A Direct-to-Public Peer Support Program (Big White Wall) Versus Web-Based Information to Aid the Self-management of Depression and Anxiety: Results and Challenges of an Automated Randomized Controlled Trial

Background Effective help for depression and anxiety reaches a small proportion of people who might benefit from it. The scale of the problem suggests the need for effective, safe web-based public health services delivered directly to the public. One model, the Big White Wall (BWW), offers peer support at low cost. As these interventions are delivered digitally, we tested whether a randomized controlled trial (RCT) intervention could also be fully delivered and evaluated digitally. Objective This study aims to determine the reach, feasibility, acceptability, baseline costs, and outcomes of a public health campaign for an automated RCT of the BWW, providing digital peer support and information, compared with a standard website used by the National Health Service Moodzone (MZ), to people with probable mild-to-moderate depression and anxiety disorder. The primary outcome was the change in self-rated well-being at 6 weeks, measured using the Warwick-Edinburgh Mental Well-Being Scale. Methods An 18-month campaign was conducted across Nottinghamshire, the United Kingdom (target population 914,000) to advertise the trial directly to the public through general marketing, web-based and social media sources, health services, other public services, and third-sector groups. The population reach of this campaign was examined by the number of people accessing the study website and self-registering to the study. A pragmatic, parallel-group, single-blind RCT was then conducted using a fully automated trial website in which eligible participants were randomized to receive either 6 months of access to BWW or signposted to MZ. Those eligible for participation were aged >16 years with probable mild-to-moderate depression or anxiety disorders. Results Of 6483 visitors to the study website, 1510 (23.29%) were eligible. Overall, 790 of 1510 (52.32%) visitors participated. Of 790 visitors, 397 (50.3%) were randomized to BWW and 393 (49.7%) to MZ. Their mean age was 38 (SD 13.8) years, 81.0% (640/790) were female, 93.4% (738/790) were White, and 47.4% (271/572) had no contact with health services in the previous 3 months. We estimated 3-month productivity losses of £1001.01 (95% CI 868.75-1133.27; US $1380.79; 95% CI 1198.35-1563.23) per person for those employed. Only 16.6% (131/790) participants completed the primary outcome assessment. There were no differences in the primary or secondary outcomes between the 2 groups. Conclusions Most participants reached and those eligible for this trial of digital interventions were White women not in recent contact with health services and whose productivity losses represent a significant annual societal burden. A fully automated RCT recruiting directly from the public failed to recruit and retain sufficient participants to test the clinical effectiveness of this digital intervention, primarily because it did not personally engage participants and explain how these unfamiliar interventions might benefit them. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 12673428; https://www.isrctn.com/ISRCTN12673428 International Registered Report Identifier (IRRID) RR2-10.2196/resprot.8061

yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly 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 3 months * Overall, was the app/intervention effective? * subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 offline 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.

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "automated randomised controlled trial of a direct to public peer support programme (Big White Wall) versus web-based information to aid selfmanagement of depression and anxiety"

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 briefly explain why the item is not applicable/relevant for your study "automated randomised controlled trial of a direct to public peer support programme (Big White Wall) versus web-based information to aid selfmanagement of depression and anxiety." Automated only.

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

Clear selection
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 briefly explain why the item is not applicable/relevant for your study automated randomised controlled trial of a direct to public peer support programme (Big White Wall) versus web-based information to aid selfmanagement of depression and anxiety Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (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)

Clear selection
Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A pragmatic, parallel group, single blind RCT was then conducted using a fully automated trial website in which eligible participants were randomised to receive either 6 months access to BWW or signposted to MZ". Theory behind design in published and reference protocol paper.

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) Clear selection 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 briefly explain why the item is not applicable/relevant for your study "A pragmatic, parallel group, single blind RCT was then conducted using a fully automated trial website in which eligible participants were randomised to receive either 6 months access to BWW or signposted to MZ." Fully automated trial.
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "An 18 month campaign was performed across Nottinghamshire, United Kingdom (target population 914,000) to advertise the trial direct to the public through general marketing, online and social media sources, health services, other public services and third sector groups." "The primary outcome was change in self-rated well-being at 6 weeks, measured by the Warwick-Edinburgh Mental Well-Being Scale." "A pragmatic, parallel group, single blind RCT was then conducted using a fully automated trial website in which eligible participants were randomised to receive either 6 months access to BWW or signposted to MZ." Statistician who carried out analysis of this otherwise fully automated trial was blinded ( detail in main manuscript not abstract) 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)

Clear selection
Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "A fully automated RCT recruiting directly from the public failed to recruit and retain su cient participants to test the clinical effectiveness of this digital intervention."

