Effectiveness of Mental Health Apps for Distress During COVID-19 in US Unemployed and Essential Workers: Remote Pragmatic Randomized Clinical Trial

Background During the COVID-19 pandemic, the general public was concerned about the mental health impacts of unemployment due to COVID-19 and the stress essential workers experienced during this time. Several reports indicated that people in distress were turning to digital technology, but there was little evidence about the impact of these tools on mitigating distress. Objective This study seeks to determine the acceptability, feasibility, usability, and effectiveness of mobile mental health apps for decreasing mental health symptoms in essential workers and unemployed individuals with suicide risk. Methods We recruited participants who indicated that they were unemployed because of COVID-19 or were COVID-19–designated essential workers. Participants were randomized to 1 of 4 free commercial mobile apps for managing distress that were (1) highly rated by PsyberGuide and (2) met the criteria for intervention features these participants indicated were desirable in a previous survey. Participants used the apps for 4 weeks and completed baseline and 4-week self-assessments of depression, anxiety emotional regulation, and suicide risk. Results We found no differences between the apps in any outcome but did find significant changes in depression and anxiety over time (Patient Health Questionnaire [PHQ]-9: estimate=–1.5, SE 0.2, 95% CI –1.1 to –1.8, P<.001; Generalized Anxiety Disorder Scale [GAD]-7: estimate=–1.3, SE 0.2, 95% CI –1.0 to –1.6, P<.001). We found no significant changes in suicidal behavior (Suicide Behaviors Questionnaire-Revised [SBQ-R]) or emotional regulation (Difficulties in Emotion Regulation Scale – Short Form [DERS-SF]) for the 4 weeks. We did find a significant dose-response pattern for changes in depression and anxiety. Using the app at least once a week resulted in greater improvements in treatment conditions over time on depression (estimate=–0.6, SE 0.2, 95% CI 1.0-0.2, P=.003) and anxiety (estimate=0.1, SE 0.2, 95% CI 0.4-0.6, P=.78). There was no association between app frequency and changes in suicidal behavior (SBQ-R) or emotional regulation (DERS-SF). We further found a significant difference between the conditions with regard to app usability, with the control app being the most usable (meanBeautiful Mood 72.9, SD 16.7; meanCOVID Coach 71.2, SD 15.4; meanCalm 66.8, SD 17.3; mean7 Cups 65.2, SD 17.7). We found no significant differences for app acceptability or appropriateness. Conclusions Few studies have evaluated prospectively the utility and usability of commercial apps for mood. This study found that free, self-guided commercial mobile mental health apps are seen as usable, but no one app is superior to the other. Although we found that regular use is indicated for effects on depression and anxiety to occur in those who are more symptomatic, regression to the mean cannot be ruled out. Trial Registration ClinicalTrials.gov NCT04536935; https://tinyurl.com/mr36zx3s

yes: all primary outcomes were signi cantly better in intervention group vs control partly: SOME primary outcomes were signi cantly better in intervention group vs control no statistically signi cant difference between control and intervention potentially harmful: control was signi cantly better than intervention in one or more outcomes inconclusive: more research is needed Other: Approx. Percentage of Users (starters) still using the app as recommended after 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.
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 All interventions considered in this study were mental health apps, which is included in the title.

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"). 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 Our trial was only concerned with mental health apps so no non-web-based components were included.

1a-iii) Primary condition or target group in the title
Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This study evaluated effectiveness of mental health apps for distress during COVID-19 in U.S. unemployed and essential Workers, which is described in the title. 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 The following sentence is included in the abstract: "Participants were randomized to one of four free commercial mobile applications for managing distress that were (1) highly rated by PsyberGuide and (2) met criteria for intervention features these participants indicated were desirable in a previous survey."

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) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study A description of the level of human involvement does not seem necessary for this study and has not been included in the abstract.
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The is described throughout the paper including "Participants used the apps for 4 weeks and completed baseline and 4-weeks self-assessments of depression, anxiety emotional regulation and suicide risk." 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 This information is provided in the results section and included CONSORT diagram including "There were 3486 individuals assessed for eligibility, 1569 were excluded for not meeting good-actor criteria (n= 988) or not meeting RCT inclusion criteria (n=581). A total of 1,717 individuals were randomized to Beautiful Mood (n=425), COVID Coach (n=431), Calm (n=424), or 7 Cups of Tea (n=437). Among those allocated to a condition, 838 participants completed the RCT baseline assessment while 643 participants completed the follow-up assessment. 581 individuals reported using the assigned app and 62 reported using a nonassigned app." Usage is also specifically reported throughout the paper including Table 2. Clinical outcomes are discussed starting on page 15 and in Table 3 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 Our study is not a negative trial but we do state the following: "We also cannot rule out regression to the mean, as people who used the attention control app had outcomes similar to participants who used the active apps." Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The main objectives of this study were 1. Determine if users of these apps show significant improvement on anxiety, depression, emotion regulation, and suicide risk. 2. Identify differences among the apps in use, usability, and acceptability. 3. Determine if there is a dose-response relationship such that frequency of app use is positively associated with improvement on depression, anxiety, emotional regulation, and suicide risk. 4. Identify outcome differences among apps in this dose-response relationship." 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "This remote pragmatic clinical trial used simple randomization with parallel assignment comparing 3 active apps to an attention control app. " 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 No important changes to methods occurred after trial commencement.

