Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Symptoms of Postpartum Anxiety and Depression: Feasibility Randomized Controlled Trial

Background Postpartum depression (PPD) and postpartum anxiety (PPA) are often comorbid and are associated with significant personal and economic costs. Fewer than half of the mothers experiencing PPD or PPA symptoms receive face-to-face treatment, suggesting a need for alternative delivery formats such as internet-delivered cognitive behavioral therapy (ICBT). Objective This pilot study aimed to examine the impact of a therapist-assisted, transdiagnostic ICBT program on symptoms of PPD and PPA, as there is only one previous study on transdiagnostic ICBT with this population, which did not include therapist assistance. Methods Clients endorsing the symptoms of PPD or PPA (N=63) were randomized to an 8-week transdiagnostic ICBT course (Wellbeing Course for New Moms) or to treatment as usual (TAU). Clients completed measures of depression, anxiety, stress, postnatal bonding, and relationship satisfaction, as well as measures of treatment satisfaction and therapeutic alliance, before treatment, after treatment, and at the 1-month follow-up. Outcome measures were also completed at the 6-month follow-up for clients who completed the ICBT course. Results Both the ICBT and TAU groups experienced statistically significant improvements over time. The ICBT group experienced larger improvements after treatment and at the 1-month follow-up on more measures than the TAU group, with medium between-group Cohen d effects on primary outcome measures for anxiety (Cohen d=0.65, 95% CI 0.13-1.17), PPD (Cohen d=0.52, 95% CI 0.01-1.04), and depression (Cohen d=0.56, 95% CI 0.05-1.08), and on secondary outcome measures of overall distress (Cohen d=0.69, 95% CI 0.17-1.21), anxiety (Cohen d=0.59, 95% CI 0.07-1.11), and stress (Cohen d=0.76, 95% CI 0.23-1.28). Time-by-group interactions for proportional reductions between groups over time were only significant after treatment and at the 1-month follow-up for the primary anxiety measure (P=.006). This study was underpowered for detecting small or medium effects. Overall, clients perceived the treatment as credible, and 95% (21/22) of the clients were satisfied with the treatment content and therapist support. Conclusions Findings from this pilot study provide preliminary support for transdiagnostic ICBT in treating PPD and PPA symptoms to improve access to psychological treatments. Trial Registration ClinicalTrials.gov NCT04012580; https://clinicaltrials.gov/ct2/show/NCT04012580

yes: all primary outcomes were signi cantly better in intervention group vs control partly: SOME primary outcomes were signi cantly better in intervention group vs control no statistically signi cant difference between control and intervention potentially harmful: control was signi cantly better than intervention in one or more outcomes inconclusive: more research is needed Other: Approx. Percentage of Users (starters) still using the app as recommended after 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.
C l e a r s e l e c t i o n 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 "Internet-Delivered Cognitive Behavioral Therapy"

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"). Does your paper address subitem 1a-ii?
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 Your answer 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 C l e a r s e l e c t i o n 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 "for Symptoms of Postpartum Anxiety and Depression" 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 Largely not included in abstract due to word limitations. Does state: "Clients endorsing the symptoms of PPD or PA (N=63) were randomized to an 8-week transdiagnostic ICBT course (Wellbeing Course for New Moms) or to treatment as usual (TAU)."

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). subitem not at all important 1 2 3 4 5 essential 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 In the objectives section we state: "This pilot study aimed to examine the impact of a therapist-assisted, transdiagnostic ICBT program on symptoms of PPD and PPA..." 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 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 "Time-by-group interactions for proportional reductions between groups over time were only significant after treatment and at the 1-month follow-up for the primary anxiety measure (P=.006). This study was underpowered for detecting small or medium effects."

