MoodHacker Mobile Web App With Email for Adults to Self-Manage Mild-to-Moderate Depression: Randomized Controlled Trial

Background Worldwide, depression is rated as the fourth leading cause of disease burden and is projected to be the second leading cause of disability by 2020. Annual depression-related costs in the United States are estimated at US $210.5 billion, with employers bearing over 50% of these costs in productivity loss, absenteeism, and disability. Because most adults with depression never receive treatment, there is a need to develop effective interventions that can be more widely disseminated through new channels, such as employee assistance programs (EAPs), and directly to individuals who will not seek face-to-face care. Objective This study evaluated a self-guided intervention, using the MoodHacker mobile Web app to activate the use of cognitive behavioral therapy (CBT) skills in working adults with mild-to-moderate depression. It was hypothesized that MoodHacker users would experience reduced depression symptoms and negative cognitions, and increased behavioral activation, knowledge of depression, and functioning in the workplace. Methods A parallel two-group randomized controlled trial was conducted with 300 employed adults exhibiting mild-to-moderate depression. Participants were recruited from August 2012 through April 2013 in partnership with an EAP and with outreach through a variety of additional non-EAP organizations. Participants were blocked on race/ethnicity and then randomly assigned within each block to receive, without clinical support, either the MoodHacker intervention (n=150) or alternative care consisting of links to vetted websites on depression (n=150). Participants in both groups completed online self-assessment surveys at baseline, 6 weeks after baseline, and 10 weeks after baseline. Surveys assessed (1) depression symptoms, (2) behavioral activation, (3) negative thoughts, (4) worksite outcomes, (5) depression knowledge, and (6) user satisfaction and usability. After randomization, all interactions with subjects were automated with the exception of safety-related follow-up calls to subjects reporting current suicidal ideation and/or severe depression symptoms. Results At 6-week follow-up, significant effects were found on depression, behavioral activation, negative thoughts, knowledge, work productivity, work absence, and workplace distress. MoodHacker yielded significant effects on depression symptoms, work productivity, work absence, and workplace distress for those who reported access to an EAP, but no significant effects on these outcome measures for those without EAP access. Participants in the treatment arm used the MoodHacker app an average of 16.0 times (SD 13.3), totaling an average of 1.3 hours (SD 1.3) of use between pretest and 6-week follow-up. Significant effects on work absence in those with EAP access persisted at 10-week follow-up. Conclusions This randomized effectiveness trial found that the MoodHacker app produced significant effects on depression symptoms (partial eta2 = .021) among employed adults at 6-week follow-up when compared to subjects with access to relevant depression Internet sites. The app had stronger effects for individuals with access to an EAP (partial eta2 = .093). For all users, the MoodHacker program also yielded greater improvement on work absence, as well as the mediating factors of behavioral activation, negative thoughts, and knowledge of depression self-care. Significant effects were maintained at 10-week follow-up for work absence. General attenuation of effects at 10-week follow-up underscores the importance of extending program contacts to maintain user engagement. This study suggests that light-touch, CBT-based mobile interventions like MoodHacker may be appropriate for implementation within EAPs and similar environments. In addition, it seems likely that supporting MoodHacker users with guidance from counselors may improve effectiveness for those who seek in-person support. Trial Registration ClinicalTrials.gov NCT02335554; https://clinicaltrials.gov/ct2/show/NCT02335554 (Archived by WebCite at http://www.webcitation.org/6dGXKWjWE)

