The Role of Daily Steps in the Treatment of Major Depressive Disorder: Secondary Analysis of a Randomized Controlled Trial of a 6-Month Internet-Based, Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth

Background Current evidence supports physical activity (PA) as an adjunctive treatment for major depressive disorder (MDD). Few studies, however, have examined the relationship between objectively measured PA and MDD treatment outcomes using prospective data. Objective This study is a secondary analysis of data from a 24-week internet-based, mindfulness-based cognitive behavioral therapy program for MDD. The purpose of this analysis was twofold: (1) to examine average daily step counts in relation to MDD symptom improvement, and whether pain moderated this relationship; and (2) to examine whether changes in step activity (ie, step trajectories) during treatment were associated with baseline symptoms and symptom improvement. Methods Patients from the Centre for Addiction and Mental Health were part of a randomized controlled trial evaluating the effects of internet-based, mindfulness-based cognitive behavioral therapy for young adults (aged 18-30 years old) with MDD. Data from 20 participants who had completed the intervention were analyzed. PA, in the form of objectively measured steps, was measured using the Fitbit-HR Charge 2 (Fitbit Inc), and self-reported depression severity was measured with the Beck Depression Inventory-II (BDI-II). Linear regression analysis was used to test PA’s relationship with depression improvement and the moderating effect of pain severity and pain interference. Growth curve and multivariable regression models were used to test longitudinal associations. Results Participants walked an average of 8269 steps per day, and each additional +1000-step difference between participants was significantly associated with a 2.66-point greater improvement (reduction) in BDI-II, controlling for anxiety, pain interference, and adherence to Fitbit monitoring (P=.02). Pain severity appeared to moderate (reduce) the positive effect of average daily steps on BDI-II improvement (P=.03). Higher baseline depression and anxiety symptoms predicted less positive step trajectories throughout treatment (Ps≤.001), and more positive step trajectories early in the trial predicted greater MDD improvement at the end of the trial (Ps<.04). However, step trajectories across the full duration of the trial did not significantly predict MDD improvement (Ps=.40). Conclusions This study used objective measurements to demonstrate positive associations between PA and depression improvement in the context of cognitive behavioral treatment. Pain appeared to moderate this relationship, and baseline symptoms of anxiety and depression predicted PA trajectories. The findings inform future interventions for major depression. Future research with larger samples should consider additional moderators of PA-related treatment success and the extent to which outcomes are related to PA change in multimodal interventions. Trial Registration Clinical Trials.gov NCT03406052; https://www.clinicaltrials.gov/ct2/show/NCT03406052 International Registered Report Identifier (IRRID) RR2-10.2196/11591

Is this a full powered effectiveness trial or a pilot/feasibility trial?* Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR.If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 46419 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"?(if not, explain the reason under "other") Title does not contain this phrase because it is a secondary analysis o 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 o ine 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.

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

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").

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Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No, the other components like text-message communications are not especially relevant, but they are mentioned in the methods section and our reference to the protocol paper provides all other details.
1a-iii) Primary condition or target group in the title

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Does your paper address subitem 1b-i?* Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this is a secondary analysis of just the intervention arm, we describe features intervention features most pertinent to the present study.For example, objectivemeasurement of steps and core features of the intervention (e.g., 24-week, mindfulnessbased) are described.
"This study is a secondary analysis of data from a 24-week internet-based, mindfulnessbased cognitive-behavioral therapy (iMCBT) program for MDD ... Data from twenty intervention completers were analysed.PA, in the form of objectively-measured steps, was measured using the Fitbit-HR Charge 2 ... " 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)

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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 brie y explain why the item is not applicable/relevant for your study Not quite relevant as this secondary analysis is not an analysis of the intervention per se.Nonetheless, the level of involvement is described for the measured variables: "PA, in the form of objectively-measured steps, was measured using the Fitbit-HR Charge 2 and self-reported depression severity was measured with the Beck Depression Inventory-II (BDI-II)." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT

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Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Number of participants assessed is mentioned, but we don't believe use/uptake of the intervention is relevant enough to be described in the results section of the abstract.Participant flow is described in the results (Figure 1) in the paper along with adherence to Fitbit monitoring.
1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials 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)

