Effectiveness of a Web-Based Intervention in Reducing Depression and Sickness Absence: Randomized Controlled Trial

Background Depression is highly prevalent in the working population and is associated with significant loss of workdays; however, access to evidence-based treatment is limited. Objective This study evaluated the effectiveness of a Web-based intervention in reducing mild to moderate depression and sickness absence. Methods In an open-label randomized controlled trial, participants were recruited from a large-scale statutory health insurance and were assigned to two groups. The intervention group had access to a 12 week Web-based program consisting of structured interactive sessions and therapist support upon request. The wait-list control group had access to unguided Web-based psycho-education. Depressive symptoms were self-assessed at baseline, post-treatment, and follow-up (12 weeks after treatment) using the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI-II) as primary outcome measures. Data on sickness absence was retrieved from health insurance records. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were performed. Results Of the 180 participants who were randomized, 88 completed the post-assessment (retention rate: 48.8%, 88/180). ITT analysis showed a significant between-group difference in depressive symptoms during post-treatment in favor of the intervention group, corresponding to a moderate effect size (PHQ-9: d=0.55, 95% CI 0.25-0.85, P<.001, and BDI-II: d=0.41, CI 0.11-0.70, P=.004). PP analysis partially supported this result, but showed a non-significant effect on one primary outcome (PHQ-9: d=0.61, 95% CI 0.15-1.07, P=.04, and BDI-II: d=0.25 95% CI −0.18 to 0.65, P=.37). Analysis of clinical significance using reliable change index revealed that significantly more participants who used the Web-based intervention (63%, 63/100) responded to the treatment versus the control group (33%, 27/80; P<.001). The number needed to treat (NNT) was 4.08. Within both groups, there was a reduction in work absence frequency (IG: −67.23%, P<.001, CG: −82.61%, P<.001), but no statistical difference in sickness absence between groups was found (P=.07). Conclusions The Web-based intervention was effective in reducing depressive symptoms among adults with sickness absence. As this trial achieved a lower power than calculated, its results should be replicated in a larger sample. Further validation of health insurance records as an outcome measure for eHealth trials is needed. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 02446836; http://www.isrctn.com/ISRCTN02446836 (Archived by WebCite at http://www.webcitation.org/6jx4SObnw)

I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") yes Other: 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if of耀ೠine 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. 1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study "Effectiveness of a webbased intervention in reducing sickness absence due to mild to moderate depression: A randomized controlled trial"

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").
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study Not applicable, as nonwebbased components are not included in the intervention 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 1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study "Effectiveness of a webbased intervention in reducing sickness absence due to mild to moderate depression: A randomized controlled trial" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
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) 1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study "The internetbased intervention had access to a 12 week webbased program containing structured interactive sessions and minimal therapist support. The control group had access to unguided webbased psycho education." 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) 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耀ೠy explain why the item is not applicable/relevant for your study "The internetbased intervention had access to a 12 week webbased program containing structured interactive sessions and minimal therapist support. The control group had access to unguided webbased psycho education." 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. of耀ೠine), 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 of耀ೠine 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) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study from a largescale statutory health insurance and were assigned to two groups." "Depressive symptoms were selfassessed at baseline, posttreatment, and at followup (12 weeks after treatment) using the Patient Health Questionnaire (PHQ9) as primary outcome, Beck Depression Inventory (BDIII) as secondary outcome. Data on sickness absence was retrieved from health insurance records." 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) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study subitem not at all important essential Does your paper address subitem 2a-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耀ೠy explain why the item is not applicable/relevant for your study validity of efficacy studies (Kiluk et al., 2011). To date, few studies employ independent outcomes and such attempts are limited to observer ratings of symptoms and do not extend to objective behavioral measurement of work absenteeism (Thiart et al., 2015, Geraedts et al., 2014, Buntrock et al., 2016. The lack of objective sickness absence measurements in research on internetbased interventions is surprising because sickness absence is frequently used as an integrated measure of health in other fields (Hensing et al., 1998)."

