Effectiveness of an App-Based Short Intervention to Improve Sleep: Randomized Controlled Trial

Background A growing body of evidence for digital interventions to improve sleep shows promising effects. The interventions investigated so far have been primarily web-based; however, app-based interventions may reach a wider audience and be more suitable for daily use. Objective This study aims to evaluate the intervention effects, adherence, and acceptance of an unguided app-based intervention for individuals who wish to improve their sleep. Methods In a randomized controlled trial, we evaluated the effects of an app-based short intervention (Refresh) to improve sleep compared with a waitlist condition. Refresh is an 8-week unguided intervention covering the principles of cognitive behavioral therapy for insomnia (CBT-I) and including a sleep diary. The primary outcome was sleep quality (insomnia symptoms) as self-assessed by the Regensburg Insomnia Scale (RIS). The secondary outcomes were depression (9-item Patient Health Questionnaire [PHQ-9] score) and perceived insomnia-related impairment. Results We included 371 participants, of which 245 reported poor sleep at baseline. About 1 in 3 participants who were allocated to the intervention group never accessed the intervention. Active participants completed on average 4 out of 8 chapters. Retention rates were 67.4% (n=250) at postassessment and 57.7% (n=214) at the 6-month follow-up. At postintervention, insomnia symptoms in the intervention group had improved more than those in the waitlist group, with a small effect (d=0.26) in the whole sample and a medium effect (d=0.45) in the subgroup with poor sleep. Effects in the intervention group were maintained at follow-up. Perceived insomnia-related impairment also improved from pre- to postassessment. No significant intervention effect on depression was detected. Working alliance and acceptance were moderate to good. Conclusions An app-based, unguided intervention is a feasible and effective option to scale-up CBT-I-based treatment, but intervention uptake and adherence need to be carefully addressed. Trial Registration ISRCTN Registry ISRCTN53553517; https://www.isrctn.com/ISRCTN53553517

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) JMH ms#39052 TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title yes Sonstiges: subitem not at all important 1 2 3 4 5 essential 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other")

1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-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 brie y explain why the item is not applicable/relevant for your study "an app-based short intervention" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
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1a-iii) Primary condition or target group in the title
Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * 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 brie y explain why the item is not applicable/relevant for your study "Effectiveness of an app-based short intervention to improve sleep" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 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 brie y explain why the item is not applicable/relevant for your study "In a randomized controlled trial, we evaluated the effects of an app-based short intervention (Refresh) to improve sleep compared to a waitlist condition. Refresh is an eightweek unguided intervention covering the principles of cognitive behavioral therapy for insomnia (CBT-I) and including a sleep diary." 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) 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 brie y explain why the item is not applicable/relevant for your study "Refresh is an eight-week unguided intervention" 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. o ine), 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 o ine 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) 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 brie y explain why the item is not applicable/relevant for your study Outcomes were self-assessed through questionnaires.
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) 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 brie y explain why the item is not applicable/relevant for your study "We included 371 participants, of which 245 reported poor sleep at baseline. About one in three participants who were allocated to the intervention group never accessed the intervention. Active participants completed on average four out of eight chapters. Retention rates were 67% (n=250) at post-intervention and 56% (n=214) at six-month follow-up. At post-intervention, insomnia symptoms in the intervention group had improved more than in the waitlist group, with a small effect (d=.26) in the whole sample and a medium effect (d=.45) in the subgroup with poor sleep. Effects in the intervention were maintained at follow-up, while in the waitlist group insomnia symptoms continued to improve during the follow-up period. Perceived insomnia-related impairment also improved from pre-to postassessment. No significant intervention effect on depression was detected. Working alliance and acceptance were moderate to good." Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons.
(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) Does your paper address subitem 1b-v?
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 brie y explain why the item is not applicable/relevant for your study Meine Antwort

2a-i) Problem and the type of system/solution
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) 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 brie y explain why the item is not applicable/relevant for your study "However, reach and access to face-to-face, therapist-delivered CBT-I is limited [41][42][43] METHODS 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 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 brie y explain why the item is not applicable/relevant for your study "Given the relative lack of evidence for mobile CBT-I interventions, the aim of the present study is to evaluate an unguided app-based training for individuals who wish to improve their sleep. The primary aim is to evaluate the effect of the intervention on sleep quality (insomnia symptoms). Secondary, exploratory aims include the intervention effects on insomnia-related impairment and depression symptoms as well as participant adherence to the intervention, working alliance and intervention acceptance." 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 brie y explain why the item is not applicable/relevant for your study "Following an uncontrolled feasibility pilot study with N=189 participants [71] we conducted a randomized controlled trial comparing an intervention group with access to a mobile CBT-I intervention to a waiting list control group. Outcomes were assessed through online questionnaires at baseline (pre-treatment), post-intervention (8 weeks after randomization) and 6-month follow-up." subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 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 brie y explain why the item is not applicable/relevant for your study This item is not applicable to our study.

