An Eight-Week, Web-Based Mindfulness Virtual Community Intervention for Students’ Mental Health: Randomized Controlled Trial

Background Innovative interventions are needed to address the increasing mental health needs of university students. Given the demonstrated anxiolytic and antidepressant benefits of mindfulness training, we developed an 8-week, Web-based Mindfulness Virtual Community (MVC) intervention informed by cognitive behavioral therapy (CBT) constructs. Objective This study investigated the efficacy of the MVC intervention in reducing symptoms of depression, anxiety, and stress among undergraduate students in Toronto, Canada. The secondary outcomes included quality of life, life satisfaction, and mindfulness. Methods The first 4 weeks of the full MVC intervention (F-MVC) comprised: (1) 12 video-based modules with psycho-education on students’ preidentified stressful topics and topically applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided, 20-min live videoconferences. The second 4 weeks of F-MVC involved access only to video-based modules. The 8-week partial MVC (P-MVC) comprised 12 video-based modules. A randomized controlled trial was conducted with 4 parallel arms: F-MVC, P-MVC, waitlist control (WLC), and group-based face-to-face CBT; results for the latter group are presented elsewhere. Students recruited through multiple strategies consented and were randomized: WLC=40; F-MVC=40, P-MVC=39; all learned about allocation after consenting. The online surveys at baseline (T1), 4 weeks (T2), and 8 weeks (T3) included the Patient Health Questionnaire-9 item, Beck Anxiety Inventory, Perceived Stress Scale, Quality of Life Scale, Brief Multi-Dimensional Students Life Satisfaction Scale, and Five-Facet Mindfulness Questionnaire. Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible confounders (gender, age, birth country, paid work, unpaid work, physical activities, self-rated health, and mental health counseling access). Results Of the 113 students who provided T1 data, 28 were males and 85 were females with a mean age of 24.8 years. Participants in F-MVC (n=39), P-MVC (n=35), and WLC (n=39) groups were similar in sociodemographic characteristics at T1. At T3 follow-up, per adjusted comparisons, there were statistically significant reductions in depression scores for F-MVC (score change −4.03; P<.001) and P-MVC (score change −4.82; P<.001) when compared with WLC. At T3, there was a statistically significant reduction in anxiety scores only for P-MVC (score change −7.35; P=.01) when compared with WLC. There was a statistically significant reduction in scores for perceived stress for both F-MVC (score change −5.32; P<.001) and P-MVC (score change −5.61; P=.005) compared with WLC. There were statistically significant changes at T3 for quality of life and mindfulness for F-MVC and P-MVC vs WLC but not for life satisfaction. Conclusions Internet-based mindfulness CBT–based interventions, such as F-MVC and P-MVC, can result in significant reductions in symptoms of depression, anxiety, and stress in a student population. Future research with a larger sample from multiple universities would more precisely test generalizability. Trial Registration International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275


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.

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

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").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All co-interventions were delivered via the web-based platform 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Students' Mental Health" subitem not at all important 1 2 3 4 5 essential

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) 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 The intervention features/functionalities/components are described like this "The first 4 weeks of the full MVC intervention (F-MVC) comprised: (1) 12 video-based modules with psycho-education on students' preidentified stressful topics and topically applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided, 20-min live videoconferences. The second 4 weeks of F-MVC involved access only to videobased modules. The 8-week partial MVC (P-MVC) comprised 12 video-based modules." The comparator is described like this "A randomized controlled trial was conducted with 4 parallel arms: F-MVC, P-MVC, waitlist control (WLC), and group-based face-to-subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The word count limit for Abstract is a challenge to add so much detail. We tried to add some of it like this "The first 4 weeks of the full MVC intervention (F-MVC) comprised: (1) 12 video-based modules with psycho-education on students' preidentified stressful topics and topically applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided, 20-min live videoconferences. The second 4 weeks of F-MVC subitem not at all important 1 2 3 4 5 essential 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) 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 Like this "Students recruited through multiple strategies consented and were randomized: WLC=40; F-MVC=40, P-MVC=39; all learned about allocation after consenting." We could not use the exact wording of "blinded" in the Abstract as students and research assistant were blind only up to the stage of consent provision. The main paper to describe the full context and uses the word "blinded'.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study First in the Methods it is provided like this "students recruited through multiple strategies consented and were randomized: WLC=40; F-MVC=40, P-MVC=39". Then, in the Results it is provided like this "Of the 113 students who provided T1 data.... Participants in F-MVC (n=39), P-MVC (n=35), and WLC (n=39)  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 Not applicable as the intervention was effective for changing primary outcomes.