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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 brie y explain why the item is not applicable/relevant for your study This is a secondary analysis of just the intervention arm; thus, the primary trial outcome is not reported.However, all secondary analysis results are reported, including negative results.
subitem not at all important 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)

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Does your paper address subitem 2a-i?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, paper addresses this item: "Given the burden of depression, there is a growing emphasis on developing costeffective, complementary interventions that improve treatment response and relapse risk.
Current evidence supports increased physical activity (PA) and its exercise subsets [6,7] as an adjunctive treatment for major depressive disorder (MDD) or as a singlemodality treatment [8][9][10][11][12] with small-to-moderate antidepressant effects [13,14]  We do not mention allocation ratio as this is a secondary analysis of just the intervention arm.Also, we have referenced the protocol and RCT paper which describe those details.
Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Re.sample size considerations pertaining to the RCT pre-registration: " ... participant enrollment was reduced due to the reluctance of individuals from First Nations backgrounds to participate, despite extensive recruitment efforts.Additionally, given that each recruited patient had to undergo an extensive psychiatric exam to establish a MDD diagnosis, we confronted a limit to the pace of psychiatric examinations that could be scheduled given the existing staff of psychiatrists."

3b-i) Bug fixes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems.A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].

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Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Exclusion criteria: individuals (1) currently receiving weekly structured psychotherapy; (2) meeting the DSM-V criteria for severe alcohol/substance use disorder in the past three months; (3) demonstrating clinically significant suicidal ideation, defined as imminent intent; (4) who had attempted suicide in the past 6 months; or (5) diagnosed with borderline personality, bipolar disorder, schizophrenia, or obsessive compulsive disorder."

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

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Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We did not formally assess computer / internet literacy, but it was confirmed by clinical and health-coach observations during the intervention process.There were no known issues with technological literacy.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), 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 con rmation, phone calls) were used to detect/prevent these.

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Does your paper address subitem 4a-ii?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study We do not include this information in this paper, which is a secondary analysis of just the intervention arm.Further, these details are described in the referenced protocol and RCT papers: "The clinician then asked the patient if she/he was willing to meet with a study team member to explore participation.Information about the study was only shared once the clients agreed to meet for potential participation." Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "All self-report measures and clinical interviews were conducted at the same CAMH Ambulatory Service setting."

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 brie y explain why the item is not applicable/relevant for your study Outcomes were assessed in person: "All self-report measures and clinical interviews were conducted at the same CAMH Ambulatory Service setting." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This was a secondary analysis of just the intervention arm, so this item is not so relevant.Nonetheless, institutional affiliations were provided for each investigator.We don't believe recruitment success or failure was meaningfully affected by institutional affiliation.
5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).

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Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

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.

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Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

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).

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Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There were no modification during trial and the developmental process was 'frozen' during the trial.

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

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Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There was extensive peer review within the investigator group during all phases of planning, conducting, analyzing, and writing up the trial.
5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used.Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c 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 brie y explain why the item is not applicable/relevant for your study This is not relevant to this secondary analysis.
subitem not at all important

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

Clear selection
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The intervention is not intended for sharing with other research personnel from other institutions.If there is interest in establishing the collaborative relationship, this can be done by inter-scientist communications.

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 speci c group.If known, describe how participants obtained "access to the platform and Internet" [1].To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).

Clear selection
Does your paper address subitem 5-vii?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants in the iMCBT intervention also received a Fitbit-HR Charge 2 (Fitbit Inc., San Francisco, United States) and access to NexJ Connected Wellness (NexJ Health Inc., Toronto, Canada), a cloud-based digital health platform accessible through smartphone and internet-connected devices." No payments were accepted or made, as implied by the above language.
5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework

Clear selection
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Fitbit use: "Participants were instructed to wear their Fitbit monitors 24 hours daily." Intervention participants received weekly health-coaching: "Intervention participants additionally received weekly phone support from Health Navigator-Coaches" Number of workbooks translate to completing 1 workbook/week: "iMCBT content delivered through 24 workbooks"

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).