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 "The aim of this pilot study, which was planned before the abovementioned study was published, was to examine the efficacy of a therapist-assisted transdiagnostic program (ie, the Wellbeing Course for New Moms) for new mothers experiencing symptoms of PPD or PPA when delivered by a clinic specializing in the provision of ICBT and providing services on a continuous basis funded by the government. Examining the program in a routine care setting allows for greater generalizability of findings outside the initial research setting in which a program is developed [19,20]." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 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 ""The aim of this pilot study, which was planned before the abovementioned study was published, was to examine the efficacy of a therapist-assisted transdiagnostic program (ie, the Wellbeing Course for New Moms) for new mothers experiencing symptoms of PPD or PPA when delivered by a clinic specializing in the provision of ICBT and providing services on a continuous basis funded by the government. Examining the program in a routine care setting allows for greater generalizability of findings outside the initial research setting in which a program is developed [19,20].""; "It was hypothesized that new mothers who received the Wellbeing Course for New Moms would show greater improvements in anxiety, depression, stress, bonding with their infants, and relationship satisfaction and that, overall, new mothers would rate the intervention as acceptable." 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 "Before recruitment for this study, the primary investigator (VS) generated a random allocation sequence using a randomizer website and specified a 1:1 ratio in blocks of 50. The sequence was produced in the form of a Microsoft Excel file, which was then uploaded directly to the website hosting the web-based screening (REDCap [Research Electronic Data Capture]; Vanderbilt University)." 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 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 Not included as there were no changes to methods after trial was launched.

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].
C l e a r s e l e c t i o n 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 occurred to the intervention once it was launched. 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 "To be eligible for this study, potential clients had to (1) be aged ≥18 years, (2) be female, (3) have given birth and have a child aged <1 year, (4) have a score ≥10 on the Edinburgh Postnatal Depression Scale (EPDS; [22]) or score ≥9 on the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire [23], (5) be a resident of Saskatchewan, (6) be comfortable using technology, (7) have access to a secure computer and the internet, and (8) be willing to provide a medical contact as an emergency contact. Potential clients were excluded if they did not meet the abovementioned inclusion criteria or if they (1) were hospitalized in the prior year for mental health concerns or suicidality; (2) had unmanaged alcohol or drug use, mania, or psychosis; or (3) started a new psychotropic medication within the past month."

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 "be comfortable using technology" was an explicit criteria for eligibility 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.
C l e a r s e l e c t i o n 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 "Clients were recruited through web-based advertisements, presentations to health care professionals, and printed promotional materials over a span of 6 months (September 2019 to March 2020). Clients began by visiting the Online Therapy Unit website, where they completed a web-based consent form, initial eligibility questions, and a web-based screening questionnaire." subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 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.
C l e a r s e l e c t i o n 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

Your answer
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 "This pilot study was conducted through the Online Therapy Unit at the University of Regina. The Online Therapy Unit is a publicly funded specialized clinic that offers free ICBT to residents of Saskatchewan experiencing symptoms of anxiety or depression." 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.
C l e a r s e l e c t i o n 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 "Outcome measures were administered before treatment, after treatment, and at the 1month follow-up. Clients who were assigned to ICBT also completed the outcome measures at the 6-month follow-up. 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 Participants were made aware at several points that this research was affiliated with the University of Regina.

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).
C l e a r s e l e c t i o n

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 brie y explain why the item is not applicable/relevant for your study Each author's affiliations are denoted subitem not at all important 1 2 3 4 5 essential 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.
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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 "The Wellbeing Course for New Moms is a transdiagnostic course based on the principles of CBT. It was adapted from the Wellbeing Course [24] to reflect the common concerns faced by new mothers."; "The resource was created by one of the authors (VS) and then revised before use based on feedback from the coauthor (HH), 2 psychologists with young children, and 8 mothers recruited from the community."

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).
C l e a r s e l e c t i o n

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 revisions/updates once the trial began.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of subitem not at all important 1 2 3 4 5 essential 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 "Each therapist message was personalized but included several important elements: warmth and concern, feedback on symptom measures, highlighting key skills, answering client questions about the lessons, acknowledging any stated areas of difficulty, providing encouragement reinforcing progress, managing risk, and reminding clients about course instructions (see the study by Hadjistavropoulos et al [25] for more details)."