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) Clear selection

4a) Eligibility criteria for participants
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No bug xes or content changes. "The study experienced technical issues, such as website downtime, problems with progression through the site and errors within the measures, which may have deterred completion of some measures and retention in the study." Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Inclusion criteria were: • Aged 16 years or over • Resident in the County of Nottinghamshire • Scores between 10-20 on the 9-Item Personal Health Questionnaire (PHQ-9) [25] or 10 or more on the 7-Item Generalised Anxiety Disorder questionnaire (GAD-7) [26], indicating probable caseness for depression and anxiety respectively but not a de nite diagnosis of depression or anxiety disorder • Access to internet through a computer, tablet or smartphone (Windows, iOS, Android) and email address. • Able and willing to give informed consent (through electronic consent) Exclusion Criteria: • Scores >21 on the PHQ-9 (severe depression) • Scores 2 or 3 on PHQ-9 item "thoughts that you would be better off dead or of hurting yourself in some way". • Scores <10 on PHQ-9 and GAD-7 • BWW and Moodzone are only available in English. Therefore the website recommended non-participation for those who believed they were insu ciently pro cient in the use of the English language ." 19/08/2020 CONSORT-EHEALTH (V 1.6.1) -

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

Clear selection
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There was no test of pro ciency in English or information technology literacy.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We ran a public health campaign using these terms and offering the opportunity to take part in a study free of charge comparing an information-giving website (MZ) that is a standard designed with and used within the English NHS, with an online peer support site (BWW). We used a mix of traditional health research recruitment strategies, such as GP endorsement, outpatient clinics and support groups as well as less traditional advertising, such as on buses and trams and via letter box lea eting. Special effort was made to reach groups regarded as higher risk and harder to reach, e.g. the farming community." "The second stage of the study was a single-blind, randomised controlled feasibility trial (RCT) using a fully automated bespoke study website. Full details are available in the published protocol [24]. Eligible participants self-referred and were recruited through the study website following the public health campaign. Consenting participants were allocated at random to receive either six months free access to BWW or signposted to the NHS Moodzone (MZ) website." " Potential participants from the county of Nottinghamshire self-referred to the study and their eligibility was assessed by an automated digital programme on the study website. " "Once consented, participants were asked to complete self-rated questionnaires to measure well-being, depression, anxiety, work and social adjustment, receipt of services (for economic analysis), social support, and personality dysfunction at baseline. These were completed online (though the study website) in approximately 20-30 minutes. All data was stored on the website and downloaded and anonymised by the clinical trial manager.
Participation in the study was for six months. Participants received electronic follow up invitations at 3, 6, 12 and 26 weeks after randomisation to be completed on the website. Each participant was reminded to log onto the study website and complete follow up measures by email 24 hours before each follow up and at the follow up time point. If follow up was not completed, they received another reminder 48 hours later. Participants were emailed motivational statements encouraging follow up as well as the offer of entry into a prize draw at the end of the study if they completed at least the primary outcome measure in all follow up assessments. There were no other attempts to follow up participants using any form of digital, telephone or face to face contact." 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.

Clear selection
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Information for participants and the associated consent forms were provided electronically within the study website. Participants who wished to discuss the study could email and telephone the study team if they had any further questions before consenting to the study. An email con rming consent was sent to each participant once they had fully enrolled." Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential 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.

Clear selection
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Once consented, participants were asked to complete self-rated questionnaires to measure well-being, depression, anxiety, work and social adjustment, receipt of services (for economic analysis), social support, and personality dysfunction at baseline. These were completed online (though the study website) in approximately 20-30 minutes. All data was stored on the website and downloaded and anonymised by the clinical trial manager." "Participation in the study was for six months. Participants received electronic follow up invitations at 3, 6, 12 and 26 weeks after randomisation to be completed on the website. Each participant was reminded to log onto the study website and complete follow up measures by email 24 hours before each follow up and at the follow up time point. If follow up was not completed, they received another reminder 48 hours later. Participants were emailed motivational statements encouraging follow up as well as the offer of entry into a prize draw at the end of the study if they completed at least the primary outcome measure in all follow up assessments. There were no other attempts to follow up participants using any form of digital, telephone or face to face contact. "

Clear selection
Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All publicity indicated that the study was funded by NIHR CLAHRC East Midlands and conducted by the University of Nottingham. We were advised by our LIved Experience Advisory Panel on the wording of such publicity including what institutional a liations to report and their prominence in the publicity material.