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subitem not at all important 1 2 3 4 5 essential 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-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Psychiatric care: "treatment-as-usual sessions with a CAMH psychiatrist focused primarily on medication adjustment." Text messaging support: "The platform also enabled text-message communications between participants and Health Navigator-Coaches" Weekly health-coaching: "Intervention participants additionally received weekly phone support from Health Navigator-Coaches"

5-xi) Report any 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).
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Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text N/A.Measures were completed in person.
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 de ned/measured/monitored (logins, log le analysis, etc.).Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "adherence to behavioral monitoring was operationalized as (Number of Fitbit-tracked days)/(Intervention period days) × 100" 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
Clear selection 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text No qualitative feedback elicited in this trial 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 brie y explain why the item is not applicable/relevant for your study No changes were made to trial outcomes after the trial commenced 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.

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Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "As this is a secondary analysis, no formal power calculations were performed.This approach adheres to the International Council for Harmonisation E9 statistical principles for clinical trials stating that sample size should be "determined by the primary objective of the trial" [78]."Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We do not include this information in this paper, which is a secondary analysis of just the intervention arm.These details are described in the referenced protocol and RCT papers: "Randomization of participants was carried out electronically by a biostatistician using simple randomization, assigning study IDs to intervention and waitlist control groups." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Randomization details are not relevant to the present secondary analysis of just the intervention arm of the RCT.Nonetheless, simple randomization was used, assigning study IDs to intervention and waitlist control groups with a 1:1 allocation.

Does your paper address CONSORT subitem 9? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study These procedural details are not relevant to the present secondary analysis of just the intervention arm of the RCT, and are described in the referenced protocol and RCT papers: "Each study ID with its respective group allocation was placed in individually sealed opaque envelopes.After a participant completed the baseline measures, a research coordinator opened the next envelope in sequence to assign the condition and respective study ID." 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 brie y explain why the item is not applicable/relevant for your study We do not include these details in this paper as they are not relevant to the present secondary analysis of just the intervention arm of the RCT, and are described in the referenced protocol and RCT papers: "Randomization of participants was carried out electronically by a biostatistician"

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 brie y explain why the item is not applicable/relevant for your study Not relevant to secondary analysis.Nonetheless, study psychiatrists administering TAU to control and intervention participants were not blind to which participants were in the intervention versus control groups, and this might have led to biased treatment.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Clear selection
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not relevant to secondary analysis.Nonetheless, participants knew that the online intervention + psychiatric care was the intervention of interest and that the psychiatric care alone was the comparator.

Does your paper address CONSORT subitem 11b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not relevant.Nonetheless, psychiatric care was similar between intervention group and control group.

Does your paper address CONSORT subitem 12a? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.Secondary analysis focused only on the intervention arm.
subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 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 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]).

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Does your paper address subitem 12a-i?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This secondary analysis of just the intervention arm employs complete case analysis.
As there are only 2 drop-outs in the experimental condition, a complete-case analysis is considered acceptable.Guidelines indicate that complete-case analyses are acceptable when the rate of missingness is between 5% and 10% (Bennett, 2001, p. 464;Jakobsen et al., 2017, p. 3).Simulation evidence also demonstrates that different procedures for handling missing data yield similar results when the proportion of missingness is 10% (Langkamp et al., 2010).It has also been suggested that with only a few missing cases, the assumption of "missing completely at random" (MCAR) is more likely to apply, implying a greater chance that the complete cases represent the population when only a few cases are missing (Pigott, 2001, p. 362).Altogether, given that only two subjects were lost to follow-up, we believe there is little risk of bias from using complete-case analyses.
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.Secondary analysis focused only on intervention arm.

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subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address 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 brie y explain why the item is not applicable/relevant for your study "Ethics approval was obtained from the Research and Ethics Boards of the Centre for Addiction and Mental Health (Protocol Reference #115/2016-01) and York University (Certificate #2017-154) in Toronto, Canada (Clinical Trial registration.govNCT03406052)."

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

Clear selection
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Offline consent: "All participants provided in-person written consent for the use of data in primary and secondary analyses."

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

Clear selection
Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The intervention per se is not the focus of this secondary analysis; thus safety and security procedures are not mentioned, though they were addressed throughout the trial and as part of standard psychiatric care.Nonetheless, regarding privacy: "Participant confidentiality was maintained throughout the study via careful deidentification of data." Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, addressed through Figure 1 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 brie y explain why the item is not applicable/relevant for your study Yes, addressed through Figure 1 CONSORT flow diagram.

