A Mindfulness-Based Intervention for Student Depression, Anxiety, and Stress: Randomized Controlled Trial

Background University students are experiencing higher levels of distress and mental health disorders than before. In addressing mental health needs, web-based interventions have shown increasing promise in overcoming geographic distances and high student-to-counselor ratios, leading to the potential for wider implementation. The Mindfulness Virtual Community (MVC) program, a web-based program, guided by mindfulness and cognitive behavioral therapy principles, is among efforts aimed at effectively and efficiently reducing symptoms of depression, anxiety, and perceived stress in students. Objective This study’s aim was to evaluate the efficacy of an 8-week MVC program in reducing depression, anxiety, and perceived stress (primary outcomes), and improving mindfulness (secondary outcome) in undergraduate students at a large Canadian university. Guided by two prior randomized controlled trials (RCTs) that each demonstrated efficacy when conducted during regular university operations, this study coincided with a university-wide labor strike. Nonetheless, the students’ response to an online mental health program on a disrupted campus can provide useful information for anticipating the impact of other disruptions, including those related to the COVID-19 pandemic as well as future disruptions. Methods In this parallel-arm RCT, 154 students were randomly allocated to an 8-week MVC intervention (n=76) or a wait-list control (WLC) condition (n=78). The MVC intervention included the following: (1) educational and mindfulness video modules, (2) anonymous peer-to-peer discussions, and (3) anonymous, group-based, professionally guided, 20-minute videoconferences. Study outcomes were evaluated at baseline and at 8-week follow-up using the following: Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Generalized estimation equations with an AR (1) covariance structure were used to evaluate the impact of the intervention, with outcome evaluations performed on both an intention-to-treat (ITT) and per-protocol (PP) basis. Results Participants (n=154) included 35 males and 117 females with a mean age of 23.1 years. There were no statistically significant differences at baseline between the MVC and WLC groups on demographics and psychological characteristics, indicating similar demographic and psychological characteristics across the two groups. Results under both ITT and PP approaches indicated that there were no statistically significant between-group differences in PHQ-9 (ITT: β=–0.44, P=.64; PP: β=–0.62, P=.053), BAI (ITT: β=–2.06, P=.31; PP: β=–2.32, P=.27), and FFMQ-SF (ITT: β=1.33, P=.43; PP: β=1.44, P=.41) compared to WLC. There was a significant difference for the PSS (ITT: β=–2.31, P=.03; PP: β=–2.38, P=.03). Conclusions During a university labor strike, the MVC program led to statistically significant reductions in PSS compared to the WLC group, but there were no other significant between-group differences. Comparisons with previous cycles of intervention testing, undertaken during nondisrupted university operations, when efficacy was demonstrated, are discussed. Trial Registration ISRCTN Registry 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.

Clear selection
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Web-based 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
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)

Clear selection
Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In this parallel-arm RCT, n = 154 students were randomly allocated to an 8 week MVC intervention (n = 76) or a wait-list control (WLC) condition (n = 78). The MVC intervention included the following: 1) education and mindfulness video modules, 2) anonymous peer-to-peer discussion and 3) anonymous group-based, professionally guided, 20-minute video conferences." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 11/77 subitem not at all important 1 2 3 4 5 essential 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)

Clear selection
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 MVC intervention included the following: 1) educational and mindfulness video modules, 2) anonymous peer-to-peer discussions, and 3) anonymous, groupbased, professionally guided, 20-minute video conferences." 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) subitem not at all important 1 2 3 4 5 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 "In this parallel-arm RCT, n = 154 student were randomly allocated to an 8-week MVC intervention (n = 76) or a wait-list control (WLC) condition (n = 78)." We could not use the exact wording of "blinded" in the Abstract as students and research assists were blinded only until the stage of consent provision.
1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

Clear selection
Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants (n = 154) included 35 males and 117 females with a mean age of 23.1 years. There were no statistically signi cant differences at baseline between the MVC and WLC groups on demographics and psychological characteristics, Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