3b-i) Bug fixes, Downtimes, Content Changes
Bug xes, 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 xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
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 brie y explain why the item is not applicable/relevant for your study No changes after trial commercement.
subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "We included participants over 18 years of age who were fluent in German and had access to the Internet during the intervention period. Exclusion criteria were (1) current treatment for depression, (2) a history of psychotic or bipolar disorders and (3) a suicidal ideation according to the answer in the last item of the PHQ-9. Poor sleep was not necessary to participate in the study. All adults showing interest in improving their sleep were welcome if none of the exclusion criteria were present."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
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 brie y explain why the item is not applicable/relevant for your study "We included participants over 18 years of age who were fluent in German and had access to the Internet during the intervention period." 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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. o ine), e.g., from an open access website or from a clinic, 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), 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 con rmation, phone calls) were used to detect/prevent these.
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 brie y explain why the item is not applicable/relevant for your study "Participants were recruited through flyers, postcards and posters in several sleep laboratories in Germany as well as in practices of general practitioners, pharmacies and medical supply stores in Dresden. In addition, recruitment activities took place at Technical University Dresden and included a press release, student email newsletters as well as postcards and posters distributed on the campus. A newspaper article was published in a regional newspaper. Social media channels, e.g., Facebook groups dealing with sleep issues, were used to address further potential participants."

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.
4b) Settings and locations where the data were collected subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "The recruitment material included a link and a QR-Code leading to the study website.
Interested participant received written information about the study and informed consent was obtained online." 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 brie y explain why the item is not applicable/relevant for your study "Study data were collected and managed using REDCap electronic data capture tools hosted at the Centre for Clinical Studies at TU Dresden. REDCap [Research Electronic Data Capture; 73] is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources."

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.
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 brie y explain why the item is not applicable/relevant for your study "Outcomes were assessed through online questionnaires at baseline (pre-treatment), postintervention (8 weeks after randomization) and 6-month follow-up."

4b-ii) Report how institutional affiliations are displayed
Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 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 brie y explain why the item is not applicable/relevant for your study 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
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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.
subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "Intervention: "Refresh is an unguided app-based intervention adapted and translated from an e-mail delivered CBT for sleep-health program for college students that was originally developed and evaluated in the US [73], and subsequently translated and evaluated in a Japanese college student population [74]. The intervention was adapted for the general adult population and designed as an app-based self-help intervention." Study Design: "Following an uncontrolled feasibility pilot study with N=189 participants [70] we conducted a randomized controlled trial comparing an intervention group with access to a mobile CBT-I intervention to a waiting list control group."

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).

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 brie y explain why the item is not applicable/relevant for your study There were no changes during the evaluation process.
subitem not at all important

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
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 brie y explain why the item is not applicable/relevant for your study Meine Antwort 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/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study Meine Antwort

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.
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 brie y explain why the item is not applicable/relevant for your study

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 speci c 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).
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 brie y explain why the item is not applicable/relevant for your study Participants did not have to be a member of a specific group. The study did not include payments from or to participants. "Poor sleep was not necessary to participate in the study. All adults showing interest in improving their sleep were welcome if none of the exclusion criteria were present." subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "The intervention consists of eight consecutive chapters that can be completed in about ten minutes each and cover all CBT-I components recommended by the German Sleep Society (DGSM): Psychoeducation, sleep hygiene, stimulus control, sleep restriction, cognitive restructuring and relaxation [30]. Table 1 summarizes the content of the individual chapters. The chapters are multimedia-based with short text passages, audio and video content, vignettes, as well as questions (multiple choice or free text) to foster an active engagement with the intervention content and also to tailor subsequent content based on the participants' preference (e.g., whether they preferred information to be presented as text or video). The number of pages per chapter and the amount of plain text per page were kept to a minimum as factors like extensive text content and text-content complexity are likely to increase the risk of non-adherence [76]. The intervention is supplemented by a "30-second sleep diary" to be filled in every morning to monitor insomnia symptoms. For a duration of eight weeks, an automated reminder to fill in the sleep diary was sent every morning at 7:00 am. There were no reminders for progressing through the intervention. At the beginning, participants received a short automated feedback about their sleep based on the baseline RIS score. Participants reporting poor sleep were especially encouraged to use parts of the intervention that were marked as for "people with poor sleep" (e.g., sleep restriction)."