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.
C l e a r s e l e c t i o n 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 The materials developed for this study are copyrighted and not able to be widely disseminated to protect intellectual property.

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.
C l e a r s e l e c t i o n 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 Your answer

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 subitem not at all important 1 2 3 4 5 essential 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 "The Online Therapy Unit is a publicly funded specialized clinic that offers free ICBT to residents of Saskatchewan experiencing symptoms of anxiety or depression."; "Clients accessed the course through the Online Therapy Unit web platform." 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 Wellbeing Course for New Moms is a transdiagnostic course based on the principles of CBT. It was adapted from the Wellbeing Course [24] to reflect the common concerns faced by new mothers. Clients accessed the course through the Online Therapy Unit web platform. The content of any messages and questionnaire responses were encrypted using Advanced Encryption Standard encryption with 256-bit key length. Clients completed 5 web-based lessons spanning over the course of 8 weeks, with weekly support from a therapist. The lessons resemble a Microsoft PowerPoint presentation, which participants can read through independently and move through at their own pace. Lesson 1 (1 week) provides psychoeducation about anxiety and depression in general and in postpartum populations; description of symptoms; and explanation of the relationship between unhelpful thoughts, physical symptoms, and unhelpful behaviors. Lesson 2 (2 weeks) provides information on unhelpful thoughts in relation to the CBT model and strategies for monitoring and challenging thoughts. Lesson 3 (1 week) comprises psychoeducation on physical symptoms in relation to the CBT model and strategies for managing both under-and overarousal (eg, controlled breathing). Lesson 4 (2 weeks) focuses on information related to unhelpful behaviors in relation to the CBT model and guidelines about behavioral activation and graded exposure. The fifth and final lesson (2 weeks) includes information about relapse prevention, normalization, and creation of relapse prevention plans. Each lesson includes case stories and do-it-yourself guides that were modified to be relevant to new mothers to promote the practice of strategies from the course, as well as additional resources that could be accessed at any point throughout the course (ie, assertiveness, managing beliefs, communication, mental skills, managing panic attacks, managing posttraumatic stress disorder, sleep hygiene, problem-solving and worry time, and balancing new motherhood). A new resource (ie, balancing new motherhood) was created for the purpose of this study to specifically provide information about PPD and PPA, as well as common struggles that new mothers face (eg, limited sleep, new roles, isolation, and low self-esteem)."

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.
C l e a r s e l e c t i o n 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 Clients were aware of the timing of each lesson (i.e., that some lessons should be completed over 1 week and some lessons over 2). During the online screening, they were informed that the course typically takes several hours 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 subitem not at all important 1 2 3 4 5 essential 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 "All clients assigned to ICBT received weekly therapist support from a master-level, registered social worker trained in the provision of ICBT. The therapist contacted clients on the same day each week throughout the 8-week course using secure emails on the Online Therapy Unit's platform."; "Phone calls were made to clients in specific cases (ie, heightened risk of suicide, significant increase in symptoms of anxiety or depression, or to clarify client concerns). The clients also received automated messages as reminders of new lessons or questionnaires to complete." including how and when they were assessed 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 "The clients also received automated messages as reminders of new lessons or questionnaires to complete."

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. C l e a r s e l e c t i o n 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 There were not any other training/support sessions required. 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 "Outcome measures were administered before treatment, after treatment, and at the 1month follow-up. Clients who were assigned to ICBT also completed the outcome measures at the 6-month follow-up. The measures took approximately 15 minutes to complete." All primary and secondary measures are clearly described in the manuscript. 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed Does your paper address subitem 6a-iii?