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. 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 briefly explain why the item is not applicable/relevant for your study responsive mobileweb intervention app, MoodHacker, designed to teach cognitivebehavioral skills to workers with mildtomoderate depression AND alternate care consisting of links to vetted websites on depression 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) https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?rm=full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWW… 6/42 subitem not at all important 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 randomly assigned to receive "without clinical support" either the MoodHacker intervention or alternate care 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) 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 briefly explain why the item is not applicable/relevant for your study Participants were recruited through an employee assistance program (EAP) and a variety of additional nonEAP organizations. AND Participants in both groups completed online selfassessment surveys at baseline, 6 weeks after baseline, and 10 weeks after baseline 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. 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) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Major depressive disorder is one of the most prevalent mental conditions to afflict adults in the U.S., with estimates for major depression of 16.6% for lifetime occurrence and 6.7% for a oneyear period [1,2]. The prevalence of mildtomoderate or subclinical depression is equal to or greater than major depressive disorder, with lifetime rates up to 26% and annual prevalence of 510% [3,4]. Subclinical depression is associated with substantial functional impairment including poor work performance [1013]. Further, subclinical depression is associated with a 2 to 5fold increased risk of fullsyndrome depressive disorders [58]. Depressionrelated costs exceed $83 billion annually in the U.S., with more than half incurred by employers in lower productivity, absenteeism, and disability [9]. Inclusion criteria for participation were defined as: (a) 18 years or older; (b) mildtomoderate depressive symptoms as measured by the PHQ9 (score of 1019); (c) not currently suicidal or meeting criteria for bipolar or schizoaffective disorder; (d) employed at least parttime; (e) English speaking; and (f) had access to a highspeed internet connection.

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
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 briefly explain why the item is not applicable/relevant for your study Inclusion criteria for participation were defined as: ... (f) had access to a highspeed internet connection.
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. screening survey, research staff conducted telephone interviews with potential participants to determine eligibility per the inclusion criteria referenced above. Potential participants who reported current suicidal ideation and/or bipolar or schizoaffective disorder were offered appropriate resources according to an IRBapproved crisis protocol. In addition, demographic and contact data were checked for fraudulent information against other individuals in the study database as well as in our database of over 20,000 records of previous Internet study applicants, and fraudsuspect individuals were dropped.
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 briefly explain why the item is not applicable/relevant for your study Outreach was conducted via the Chestnut EAP call center, print ads, online postings and ads, email listservs, and flyers. Interested potential participants from all sources were directed to an informational website that described the broad characteristics of the study's purpose, activities and compensation, concluding with an online screening survey.
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 briefly explain why the item is not applicable/relevant for your study Upon completion of the consent form they were immediately linked to the online baseline selfassessment. ... Participants completed online followup selfassessments at 6 weeks and 10 weeks after baseline. 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 briefly explain why the item is not applicable/relevant for your study Upon completion of the consent form they were immediately linked to the online baseline selfassessment. ... Participants completed online followup selfassessments at 6 weeks and 10 weeks after baseline. 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 briefly explain why the item is not applicable/relevant for your study Not specified in the manuscript. The ORCAS logo and contact information was included on all recruitment and assessment materials, but was not likely to influence potential participants.

5)
The interventions for each group with sufficient details to allow replication, including how and when they were actually administered https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?rm=full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aW… 14/42 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).
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 briefly explain why the item is not applicable/relevant for your study The ORCAS research (all of the coauthors) and development (listed in acknowledgements) team developed the MoodHacker app with assistance from consultants with expertise in the Coping with Depression CBT course and positive psychology strategies for mood management.

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study . Development of the MoodHacker app was undertaken by a multidisciplinary team of researchers and developers at ORCAS, with input from experts with extensive experience in CBTbased self management interventions for adults with depression and the benefits of positive psychology. Additional program modifications were made based on data from individual interviews and iterative user testing with the population of interest during the formative and production phases of the project.

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 briefly explain why the item is not applicable/relevant for your study The randomized trial was conducted with the first version of the MoodHacker app. No changes were made to the app during the study period.

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 briefly explain why the item is not applicable/relevant for your study The app was extensively tested for quality assurance by the ORCAS research and development teams.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screencapture 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. 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 briefly explain why the item is not applicable/relevant for your study See Figures 24 for screen shots of the emails and key app pages.

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The version of MoodHacker that was used in the study is no longer maintained/available.

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). subitem not at all important essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participants in the treatment arm accessed the passwordprotected MoodHacker app with unique user names and passwords provided for the study. subitem not at all important essential Does your paper address subitem 5-ix?