2b) In INTRODUCTION: Speci췍蹶c objectives or hypotheses
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耀ೠy explain why the item is not applicable/relevant for your study "This study examined the effectiveness of a guided internetbased intervention in reducing depression and sickness absence among a high risk population using both selfreported depression and objective sickness absence assessments. We hypothesized that the internetbased intervention would be more effective in reducing depressive symptoms and sickness absence than the control group." 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耀ೠy explain why the item is not applicable/relevant for your study "This was a twoarmed unblinded randomized controlled trial. Participants were randomly assigned to either the intervention group with access to the guided internetbased intervention or the control group with access to unguided internetbased psychoeducation. We used a computerized procedure for randomization (Allocation ratio 1:1)." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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耀ೠy explain why the item is not applicable/relevant for your study not applicable/relevant for your study No changes to methods after trial commencement were made 3b-i) Bug 䀔瘔xes, Downtimes, Content Changes Bug 췍蹶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 췍蹶xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in耀ೠuenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study not applicable/relevant for your study To our knowledge, there were no Bug fixes, Downtimes, Content Changes 4a) Eligibility criteria for participants 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耀ೠy explain why the item is not applicable/relevant for your study "Adults with mild to moderate symptoms or dysthymia were included to avoid giving less intensive treatment than necessary. Participants with a score of ≥20 on the Patient Health Questionnaire (PHQ9) indicating severe depression or the presence of suicidal thoughts were excluded."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari췍蹶ed.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study Computer / Internet literacy was not defined as eligibility criterion in this study 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. of耀ೠine), 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 quasianonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con췍蹶rmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study "Participants were recruited from a largescale German statutory health insurance between January 2013 and March 2014. Recruitment was done by an invitation letter that was sent to insurance members along with study information and the informed consent form (see Appendix 1).
To identify participants who were at high risk for sick leave due to depression, insurance members were screened for previous diagnosis of depression (International Classification of Disease codes F32.0, F32.1, F33.0, F33.1 and F34.1), previous sickness absence due to depression and current sickness absence." 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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study "Recruitment was done by an invitation letter that was sent to insurance members along with study information and the informed consent form (see Appendix 1)." 4b) Settings and locations where the data were collected 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耀ೠy explain why the item is not applicable/relevant for your study "Participants were recruited from a largescale German statutory health insurance between January 2013 and March 2014." 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.
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study "The primary outcome was depressive symptoms selfassessed with the Patient Health Questionnaire (PHQ9) (Kroenke et al., 2001, Löwe et al., 2002. The PHQ9 measures the severity of depressive symptoms over the past 2 weeks resulting in a score between 0 to 27 points with higher values indicating more severe depression. As a secondary outcome, depressive symptoms were assessed with the Beck Depression Inventory (BDI II) (Beck et al., 1996, Hautzinger et al., 2006. Quality of life was assessed using the Manchester Short Assessment of Quality of Life (MANSA) (Priebe et al., 1999)-a 12 4b-ii) Report how institutional af䀔瘔liations are displayed Report how institutional af췍蹶liations are displayed to potential participants [on ehealth media], as af췍蹶liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study Not relevant; University and health insurance affiliation were given on invitation letter to obtian participant trust but no bias was expected from displaying this information 5) The interventions for each group with suf췍蹶cient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, af䀔瘔liations of the developers, sponsors, and owners
Mention names, credential, af췍蹶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耀ೠict of interest" section or mentioned elsewhere in the manuscript).
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study "The intervention was developed by trained psychologists and therapists at Novego AG and can be assessed online at https://www.novego.de/programme/depression/ (von Waldenfels et al.,

2011)"
"Novego AG is the developer and commercial distributor of the internet based intervention "HelpID". The developer made the intervention available at no cost to the participants in the trial. Neither funder nor developer had a role in study design, data analysis, decision to publish,