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].

4a) Eligibility criteria for participants
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable to this study.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Inclusion criteria included: ≥19 years old, living in the United States, English-speaking, access to a mobile device, agreement to be contacted after the initial survey, and report of depression (

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed. 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 "Participants were recruited nationally via Prolific, an online research platform which includes several safeguards to preserve data quality [20][21][22], to minimize bad actors and has shown to be reliable, efficient, and affordable for remote data collection for behavioral research [23]." 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.
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 This is addressed throughout the paper, including "Participants were recruited nationally via Prolific, an online research platform...." and "After volunteering on Prolific and providing consent, participants completed all measures in a web-based REDCap interface." subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In the consent, participants were explained the purpose of the study, that that would be randomized to one of four mobile apps, and would be asked to complete surveys before treatment began and four weeks later. Participants were also told how data were stored and managed and approximately how long each survey would take." 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 data were collected online from English-speaking individuals living in the US 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.
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 "Participants were randomized after completing a web-based baseline assessment of mood and paid $1 (see measures). Participants were asked to use the app as instructed by the developers and then completed a web-based post-treatment survey at four weeks."

4b-ii) Report how institutional affiliations are displayed
Report 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.(Not a required item -describe only if this may bias results) 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We do not believe this would bias results and have not discussed this in the paper. Institutional affiliation was shared on the consent form and on each screen of the webbased assessments.

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).

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 No developers or sponsors of the apps examined were involved in the 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.
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 No authors were involved in the development of the apps or any formative evaluations evaluated in this 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). 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 No authors were or are involved with the apps and have no history or specific knowledge of revisions or updates to those platforms.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We selected apps based on the following criteria: (1) they were free, (2 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 No authors were or are involved with the apps and have no history or specific knowledge of source code, algorithms, etc of the apps involved.

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

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of 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).
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 "We selected apps based on the following criteria: (1) they were free..." "Participants received their app assignment through a URL to the Google Play store or Apple App Store." Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No authors were involved in the design of the apps evaluated.
"We selected apps based on the following criteria: (1) they were free, (2)

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A dichotomized fidelity measure was created in accordance with each app's recommended use found on their websites.