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Treatment arm: Although daily app use was recommended in the app content, participants were not required to achieve any app use milestones to advance through the 6week app experience.
Alternative care arm: ...encouraged to browse these sites on their own schedule for 6 weeks

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 briefly explain why the item is not applicable/relevant for your study Participants received no clinical support as part of the study.

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). 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 briefly explain why the item is not applicable/relevant for your study Daily emails (Figure 1) are sent to engage users in program content, provide sequenced guidance through the learning objectives in the articles and whiteboardstyle videos, give tips for getting the most out of MoodHacker, and prompt the user to track their mood and activities daily. Users are encouraged to view the articles and videos as ordered, but viewing is not restricted, and users can view content according to their interest. The emails, articles, and videos promote daily use of the featured cognitive and behavioral skills outside the app experience.

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 briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study physical demands, (3) mental demands, and (4) output demands. Worksite outcomes were also assessed using the Workplace Outcome Suite (α = .74.88; WOS) [37]. The WOS was designed as an openaccess instrument to facilitate empirical research on EAP interventions. The suite contains five 5item scales that assess: absenteeism, presenteeism, work engagement, life satisfaction, and workplace distress. User satisfaction and program usability At 6 weeks, treatment participants completed the System Usability Scale, which is a quantitative measure of program ease of use [38]. The scale includes 10 items, and users were asked to what degree they agreed or disagreed with program use and satisfaction statements on a 6point scale (1=strongly disagree; 6=strongly agree).
6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed Program utilization was quantified as number of logins and total duration of use over 6 weeks.
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). 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 briefly explain why the item is not applicable/relevant for your study The analysis plan allowed for 15% attrition at the 6week assessment and 20% at the 10week assessment.
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 briefly explain why the item is not applicable/relevant for your study 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 After screening into the study, agreeing to the online informed consent, and submitting the baseline assessment, participants were randomized into either: (a) treatment intervention group (n = 150), which used the MoodHacker intervention for 6 weeks or (b) alternative care group (n = 150), which received links to 6 websites with information about depression.
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 briefly explain why the item is not applicable/relevant for your study Qualified participants were blocked on race/ethnicity and then randomly assigned to condition (treatment or alternative care). 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 briefly explain why the item is not applicable/relevant for your study After blocking, subjects were randomized based on a randomnumber generation feature in the Filemaker database used for subject management.
https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?rm=full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aW… 24/42 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 After blocking, subjects were randomized based on a randomnumber generation feature in the Filemaker database used for subject management. Thereafter, all subject management was handled by trained research assistants.
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).

2 3 4 5
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 briefly explain why the item is not applicable/relevant for your study Throughout the study, individuals who reported current suicidal ideation and/or severe depression symptoms (PHQ9 > 19) were contacted by telephone and offered appropriate resources according to an IRB approved crisis protocol. Although research assistants were aware of group assignment, this was their only direct interaction with subjects after randomization. All other research team members were blinded. 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 briefly explain why the item is not applicable/relevant for your study [Participants] were then emailed a link to an online informed consent form, which indicated that participants would receive the MoodHacker intervention immediately or after a wait period.

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 briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Univariate effects of intervention condition, EAP access, and their interaction on outcome measures were examined using between subjects analysis of covariance (ANCOVA), adjusting for pretest outcomes. These analyses were conducted to evaluate effects on outcome measures assessed at both 6week and 10week followup. If the condition by EAP access interaction was significant for an outcome measure, separate subpopulation ANCOVA analyses were conducted on that outcome measure for subjects with and without EAP access. We explored doseresponse and selfmonitoring participation within the treatment group by correlating process indicants with change in outcome measures. Prior to conducting these analyses, we employed the single imputation procedure available in SPSS 21 to account for missing data. Alpha was set to P < .05, twotailed, for all tests.
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 briefly explain why the item is not applicable/relevant for your study Prior to conducting these analyses, we employed the single imputation procedure available in SPSS 21 to account for missing data.