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?
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耀ೠy explain why the item is not applicable/relevant for your study "The intervention was developed by trained psychologists and therapists at Novego AG and can be assessed online at https://www.novego.de/programme/depression/ (von Waldenfels et al., 2011)"

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).
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study There were no revisions or updating of intervention or comparator after study begin.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important 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耀ೠy explain why the item is not applicable/relevant for your study Trained psychologists, therapists and researchers designed and administered the study. A research coordinator and a scientific head were responsible for quality assurance and ensured accuracy and quality of the data.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2… 13/35 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing 솃豱owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing 耀ೠowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti췍蹶c reporting.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study Screenshots of the intervention will be published in the Appendix.

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.

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 speci췍蹶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). 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耀ೠy explain why the item is not applicable/relevant for your study "Recruitment was done by an invitation letter that was sent to insurance members along with study information, the informed consent form (see Appendix 1), and a 6digit code to login into the platform." subitem not at all important essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study the 12week study period with textbased information on the nature of depression, its symptoms and treatment. This type of control condition was chosen because more active control groups (i.e. psychoeducation) are considered to be more methodologically valid than passive control groups (i.e. waitlist conditions) (Kiluk et al., 2011). There is evidence that psychoeducation can reduce depressive symptoms and serve as an initial treatment in primary care (Donker et al., 2009). The control group did not have access to therapist guidance."

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study login on the plattform for the weekly session. Users were instructed to complete all 12 weekly sessions for optimal effects on depression.
We have pointed out in the discussion that it is a limitation of this study that no other use parameters were assessed: "Furthermore, only questionnaire data was assessed as a proxy of use parameters, but no uptake data was available on the actual usage of the program (e.g. frequency and length of website usage)."

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).
1 2 3 4 5 subitem not at all important 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耀ೠy explain why the item is not applicable/relevant for your study "Participants were randomly assigned to either the intervention group with access to the guided internetbased intervention or the control group with access to unguided internetbased psychoeducation." "The program is a guided format with minimal therapist contact; i.e. a trained psychologist provided feedback via email or telephone upon request." "The control group did not have access to therapist guidance."

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study "Each session was available one week after completing the prior session. Participants received weekly reminder emails when a new session was available." 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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study "All participants had unrestricted access to treatment as usual during the study period." 6a) Completely de췍蹶ned pre-speci췍蹶ed primary and secondary outcome measures, including how and when they were assessed 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耀ೠy explain why the item is not applicable/relevant for your study "Outcome variables were assessed at baseline (T0) and 12 weeks after randomization (posttreatment, T1). In addition, a followup measurement was assessed 24 weeks after randomization (12 weeks after treatment, T2)." "The primary outcome was depressive symptoms selfassessed with the Patient Health Questionnaire (PHQ9) (Kroenke et al., 2001, Löwe et al., 2002. The PHQ9 measures the severity of depressive symptoms over the past 2 weeks resulting in a score between 0 to 27 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de䀔瘔ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de췍蹶ned/measured/monitored (logins, log췍蹶le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text The use parameter was completing weekly PHQ9 assessments after login on the plattform for the weekly session. Users were instructed to complete all 12 weekly sessions for optimal effects on depression.
We have pointed out in the discussion that it is a limitation of this study that no other use parameters were assessed: "Furthermore, only questionnaire data was assessed as a proxy of use parameters, but no uptake data was available on the actual usage of 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). There were no changes to trial outcomes after the trial commenced.
7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 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.
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study "Sample size calculation was based on expected betweengroup differences at posttreatment. Assuming a 20% attrition rate, a power of 0.80, and an alpha level of 0.05, we calculated that 608 participants needed to be enrolled in order to detect small to medium effect sizes (d=0.3)."