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) The information is provided like this "Mental health disorders, especially those involving depression, anxiety, and stress, are a rising problem among college students internationally. In the United States, analyses of college data show that mental health disorders are among the top five diagnostic categories seen at college health services and responsible for the highest number of visits per student (4.93) with depression and anxiety at the top [1]. Furthermore, multiple studies indicate an increasing prevalence of mental health disorders, especially depression and anxiety, in undergraduate students [1][2][3][4][5][6][7][8]. In Canada, a large study of nursing students indicated the prevalence of mild-to-severe depression, anxiety, and stress at 33%, 39%, and 38%, respectively [9]. Similar rates of mental health difficulties are reported among students from other countries [10][11][12][13][14]. The counseling centers in colleges and universities provide care to students in distress through various models such as clinical services, advising, awareness workshops, and training programs [15]. However, students often experience difficulties in accessing these services (eg, stigma and time concerns for in-person sessions along with financial cost for some services) [16,17], while counseling centers are overwhelmed due to limited resources. An analysis of Canadian colleges and universities revealed that enrollment in the province of Ontario increased by 27% between 2004 and 2012, but the budget for counseling centers increased by 5%, leading to just 1 campus-based counselor for 1300 to 4835 students [18]. Similarly, in the United States, a 2014 study indicated that the average ratio of counselors to students was 1 to 2081 [19]. New and accessible strategies are needed to address the students' mental health and at an early stage. One such approach is mindfulness-based techniques.
Mindfulness is defined as "the awareness that emerges through paying attention on purpose, in the present, and nonjudgmentally to the unfolding of experience moment by moment" [20]. The techniques learned in mindfulness practices involve nonjudgmental attention directed to each present moment. Although mindfulness meditation has been practiced for centuries in Buddhist and other spiritual traditions, its application to psychological health in the West emerged in 1980s when Jon Kabat-Zinn examined its clinical use in treating chronic pain [21]. This technique known as mindfulness-based stress reduction has a core focus on "intensive [and repeated] training of mindfulness meditation to help individuals relate to their physical and psychological conditions in a more accepting and nonjudgmental ways" [22]. Further scholarly work, such as by Segal et al [23], combined the principles of mindfulness with cognitive behavioral therapy (CBT). This program called mindfulness-based cognitive therapy (MBCT) has been researched for treating mental health conditions, especially depression. In addition to the principles of mindfulness practice, MBCT "aims to change one's awareness of and relationship to thoughts and emotions" to reduce the associations between negative automatic thinking and dysphoria [22]. Other psychotherapeutic techniques with mindfulness-orientation include dialectical behavior therapy and acceptance and commitment therapy, but the meditation practice is only one aspect of the full approach. Evidence shows that mindfulness-based interventions positively impact psychological [22,24]  Like this " In relation to student population, several recent reviews have indicated that in-person mindfulness-based interventions have a positive effect on students' mood and their levels of stress, anxiety, and depression [39][40][41][42].
However, a handful of student studies exist on Web-based mindfulness-based programs despite its potential to complement overstretched traditional counseling services on campuses [43]. This emerging scholarly work with students has examined the impact of Web-based mindfulness on a variety of mental health -related issues and demonstrated improvements in outcomes such as mental health, well-being, mindfulness, stress and depression symptoms, life satisfaction, and social connectedness [43][44][45][46][47][48][49][50]. However, the effectiveness of a Web-based mindfulness intervention when combined with the constructs of CBT remains an area requiring more rigorous examination. This is a missed opportunity given that systematic reviews show that internet-based CBT is significantly effective compared with control groups in reducing anxiety, especially when supported by therapist's email or phone contact [51], and in reducing depression symptoms [52]. There is the potential for substantial gains by combining these two techniques-mindfulness and CBT-through Web-based interventions for students who are also technologically fluent and capable; studies also indicate that students prefer to self-initiate help-seeking for Web-based services compared with in-person services [53]. There is also a need to better understand the optimal duration and delivery style of Web-based mindfulness-CBT interventions. Although durations of 6 to 8 weeks are more common, 2-week interventions [48] and a single Web session [47] have also been used. In terms of delivery, some of these studies supported the interventions with reminders, written feedback, and coaching, whereas others were passive. High attrition rate was a common problem in several student studies [44,45,48,50], although it was a significantly less prevalent problem in studies that used coaching, reminders, and feedback strategies [43,49]. Indeed, further scholarly work is needed to inform development of student-friendly and effective Web-based mindfulness-CBT programs. Thus, our team developed a Mindfulness Virtual Community (MVC) Web-based program (described below) after conducting eight METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Like this ""Thus, our team developed a Mindfulness Virtual Community (MVC) Webbased program (described below) after conducting eight focus groups with students and incorporating comprehensive review of pertinent literature [54][55][56][57][58].