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Univariate effects of intervention condition, EAP access, and their interaction on outcome measures were examined using between subjects analysis of covariance (ANCOVA), adjusting for pretest outcomes. These analyses were conducted to evaluate effects on outcome measures assessed at both 6week and 10week followup. If the condition by EAP access interaction was significant for an outcome measure, separate subpopulation ANCOVA analyses were conducted on that outcome measure for subjects with and without EAP access. We explored doseresponse and selfmonitoring participation within the treatment group by correlating process indicants with change in outcome measures. Prior to conducting these analyses, we employed the single imputation procedure available in SPSS 21 to account for missing data. Alpha was set to P < .05, twotailed, for all tests. subitem not at all important essential 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 All study protocols, the consent process, and subject communications were reviewed and approved by the ORCAS Institutional Review Board (IRB) for protection of human subjects. Qualified participants were blocked on race/ethnicity and then randomly assigned to condition (treatment or alternative care). They were then emailed a link to an online informed consent form, which indicated that participants would receive the MoodHacker intervention immediately or after a wait period.

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 briefly explain why the item is not applicable/relevant for your study All study protocols, the consent process, and subject communications were reviewed and approved by the ORCAS Institutional Review Board (IRB) for protection of human subjects. AND All selfreport online screening and assessment data were collected via encrypted websites. AND Potential participants who reported current suicidal ideation and/or bipolar or schizoaffective disorder were offered appropriate resources according to an IRBapproved crisis protocol. AND Throughout the study, individuals who reported current suicidal ideation and/or severe depression symptoms (PHQ9 > 19) were contacted by telephone and offered appropriate resources according to an IRBapproved crisis protocol.

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome

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" 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 briefly explain why the item is not applicable/relevant for your study N/A 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 briefly explain why the item is not applicable/relevant for your study

) and centers (volume) in each group
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 Table 1 15-i) Report demographics associated with digital divide issues In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
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 briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?rm=full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aW… 32/42 See Table 1 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 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.
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 briefly explain why the item is not applicable/relevant for your study See Table 2 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). Copy and paste relevant sections from the manuscript (include quotes in quotation 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 analyses were intenttotreat.
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 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 partial η2 = .005), so subpopulation analyses were not indicated. The ANCOVA with the full sample found that there were no program effects (P = .169, partial η2 = .006) at 10week followup. Mediator Outcomes: Behavioral Activation, Negative Thoughts, and Knowledge From pretest to 6week followup, the ANCOVA with the full sample found statistically significant program effects on each mediator measure: BADS (P = .004, partial η2 = .027); ATQR (P = .014, partial η2 = .020); and knowledge (P = .024, partial η2 = .017). The condition by EAP access interaction effects were not statistically significant on any of the mediator measures, indicating that there was no need for subpopulation analyses. From pretest to 10week follow up, the condition by EAP access interaction effects were not statistically significant on any of the mediator measures. The ANCOVA with the full sample found statistically significant program effects on BADS (P = .012, partial η2 = .021), but not on ATQR (P = .336, partial η2 = .003) or knowledge (P = .545, partial η2 = .001). Worksite Outcomes From pretest to 6week followup, the condition by EAP access interaction effects were not statistically significant except on the worksite distress measure (P = .025, partial η2 = .017), indicating subpopulation analysis for the worksite distress measure only. The ANCOVAs with the full sample at 6week followup found no statistically significant program effects on: WLQ (P = .098, partial η2 = .009); absenteeism (P = .161, partial η2 = .007); presenteeism (P = .089, partial η2 = .010); work engagement (P = .748, partial η2 = .001); or life satisfaction (P = .115, partial η2 = .008). However, separate subpopulation analyses at 6week followup on the workplace distress measure indicated significant program effects for subjects with EAP access (P = .007, partial η2 = .080) and no program effects for subjects without EAP access (P = .642, partial η2 = .001). From pretest to 10week followup, the condition by EAP access interaction effects were not statistically significant on any of the worksite outcome measures. The ANCOVA with the full sample at 10week followup found no statistically significant program effects on any of the worksite outcome measures.

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).