Copy and paste relevant sections from manuscript text
Qualitative feedback was gathered from participants; however, this information was not published within the current manuscript and therefore was not discussed.
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 "Owing to the timing of the trial, approximately half of the clients were enrolled in the Wellbeing Course for New Moms during the COVID-19 pandemic; of note, research indicates that the COVID-19 pandemic has led to a substantial increase in the rates of PPD and PPA [42]. Clients commented on some of the challenges of engaging with ICBT during the pandemic and noted that opportunities to practice strategies (eg, pleasant activity scheduling or graded exposure) may have been limited by public health recommendations for physical distancing and self-isolation." subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 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.
C l e a r s e l e c t i o n

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 This information was not included in the manuscript. In the proposal stages of this study, a power analysis was conducted to be sensitive to medium within-between group effect sizes using G*Power 3.1.9.2 (Faul, Erdfelder, Lang, & Buchner, 2007). To achieve sufficient power at 90% (∝ = .05) to detect a medium within-between group effect size (f = .25), 23 participants per group was recommended. Given the anticipated dropout rate of approximately 20% (Hadjistavropoulos et al., 2017;Pugh et al., 2016) we initially wanted to recruit 56 participants. Ultimately, based on a post hoc power analysis, the current study was found to be unreliably powered to detect small and medium between-group effects due to the sample 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 did not have interim analyses or stopping guidelines.
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 "Before recruitment for this study, the primary investigator (VS) generated a random allocation sequence using a randomizer website and specified a 1:1 ratio in blocks of 50. The sequence was produced in the form of a Microsoft Excel file, which was then uploaded directly to the website hosting the web-based screening (REDCap [Research Electronic Data Capture]; Vanderbilt University). After this point, the researchers were unable to view the allocation sequence. Randomization was performed after participants were deemed eligible for this study to limit the possibility of bias in conducting the telephone screen in the event that the randomization group was known." 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 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 "Before recruitment for this study, the primary investigator (VS) generated a random allocation sequence using a randomizer website and specified a 1:1 ratio in blocks of 50. The sequence was produced in the form of a Microsoft Excel file, which was then uploaded directly to the website hosting the web-based screening (REDCap [Research Electronic Data Capture]; Vanderbilt University). After this point, the researchers were unable to view the allocation sequence. Randomization was performed after participants were deemed eligible for this study to limit the possibility of bias in conducting the telephone screen in the event that the randomization group was known." 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 "Before recruitment for this study, the primary investigator (VS) generated a random allocation sequence using a randomizer website and specified a 1:1 ratio in blocks of 50. The sequence was produced in the form of a Microsoft Excel file, which was then uploaded directly to the website hosting the web-based screening (REDCap [Research Electronic Data Capture]; Vanderbilt University). After this point, the researchers were unable to view the allocation sequence. Randomization was performed after participants were deemed eligible for this study to limit the possibility of bias in conducting the telephone screen in the event that the randomization group was known." 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 subitem not at all important 1 2 3 4 5 essential 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 "Before recruitment for this study, the primary investigator (VS) generated a random allocation sequence using a randomizer website and specified a 1:1 ratio in blocks of 50. The sequence was produced in the form of a Microsoft Excel file, which was then uploaded directly to the website hosting the web-based screening (REDCap [Research Electronic Data Capture]; Vanderbilt University). After this point, the researchers were unable to view the allocation sequence. Randomization was performed after participants were deemed eligible for this study to limit the possibility of bias in conducting the telephone screen in the event that the randomization group was known." 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 "Before recruitment for this study, the primary investigator (VS) generated a random allocation sequence using a randomizer website and specified a 1:1 ratio in blocks of 50. The sequence was produced in the form of a Microsoft Excel file, which was then uploaded directly to the website hosting the web-based screening (REDCap [Research Electronic Data Capture]; Vanderbilt University). After this point, the researchers were unable to view the allocation sequence. Randomization was performed after participants were deemed eligible for this study to limit the possibility of bias in conducting the telephone screen in the event that the randomization group was known." 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".
C l e a r s e l e c t i o n