Study Objective
To examine the efficacy of an MVC program for mental health among undergraduate students in a Canadian university, we conducted a pilot RCT with 4 parallel arms: full MVC (F-MVC), partial MVC (P-MVC), waitlist control (WLC), and group-based face-to-face CBT mindfulness. As the main focus of the trial was to examine the MVC program, we report here the impact of F-MVC and P-MVC vs WLC; the results for face-to-face CBT mindfulness are presented elsewhere. The primary outcomes were symptoms of depression, anxiety, and stress, and secondary outcomes were quality of life, life satisfaction, and mindfulness. It was hypothesized that (1) symptom scores for depression, anxiety, and stress at 8 weeks (T3) will be significantly improved in the F-MVC group when compared with the WLC group and (2) scores for quality of life, life satisfaction, and mindfulness at T3 will be significantly better for the F-MVC intervention group than the WLC group. The P-MVC intervention was included to explore a significantly less expensive alternative to delivering beneficial effects and was hypothesized to have similar but 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Like this "These students started the parallel-arm RCT on January 16, 2017", and like this "Participating students were randomized to either the F-MVC intervention, P-MVC intervention, WLC, or a face-to-face CBT mindfulness group using 1:1:1:1 block randomization. We report here the impact of F-MVC and P-MVC vs WLC, whereas the results for face-to-face CBT mindfulness are being presented elsewhere (manuscript under review). The randomization allocation sequence was computer-generated by an off-site team member who concealed it in sequentially numbered, opaque envelopes [61]. These envelopes were opened only after a written consent, keeping participants and research assistants blind to allocation." 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 briefly explain why the item is not applicable/relevant for your study There were no changes in the eligibility criteria or recruitment methods.
subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, 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 fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The main paper also provides information about the intervention like this "Once the intervention was deployed, the content of modules and platform structure remained unchanged." subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Student eligibility criteria were a minimal age of 18 years, English language fluency, self-reported high level of confidence to complete the study, and current undergraduate student status. Their ability to use a computer and smartphone and internet literacy were assumed to be de facto skills. The study was advertised as "Mindfulness Approaches to Wellbeing on Campus" and used multiple recruitment strategies including study posters, class visits on permission of course directors, and email invitations via listservs of student associations in the Faculty of Health and Faculty of Liberal Arts. Interested students contacted the research staff via email or phone and were further screened for substance abuse and indications of psychoses (ie, hallucinations). If either of these two conditions "interfered in routine life within last month," they were excluded and provided a list of mental health resources for access. Eligible and willing students received detailed information in-person about the study and provided informed

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

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 Like this "Their ability to use a computer and smartphone and internet literacy were assumed to be de facto skills." subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.