7b) When applicable, explanation of any interim analyses and stopping guidelines
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耀ೠy explain why the item is not applicable/relevant for your study There were no interim analyses. Recruitment was stopped when the pool of health insurance member that met the inclusion criteria was depleted.
8a) Method used to generate the random allocation sequence 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耀ೠy explain why the item is not applicable/relevant for your study "We used a computerized procedure for randomization (Allocation ratio 1:1)." 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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耀ೠy explain why the item is not applicable/relevant for your study Not applicable, there were no restrictions 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 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耀ೠy explain why the item is not applicable/relevant for your study The result of the randomization procedure was concealed until first login to the platform.
"We used a computerized procedure for randomization (Allocation ratio 1:1)." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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耀ೠy explain why the item is not applicable/relevant for your study The study team at Leuphana University Lüneburg was responsible for random allocation, enrollment, and assigning participants to interventions. The statutory health insurance assisted in enrollment by sending inviation letters to its pool of insurance members.
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 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).

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subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study This was an unblinded randomized controlled trial. Participants and the study team were not blinded to intervention assignment.
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".
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study The invitation letter and the informed consent form described the intervention and the control group, and explained that allocation was random. It was clarified that this is a support for selfhelp that is provided in addition to TAU. It was also clarified that there was no relationship to insurance status or health care benefits received from insurance. Upon request, participants allocated to the control group received access to the intervention after the study had ended.
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 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耀ೠy explain why the item is not applicable/relevant for your study Not applicable/relevant as no placebo or sham intervention were given.
12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study baseline depression scores were included as the covariate. Cohen's d was calculated as a measure of the effect size (Cohen, 1988). To assess clinical significance on an individual level, the reliable change index was computed (Jacobson and Truax, 1991). Participants were classified as 'responders' if they displayed a reliable positive change or as 'deteriorated' if they displayed a negative change on the reliable change index. Finally, the number needed to treat (NNT) (Cook and Sackett, 1995) was computed. All analysis was performed using Stata 13. The reported p values are two sided and on the 95% confidence interval." 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]).
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study "Missing data at posttreatment was imputed using the Markov Chain Monte Carlo multiple imputation (missing data module in SPSS 22). Multiple imputation is considered to produce more precise estimates of the true intervention effect than other imputation methods, i.e. last observation carried forward (Schafer and Graham, 2002). In addition, per protocol (PP) analysis was performed to examine the robustness and sensitivity of the findings when including only participants who completed the post assessment." 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study "In addition, per protocol (PP) analysis was performed to examine the robustness and sensitivity of the findings when including only participants who completed the postassessment."" 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耀ೠy explain why the item is not applicable/relevant for your study "Recruitment was done by an invitation letter that was sent to insurance members along with study information, the informed consent form (see Appendix 1), and a 6digit code to login into the platform."

X26) REB/IRB Approval and Ethical Considerations
Participant signature was required for informed consent. The consent form was sent by letter to the study team ("offline"). Information on depression and webbased supported selfhelp was provided.

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) 1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study "Participants with a score of ≥20 on the Patient Health Questionnaire (PHQ9) indicating severe depression or the presence of suicidal thoughts were excluded." To increase safety and security, trained psychologists were available by telephone hotline or by email.

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address 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耀ೠy explain why the item is not applicable/relevant for your study " Figure 1 shows the flow of participants through the study. Of the 3929 insurance members invited to participate, 180 responded and met the inclusion criteria. Of the 180 participants that were randomized, 98 completed the postassessment after 12 weeks (attrition rate: 45.5%), and 58 completed the followup assessment after 24 weeks (attrition rate: 67.7%)." The information for each group is given in Figure 1: Study flow chart.
13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT 솃豱ow 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耀ೠy explain why the item is not applicable/relevant for your study Information on losses and exclusions after randomisation, together with reasons for each group is given in Figure 1: Study flow chart.