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.
subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "The intervention is self-paced, but the recommended duration was eight weeks with one chapter per week."

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).

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 brie y explain why the item is not applicable/relevant for your study Refresh is an unguided intervention without any human input or guidance.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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).
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 brie y explain why the item is not applicable/relevant for your study "Participants in both groups were invited to the post-and follow up assessment via emails. They received up to five reminders at intervals of three days." "For a duration of eight weeks, an automated reminder to fill in the sleep diary was sent every morning at 7:00 am. There were no reminders for progressing through the intervention."

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. 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study No co-interventions were applied.
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 brie y explain why the item is not applicable/relevant for your study Outcomes were assessed through online questionnaires at baseline (pre-treatment), postintervention (8 weeks after randomization) and 6-month follow-up. The primary outcome was the change in sleep quality (insomnia symptoms, RIS total score) at post assessment compared to the baseline assessment." 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].
Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text "Regensburg Insomnia Scale (RIS). Sleep quality (insomnia symptoms) was assessed using the German Regensburg Insomnia Scale [72]. The scale covers psychophysiological (cognitive, emotional and behavioral) aspects of insomnia during the previous four weeks. The instrument consists of ten items to be answered on a 5-point self-rating scale ranging from 0 to 4. A total score of ≥13 indicates poor sleep [72]. The RIS has shown to be a well accepted, valid instrument that has discriminative power and is sensitive to detect improvements in insomnia parameters after CBT-I [72]. One additional item asked the participants about their perceived insomnia-related impairment in the past seven days on a scale ranging from 0 to 100. Patient Health Questionnaire-9 (PHQ-9). Depressive symptoms and depression severity were measured using the German version of the Patient Health Questionnaire-9 [77]. This widely used brief self-report instrument consists of nine items covering the DSM-5 diagnostic criteria of depression which are scored on a four-point Likert scale from 0 ("not at all") to 3 ("nearly every day"). The PHQ-9 has been shown to have good psychometric properties [78] and also has demonstrated to be sensitive to changes in depressive symptomatology over time [79]. Working Alliance Inventory-Short Revised (WAI-SR). Acceptance of the intervention was assessed using the subscales "task" and "goal" of the Working Alliance Inventory-Short Revised [80,81], adapted for online interventions. The inventory is based on Bordin's alliance theory [82]. The "task" subscale (4 items) measures the agreement on the tasks of the intervention, whereas the "goal" subscale (4 items) measures the agreement on the goals of the intervention. Due to the unguided nature of the study, the "bond" subscale (measuring the quality of an affective bond between patient [participant] and therapist [coach]) was removed. Items are answered on a scale from 1 ("seldom") to 5 ("always"), but participants could also choose the additional answer category "I don't know". In addition to the WAI-SR, each chapter of the intervention could be rated on a five-point scale." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "Adherence to the intervention was defined as the number of chapters completed and the proportional progress through the intervention (in percent). In addition, the number of entries in the sleep diary was used to describe the usage of the intervention." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Qualitative feedback was not a part of this RCT, but the Working Alliance Inventory-Short Revised (WAI-SR) and session ratings were applied in order to evaluate the acceptance of the intervention.

7a) How sample size was determined
NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 brie y explain why the item is not applicable/relevant for your study There were no changes required.

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.
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 brie y explain why the item is not applicable/relevant for your study "Based on results from the pilot study [71], we assumed a pre-post between-group effect size (Cohen's d) of 0.30 and a dropout rate of 60% at post-intervention. To detect the anticipated effect with an 80% probability at a significance level of 5%, a sample size of N=586 participants was required." 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 brie y explain why the item is not applicable/relevant for your study We closed the recruitment when we had reached the required number of completed post assessments (according to our sample size calculation). "Given that the pre-post dropout rate was much smaller than expected, we included fewer participants than originally planned." 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 brie y explain why the item is not applicable/relevant for your study Respondents were allocated to either the intervention or control group by means of an automated randomization algorithm implemented in REDCap. 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 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 brie y explain why the item is not applicable/relevant for your study "Participants were randomized in a 1:1 ratio. 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 brie y explain why the item is not applicable/relevant for your study Randomization took place after a respondent had completed the baseline questionnaires and was checked for eligibility. A research assistant without access to the implemented random allocation sequence randomized the participants after baseline in REDCap.
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 brie y explain why the item is not applicable/relevant for your study The random allocation sequence was implemented on the data collection platform.
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 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 cointerventions (if any).
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 brie y explain why the item is not applicable/relevant for your study Participants were not blinded to the group they were allocated to.
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".