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 "At the end of the telephone screen, the screener informed participants of their allocation." 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 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 Not specifically addressed as the control group did not have a 'sham' treatment provided 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 "Descriptive statistics were calculated for demographic and clinical characteristics to summarize the sample and check for pretreatment differences between the conditions. Changes in outcome measures over time were modeled using generalized estimating equations (GEEs; [35]). For all GEE models, we used an exchangeable working correlation and robust "sandwich" estimates of SEs. Gamma distributions were used to accommodate the observed skewed responses. We used a log-link function, which leads to regression coefficients and hypothesis tests assuming that changes are proportional to pretreatment measures. Modeling changes as proportional reductions from pretreatment has been recommended to provide a better model fit and reduce measurement error. To compare improvements from before treatment to after treatment and at the 1-month follow-up, we calculated proportional improvements from the pretreatment time point and within-group and between-group Cohen d effect sizes. Proportional improvements and within-group Cohen d effect sizes are also reported for the ICBT treatment group at the 6-month followup. Hypothesis tests of differences in improvements between groups were performed using Wald tests on the estimated time×group interaction coefficients from the GEE models." 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 "Therefore, we used multiple imputation to replace missing outcome measures, controlling for pretreatment symptom severity and course completion rates. In the TAU, course completion was not available; rather, we controlled for pretreatment symptom severity and whether the client accessed other mental health supports (ie, general practitioner, mental health worker, or other support groups), treating the mental health support access as a proxy measure for course engagement." 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 Due to our small sample, subgroup analyses were not able to be completed. 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 "Ethics approval was obtained from the University of Regina Ethics Board (approval number: 2019-077), and the trial was registered at ClinicalTrials.gov (NCT04012580)."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine 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.

RESULTS
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 "Participants provided consent at various points during the study, including completing a consent form before filling out the web-based screening, providing verbal consent during the telephone screening, and before initiating the Wellbeing Course for New Moms."

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) C l e a r s e l e c t i o n 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 "The content of any messages and questionnaire responses were encrypted using Advanced Encryption Standard encryption with 256-bit key length." As per eligibility criteria, participants have to "have access to a secure computer and the internet" to help protect their privacy.
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 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 brie y explain why the item is not applicable/relevant for your study This information is available in Figure 1 (participant flow) 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 This information is available in Figure 1  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 Participants did not have access to this intervention indefinitely, so much of this information is not available.
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 "Clients were recruited through web-based advertisements, presentations to health care professionals, and printed promotional materials over a span of 6 months (September 2019 to March 2020).".... "Outcome measures were also completed at the 6-month follow-up for clients who completed the ICBT course." 14b) Why the trial ended or was stopped (early) 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" C l e a r s e l e c t i o n 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 The onset of the COVID-19 pandemic during this study was discussed.
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 did not end or stop early, it was concluded after a pre-determined number of participants were recruited.

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.
C l e a r s e l e c t i o n 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 The two groups (i.e., intervention vs. control) are clearly described including their denominators. We hope that in referencing analyses completed on each group, it implies that set of participants were included. 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)

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).
C l e a r s e l e c t i o n 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 All post-questionnaires and follow-up analyses employed an intention-to-treat (ITT) design. ITT principles have been developed to address and advise researchers that encounter missing data in RCTs (Gupta, 2011). Researchers assert that aspects of certain treatments may contribute to missing data, and thereby if data from those participants is excluded, the generalizability of the research results is limited (e.g., Montori & Guyatt, 2001). As such, data from all participants who consented and accessed the first lesson, regardless of whether they completed treatment, were included in the analyses; missing data was imputed (Armijo-Olivo, Warren, & Magee, 2009). subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 This information is available in Table 2 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).
C l e a r s e l e c t i o n 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 Information about intervention usage (e.g., number of logins, number of messages sent to therapist) is available in Table 4. Unfortunately we were not able to track how long participants spent engage in each lesson due to platform limitations at the time.
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 brie y explain why the item is not applicable/relevant for your study Binary outcome measures were not utilized in this study.
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 brie y explain why the item is not applicable/relevant for your study All analyses that were completed were included within the manuscript.