Does your paper address subitem 4a-ii? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Like this in the Recruitment and Randomization section "The study was advertised as "Mindfulness Approaches to Wellbeing on Campus" and used multiple recruitment strategies including study posters, class visits on permission of course directors, and email invitations via listservs of student associations in the Faculty of Health and Faculty of Liberal Arts. Interested students contacted the research staff via email or phone and were further screened for substance abuse and indications of psychoses (ie, hallucinations). If either of these two conditions 'interfered in routine life within last month,' they were excluded and provided a list of mental health resources for access. Eligible and willing students received detailed information in-person about the study and provided informed written consent." In the same in-person meeting the research assistant opened the opaque envelopes with concealed allocations after written consent and students were randomized.
In the Recruitment and Randomization section, we also provide information on how we withheld the possibility of multiple-account creation by the participants like this "Each participant received a unique ID number. Those in the F-MVC and P-MVC groups also received a temporary password to access the Web-based intervention; they changed the password after first login while IDs remained the same to eliminate the possibility of creating multiple accounts or identities." In the section on Study Arms, we provide more information on the contact with the research staff like this "The students in both [intervention] groups received email reminders from the project staff before the release of each new module, whereas the reminders for conference chat were sent only to the F-MVC group." The measurement of demographics and outcomes were all online and its described subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

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 The information is provided like this "Interested students contacted the research staff via email or phone and were further screened for substance abuse and indications of psychoses (ie, hallucinations). If either of these two conditions "interfered in routine life within last month," they were excluded and provided a list of mental health resources for access. Eligible and willing students received detailed information in-person about the study and provided informed written consent. Participants were able to select an honorarium of Can $50 or 2% in course grade (for professors who gave this permission) or three credits (equivalent to 2% course grade) in the Undergraduate Research Participation Pool of the Department of Psychology. Each participant also received a resource list that included information about health and social services on campus and in the community (eg, 24×7 "Good To Talk" helpline for postsecondary students in Ontario). Although our study participants largely comprised healthy volunteers, our protocol included a safety mechanism whereby participants were asked verbally and in the consent form to contact the research staff if they felt distress during the trial period so that "limited counselling with a clinical psychologist could be arranged, if needed"; the collaborating psychologist was at arms' length from the subitem not at all important 1 2 3 4 5 essential 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 The outcomes were measured by online surveys completed by students. This is described in the paper under the Measurement section like this "Participants in all groups completed online surveys at T1, T2, and T3." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
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 The outcomes were measured by online surveys completed by students. This is described in the paper under the Measurement section like this "Participants in all groups completed online surveys at T1, T2, and T3." subitem not at all important 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 Please see the screen shot in Figure 2 in the paper. Only the university name, which received the research grant, and the partnering IT company name appear on it.

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).

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 Under the section The Mindfulness Virtual Community Program, we provide information "The modules' topics were informed by our findings from the focus groups with students [54,55]. The module scripts and audio recordings were created by one of the investigator with extensive clinical experience (PR) and drew from combined mindfulness and CBT principles. The choice of moving and still images used in the creation of the videos involved collaborative work (PR, CE, and FA)." In the same section, more information is provided "The Web platform for the intervention had separate logins for the student participant and the videoconference moderator ( Figure 2). This was developed in partnership with the industry partner, ForaHealthyme Inc....The moderator (independent counselor with a master's degree in psychology and training in mindfulness) had weekly discussions with the team clinician (PR) to optimize engagement during videoconferences." The Conflict of Interest section states "It is the understanding of the university and researchers that the Project Intellectual Property belongs to the CE, FA, and PR. The industry partner ForaHealthyme has title to the copyrights of any computer source code software that was developed out of this research project." The Acknowledgement section statement includes "The work reported in this paper was funded by the Canadian Institutes for Health Research (CIHR), eHealth Innovations Partnership Program Grant; grant number EH1-143553. The project principal investigators are CE (nominated), FA, and PR." Further, "The data analysis was conducted by biostatistician on our team (RM) who was not involved in the content development of the intervention and its deployment. The statistical software SAS 9.4 was used for statistical analyses." subitem not at all important 1 2 3 4 5 essential