Clear selection
Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This study was undertaken at a labor strike-affected university, following identical procedures described in two prior studies at the same site, conducted when no crises existed [4,5]. Accordingly, participant responses to the previous RCTs are usefully compared to responses in this study (referred to as "Study 3" below).
In the previously reported RCTs [4,5], signi cant between-group differences were observed in depression (PHQ-9), anxiety (BAI), quality of life (QOLS), and mindfulness (FFMQ-SF). In the rst RCT, signi cant between-group differences were additionally found in perceived stress (PSS). In this study, a signi cant between-group difference was only found in the PSS (P=.03), while a marginal (P=.06) difference was observed in the Nonjudgment subscale of FFMQ-SF.
Despite the limited between-group differences in this disrupted-campus study, week online M-CBT program and signi cant between-group differences were again found on identical measures of depression (PHQ-9), anxiety (BAI), mindfulness (FFMQ-SF), and quality of life in intervention participants, compared to wait-list "Additionally, of concern for online researchers, there are possible links between decreased youth mental health and increased online activity (ie, "screen time") [15][16][17]. Strong arguments and reliable data support the perspective that online activities, particularly social media engagement, have unhealthy impacts for some youth populations [15][16][17]. Disruptions of regular face-to-face classes at universities and high schools may have elevated levels of unhealthy "screen time" for select populations. Accordingly, it is worthwhile to ascertain what changes might have occurred when university students experiencing a disruption that likely increased time spent online used an online mental health intervention." "Accordingly, we developed a web-delivered M-CBT program (aimed at creating a Mindfulness Virtual Community, or MVC) to reduce depression, anxiety, and stress in university students and, as mentioned above, previously assessed in two prior RCTs targeting Canadian university students that indicated e cacy [4,5]. " 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

4a) Eligibility criteria for participants
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.

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].

Clear selection
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 content of the modules and the platform structure remained unchanged during the 8-week intervention." 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 "Eligibility criteria were applied to recruit actively enrolled undergraduates aged ≥18 years, with English-language uency and self-reported con dence in completing the study. Students were excluded if they reported substance abuse or episodes of psychosis during the month prior to the trial.
The study was advertised using study posters, class announcements, and email invitations via list servs of student associations in the Faculties of Health and Liberal Arts. Interested students contacted the research staff via email or phone and were screened for student registration, substance abuse, and indications of psychoses. If abuse or psychotic behaviors "interfered in routine life within the last month," students were excluded and provided with a list of accessible mental health resources. In addition, a registered clinical psychologist could be contacted directly if there was a perceived need for interim mental health counseling."

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?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Average university-student levels of computer and internet literacy were assumed.
If there were participant reported di culties, these were addressed in personal, con dential consultations with the study coordinators.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study was advertised using study posters, class announcements, and email invitations via list servs of student associations in the Faculties of Health and Liberal Arts. Interested students contacted the research staff via email or phone and were screened for student registration, substance abuse, and indications of psychoses. If abuse or psychotic behaviors "interfered in routine life within the last month," students were excluded and provided with a list of accessible mental health resources. In addition, a registered clinical psychologist could be contacted directly if there was a perceived need for interim mental health counseling.
Eligible and willing students received detailed in-person information about the study and provided informed written consent. Participants had the option to receive an honorarium of Can $50 (US $39) or 2% in course grade (for professors who gave permission for this option) or three credits (equivalent to 2% course grade) in the

Undergraduate Research Participation Pool (URPP) 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, the 24/7 "Good to Talk" helpline for postsecondary students in Ontario). Our protocol included a safety mechanism whereby participants were asked verbally and on 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." "Each participant in the MVC group received a unique ID and a temporary password; participants changed passwords after their rst login, while IDs remained the same to reduce the potential of multiple accounts or identities.
Participants in all groups completed online questionnaires at baseline (T1) and 8 weeks (T2)." subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Clear selection
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Eligible and willing students received detailed in-person information about the study and provided informed written consent. Participants had the option to receive an honorarium of Can $50 (US $39) or 2% in course grade (for professors who gave permission for this option) or three credits (equivalent to 2% course grade) in the Undergraduate Research Participation Pool (URPP) 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, the 24/7 "Good to Talk" helpline for postsecondary students in Ontario). Our protocol included a safety mechanism whereby participants were asked verbally and on 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." No such requests arose during the reported study period." 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 Participants in all groups completed the online questionnaires at baseline (T1) and 8 weeks (T2).

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

Clear selection
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants in all groups completed the online questionnaires at baseline (T1) and

Clear selection
Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The name of the university that received the research grant and the name of the partnering information technology company appeared on the main page of the platform.