2 3 4 5
subitem not at all important essential 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 Program Utilization, Satisfaction, and Usability On average, participants in the treatment arm logged into the MoodHacker app 16.0 times (SD = 13.3, range = 149) for a total duration of 1.3 hour (SD = 1.3, range = 06.5) between pretest and 6 week followup. The average rating of program satisfaction was 4.6 (SD = 1.0) on a 6point scale indicating that the participants were mostly satisfied with the intervention. Participants also completed the System Usability Scale [38] at the 6week followup, which provides a quantitative measure of program ease of use. The average System Usability Scale score was 79.7 (SD = 17.1), corresponding to a usability grade of B+ for the intervention program.
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 briefly explain why the item is not applicable/relevant for your study N/A 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified 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 briefly explain why the item is not applicable/relevant for your study See Table 2 and Intervention Effects section: Intervention Effects Table 2 provides means and standard deviations for each outcome by assessment time and condition, along with pretest to 6week followup and pretest to 10week followup outcome analyses. Depression Symptoms From pretest to 6week followup, the ANCOVA with the full sample found statistically significant program effects on depression symptoms (PHQ9) (P = .013, partial η2 = .021). However, a statistically significant condition by user EAP access interaction effect was also obtained (P = .050, partial η2 = .013), indicating differential program effects depending upon subjects' access to an EAP. Separate subpopulation analyses indicated significant program effects for subjects with EAP access (P = .004, partial η2 = .093) and no program effects for subjects without EAP access (P = .655, partial η2 = .001). From pretest to 10week followup, the condition by EAP access interaction effect was not statistically significant (P = .211, partial η2 = .005), so subpopulation analyses were not indicated. The ANCOVA with the full sample found that there were no program effects (P = .169, partial η2 = .006) at 10week followup. Mediator Outcomes: Behavioral Activation, Negative Thoughts, and Knowledge From pretest to 6week followup, the ANCOVA with the full sample found statistically significant program effects on each mediator measure: BADS (P = .004, partial η2 = .027); ATQR (P = .014, partial η2 = .020); and knowledge (P = .024, partial η2 = .017). The condition by EAP access interaction effects were not statistically significant on any of the mediator measures, indicating that there was no need for subpopulation analyses. From pretest to 10week follow up, the condition by EAP access interaction effects were not statistically significant on any of the mediator measures. The ANCOVA with the full sample found statistically significant program effects on BADS (P = .012, partial η2 = .021), but not on ATQR (P = .336, partial η2 = .003) or knowledge (P = .545, partial η2 = .001). Worksite Outcomes From pretest to 6week followup, the condition by EAP access interaction effects were not statistically significant except on the worksite distress measure (P = .025, partial η2 = .017), indicating subpopulation analysis for the worksite distress measure only. The ANCOVAs with the full sample at 6week followup found no statistically significant program effects on: WLQ (P = .098, partial η2 = .009); absenteeism (P = .161, partial η2 = .007); presenteeism (P = .089, partial η2 = .010); work engagement (P = .748, partial η2 = .001); or life satisfaction (P = .115, partial η2 = .008). However, separate subpopulation analyses at 6week followup on the workplace distress measure indicated significant program effects for subjects with EAP access (P = .007, partial η2 = .080) and no program effects for subjects without EAP access (P = .642, partial η2 = .001). From pretest to 10week followup, the condition by EAP access interaction effects were not statistically significant on any of the worksite outcome measures. The ANCOVA with the full sample at 10week followup found no statistically significant program effects on any of the worksite outcome measures.