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
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 We describe it like this "Each of the 12 modules consists of one educational content and one mindfulness-practice content video, recorded in male and female voices with low volume background music, and offered in high-and low-resolution videos (a total of 8 videos per module). The modules' topics were informed by our findings from the focus groups with students [54,55]. The module scripts and audio recordings were created by one of the investigators with extensive clinical experience (PR) and drew from combined mindfulness and CBT principles. The choice of moving and still images used in the creation of the videos involved collaborative work (PR, CE, and FA).
The Web platform for the intervention had separate logins for the student participant and the videoconference moderator ( Figure 2). This was developed in partnership with the industry partner, ForaHealthyme Inc.......The moderator (independent counselor with a master's degree in psychology and training in mindfulness) had weekly discussions with the team clinician (PR) to optimize engagement during videoconferences. Once the intervention was deployed, the content of modules and platform structure remained unchanged." subitem not at all important

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

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study its provided like this "Once the intervention was deployed, the content of modules and platform structure remained unchanged."

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Summary of some of the quality elements: We used the parallel-arm RCT design and registered it before collecting data and starting the intervention delivery. We provide comprehensive details about the development of intervention and conducted focus groups to inform its content and design. We used validated scales to measure the primary and secondary outcomes. The group allocation was generated by an off-site biostatistician and it was sealed in opaque envelopes. The participants and research assistant were blind to the allocation until after the written consent.
In the paper, an example of ensuring the quality process in the delivery/use/measurement of intervention is "Each participant received a unique ID number. Those in the F-MVC and P-MVC groups also received a temporary password to access the Web-based intervention; they changed the password after first login while IDs remained the same to eliminate the possibility of creating multiple accounts or identities." The statistical analysis section provides several details, such as : 1. "The data analysis was conducted by biostatistician on our team (RM) who was not involved in the content development of the intervention and its deployment. The statistical software SAS 9.4 was used for statistical analyses." 2. "To account for multiple comparisons, due to the multiple outcomes analyzed, we considered P<.02 as statistically significant." 3. "The approach to the outcome analysis was Intention-to-Treat. First, we analyzed the data without any imputation for missing values and then repeated the analysis with an imputation of missing values using a last observation carried forward 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.

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 Figure 1 presents the components of the full intervention. The details on the module content are provided in Table 1 for the 12 topics and duration of each. Textbox1 provides examples of 2 modules for the psychoeducation part and the mindfulness practice part. A screen shot provides information on the look of the platform for users. A flow chart provides the recruitment process.

teh5-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.
subitem not at all important 1 2 3 4 5 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 Screen shot is provided in the paper.