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 gures 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 gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, addressed through Figure 1 CONSORT flow diagram.
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 brie y explain why the item is not applicable/relevant for your study "participants recruited from February 2018 to September 2018 were enrolled in the iMCBT intervention" 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant 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 brie y explain why the item is not applicable/relevant for your study No secular events fell into the study period Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study is a secondary analysis of an RCT [55] that originally aimed to enroll 168 subjects, with 50% of the subjects from a First Nations background and the other 50% from all other ethnic backgrounds, stratified into 2 intervention groups and 2 wait-list control groups (ie, n = 42 per group).However, participant enrollment was reduced due to the reluctance of individuals from First Nations backgrounds to participate, despite extensive recruitment efforts.Additionally, given that each recruited patient had to undergo an extensive psychiatric exam to establish a MDD diagnosis, we confronted a limit to the pace of psychiatric examinations that could be scheduled given the existing staff of psychiatrists." 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 brie y explain why the item is not applicable/relevant for your study Yes, please see Table 1.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.

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 brie y explain why the item is not applicable/relevant for your study Such demographics are included; please see Table 1 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group).Always clearly de ne "use" of the intervention.

Clear selection
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) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 16-i?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The analysis is a secondary analysis of only the intervention arm; thus, ITT principles don't apply.Nonetheless, we make clear how many participants were included in each analysis (Tables 1-7 and Table S1).
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 brie y explain why the item is not applicable/relevant for your study Intention-to-treat principles are applicable for assessing between-group differences in randomized controlled trials (RCT) but are not relevant for analyses involving only a single arm (Detry & Lewis, 2014).As this secondary analysis is a single-arm secondary analysis of the experimental condition of an RCT, an intention-to-treat analysis is not applicable Detry, M. A., & Lewis, R. J. ( 2014).The intention-to-treat principle: How to assess the true effect of choosing a medical treatment.JAMA, 312(1), 85. https://doi.org/10.1001/jama.2014.7523 Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Such statistics are reported for all analyses in the results section.

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 de nitions is critical.This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length".These must be accompanied by a technical description how a metric like a "session" is de ned (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 brie y explain why the item is not applicable/relevant for your study Yes, adherence to Fitbit monitoring is reported in

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

Clear selection
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, we emphasize the secondary-analytic nature of this study with use of data from only the intervention arm.

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 brie y explain why the item is not applicable/relevant for your study None undertaken or reported.

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).

Clear selection
subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study examined daily steps in relation to MDD symptom improvement and baseline characteristics in a youth sample who had completed a 24-week iMCBT treatment for mild to severe depression." "We found that each additional 1,000-step increment was significantly associated with a 2.66-point reduction in MDD symptoms (BDI-II) after controlling for adherence, anxiety, and pain interference." "Analyses showed that as pain levels increased, the effect of steps on depression symptom reduction decreased." "Additional study findings suggest that higher baseline levels of depression and anxiety were associated with decreasing PA over the course of iMCBT treatment." "There was evidence that early PA increases predict greater MDD symptom improvement at the end of the trial.Specifically, during the early weeks of iMCBT, each 100-unit increase in the weekly average of steps was associated with a 1.65-point reduction in BDI-II severity, controlling for pain interference, anxiety, and estimated step levels at baseline." "We did not find support for the hypothesis that across the full duration of iMCBT, positive step trajectories would predict greater depression improvement" 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 brie y explain why the item is not applicable/relevant for your study "Future research is needed to examine how and to what extent physical activity changes can maximize treatment response in the context of multimodal interventions."

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 brie y explain why the item is not applicable/relevant for your study Limitations related to the secondary analysis are discussed in the limitations section.Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We state the limits of generalizability due to the small sample size of this study: "This study has several limitations.First, our sample size was modest, but this limitation was balanced against strict sampling criteria and intervention duration.