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-i?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participants were able to access all the available material on mental health including depression and anxiety. We did not have records of time on site or use of the site. NHS MZ access was used as the control digital resource so all participants were offered some help for their problems with depression or anxiety but this control group did not have access to moderated, anonymised peer social support." " Figure 1 shows that there were 6483 visitors to the study website (14 per day) over 18 months of recruitment from September 16th 2016 to May 30th 2018. "

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. Does your paper address subitem 5-ii?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A Lived Experience Advisory Panel of patients and public representatives with personal experience of depression and anxiety that was formed for the study advised us on the best approaches to recruiting people with depression and anxiety in the community. They recommended using the terms "low in mood" for depression and "stressed" for anxiety. We ran a public health campaign using these terms and offering the opportunity to take part in a study free of charge comparing an information-giving website (MZ) that is a standard designed with and used within the English NHS, with an online peer support site (BWW). We used a mix of traditional health research recruitment strategies, such as GP endorsement, outpatient clinics and support groups as well as less traditional advertising, such as on buses and trams and via letter box lea eting. Special effort was made to reach groups regarded as higher risk and harder to reach, e.g. the farming community. Reach was de ned as the absolute number, proportion, and representativeness of individuals who were willing to participate in a given initiative the web developer (Ayup). The aim was to establish a brand for the study that was considered by the LEAP and study team to appeal to people who may be suffering from low mood and/or stress in line with marketing materials, but also instilled professionalism and con dence with respect to the research project." More detail on the development of Big White Wall is given in the published and referenced trial protocol paper.

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

Clear selection
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study " Figure 1 shows that there were 6483 visitors to the study website (14 per day) over 18 months of recruitment from September 16th 2016 to May 30th 2018." There were no revisions or updates during the trial.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "These were completed online (though the study website) in approximately 20-30 minutes. All data was stored on the website and downloaded and anonymised by the clinical trial manager. Participation in the study was for six months.
Participants received electronic follow up invitations at 3, 6, 12 and 26 weeks after randomisation to be completed on the website. Each participant was reminded to log onto the study website and complete follow up measures by email 24 hours before each follow up and at the follow up time point. If follow up was not completed, they received another reminder 48 hours later. Participants were emailed motivational statements encouraging follow up as well as the offer of entry into a prize draw at the end of the study if they completed at least the primary outcome measure in all follow up assessments. There were no other attempts to follow up participants using any form of digital, telephone or face to face contact." "All the analysis was performed on an intention to treat basis by the trial statistician blinded to treatment allocation using STATA 16. " 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The interventions are interactive websites for which URLs are provided. We do not own the IP so cannot give algorithms and a snapshot or video would also not be informative.

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

Clear selection
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The interventions are interactive websites for which URLs are provided. We do not own the IP so cannot give algorithms and a snapshot or video would also not be informative. We give the dates of recruitment into the study ( see previous answers).

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

Clear selection
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The second stage of the study was a single-blind, randomised controlled feasibility trial (RCT) using a fully automated bespoke study website. Participants were able to access all the available material on mental health including depression and anxiety. We did not have records of time on site or use of the site. NHS MZ access was used as the control digital resource so all participants were offered some help for their problems with depression or anxiety but this control group did not have access to moderated, anonymised peer social support." More detail on the development and theory behind these interventions is given in the published and referenced trial protocol paper.

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. including depression and anxiety. We did not have records of time on site or use of the site. NHS MZ access was used as the control digital resource so all participants were offered some help for their problems with depression or anxiety but this control group did not have access to moderated, anonymised peer social support."

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?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Potential participants from the county of Nottinghamshire self-referred to the study and their eligibility was assessed by an automated digital programme on the study website. " "Information for participants and the associated consent forms were provided electronically within the study website. Participants who wished to discuss the study could email and telephone the study team if they had any further questions before consenting to the study. An email con rming consent was sent to each participant once they had fully enrolled." "Once consented, participants were asked to complete self-rated questionnaires to measure well-being, depression, anxiety, work and social adjustment, receipt of services (for economic analysis), social support, and personality dysfunction at 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).

Clear selection
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participation in the study was for six months. Participants received electronic follow up invitations at 3, 6, 12 and 26 weeks after randomisation to be completed on the website. Each participant was reminded to log onto the study website and assessments. There were no other attempts to follow up participants using any form of digital, telephone or face to face contact."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Clear selection 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Clear selection
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "Primary Outcome Measure: 1. Change in self-rated well-being from baseline and 6 weeks after baseline using the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) [28].
2. 7-Item Generalised Anxiety Disorder Scale (GAD-7) [25] completed as part of eligibility at baseline and then at 3, 6, 12 and 26 weeks, as a measure of anxiety severity . subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 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).