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).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The participation was completely voluntary and its described in the paper as "Student eligibility criteria were a minimal age of 18 years, English language fluency, self-reported high level of confidence to complete the study, and current undergraduate student status. Their ability to use a computer and smartphone and internet literacy were assumed to be de facto skills. The study was advertised as "Mindfulness Approaches to Wellbeing on Campus" and used multiple recruitment strategies including study posters, class visits on permission of course directors, and email invitations via listservs of student associations in the Faculty of Health and Faculty of Liberal Arts. Interested students contacted the research staff via email or phone and were further screened for substance abuse and indications of psychoses (ie, hallucinations). If either of these two conditions "interfered in routine life within last month," they were excluded and provided a list of mental health resources for access. Eligible and willing students received detailed information in-person about the study and provided informed written consent. Participants were able to select an honorarium of Can $50 or 2% in course grade (for professors who gave this permission) or three credits (equivalent to 2% course grade) in the Undergraduate Research Participation Pool of the Department of Psychology. Each participant also received a resource list that included information about health and social services on campus and in the community (eg, 24×7 "Good To Talk" helpline for postsecondary students in Ontario). Although our study participants largely comprised healthy volunteers, our protocol included a safety mechanism whereby participants were asked verbally and in the consent form to contact the research staff if they felt distress during the subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study "The Mindfulness Virtual Community Program: A total of three components of the Web-based MVC program ( Figure 1) were (1) youth-specific mental health education and mindfulness-practice modules, delivered via video recordings for participants to watch and listen to on personal computers, phones, and tablets at convenient times; (2) anonymous, asynchronous peer-to-peer discussion boards pertaining to mental health and mindfulness practice; and (3) anonymous, 20-min live videoconferences (group-based) on module topics guided by a mental health professional.
Each of the 12 modules consists of one educational content and one mindfulnesspractice content video, recorded in male and female voices with low volume background music, and offered in high-and low-resolution videos (a total of 8 videos per module). The modules' topics were informed by our findings from the focus groups with students [54,55]. The module scripts and audio recordings were created by one of the investigators with extensive clinical experience (PR) and drew from combined mindfulness and CBT principles. The choice of moving and still images used in the creation of the videos involved collaborative work (PR, CE, and FA). Table 1 lists the topics of 12 modules and video duration (average of male and female voice), and Textbox 1 provides examples of the module content.
The Web platform for the intervention had separate logins for the student participant and the videoconference moderator ( Figure 2). This was developed in partnership with the industry partner, ForaHealthyme Inc. The F-MVC student version provided access to the video-based modules, text-based peer-to-peer discussion forum, a calendar to book an upcoming live videoconference, a video room (camera being off as default) with ability to privately text the moderator, and a resource page with contact information on various social and health services. The moderator version offered access to the student version along with additional features such as populating the calendar with dates and times for the live videoconferences, starting the videoconference with camera turned on for the moderator by default, and responding privately to incoming text messages. The moderator (independent counselor with a master's degree in psychology and training in mindfulness) had weekly discussions with the team clinician (PR) to optimize engagement during videoconferences. Once the intervention was

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.

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 briefly explain why the item is not applicable/relevant for your study "The partial and full intervention participants were instructed to use the platform ad

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The students in both groups received email reminders from the project staff before the release of each new module, whereas the reminders for conference chat were sent only to the F-MVC group." subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

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.

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 No other co-intervention was provided.
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 "Main Outcomes and Measurement: Participants in all groups completed online surveys at T1, T2, and T3. The primary outcomes were depression, anxiety, and stress symptoms. For the measurement of depression symptoms, we used the 9-item Patient Health Questionnaire (PHQ-9) [62]; each item is rated on a scale of 0 to 3, and the total score range is 0 to 27 (score 0-9 indicates no/subclinical level of depression, 10-14 moderate, 15-19 moderately severe, and ≥20 severe). The symptoms of anxiety were measured by using the 21-item Beck Anxiety Inventory (BAI) [63]; each item is rated on a scale of 0 to 3, and the total score range is 0 to 63 (score 0-21 indicates no/low level of anxiety, 22-35 moderate, and ≥36 severe). For the measurement of stress, we used the 10-item Perceived Stress Scale (PSS) [64]; each item is rated on a scale of 0 to 4, and the total score range is 0 to 40 (score 0-13 indicates mild level of stress, 14-26 moderate, and 27-40 high). The secondary outcomes were quality of life, life satisfaction, and mindfulness. We used the 16-item Quality of Life Scale (QOLS) [65], which has a total score range of 16 to 112, and each item is rated on a scale of 1 to 7. The student life satisfaction was measured by using the 6-item Brief Multidimensional Students' Life Satisfaction Scale-Peabody Treatment Progress Battery (BMSLSS-PTPB) [66]; each item is rated on a scale of 1 to 5, and item scores are averaged together to give a total score that ranges from 1 to 5. The level of mindfulness was measured by the 24-item Five-Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) [67]; each item is rated on a scale of 1 to 5, and the total score range is 24 to 120. The subscales in the FFMQ-SF are nonreactivity to inner experience (5 items), observing (4 items), acting with awareness (5 items), describing (5 items), and nonjudging of inner experience (5 items). We assessed each of the scale for internal consistency at the T1, T2, and T3 datasets, and Cronbach alpha ranged from .82 to .94: .89,and .86;BAI .93,.93,and .94;PSS .90,.89,and .90;QOLS .87,.91,and .