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

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subitem not at all important essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the 췍蹶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耀ೠy explain why the item is not applicable/relevant for your study See Figure 1: Study flow chart.
14a) Dates de췍蹶ning the periods of recruitment and followup 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耀ೠy explain why the item is not applicable/relevant for your study "Participants were recruited from a largescale German statutory health insurance between January 2013 and March 2014." "Of the 180 participants that were randomized, 98 completed the post assessment after 12 weeks (attrition rate: 45.5%), and 58 completed the followup assessment after 24 weeks (attrition rate: 67.7%)." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi췍蹶cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study To our knowledge, there were no secular events that fell into the study period.
14b) Why the trial ended or was stopped (early) 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耀ೠy explain why the item is not applicable/relevant for your study Recruitment was stopped when the available pool of health insurance members that met the inclusion criteria was depleted (n= 3929).

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study Age, education, gender, and socialeconomic status were reported in Table  1, but there was no assessment of computer/Internet/ehealth literacy.
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide de䀔瘔nitions Report multiple "denominators" and provide de췍蹶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 speci췍蹶c pre-de췍蹶ned time points of interest (in absolute and relative numbers per group). Always clearly de췍蹶ne "use" of the intervention.
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study Results are reported for those participants who 1) completed the intervention and (=per protocol analysis) and 2) all particpants that were randomized (=intention to treat analysis). No other thresholds for participation were examined.

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).
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study et al., 2012) and its adaption for ehealth trials (Eysenbach and CONSORTEHEALTH Group, 2011). Missing data at posttreatment was imputed using the Markov Chain Monte Carlo multiple imputation (missing data module in SPSS 22). Multiple imputation is considered to produce more precise estimates of the true intervention effect than other imputation methods, i.e. last observation carried forward (Schafer and Graham, 2002). In addition, per protocol (PP) analysis was performed to examine the robustness and sensitivity of the findings when including only participants who completed the postassessment." 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con췍蹶dence interval) 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耀ೠy explain why the item is not applicable/relevant for your study points in the intervention group and by 2.24 points in the control group -this corresponds to a large effect size (d=1.72, CI: 1.23 -2.22) and a moderate effect size (d=0.49, CI: 0.14 -0.82) for withingroup changes among completers, respectively." See Table 2: Means, standard deviations (SD) and effect sizes for intervention outcomes based on intentiontotreat sample (imputed data).

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 de췍蹶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 de췍蹶ned (e.g., timeout after idle time) [1] (report under item 6a). 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耀ೠy explain why the item is not applicable/relevant for your study Unfortunately, no usage metrics were assessed.
We have pointed out in the discussion that it is a limitation of this study that no use parameters were assessed: "Furthermore, only questionnaire data was assessed as a proxy of use parameters, but no uptake data was available on the actual usage of the program (e.g. frequency and length of website usage)." 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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耀ೠy explain why the item is not applicable/relevant for your study No binary outcomes were used in this study.
18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speci췍蹶ed from exploratory 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耀ೠy explain why the item is not applicable/relevant for your study "Information on sickness absenteeism was available for 160 participants (Intervention group: n=88, control group: n=72)."

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).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study favor of the intervention group was found among completers (p=.004) indicating a moderate effect size (d: 0.68, CI: 0.22 -1.14). The mean PHQ9 scores among intervention completers was reduced by 5.70 points in the intervention group and by 2.24 points in the control group -this corresponds to a large effect size (d=1.72, CI: 1.23 -2.22) and a moderate effect size (d=0.49, CI: 0.14 -0.82) for withingroup changes among completers, respectively."

19) All important harms or unintended effects in each group
(for speci췍蹶c guidance see CONSORT for harms) 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耀ೠy explain why the item is not applicable/relevant for your study Harms or unintended effects were reported by the number of participants who experienced a symptom deterioration from baseline to postassessment.
"In the intervention group, 63% (63/100) of the participants showed a reliable symptom change from baseline to postintervention and were thus classified as responders. In the control group, 33% (27/80) were classified as responders. The difference in reliable symptom change between intervention and control group was significant (p=<.001). This

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]. 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耀ೠy explain why the item is not applicable/relevant for your study No qualitative feedback from participants or observations from staff/researchers on strengths and shortcomings of the application were available.