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

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study In the intervention sub-section: The module scripts and resulting audio recordings were created by an investigator with extensive experience as a clinical research psychologist and mindfulness researcher (PR) [29][30][31][32][33][34]. They drew on mindfulness and CBT principles, with the topics informed by prior focus group study [35,36]. The choice of moving and still images used in the videos involved collaborative work (PR, CE, and FA).
In the Con icts of Interest section: "It is the understanding of the university and researchers that the Project Intellectual Property belongs to CEM, FA and PR. The industry partner, ForaHealthyMe.com owns all rights and titles to the copyrights of any computer source code software that was developed out of this research project." In the Acknowledgements section: " The authors acknowledge the contribution of all students who gave their valuable time to participate in the study. We thank ForaHealthyMe.com, Inc. as an industry partner who provided great support. The work reported was funded by the

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. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The module scripts and resulting audio recordings were created by an investigator with extensive experience as a clinical research psychologist and mindfulness researcher (PR) [29][30][31][32][33][34]. They drew on mindfulness and CBT principles, with the topics informed by prior focus group study [35,36]. "

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

Clear selection
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The content of the modules and the platform structure remained unchanged during the 8-week intervention."

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

Clear selection
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 We used the parallel-arm RCT design and registered the trial before collecting data and initiating intervention delivery. We provide comprehensive details about intervention development and the focus groups that informed content and design.
We used validated measures for 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 assistants were blind to the allocation until after the written consent.
Each participant in the MVC intervention group received a unique ID and a temporary password; participants changed the passwords after their rst login, while IDs remained the same until after the written consent. -v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

Clear selection
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 intervention components. Details on the module content are provided in Table 1 for the 12 topics and the durations of each video.

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. Does your paper address subitem 5-vi?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Screen short is provided in a previous (linked) publication.

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).
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 32/77 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 "Eligibility criteria were applied to recruit actively enrolled undergraduates aged ≥18 years, with English-language uency and self-reported con dence in completing the study. Students were excluded if they reported substance abuse or episodes of psychosis during the month prior to the trial.
The study was advertised using study posters, class announcements, and email invitations via list servs of student associations in the Faculties of Health and Liberal Arts. Interested students contacted the research staff via email or phone and were screened for student registration, substance abuse, and indications of psychoses. If abuse or psychotic behaviors "interfered in routine life within the last month," students were excluded and provided with a list of accessible mental health resources. In addition, a registered clinical psychologist could be contacted directly if there was a perceived need for interim mental health counseling.
Eligible and willing students received detailed in-person information about the study and provided informed written consent. Participants had the option to receive an honorarium of Can $50 (US $39) or 2% in course grade (for professors who gave permission for this option) or three credits (equivalent to 2% course grade) in the Undergraduate Research Participation Pool (URPP) 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, the 24/7 "Good to Talk" helpline for postsecondary students in Ontario). Our protocol included a safety mechanism whereby participants were asked verbally and on 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." No such requests arose during the reported study period.
A sample of 480 students (160 students per group) was recruited over 3 semesters (Fall 2017, Winter 2018, and Fall 2018. The 3 samples were not combined due to the campus environment differences related to the 3-month strike in Winter 2018. Here, we report on a sample of n=154 students in a two-arm RCT." 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 MVC intervention was 8 weeks in duration and featured the following: (1) 12 student-speci c mental health modules conveyed by online video, (2) 3 anonymous discussion boards dedicated to depression, anxiety, and stress, and (3) an anonymous 20-minute group-based live videoconference led by a moderator (with a master's degree in psychology), during which students raised and discussed topics  Table 1."

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?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were encouraged to use the platform as often as desired."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability). Does your paper address subitem 5-x?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The MVC intervention was 8 weeks in duration and featured the following: (1) 12 student-speci c mental health modules conveyed by online video, (2) 3 anonymous discussion boards dedicated to depression, anxiety, and stress, and (3) an anonymous 20-minute group-based live videoconference led by a moderator (with a master's degree in psychology), during which students raised and discussed topics covered in the modules (Figure 1). " "The MVC was constructed in partnership with an industry partner (ForaHealthyme Inc) and designed to be a virtual environment supportive of personal mindfulness practice and related CBT self-help. It facilitated mutual help interactions between participants, and between participants and the moderator. The two categories of users were students and health professionals (who moderated the discussion board dialogues and led the live videoconferences). All users used a login and a password to gain access." " The video conferences were offered biweekly in three 20 minute evening sessions. The students in the intervention group received email reminders from project staff prior to the release of each module and prior to the live video conferences."