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 brie y explain why the item is not applicable/relevant for your study This is stated by virtue of the contrast between iMCBT and (routine) TAU, both of which are explicitly described in the methods section.
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study : Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
INTRODUCTION: Specific objectives or hypotheses 2a-i) Problem and the type of system/solution

"
All participants were diagnosed by a Centre for Addiction and Mental Health (CAMH) psychiatrist, with diagnoses confirmed through a Mini-International Neuropsychiatric Interview (MINI) administered at the screening visit.Participants were identified from CAMH service waitlists by research coordinators and in the prescreening of new clinic referrals.
4b-ii) Report how institutional affiliations are displayedReport how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Nota required item -describe only if this may bias results)Clear selection5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered the trial ended or was stopped (early) Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses (external validity, applicability) of the trial findings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial Does your paper address subitem 22-i?* number and name of trial registry 24) Where the full trial protocol can be accessed, if available 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 organizationsClear selectionDoes your paper address subitem 21-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) 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 Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Clinic recruitment: "Patients from the Centre for Addiction and Mental Health ... " How variables were assessed: "PA, in the form of objectively-measured steps, was measured using the Fitbit-HR Charge 2, and self-reported depression severity was measured with the Beck Depression Inventory-II (BDI-II)." "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) Describe mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework[6]used to design them (instructional strategy[1], behaviour change techniques, persuasive features, etc., see e.g.,[7, 8]for terminology).This includes an in-depth description of the content (including where it is coming from and who developed it) [1]," whether [and how] it is tailored to individual circumstances and allows users to track their progress and receive feedback"[6].This also includes a description of communication delivery channels and -if computer-mediated communication is a component -whether communication was synchronous or asynchronous[6].It also includes information on presentation strategies [1], including page design principles, average amount of text on pages, presence of hyperlinks to other resources, etc.[1].Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "All RCT participants received standard psychiatric care, defined as monthly treatmentas-usual sessions with a CAMH psychiatrist focused primarily on medication adjustment.Participants in the iMCBT intervention also received a Fitbit-HR Charge 2 (Fitbit Inc., San Francisco, United States) and access to NexJ Connected Wellness (NexJ Health Inc., Toronto, Canada), a cloud-based digital health platform accessible through smartphone and internet-connected devices.Participants were instructed to wear their Fitbit monitors 24 hours daily.Fitbit-tracked daily step counts were automatically uploaded to the NexJ platform, allowing participants and Health Navigator-Coaches to review daily step activity.The purpose of step monitoring was to reinforce iMCBT concepts by providing participants real-time feedback about how the behaviors they modify link to cognitive-affective changes.The platform also enabled text-message communications between participants and Health Navigator-Coaches, and access to iMCBT content delivered through 24 workbooks and 56 instructional videos reflecting CBT and mindfulness principles.Intervention participants additionally received weekly phone support from Health Navigator-Coaches to facilitate behavior change, application of iMCBT content, and participant adherence.The workbook content was built on prior web-based MCBT RCTs[58,59]and included a spectrum of MDD-targeted topics such as Living by Your Truths, Overcoming Wired-ness and Tired-ness, Mindfulness and Relationships, Loss and Grief, Resilience, Befriending Ourselves, Befriending Your Body With Exercise, Body Image and Mindfulness, Intimacy, Forgiveness, Overcoming Procrastination, Dealing With Negative Moods, Stress Resilience, Overcoming Performance Anxiety, and Cultivating Inspiration"5-ix) Describe use parametersDescribe 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.
your paper address subitem 5-xi?*Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your studyCopy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "All self-report measures and clinical interviews were conducted at the same CAMH Ambulatory Service setting" Please see measures section: "Depression symptoms at baseline and at the end of the 24-week intervention were measured using the Beck Depression Inventory-II (BDI-II)[60].The BDI-II is a ..." "The platform also enabled text-message communications between participants and Health Navigator-Coaches... Intervention participants additionally received weekly phone support from Health Navigator-Coaches to facilitate ... participant adherence" 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. 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 cointerventions (if any).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable; outcomes were continuous.Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, we report all results of this secondary analysis.
Table 1: "Adherence (%), median (IQR) = 84.35(28.28)" Does your paper address CONSORT subitem 19? *Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No harms or unintended effects were observed.Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No known privacy breaches or technical problems.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.
Whether study findings generalize will be confirmed in a future, larger trial targeting MDD in a broader age group [107]."21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other cointerventions) 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 CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The RCT design [54] and results[55]have been described elsewhere."25) Sources of funding and other support (such as supply of drugs), role of funders X27) Conflicts of Interest (not a CONSORT item) Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Acknowledgements PR has received research support from the Canadian Institutes of Health Research and the Federal Development Program of Southern Ontario.JK is supported by a Canadian Institutes of Health Research Canada Research Chair in Health Psychology at York University.