figure 1. Of the 225 people who expressed an interest in the study, completed eligibility screening information and provided consent to participate, 54 (24%) did not complete the pre-intervention questionnaire and 2 declined to participate (1%). These 56 individuals were excluded from the analyses, leaving a study sample of N = 169 participants. The distribution of participant characteristics at baseline and post-intervention are reported in Table 1." subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.

Clear selection
Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Details of enrolment into the trial, organised according to the CONSORT guidelines [44], are shown in Figure 1. Of the 225 people who expressed an interest in the study, completed eligibility screening information and provided consent to participate, 54 (24%) did not complete the pre-intervention questionnaire and 2 declined to participate (1%). These 56 individuals were excluded from the analyses, leaving a study sample of N = 169 participants. The distribution of participant characteristics at baseline and post-intervention are reported in Table 1." subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Participants were recruited locally and online between July 2020 and September 2020. Data collection took place at the beginning, middle and end of the pilot RCT intervention phase, which ran from September 2020 to October 2020. " "This study was a part of the Scottish Government's Rapid Research into COVID-19 and time restrictions limited recruitment activities; it was not possible to extend recruitment activities or product development beyond the grant's funding timeframe. Written informed consent was provided by all participants. The RCT was approved by the NHS Health Research Authority (20/SW/0098) and registered at ISRCTN18107122. The intervention phase ran from September 7 to October 5 2020, during the start of the second wave of the COVID-19 pandemic in Scotland.

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each
group NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Participants were recruited locally and online between July 2020 and September 2020. Data collection took place at the beginning, middle and end of the pilot RCT intervention phase, which ran from September 2020 to October 2020. " "This study was a part of the Scottish Government's Rapid Research into COVID-19 and time restrictions limited recruitment activities; it was not possible to extend recruitment activities or product development beyond the grant's funding timeframe. Written informed consent was provided by all participants. The RCT was approved by the NHS Health Research Authority (20/SW/0098) and registered at ISRCTN18107122. The intervention phase ran from September 7 to October 5 2020, during the start of the second wave of the COVID-19 pandemic in Scotland.
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This was not applicable to our study subitem not at all important 1 2 3 4 5 essential 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Rates of attrition across the demographic, professional, and clinical characteristics of the participants are presented in Table 1"

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.

Clear selection
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Rates of attrition across the demographic, professional, and clinical characteristics of the participants are presented in Table 1," subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Primary outcomes Post-intervention was the primary timepoint for all outcomes.
Depression. The Patient Health Questionnaire (PHQ-9)[23] was used to measure depression. The 9 items ask participants to consider how bothered they have been over the past two weeks according to each statement (e.g., "feeling tired or having little energy"). The questionnaire score ranges from 0-27; each question is given a four-point response ("Not at all" = 0, "Nearly every day" = 3 Anxiety. The 7-item General Anxiety Disorder (GAD-7) [26] scale was used to measure anxiety. Similar to the PHQ-9, each item asks the respondent to consider the statement based on how much they have been bothered over a two-week period (e.g., "Feeling nervous anxious or on edge"). Each item is scaled from 0 ("Not at all") to 3 ("Nearly every day") with a total score range of 0-21. A number of studies during the COVID-19 pandemic have used the GAD-7 to measure levels of anxiety in various UK and international population settings, including in frontline staff working through this pandemic [8,24]. Mental Well-being. Mental well-being was measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) [27]. The scale consists of 14-items used to measure subjective well-being and psychological functioning. The wording of each item is positive and aimed to address positive aspects of MH.
Responses are completed using a 5point scale (1 = "None of the time", 5 = "All of the time"); the total score ranges from 14-70. WEMWBS has been validated for use in the UK [27], and has been used internationally [28] and in the UK [29] to measure the MWB of HSCWs during this pandemic." Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Outcomes Table 2 reports the observed mean scores for each outcome at baseline, mid-intervention and post-intervention in the three treatment groups (see Table S2 for estimated marginal mean scores for individual times and groups). Figure 2 depicts these scores for the three conditions on the primary and secondary outcome measures at baseline, midintervention and post-intervention. " "Standardised effect size The between and within-group effect sizes (standardised mean difference) on the primary and secondary outcomes calculated using observed means are presented in 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

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Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Program adherence Adherence, defined as the extent to which participants engaged with the intervention, was examined for both the NHSWBP and MPS groups with respect to average interactions per user. Adherence was deemed to be good for both digital interventions with participants in the NHSWBP group interacted on average 37.4 times with theintervention (more than once per day on average) during the month long intervention, whilst the MPS group interacted on average 37.5 times. None of the adherence indices correlated with demographic, clinical history and primary and secondary outcome data obtained at baseline. No harmful or unintended effects were reported by the participants." 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable to our paper Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable to our paper

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable to our paper 19) All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "No harmful or unintended effects were reported by the participants."