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 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Clear selection
The student in the intervention group received email reminders from project staff prior to the release of each module and prior to the live videoconferences.

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.

Clear selection
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-interventions were provided. The primary outcomes were depression, anxiety, and perceived symptoms of stress. Depression symptoms were assessed with the PHQ-9 [38], where each item is rated on a 0-3 scale and total scores range from 0 to 27 (0-4 indicates minimal/subclinical depression, 5-9 indicates mild depression, 10-14 moderate, 15-19 moderately severe, and ≥20 indicates severe depression). Anxiety was measured using the 21-item BAI [39], where each item is rated on a 0-3 scale and the total score range is 0 to 63 ( ; each item is rated on a scale from 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 FFMQ-SF [43]; each item is rated on a scale from 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

Clear selection
Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
The questionnaires have been used online but have not been speci cally validated for online use.
6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Clear selection
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Not addressed.
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.

Clear selection
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The sample size was calculated for 80% power and 5% type I error to detect of standardized effect size of 0.5 or larger. The required sample size was 63 students per arm. Our recruitment goal was set at 80 participants per arm, assuming an attrition rate of ~ 20%" 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 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) 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 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 "Participating students were randomized to the MVC intervention or the wait-list (control) using 1:1 block randomization. The randomized allocation sequence was computer-generated by an off-site research team member and allocations were concealed in sequentially numbered opaque envelopes [28]. The envelopes were only opened after written consent was obtained, ensuring participants and staff were blind prior to the allocation." 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 the MVC intervention or the wait-list (control) using 1:1 block randomization. " 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment 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 randomized allocation sequence was computer-generated by an off-site research team member and allocations were concealed in sequentially numbered opaque envelopes [28]. The envelopes were only opened after written consent was obtained, ensuring participants and staff were blind prior to the allocation." 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 "An off-site research team member (biostatistician). Allocations were concealed in sequentially numbered opaque envelopes. Research coordinator selected the next opaque envelope to allocate subjects to comparison groups." 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).

Clear selection
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 envelopes were only opened after written consent was obtained, ensuring that participants and the research coordinator (and other staff) were blind prior 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".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address 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 Student were aware of being allocated to the MVC intervention or to a wait list control group.
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 relevant. subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Descriptive statistics for demographic and psychological characteristics were calculated at baseline, and potential between-group differences were assessed using chi-square tests of independence for categorical variables, and t tests for numeric variables. To evaluate the impact of the intervention on study outcomes (ie, depression, anxiety, perceived stress, and mindfulness), generalized estimating equations with an AR (1) covariance structure were employed. Outcome evaluations were performed on both an intention-to-treat (ITT) and per-protocol (PP) basis, with the group × time interaction indicating a between-group change in study outcomes. As the missing data were minimal (<10% overall) and considered to be missing at random, multiple imputations were used to estimate missing observations. For all outcomes, effect sizes are presented for between-group comparisons at follow-up, evaluated by Cohen d and calculated as difference between MVC and WLC means divided by their pooled standard deviations.

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]

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
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 "As the missing data were minimal (<10% overall) and considered to be missing at random, multiple imputations were used to estimate missing observations. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 49/77 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 Tables 5 and 6 show additional analyses that focused on discerning which subgroups were affected more or less by the intervention (given varying baseline depression, anxiety, and perceived stress levels). Across 3 levels of depressive symptoms per PHQ-9 categories (ie, mild, moderate, and severe symptom levels), intervention group reductions were greater than those of the control group. An exception was the moderately severe category, where the greater effect size observed was in the controls. We have highlighted the Cohen d effect sizes to facilitate comparisons. The moderately severe category has modest effect size differences. When similar analyses involved female-male comparisons, the effect sizes and mean reductions were greater in females across mild, moderate, moderately severe, and severe categories. Reductions in cell size are noted, particularly for the male data, as the female study sample far exceeded the male sample (Tables 7  and 8).   (Tables 9 and 10). When analyses focused on comparing females with males, the effect sizes and mean reductions were greater in females across moderate and high categories, while the low category results can be characterized as equal. There were reductions in cell size due to the female-male comparisons (Tables 11 and 12).   Altogether, females gained more bene t than males and intervention subjects bene tted more than controls. Gains were most evident in depression and perceived stress reductions. Anxiety results (BAI outcomes) were more variable, likely re ecting the immediate anxiety reduction effects in controls with the suspension of expected exams and assignments. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-i?