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) 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 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 brie y explain why the item is not applicable/relevant for your study The intervention group was compared to a control group without access to the intervention during the study period. There was no active control group.
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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study "All statistical analyses were performed with IBM SPSS Statistics version 27. Statistical significance was set at α=.05. Differences in baseline socio-demographic and clinical scores between the intervention and the control group as well as between participants with poor vs. good sleep were analyzed using Pearson χ²-tests for dichotomous variables and independent-sample t-tests (two-sided) for metric variables. Differences between completers and non-completers were analyzed in the same way. Adherence and acceptance data were analyzed descriptively and compared between participants with a poor vs. a good sleep applying independent-sample t-tests. To identify potential predictors of adherence, Pearson's correlations were calculated between adherence markers (number of chapters completed, number of sleep diary entries) and baseline variables. Primary (RIS) and secondary (perceived insomnia-related impairment, PHQ-9) outcomes were analyzed using linear repeated-measures mixed-effect models with restricted maximum likelihood estimation (REML) and an unstructured covariance matrix. This method follows the ITT approach and is recommended for RCTs with missing data [83]. Group, time and interaction of group and time were entered as fixed variables with group as a betweengroup variable and time as a within-group variable. The outcomes RIS, perceived insomniarelated impairment and PHQ-9 were entered as dependent variables in separate analyses. Within-group effect sizes (Cohen's d) were calculated by dividing the estimated mean change from baseline to post-assessment (or follow-up) by the pooled standard deviation [84]. Between-group effect sizes (Cohen's d) were computed based on the difference of the estimated mean change from baseline to post-assessment (or follow-up) in the intervention group compared to the control group divided by the pooled standard deviation at baseline as recommended by [85]." subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 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]).
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 brie y explain why the item is not applicable/relevant for your study "Primary (RIS) and secondary (perceived insomnia-related impairment, PHQ-9) outcomes were analyzed using linear repeated-measures mixed-effect models with restricted maximum likelihood estimation (REML) and an unstructured covariance matrix. This method follows the ITT approach and is recommended for RCTs with missing data [83]." "In addition, the odds of suffering from poor sleep (RIS≥13) at post-intervention was compared between the two groups using a more conservative ITT approach including all randomized participants with poor sleep. We used a logistic regression model and adjusted for sex, age, and RIS score at baseline. Data of participants who did not complete postassessments were imputed assuming poor sleep at post-intervention."

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "The analyses for the whole sample were repeated including only participants with poor sleep at baseline as indicated by a RIS score ≥13 at baseline. Improvements in insomnia symptoms were tested for clinical relevance comparing the frequency of participants with poor sleep (RIS≥13) at baseline in both study arms who had improved at post-intervention and follow-up using Pearson χ²-tests for assessment completers. In addition, the odds of suffering from poor sleep (RIS≥13) at post-intervention was compared between the two groups using a more conservative ITT approach including all randomized participants with poor sleep. We used a logistic regression model and adjusted for sex, age, and RIS score at baseline. Data of participants who did not complete post-assessments were imputed assuming poor sleep at post-intervention."

X26-i) Comment on ethics committee approval
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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study Informed consent was obtained online.

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)

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-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 brie y explain why the item is not applicable/relevant for your study In case of exlusion from the study due to suicidal ideation (according to the PHQ-9 item), the respondent received recommendations about support services.
Study data were collected and managed using REDCap electronic data capture tools hosted at the Centre for Clinical Studies at TU Dresden. REDCap [Research Electronic Data Capture; 72] is a secure, web-based application designed to support data capture for research studies 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 brie y explain why the item is not applicable/relevant for your study "A total of N=393 completed the baseline assessment, of which N=371 were randomized (see Figure 1). About two thirds of participants (N=245; 66%) reported poor sleep according to a RIS total score of ≥13. N=250 participants (67.4%) provided the primary outcome (RIS total score) at post assessment and N=214 (57.7%) completed the RIS at follow-up assessment. Dropout was higher in the intervention group than in the control group at both assessment points (χ²post=24.477; P<.001; χ²FU6=28.247; p<.001)." 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "A total of N=393 completed the baseline assessment, of which N=371 were randomized (see Figure 1). About two thirds of participants (N=245; 66%) reported poor sleep according to a RIS total score of ≥13. N=250 participants (67.4%) provided the primary outcome (RIS total score) at post assessment and N=214 (57.7%) completed the RIS at follow-up assessment. Dropout was higher in the intervention group than in the control group at both assessment points (χ²post=24.477; P<.001; χ²FU6=28.247; p<.001). Participants with a poor initial sleep did not differ from those with good sleep in dropout rates."