Clear selection
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "We asked for survey feedback at baseline and every follow up and also received email and telephone feedback when participants wished to contact the research team". We have also performed qualitative interviews and analysed this data that we will separately report. It con rms the ndings reported on barriers to recruitment and retention to the study and intervention but not reported her because of lack of space.

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 Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Feedback left by the rst 50 participants suggested they disliked the intrusiveness and length of some of the measures and the assessments at baseline. One participant withdrew from the study for this reason. Therefore, compared to our protocol [24], we omitted the 12-item medical outcomes study short form health Clear selection 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The sample size calculation and justi cation was outlined in detail in our protocol Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No interim analysis reported and no stopping guidelines developed.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The treatment to which a participant was assigned was determined by a computer generated pseudo-random code using random permuted blocks of varying size by a randomisation system embedded within the website. No strati cation or minimisation was used." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 40/65 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The treatment to which a participant was assigned was determined by a computer generated pseudo-random code using random permuted blocks of varying size by a randomisation system embedded within the website. No strati cation or minimisation was used." Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The treatment to which a participant was assigned was determined by a computer generated pseudo-random code using random permuted blocks of varying size by a randomisation system embedded within the website. No strati cation or minimisation was used." "The second stage of the study was a single-blind, randomised controlled feasibility trial (RCT) using a fully automated bespoke study website. 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 briefly explain why the item is not applicable/relevant for your study "Potential participants from the county of Nottinghamshire self-referred to the study and their eligibility was assessed by an automated digital programme on the study website." "The treatment to which a participant was assigned was determined by a computer generated pseudo-random code using random permuted blocks of varying size by a randomisation system embedded within the website. No strati cation or minimisation was used." "The second stage of the study was a single-blind, randomised controlled feasibility trial (RCT) using a fully automated bespoke study website. Full details are available in the published protocol [24]. Eligible participants self-referred and were recruited through the study website following the public health campaign. Consenting participants were allocated at random to receive either six months free access to BWW or signposted to the NHS Moodzone (MZ) website." 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Fully automated trial of 2 fully automated trial interventions. Data checked and downloaded by trial manager. Analysis of outcomes conducted by a statistician fully blinded to all trial processes and meetings until data was locked. All of this has ben repeatedly described above.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Clear selection
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Description of interventions already entered several times shows that participants
were not blinded to the intervention they received (which would be impossible in this instance). 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 briefly explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Since all outcome scores were repeatedly measured at baseline, 3, 6, 12 and 26 weeks, multilevel modelling was performed to quantify the treatment effect with participant as a level 2 unit and baseline, treatment arm, follow up time and interaction of arm×time as a covariate. Missing outcome values were investigated and imputed for all outcomes under the missing at random assumption with 100 datasets imputed for data analysis. REALCOME and STATA 16 were used to impute missingness. Similar models were conducted on observed values to check the robustness of treatment effect estimates sensitive to missingness in uence."

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).

Clear selection
19/08/2020 CONSORT-EHEALTH (V 1.6.1) - Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Since all outcome scores were repeatedly measured at baseline, 3, 6, 12 and 26 weeks, multilevel modelling was performed to quantify the treatment effect with participant as a level 2 unit and baseline, treatment arm, follow up time and interaction of arm×time as a covariate. Missing outcome values were investigated and imputed for all outcomes under the missing at random assumption with 100 datasets imputed for data analysis. REALCOME and STATA 16 were used to impute missingness. Similar models were conducted on observed values to check the robustness of treatment effect estimates sensitive to missingness in uence." Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Since all outcome scores were repeatedly measured at baseline, 3, 6, 12 and 26 weeks, multilevel modelling was performed to quantify the treatment effect with participant as a level 2 unit and baseline, treatment arm, follow up time and interaction of arm×time as a covariate. Missing outcome values were investigated and imputed for all outcomes under the missing at random assumption with 100 datasets imputed for data analysis. REALCOME and STATA 16 were used to impute missingness. Similar models were conducted on observed values to check the robustness of treatment effect estimates sensitive to missingness in uence." No subgroup analysis. Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Ethical approval was granted by the Local Research Ethics Committee (REC 16/EM/0204) and nal approval received from the UK Health Research Authority.