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text

Your answer
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No changes were made.
subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.

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 Your answer 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Although our study participants largely comprised healthy volunteers, our protocol included a safety mechanism whereby participants were asked verbally and in the consent form to contact the research staff if they felt distress during the trial period so that "limited counselling with a clinical psychologist could be arranged, if needed"; the collaborating psychologist was at arms' length from the trial. No instance of such request arose during the reported study." There was no interim analysis planned given the pilot nature of the study.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The randomization allocation sequence was computer-generated by an off-site team member who concealed it in sequentially numbered, opaque envelopes [61]. These envelopes were opened only after a written consent, keeping participants and research assistants blind to allocation." 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participating students were randomized to either the F-MVC intervention, P-MVC intervention, WLC, or a face-to-face CBT mindfulness group using 1:1:1:1 block randomization. We report here the impact of F-MVC and P-MVC vs WLC, whereas the results for face-to-face CBT mindfulness are being presented elsewhere (manuscript under review). " Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The randomization allocation sequence was computer-generated by an off-site team member who concealed it in sequentially numbered, opaque envelopes [61]. These envelopes were opened only after a written consent, keeping participants and research assistants blind to allocation." 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The randomization allocation sequence was computer-generated by an off-site team member who concealed it in sequentially numbered, opaque envelopes [61]. These envelopes were opened only after a written consent, keeping participants and research assistants blind to allocation." 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).
subitem not at all important 1 2 3 4 5 essential 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The randomization allocation sequence was computer-generated by an off-site team member who concealed it in sequentially numbered, opaque envelopes [61]. These envelopes were opened only after a written consent, keeping participants and research assistants blind to allocation." 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".
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 Your answer 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Not applicable
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 "The trial data were first analyzed using descriptive statistics (means, frequencies, and proportions) to describe the sample characteristics for the control, partial intervention, and the full intervention groups at T1. The mean scores for each of the 6 scales (ie, primary and secondary outcomes) were calculated for the T1, T2, and T3 for the three groups. Effect size was calculated using Cohen d, by subtracting the mean of the treatment group from the mean of the control group and by dividing the mean difference with the pooled SD.
The approach to the outcome analysis was Intention-to-Treat. First, we analyzed the data without any imputation for missing values and then repeated the analysis with an imputation of missing values using a last observation carried forward (LOCF) method. The results were similar for the complete-case analysis and analysis with LOCF; both are reported (see Multimedia Appendices 1 and 2). The attrition rates across the three groups were low and similar between T1 and T3 (2 for F-MVC, 1 for P-MVC, and 1 for WLC). To compare score changes over time for the outcomes, linear regression analysis was done. The generalized estimation equation (GEE) with AR(1) covariance structure was used to adjust for repeated measures. The result of GEE analysis has the interpretation of population average. The mean score differences were calculated between groups and adjusted for potential confounding variables (ie, gender, age, country of birth, paid work, unpaid work, vigorous physical activities, self-rated health, and access to mental health private counseling via insurance). This choice of confounding variables was based on existing knowledge and theory. Scales were calculated as follows: if the number of missing items was more than half of the number of items of a scale, the scale was considered missing; otherwise the missing items were imputed in accord with the average of the nonmissing items of the scale. To account for multiple comparisons, due to the multiple outcomes analyzed, we considered P<.02 as statistically significant. The data analysis was conducted by biostatistician on our team (RM) who was not involved in the content development of the intervention and subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The approach to the outcome analysis was Intention-to-Treat. First, we analyzed the data without any imputation for missing values and then repeated the analysis with an imputation of missing values using a last observation carried forward (LOCF) method. The results were similar for the complete-case analysis and analysis with LOCF; both are reported (see Multimedia Appendices 1 and 2)." "Scales were calculated as follows: if the number of missing items was more than half of the number of items of a scale, the scale was considered missing; otherwise the missing items were imputed in accord with the average of the nonmissing items of the scale."