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). 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 briefly explain why the item is not applicable/relevant for your study The MoodHacker app produced clinically significant effects from pretest to 6week followup with the full sample on depression symptoms (PHQ9) (partial η2 = .021). For individuals with access to an EAP the app had stronger effects (partial η2 = .093). The app did not have significant effects on depression symptoms among participants who did not have access to an EAP. Possible reasons for the stronger program effects on participants with EAP access are discussed below. Following the 6week assessment, the daily program emails (ie, prompts to view content, introduction of key concepts and skills, tips to optimize use of program, and encouragement to track mood and activities) were ended. At 10week assessment program effects on depression symptoms were no longer significant. On measures of behavioral activation for depression (ie, actively engaging in positive selfcare activities), negative thoughts/self statements, and depression knowledge, significant program effects were found at 6week followup for all participants, regardless of EAP access. These program effects were consistent across measures, although the effects were smalltomedium in size. Program effects were not significant at the10week assessment. Regarding worksite outcome measures, program effects were found only on worksite distress at 6week followup among participants with access to an EAP. At 10week assessment no program effects on these measures were significant. In sum, intervention effects were found compared to alternativecare subjects at 6week followup on: the clinical outcome measure (ie, severity of depression symptoms) for subjects with EAP access; all three mediating outcome measures (ie, behavioral activation, negative thoughts, and depression knowledge) for all subjects; and only one of the worksite outcome measures (ie, worksite distress) among subjects with EAP access. However, no program effects remained significant at 10week followup.

Importance of Continued Engagement
The finding that all intervention effects dissipated following the termination of program contacts suggests that continued program initiated outreach with the user is likely an important factor in retaining user participation and engagement with the program. While daily email contact may not be required to maintain program effects beyond 6 weeks, some level and type of ongoing contact (eg, SMS, email, push notification) may be needed. More research is needed to determine the optimal level and type of program contact that is needed to retain program efficacy.

EAP Participants Versus NonEAP Participants
The inclusion of subjects without EAP access provided an important opportunity to evaluate program efficacy with this population and to compare program efficacy for subjects with and without EAP access. It was expected that the EAP subjects who chose to participate in this study were likely to be quite similar to realworld individuals who

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 briefly explain why the item is not applicable/relevant for your study More research is needed to determine the optimal level and type of program contact that is needed to retain program efficacy. AND ...the clinical significance of the effect size found on depression symptoms among the targeted EAP population is quite encouraging, and suggests that EAPs offering the use of this application might reasonably expect to find clinically significant reductions in depression symptoms in their employee populations. Conclusions regarding program effects for nonEAP individuals are less clear.

20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 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.
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 briefly explain why the item is not applicable/relevant for your study

Study Limitations
We acknowledge several limitations in this initial efficacy trial and offer some caution in interpreting the findings. First, although random assignment was used, all the participants volunteered for the study and thus represent a convenience sample of interested individuals and cannot be considered representative of the population of potential users. Second, participants completed selfreport surveys, the validity and reliability of which may be somewhat suspect. Third, the reliability of some measures is only moderate and this may have attenuated the effect size of the intervention effects found in the study. Fourth, while the attrition rates in the study were relatively low in this sponsored research, which included subject compensation, it cannot be concluded that the subject completion rate found here would occur at the same rate without compensation for participation. Lastly, future research might usefully explore the frequency and type of program contacts, an extended period of program contacts, and longerterm followup.

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

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 briefly explain why the item is not applicable/relevant for your study Analyses of baseline data indicated that the nonEAP subjects had lower incomes, were less likely to be fully employed, and had less education. While the veracity of such attributions regarding motivation for participation is difficult to ascertain, the lack of program effects on depression symptoms in the nonEAP participants is consistent with this notion. Regardless, the clinical significance of the effect size found on depression symptoms among the targeted EAP population is quite encouraging, and suggests that EAPs offering the use of this application might reasonably expect to find clinically significant reductions in depression symptoms in their employee populations.
https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?rm=full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aW… 39/42 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 briefly explain why the item is not applicable/relevant for your study First, although random assignment was used, all the participants volunteered for the study and thus represent a convenience sample of interested individuals and cannot be considered representative of the population of potential users. ... Fourth, while the attrition rates in the study were relatively low in this sponsored research, which included subject compensation, it cannot be concluded that the subject completion rate found here would occur at the same rate without compensation for participation.

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 briefly explain why the item is not applicable/relevant for your study

ClinicalTrials.gov NCT02335554
24) Where the full trial protocol can be accessed, if available Does your paper address CONSORT subitem 24? * X27) Conflicts 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 (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.
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 briefly explain why the item is not applicable/relevant for your study

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?
Included a variety of details throughout the manuscript that had not been previously stated.
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Several hours
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