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 gures or tables demonstrating usage/dose/engagement.

14a) Dates defining the periods of recruitment and follow-up
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure 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 brie y explain why the item is not applicable/relevant for your study "N=60 (32.3%) participants never logged onto the platform or opened the first chapter. Participants who logged onto the intervention at least once (N=126) completed on average four chapters (SD=3.06; range 0-8) and opened 51% of the intervention pages (SD=38.14). N=39 (31.0%) completed all chapters of the intervention and N=55 (43.7%) completed at least half of the intervention. N=116 (92.1%) completed at least chapter 1 (see Figure 2). N=106 participants (84.1%) used the sleep diary at least once and made entries for 25.23 days (SD=22.3, range 0-83)." 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 brie y explain why the item is not applicable/relevant for your study "The recruitment period and baseline assessment ran from April 2019 to May 2020. Followup data collection was completed in September 2020."

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., signi cant 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, quali cation, 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 brie y explain why the item is not applicable/relevant for your study

Meine Antwort
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 brie y explain why the item is not applicable/relevant for your study The trial was ended when the last FU assessment had been completed (approximately 6 months after the last participant was enrolled).
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 brie y explain why the item is not applicable/relevant for your study

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.
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 brie y explain why the item is not applicable/relevant for your study "The majority of participants in the full sample were women (63.7%), in a relationship (73.0%) and reported a higher level of education (87.3%; see Table 2). About one in four had children and about one in three were university students. The mean age of participants was 37.3 years (SD=12.24). Sleep was poor on average (indicated by the RIS score ≥ 13) and the average level of depression severity was mild."

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide de nitions: 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 speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
subitem not at all important 1 2 3 4 5 essential 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-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 brie y explain why the item is not applicable/relevant for your study See Figure 1. "N=60 (32.3%) participants never logged onto the platform or opened the first chapter. Participants who logged onto the intervention at least once (N=126) completed on average four chapters (SD=3.06; range 0-8) and opened 51% of the intervention pages (SD=38.14). N=39 (31.0%) completed all chapters of the intervention and N=55 (43.7%) completed at least half of the intervention."

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

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 brie y explain why the item is not applicable/relevant for your study "Results of the mixed model analyses are presented in Table 4." subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "Results of the mixed model analyses are presented in Table 4. For the full sample, a significant group × time interaction was found for the RIS at post assessment (F1, 269.31=11.93; P=.001) with a small between-group effect (d=.26). Participants in the intervention group showed a stronger reduction (mean difference = -2.66; dwithin=.45) in the RIS scores than participants in the control group (mean difference = -1.04; dwithin=.17). At follow up, the group × time interaction failed to reach significance (F1, 227.63=3.54; P=.06). Within-group improvements in the perceived insomnia-related impairment due to sleep problems as well as in the PHQ-9 did not differ significantly between the study arms."

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 de nitions 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 de ned (e.g., timeout after idle time) [1] (report under item 6a).
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 brie y explain why the item is not applicable/relevant for your study "N=60 (32.3%) participants never logged onto the platform or opened the first chapter. Participants who logged onto the intervention at least once (N=126) completed on average four chapters (SD=3.06; range 0-8) and opened 51% of the intervention pages (SD=38.14). N=39 (31.0%) completed all chapters of the intervention and N=55 (43.7%) completed at least half of the intervention. N=116 (92.1%) completed at least chapter 1 (see Figure 2). N=106 participants (84.1%) used the sleep diary at least once and made entries for 25.23 days (SD=22.3, range 0-83)." "Complete WAI-SR that allows calculating scores data is available for N=87 participants from the intervention group. The participants agreed between "sometimes" and "fairly often" with the tasks of the intervention and between "fairly often" and "often" with the goals of the intervention. Acceptance did not differ between participants with poor and good sleep at baseline (see Table 3). Participants who answered the session rating of the intervention chapters rated chapters 1-6 as "good" on average, whereas chapter 7-8 were rated as "moderate". There was no significant difference in session ratings between participants with poor vs. good sleep, except for session 2 that was rated better and nearly "excellent" by participants with good sleep." 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 brie y 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).