X26) REB/IRB Approval and Ethical Considerations [recommended as
subheading under "Methods"] (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We could not conduct sub-analysis, such as by gender, given modest sample size. This is acknowledged in the discussion by recommending future studies with larger sample and from multiple sites.

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer

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) 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 Your answer

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 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, please see figure 3, Study Flow Diagram. Result section states "A total of 119 undergraduate students were randomized to the WLC, F-MVC, and P-MVC groups; 1 participant, following consent, was found to be underage and was therefore excluded, and 5 additional participants were nonrespondents to the T1 survey. Out of the 113 students who completed the T1 survey, a few were lost as nonrespondents at the follow-up; altogether the attrition was relatively low across all three groups (F-MVC: 2/39, P-MVC: 1/35, and WLC: 1/39; Figure 3)." subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Result section states "A total of 119 undergraduate students were randomized to the WLC, F-MVC, and P-MVC groups; 1 participant, following consent, was found to be underage and was therefore excluded, and 5 additional participants were nonrespondents to the T1 survey. Out of the 113 students who completed the T1 survey, a few were lost as nonrespondents at the follow-up; altogether the attrition was relatively low across all three groups (F-MVC: 2/39, P-MVC: 1/35, and WLC:

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 figures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The recruitment of eligible undergraduate students occurred during December 7, 2016 and January 10, 2017. These students started the parallel-arm RCT on January 16, 2017, with a baseline survey (T1) followed by exposure to 2 interventions, a 4-week online survey (T2), and an 8-week online survey (T3). The 8-week-long interventions of F-MVC and P-MVC started on January 22, 2017 and 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" 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  Table 3. Symptom levels for depression, anxiety, and stress scales. Figure 4. Box plots for the mean scores of depression, anxiety, and stress scales. Table 4. Mean (SD) and effect size for depression, anxiety, and stress scales.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We could not do such analysis given modest sample size. Further, all participants were university students so their digital skills are likely to be quite similar.

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.
subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The tables provide "N" for each group in the trial and the Study Flow Diagram shows the participants, approached, randomized, lost and analyzed.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 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).
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 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The primary and secondary outcomes are analyzed using their mean scores and the change in mean scores.
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 All primary (depression, anxiety, stress) and secondary outcomes (life satisfaction, quality of life, mindfulness and academic performance/class absenteeism) were registered before data collection.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
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 briefly explain why the item is not applicable/relevant for your study "Although our study participants largely comprised healthy volunteers, our protocol included a safety mechanism whereby participants were asked verbally and in the consent form to contact the research staff if they felt distress during the trial period so that "limited counselling with a clinical psychologist could be arranged, if needed"; the collaborating psychologist was at arms' length from the trial. No instance of such request arose during the reported study." There were no harms or unintended effects reported by the participants during the study period.
subitem not at all important

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

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 19-ii) Include qualitative feedback from participants or observations from staff/researchers Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 19-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 Your answer 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).

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 Yes, see section on "Principal Findings" under the discussion. 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 Your answer

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

21) Generalisability (external validity, applicability) of the trial findings
NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, see "Strengths and Limitations" under the discussion.

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 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 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.

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

Your answer
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 "Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275"