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: Even though the qualitative aspects of our study was a separate part of the study. We had specific groups testing and providing feedback feedback, also for the design of a larger fully powered RCT.
"We conducted a novel pilot RCT to evaluate two brief, fully automated digital health interventions in a sample of frontline staff working through the second wave of the COVID-19 pandemic. The trial proceeded successfully during challenging circumstances in the shadow of the second wave of the COVID-19 pandemic in the UK. Our low cost study demonstrated that it was possible to recruit 169 people working in a small NHS Board within a short duration and deliver a technically innovative intervention on a modest financial budget. The NHSWBP app was designed with end-user (PPI) input and worked well throughout, with good adherence and no major flaws or bugs, nor evidence of harm reported by the participants. Furthermore, the WL control design was effective at retaining participants (who otherwise might have lost interest in the study and dropped out if it was just a no-treatment control rather than WL). We have also accumulated rich background data that could assist in identifying the possible drivers of drop-out, which could be used to modify the design of the intervention to improve retention in a larger future trial. Although this was a pilot trial that we conducted during a prescribed limited time with a relatively small sample size, the findings of this study provide encouraging results for future full trials of digital psychological interventions that are designed to support the MH and PWB of HSCWs who are working under conditions of extreme stress." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).

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Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "There are three key findings of interest in this study. First, the primary outcomes investigated showed decreases in levels depression (NHSWBP & MPS) and anxiety (NHSWBP) when compared to the WL group. The rate of decrease in depression and anxiety symptoms was the greatest among those exposed to the NHSWBP intervention. Our results also indicate that the individuals exposed to the digital interventions and WL conditions experienced an increase in mental well-being with the rate of increase again shown to be the greatest for those exposed to the NHSWBP intervention. " Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Thirdly, our results also provide preliminary support for the development or modification of digital interventions to be context specific as the NHSWBP showed the greater rates of symptom improvement of the two interventions tested. Future trials assessing context specific digital interventions for specialized populations in larger samples are warranted, as there is good reason to believe those larger studies will demonstrate efficacy. The digital nature of these interventions was seen to be safe, cost effective and rapidly modifiable to context. The future application of similar, context specific robustly tested interventions could be scalable to other contexts with mental health human resources needs [49]."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

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Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Limitations and future research directions There are several limitations of this study that need to be acknowledged. First, participants included a small sample of HSCWs from a single NHS site. Although the vast majority of respondents were female, this does not differ dramatically from the gender composition of the whole HSCW workforce in NHS Highland [50]. As our objective was to gather preliminary evidence on the potential benefits of two digital interventions in this population, the study was not powered as an efficacy trial and so confidence intervals around estimated effects were wide (indicating the small sample may have contributed to statistical uncertainty) and the findings may not be generalizable to other populations and HSCWs living in other contexts. Second, the treatment period was restricted to four weeks, and it is possible that changes in MH and PWB require more engagement in the intervention materials. In addition, some outcomes may change more gradually and require a longer period to improve. For example, gratitude exercises can orientate a person to experience more grateful emotions, but it could take more than four weeks for changes in dispositional gratitude to emerge. Future research would do well to track and monitor whether gains that are made during treatment are maintained or change over time. Third, the MPS app was publicly available for download throughout the duration of our study, and participants were not restricted to use other modalities or medications during this pilot which raises the possibility that treatment effects might be cross-contaminated. Fourth, the attrition rate at post-intervention was 36.7%. The dropout rate was lowest in WL group, which is likely attributable to participants waiting to receive either of the digital interventions. Although we did not find any substantial evidence of attrition bias, it is possible that participants who dropped out from the intervention groups were less satisfied with the program or experienced less than positive outcomes. Additional research is needed to explore the mechanisms underlying the effects that emerged in this study and to identify the relative contributions of the components that comprised each of the digital interventions. There may also be value in taking a broader approach to outcome assessment by examining other domains of well-being that extend beyond the domain of PWB. For example, previous research along these lines has reported post-intervention improvements in social relationships [51]. " 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations

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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "As our objective was to gather preliminary evidence on the potential benefits of two digital interventions in this population, the study was not powered as an efficacy trial and so confidence intervals around estimated effects were wide (indicating the small sample may have contributed to statistical uncertainty) and the findings may not be generalizable to other populations and HSCWs living in other contexts" "Future trials assessing context specific digital interventions for specialized populations in larger samples are warranted, as there is good reason to believe those larger studies will demonstrate efficacy. The digital nature of these interventions was seen to be safe, cost effective and rapidly modifiable to context. The future application of similar, context specific robustly tested interventions could be scalable to other contexts with mental health human resources needs " subitem not at all important Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

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Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: " the MPS app was publicly available for download throughout the duration of our study, and participants were not restricted to use other modalities or medications during this pilot which raises the possibility that treatment effects might be cross-contaminated" Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: this can be accessed at ISRCTN18107122 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders

X27) Conflicts of Interest (not a CONSORT item)
Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: this can be accessed at ISRCTN18107122 Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Acknowledgements Thank you to the Chief Science Office of Scotland for providing the funding for this research. Thank you to MPS for being our technical partner in this project" subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

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Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable to our pilot study As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
Your answer yes no Other: yes no Other: STOP -Save this form as PDF before you click submit To generate a record that you filled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document

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