22) Interpretation consistent with results, balancing bene췍蹶ts 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 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).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study internetbased intervention responded to treatment. We found that health insurance records are a suitable outcome for research into the effectiveness of internetbased interventions. Sickness absenteeism declined in both groups, but no statistical differences in work absence between groups was found. Overall, our findings indicate that web based, unguided psychoeducation can be helpful for adults who are at risk of missing work due to depression. However, a structured intervention containing interactive elements, video, and audio as well as access to therapist feedback upon request provides more effective help. "

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
1 2 3 4 5 subitem not at all important essential 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 brie耀ೠy explain why the item is not applicable/relevant for your study "To disentangle these explanations, future studies on the effect of internet based interventions on work absence should include a longer time period, information on organizational factors that may be related to sickness absence, and work absence data from a healthy control group for baseline comparisons. Integrating objective behavioral parameters (i.e. sickness absence data from health insurances) can increase the validity of effectiveness studies and might be a valuable addition to selfreported outcome measurements. " 20) Trial limitations, addressing sources of potential bias, limitation imprecision, and, if relevant, multiplicity of analyses 20-i) Typical limitations in ehealth trials limitation Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look limitation 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. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study needed to identify effectiveness among different subgroups. Fourth, this was an open trial, where participants and researchers were aware which group was receiving which treatment. Furthermore, only questionnaire data was assessed as a proxy of use parameters, but no uptake data was available on the actual usage of the program (e.g. frequency and length of website usage). Data on how the participants interacted with the program could provide valuable insights into the effectiveness of specific intervention elements." 21) Generalisability (external validity, applicability) of the trial 췍蹶ndings NPT: External validity of the trial 췍蹶ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial

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 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie耀ೠy explain why the item is not applicable/relevant for your study In general, the findings of this trial are generalisable to adults with mild to moderate depression. However there is one aspect that limits generalizability: "Third, the positive relationship of age and education with study dropout seen here limits the generalizability of the findings to younger and less educated groups." 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.
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study To our knowledge, there were no elements in the RCT that would be different in a routine application setting.

23) Registration number and name of trial registry
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耀ೠy explain why the item is not applicable/relevant for your study

24)
Where the full trial protocol can be accessed, if available 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耀ೠy explain why the item is not applicable/relevant for your study The full trial protocol can be assessed at http://www.isrctn.com/ISRCTN02446836 (Archived by WebCite at http://www.webcitation.org/6jx4SObnw) 25) Sources of funding and other support (such as supply of drugs), role of funders 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耀ೠy explain why the item is not applicable/relevant for your study "This research was funded by the European Union Innovation Incubator within the European Regional Development Fund. Novego AG is the developer and commercial distributor of the internetbased intervention "HelpID". The developer made the intervention available at no cost to the participants in the trial. Neither funder nor developer had a role in study design, data analysis, decision to publish, or preparation of the manuscript."

X27) Con耀ೠicts of Interest (not a CONSORT item)
X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (췍蹶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.
1 2 3 4 5 subitem not at all important essential 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耀ೠy explain why the item is not applicable/relevant for your study The study team was independent of the system being evaluated. The study team was located at Leuphana University Lüneburg. The intervention developer was Novego AG.
"Novego AG is the developer and commercial distributor of the internet based intervention "HelpID". The developer made the intervention available at no cost to the participants in the trial. Neither funder nor developer had a role in study design, data analysis, decision to publish, or preparation of the manuscript." About the CONSORT EHEALTH checklist As a result of using this checklist, did you make changes in your manuscript? * yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist?
Include usage data in Abstract Provide more detailed information on intervention and developer in Methods How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

hours
As a result of using this checklist, do you think your manuscript has improved? * yes no Other: Would you like to become involved in the CONSORT EHEALTH group? This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document yes no Other: Any other comments or questions on CONSORT EHEALTH STOP -Save this form as PDF before you click submit To generate a record that you 췍蹶lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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