X26-i) Comment on ethics committee approval
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "This study was a two-arm parallel-design RCT comparing the web-based Mindfulness Virtual Community program to a wait-list control group. The Human Participation Research Committee at York University provided research ethics approval for the RCT (Certi cate number: e2016-345)."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-ii?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Eligible and willing students received detailed in-person information about the study and provided informed written consent. Participants had the option to receive an honorarium of Can $50 (US $39) or 2% in course grade (for professors who gave permission for this option) or three credits (equivalent to 2% course grade) in the Undergraduate Research Participation Pool (URPP) 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, the 24/7 "Good to Talk" helpline for postsecondary students in Ontario). Our protocol included a safety mechanism whereby participants were asked verbally and on 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." No such requests arose during the reported study 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)

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 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 Our protocol included a safety mechanism whereby participants were asked verbally and on 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." No such requests arose during the reported study period.
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 Study participants were 154 undergraduate university students randomized to MVC (n=76) or WLC (n=78) conditions. Of the 154 participants with complete baseline assessments, 7 participants (9.2%) within the MVC and 1 (1.3%) WLC participant dropped out of the study without completing follow-up assessments. 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 Study participants were 154 undergraduate university students randomized to MVC (n=76) or WLC (n=78) conditions. Of the 154 participants with complete baseline assessments, 7 participants (9.2%) within the MVC and 1 (1.3%) WLC participant dropped out of the study without completing follow-up assessments.

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.

Clear selection
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 Attrition data is presented in 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 A sample of 480 students (160 students per group) was recruited over 3 semesters (Fall 2017, Winter 2018, and Fall 2018. The 3 samples were not combined due to the campus environment differences related to the 3-month strike in Winter 2018.
Here, we report on a sample of n=154 students in a two-arm RCT.
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"

Clear selection
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 The only relevant secular event was the 3 month strike in Winter, 2018. "A sample of 480 students (160 students per group) was recruited over 3 semesters (Fall 2017, Winter 2018, and Fall 2018. The 3 samples were not combined due to the campus environment differences related to the 3-month strike in Winter 2018. Here, we report on a sample of n=154 students in a two-arm RCT." 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 .44 aBased on n=152 participants (missing data on n=2). bBased on n=63 participants born outside of Canada. cBased on n=151 participants (missing data on n=3). Table 3 shows the means and standard deviations for study outcomes at baseline and at 8-week follow-up for the MVC and WLC groups. Table 3 further includes effect sizes for the mean difference between MVC and WLC at 8-week follow up. The PHQ-9 and the FFMQ-SF exhibited negligible between-group differences at 8 weeks, while the between-group effect sizes for the BAI, PSS, and FFMQ-SF nonjudgment subscale were in the small range (d=0.20-0.24).

Clear selection
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study These subgroups were reported although sample size restraints prevented analyses.

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. 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

Clear selection
The relevant tables provide 'N" for each group in the trial under both ITT and PP analyses/

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Clear selection
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The paper utilizes both ITT and PP analyses. subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We provide effect sizes in table 2; 95% CI and SE for table 4 for both (ITT and PP analytic approaches).
17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

Clear selection
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable at this stage of research.
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 NA 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 Between and within group effect size calculations are utilized to compare study groups and sub-groups. Table 2 outlines between group effect sizes at follow up for MVC and WLC groups. In addition, tables 5-16 describe sub-group analyse bsed on symptom severity categories for depression anxiety and stress outcomes according to study group and gender.

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). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Between and within group effect size calculations are utilized to compare study groups and sub-groups. Table 2 outlines between group effect sizes at follow up for MVC and WLC groups. In addition, tables 5-16 describe sub-group analyse bsed on symptom severity categories for depression anxiety and stress outcomes according to study group and gender.
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 There were no observed harms or unintended effects in any participants.

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].