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

Clear selection
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Information for participants and the associated consent forms were provided electronically within the study website. Participants who wished to discuss the study could email and telephone the study team if they had any further questions before consenting to the study. An email con rming consent was sent to each participant once they had fully enrolled."

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

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

Clear selection
Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants who were ineligible for the trial because they scored in the severe range on the PHQ-9, or scored 2 or 3 on the suicide item of the PHQ-9, were provided with an opportunity to request that the study team inform their GP, mental health care team or carer of their current mood state. This was in line with other digital studies [27] and was required by our national ethics committee. If the request was not completed, the study team followed up via email asking if they would like the team to inform their GP or care team. We followed up participants on one occasion." 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 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Figure 1.
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Figure 1 13b-i) Attrition diagram Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Of the 393 participants randomised to BWW, 225 (57.3%) registered to access BWW and 165 (42.5) accessed it on more than one occasion. No participation data are available for the MZ website." This is an as needed intervention so an attrition diagram is not required.
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Figure 1 shows that there were 6483 visitors to the study website (14 per day) over 18 months of recruitment from September 16th 2016 to May 30th 2018. Follow up was for a maximum of 26 weeks for all participants (automated) 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each
group NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study None occurred.
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study It was not stopped early.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See

Clear selection
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Table 2. No measure of computer literacy recorded.

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

Clear selection
19/08/2020 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 briefly explain why the item is not applicable/relevant for your study Tables 2 to 5.

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).

Clear selection
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Table 5 and statistical method ( quote already provided).
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 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 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

Clear selection
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Figure 1.
"Of the 393 participants randomised to BWW, 225 (57.3%) registered to access BWW and 165 (42.5) accessed it on more than one occasion. No participation data are available for the MZ website." More complete data on interactive conversations on Big White Wall will be reported separately.
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No binary outcomes reported. Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No subgroup analysis.

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).

Clear selection
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 briefly explain why the item is not applicable/relevant for your study No subgroup analysis necessary since retention rates in the study are so low that the results would be misleading. "Potential participants with more severe depression who were trying to take part but were turned away by the automated eligibility criteria on the REBOOT website, expressed disappointment, frustration and a sense of exclusion made apparent through a number of complaints to the study email account." "

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

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).

Clear selection
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Overall, we found that running a fully automated trial of an online intervention was very challenging. Exclusion criteria, exclusively online enrolment and measurement, restricted full enrolment and participation for complete follow-up.
We recruited and randomised only 790 (58.4%) of those who expressed interest and were eligible, despite a considerable amount of effort by the research team using traditional advertising, internet and social media, health service, other public service and third sector contacts." "Only 16.6% of the enrolled sample provided primary outcome data at 6 weeks. As a result the study did not have the statistical power to determine whether or not BWW was more clinically effective than MZ."

Clear selection
Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We failed to recruit enough males, older participants, people from BAME backgrounds, people without any educational quali cations and people in more rural areas, each of whom may require a combination of different strategies for enrolment.", "Our data suggests that a process of interaction with a human or possibly a virtual human is required to ensure fully informed consent and commitment to the study."

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.
Clear selection 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The key issues for this automated RCT are around poor retention and recruitment which are extensively discussed.

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
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We recruited an overwhelmingly female, white ethnic, and educated sample who were mostly currently in work or education. Around half of those enrolled were not in contact with any health service in the preceding three months. A core aim of providing digital mental health approaches to reach people who are not in contact with health services was achieved. Younger females are a part of the population with increasing rates of depression and anxiety in the UK [2] and this study suggests that such people might be reached through digital direct to the public services. However, we failed to recruit enough males, older participants, people from BAME backgrounds, people without any educational quali cations and people in more rural areas, each of whom may require a combination of different strategies for enrolment."

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 co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Clear selection
19/08/2020 Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We discuss what would be needed to recruit and retain participants who are not white educated women. "We recruited an overwhelmingly female, white ethnic, and educated sample who were mostly currently in work or education. Around half of those enrolled were not in contact with any health service in the preceding three months. A core aim of providing digital mental health approaches to reach people who are not in contact with health services was achieved. Younger females are a part of the population with increasing rates of depression and anxiety in the UK [2] and this study suggests that such people might be reached through digital direct to the public services. However, we failed to recruit enough males, older participants, people from BAME backgrounds, people without any educational quali cations and people in more rural areas, each of whom may require a combination of different strategies for enrolment".
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study At the end of the abstract. In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

Clear selection
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Statement in manuscript. "The authors report no competing interests." 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? None