19) All important harms or unintended effects in each group
(for speci c guidance see CONSORT for harms) Does your paper address subitem 18-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 brie y explain why the item is not applicable/relevant for your study "In the subgroup analyses including only participants with poor sleep at baseline, a significant group × time interaction was found for the RIS at post assessment ( 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 brie y explain why the item is not applicable/relevant for your study 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "The aim of the present study was to evaluate an unguided app-based training to improve sleep quality (insomnia symptoms) in individuals who wish to improve their sleep compared to a waitlist control group. Specifically, we examined participant adherence to the intervention, working alliance and intervention acceptance, and intervention effects on sleep quality (insomnia symptoms), insomnia-related impairment and depression symptoms." "In our study, the unguided app-based intervention was associated with a short-term improvement of insomnia symptoms that remained stable over a period of six months. Participants in the waitlist condition also reported an improvement in their insomnia symptoms, but this improvement took longer. Effects were more pronounced in individuals with low sleep at baseline. We detected no effect on depression symptoms in our sample, which may largely be due to low average symptom load at baseline." "Non-usage attrition was comparable to other digital interventions [86], with a larger loss of participants during the early intervention phase and about one in three participants completing the intervention. About one in three participants who were allocated to the intervention group never accessed the intervention." "Participants in the intervention group were able to form a moderate working alliance with the unguided intervention, with a slightly larger concordance regarding goals than regarding tasks." "The first six chapters of the intervention were on average rated "good", while the final two chapters were rated "moderate"." 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 brie y explain why the item is not applicable/relevant for your study "It is noteworthy however that one in four women and one in two men who were assigned to the intervention group did not start the intervention. In clinical practice, the motivation and ability to adhere to a self-guided intervention should thus be carefully assessed.

22-ii) Highlight unanswered new questions, suggest future research
In participants who did start the intervention, adherence was comparable to other digital interventions. In future adaptations of the interventions, adherence may be improved by involving a multidisciplinary team of psychologists, user experience specialists and UX designers in the design of the user interface, which unfortunately was not possible in our study due to budget constraints."

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.

21) Generalisability (external validity, applicability) of the trial findings
NPT: External validity of the trial ndings 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 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 brie y explain why the item is not applicable/relevant for your study "Limitations of our study include the lack of more specific measures for insomnia-related impairment and socioeconomic consequences including absenteeism or loss of productivity as well as an objective measure of sleep quality. However, subjective measures of sleep quality and insomnia symptoms are widely used in research on CBT-I and the added value of objective measures is a matter of debate [93]. The participants in this trial might have also suffered from sleep disorders other than insomnia , in which an intervention covering the principles of CBT-I is likely to have limited or no effect. Future studies may benefit from including insomnia diagnosis confirmed by a clinician. Adherence to the intervention was approximated by examining usage data. We did not collect information on whether and how participants in the intervention group implemented the suggested behavior changes. Also, the study design is not suitable to determine to what extent the interventions components contributed to the effects."

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 subitem not at all important 1 2 3 4 5 essential OTHER INFORMATION Does your paper address subitem 21-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 brie y explain why the item is not applicable/relevant for your study Meine Antwort 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting 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 cointerventions) 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.
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 brie y explain why the item is not applicable/relevant for your study "It is noteworthy however that one in four women and one in two men who were assigned to the intervention group did not start the intervention. In clinical practice, the motivation and ability to adhere to a self-guided intervention should thus be carefully assessed." 23) Registration number and name of trial registry 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 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 brie y explain why the item is not applicable/relevant for your study The study was registered prospectively in the ISRCTN database (ref: ISRCTN53553517).
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 brie y explain why the item is not applicable/relevant for your study No trial protocol available.
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 brie y explain why the item is not applicable/relevant for your study "The Faculty of Psychology at TU Dresden provided funding to cover the study registration and the data management support (MK201805)." 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 ( nancial 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.
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 brie y explain why the item is not applicable/relevant for your study

Meine Antwort
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?
Meine Antwort yes no Sonstiges: yes no Sonstiges: How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * about two to three hours.
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

Any other comments or questions on CONSORT EHEALTH
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