Clear selection
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 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 This study was undertaken at a labor strike-affected university, following identical procedures described in two prior studies at the same site, conducted when no crises existed [4,5]. Accordingly, participant responses to the previous RCTs are usefully compared to responses in this study (referred to as "Study 3" below).
In the previously reported RCTs [4,5], signi cant between-group differences were observed in depression (PHQ-9), anxiety (BAI), quality of life (QOLS), and mindfulness (FFMQ-SF). In the rst RCT, signi cant between-group differences were additionally found in perceived stress (PSS). In this study, a signi cant between-group difference was only found in the PSS (P=.03), while a marginal (P=.06) difference was observed in the Nonjudgment subscale of FFMQ-SF. Despite the limited between-group differences in this disrupted-campus study, signi cant group × time effects suggested that the MVC intervention had a positive impact on students. However, while in Study 1 and 2 the WLC depression scores (PHQ-9) [4,5] increased over time (Time 2>Time 1; perhaps due to anticipating increasingly demanding academic tasks), in Study 3, the WLC subjects had substantially reduced depression scores (Time 1<Time 2, by -1.4 in mean raw score). As the intervention within-group reductions were nearly equivalent across studies 1, 2, and 3, the signi cant between-group differences absent in Study 3 appeared related to the self-reported depression reductions (between Time 1 and Time 2) in WLC subjects. Cross-study differences were also observable in the BAI indices, where in Study 1 and 2, WLC scores increased over time (Time 2>Time 1), whereas in Study 3 the WLC scores decreased over time (Time 2<Time 1) by a mean (raw) scale score of -2.38. Once again, the within-group reductions were nearly equivalent across studies 1, 2, and 3 (-4.2, -4.8, and -4.5, respectively) indicating that reductions in the between-group differences in Study 3 were related to anxiety reductions in the WLC group.
Other interesting cross-study differences were observable in PSS indices where signi cant between-group differences were found in Study 1 and Study 3, but not in Study 2. In Study 1 and 3, the WLC group scores were nearly equivalent (Time 1 and Time 2) as were the reductions achieved in the intervention group (Study 1: -3.10, Study 2: -3.19, in raw scores).
One interpretation of such study comparisons is that students experienced the crisis as reducing academic pressure, with the result of them experiencing less distress (represented in lower mean WLC group depression and anxiety scores). While the lowered distress was likely temporary (outcomes were assessed 8 weeks While the lowered distress was likely temporary (outcomes were assessed 8 weeks after baseline, and prior to resumed course activity), the pattern might have also affected motivations regarding participation in the intervention. If so, this would have contributed to the lack of signi cant between-group differences in depression and anxiety in this study.

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

Clear selection
Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study NA in this study

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

Clear selection
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 Several study limitations must be taken into account. This was not a single-or double-blinded trial. The study duration of 8 weeks did not allow us to test for longer-term effects (eg, 6 or 12 months), which would have resulted in a more fully assessed crisis effect. A further limitation is the high female preponderance in the control and intervention groups, as more precise future research projects would address gender differences through strati cation with larger participant samples from multiple research sites (involving multiple universities and colleges). Missing data was also a limitation, somewhat mitigated by the use of a multiple imputation method. Lastly and importantly, given the marginal between-group differences found in this study in mindfulness self-report (FFMQ-SF), there was no measure of the participants' mindfulness practice external to platform participation.

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

Clear selection
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 Several study limitations must be taken into account. This was not a single-or double-blinded trial. The study duration of 8 weeks did not allow us to test for longer-term effects (eg, 6 or 12 months), which would have resulted in a more fully assessed crisis effect. A further limitation is the high female preponderance in the control and intervention groups, as more precise future research projects would address gender differences through strati cation with larger participant samples from multiple research sites (involving multiple universities and colleges). Missing data was also a limitation, somewhat mitigated by the use of a multiple imputation method. Lastly and importantly, given the marginal between-group differences found in this study in mindfulness self-report (FFMQ-SF), there was no measure of the participants' mindfulness practice external to platform participation. Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Clear selection
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 NA in this study.
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 subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study NA Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No other funders except for the Canadian Institutes for Health Research

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. About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no Does your paper address subitem X27-i?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study CE, FA and PR designed the study and study-speci c questionnaire items, received and administered funds and contributed equally on most components. PR led the module development, providing written content and voice. MP undertook the statistical analyses CE veri ed analysis, and PR provided the rst draft. All authors provided critical feedback relevant to the revisions undertaken.
As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?

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