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 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 did not do subanalyses on the users only 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 brie y explain why the item is not applicable/relevant for your study "After the treatment, clients were asked to indicate whether they experienced any negative effects, new psychological symptoms, or unwanted events (eg, family member death or loss of a job) during the course. If clients answered yes to these questions, they were asked to explain further. Clients were also asked to indicate whether that event negatively affected their participation, engagement, or benefit from the program."

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 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 Qualitative from participants were gathered; however, it was not included in the current manuscript as it may serve as a stand-alone manuscript in the future.

22)
Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 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 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).
C l e a r s e l e c t i o n 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 "Medium between-group Cohen d effects were observed in favor of the ICBT condition on most measures of anxiety and depression after treatment and at the follow-ups, with the exception of the depression subscale of the DASS-21. However, when examining the timeby-group interaction comparing differences in proportional reductions from before treatment between ICBT and TAU, the differences were only significant for the GAD-7 both after treatment and at the 1-month follow-up. Owing to the small sample size, this study was underpowered to detect significant differences in recovery rates between the treatment and TAU conditions, which may help explain the difference in findings based on effect sizes compared with time-by-group interactions of the proportional reductions. Improvements on all primary (EPDS, GAD-7, and PHQ-9) and most secondary measures (DASS-21 and PBQ) were maintained at the 6-month follow-up in the ICBT group. Finally, clients were satisfied with the ICBT course, perceived it as credible, and expressed high levels of alliance with their therapists." 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 will be important to assess whether the findings from this study are replicated after the pandemic."; "Future trials of the Wellbeing Course for New Moms should include larger sample sizes to ensure sufficient power for additional analyses. In future trials, it would be interesting to explore the extent to which individuals with PPA or PPD use additional resources."

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.
C l e a r s e l e c t i o n 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 "Owing to the timing of the trial, approximately half of the clients were enrolled in the Wellbeing Course for New Moms during the COVID-19 pandemic; of note, research indicates that the COVID-19 pandemic has led to a substantial increase in the rates of PPD and PPA [42]. Clients commented on some of the challenges of engaging with ICBT during the pandemic and noted that opportunities to practice strategies (eg, pleasant activity scheduling or graded exposure) may have been limited by public health recommendations for physical distancing and self-isolation."; "An additional limitation of this pilot study was its small sample size, which meant that it was not reliably powered to detect small to medium between-group effects. Furthermore, the small sample size limited the types of analyses that could be conducted and prevented us from being able to determine moderators of symptom change (eg, relationship satisfaction, symptom severity and onset, use of medication, and access to other mental health supports)."; "Finally, this study relied on self-report symptom measures as opposed to engaging participants in structured clinical interviews to ascertain information about their symptoms." 21) Generalisability (external validity, applicability) of the trial findings 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 Your answer 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.
C l e a r s e l e c t i o n 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 This was not specifically addressed. Of note, this study took place out of a specialized ICBT clinic that has a routine ICBT course. We utilized the same protocols (e.g., prompts/human involvement) as we do for the routine ICBT course. 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 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 "ClinicalTrials.gov NCT04012580; https://clinicaltrials.gov/ct2/show/NCT04012580" 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 There is not an additional appendix or reference to include a full trial protocol.
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 Online Therapy Unit receives funding from the Saskatchewan Ministry of Health to provide internet-delivered cognitive behavior therapy services. The coauthors NT and BD are funded by the Australian Government to operate the national MindSpot Clinic. The funders had no involvement in the study design, collection, analysis, or interpretation of the data."

X27) Conflicts of Interest (not a CONSORT item)
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.
C l e a r s e l e c t i o n 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

Your answer
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
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript

* 2 hours
As a result of using this checklist, do you think your manuscript has improved? * This checklist was not completed until after the manuscript was acce Would you like to become involved in the CONSORT EHEALTH group?
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