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

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The study team did not prompt participants to use their assigned app. Participants received a prompt to complete the post-app use assessment via Prolific. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is not applicable to this study as this study evaluated self-guided mental health interventions.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "App Use. As we were not able to collect in-app use data, participants were asked how often they used the app that they were assigned to over the past 4 weeks on a scale of subitem not at all important 1 2 3 4 5 essential 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 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).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Qualitative feedback was not obtained from participants.
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 There were no changes to trial outcomes after the trial commenced. subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A priori power analysis for an ANOVA F test indicated that a sample size of 800 (n=200 participants in each of the active and control app conditions) would be sufficient with a power of .80 and an alpha of .05 for a minimum detectable effect size (MDES) of Cohen's d=.24 for main effect comparisons between any two conditions. The post-hoc power analysis for 643 participants with complete data found an MDES of Cohen's d=.29 for main effect comparisons between any two conditions. Previous research has found an average Hedges g effect size (a comparable effect size to Cohen's d but corrected for small samples) on self-guided mental health apps to be 0.50, and for self-guided tools to be .24 [54]." Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study "Participants were randomized by study staff using random allocation functions in Excel and received their app assignment through a URL to the Google Play store or Apple App Store." 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 "A total of 1,717 individuals were randomized to Beautiful Mood (n=425), COVID Coach (n=431), Calm (n=424), or 7 Cups of Tea (n=437). Among those allocated to a condition, 838 participants completed the RCT baseline assessment while 643 participants completed the follow-up assessment. 581 individuals reported using the assigned app and 62 reported using a non-assigned app. For this intention to treat trial, all randomized participants were included in the primary analysis." 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 brie y explain why the item is not applicable/relevant for your study "Participants were randomized by study staff using random allocation functions in Excel and received their app assignment through a URL to the Google Play store or Apple App Store." "A total of 1,717 individuals were randomized to Beautiful Mood (n=425), COVID Coach (n=431), Calm (n=424), or 7 Cups of Tea (n=437)." 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 "Participants were randomized by study staff using random allocation functions in Excel and received their app assignment through a URL to the Google Play store or Apple App Store." 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 cointerventions (if any).
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 "Participants were blinded to the study hypotheses but not condition." "Participants were randomized by study staff using random allocation functions in Excel and received their app assignment through a URL to the Google Play store or Apple App Store." 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 brie y explain why the item is not applicable/relevant for your study "In the consent, participants were explained the purpose of the study, that that would be randomized to one of four mobile apps..." 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 "The three active app interventions included 1) meditation (Calm), 2) COVID-19 Coping (COVID Coach), and 3) chat and positive psychology (7 Cups of Tea). The attention control app used only mood tracking (Beautiful Mood) and did not include any intervention elements the other apps possessed (mindfulness meditation, emotional coping skills, social connection or positive psychology approaches)." 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 brie y explain why the item is not applicable/relevant for your study "T-tests and crosstabulations with chi-square tests compared demographic and baseline clinical outcomes by missing data status at follow-up timepoint. Chi-square tests examined the association between condition assignment and compliance (whether a participant used the app they were assigned to or used an alternative app). All analyses were intent-to-treat. Analyses of variance were used to compare conditions on AIM, IAM, and IUS scores at follow-up, with Tukey Honestly Significant Difference (HSD) tests making pairwise post-hoc comparisons among all apps. Mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the PHQ-9, GAD-7, SBQ-R, and DERS-SF, and to test for condition differences at follow-up and change slope. We applied mixed effects models with two timepoints nested within person. ... To test whether there was a dose-response relationship such that the app use frequency was associated with rate of change on PHQ-9, GAD-7, SBQ-R, and DERS-SF scores, we computed another series of mixed effects models for each outcome. An initial model included variables for time and frequency of use, a second model added condition terms for each app using Beautiful Mood as reference, a third model added condition x frequency interaction terms for each app, and the fourth model included time, frequency, and a time x frequency interaction term. Model comparisons applied -2 Log Likelihood, Akaike Information Criterion, and Bayesian Information deviance statistics. To test the impact of app use frequency on change over time, similar nested model testing was applied using an initial null model, followed by models that added dosage, dosage x time interaction, and condition assignment. "

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 X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address 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 "T-tests and crosstabulations with chi-square tests compared demographic and baseline clinical outcomes by missing data status at follow-up timepoint." "A total of 643/838 (76.7%) provided a follow-up assessment. There were no significant differences between those missing or not missing follow-up assessments on demographic data in Table 1 or clinical measures at baseline. " 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 There were no subgroup analyses or adjusted analyses. 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 brie y explain why the item is not applicable/relevant for your study "The study received ethics approval from the University of Washington Institutional Review Board (STUDY00010842)."

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.

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 "Participants completed electronic informed consent prior to study completion." "The study received ethics approval from the University of Washington Institutional Review Board (STUDY00010842). In the consent, participants were explained the purpose of the study, that that would be randomized to one of four mobile apps, and would be asked to complete surveys before treatment began and four weeks later. Participants were also told how data were stored and managed and approximately how long each survey would take." 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

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were offered crisis management resources when they endorsed the 9th item of the PHQ-9 or were over the cut-off for the SBQ-R." 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "There were 3486 individuals assessed for eligibility, 1569 were excluded for not meeting good-actor criteria (n= 988) or not meeting RCT inclusion criteria (n=581). A total of 1,717 individuals were randomized to Beautiful Mood (n=425), COVID Coach (n=431), Calm (n=424), or 7 Cups of Tea (n=437). Among those allocated to a condition, 838 participants completed the RCT baseline assessment while 643 participants completed the follow-up assessment. 581 individuals reported using the assigned app and 62 reported using a nonassigned app. For this intention to treat trial, all randomized participants were included in the primary analysis." 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 brie y explain why the item is not applicable/relevant for your study "Among those allocated to a condition, 838 participants completed the RCT baseline assessment while 643 participants completed the follow-up assessment. 581 individuals reported using the assigned app and 62 reported using a non-assigned app." 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.

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 " Figure 1 presents the Consolidated Standards of Reporting Trails (CONSORT) 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 were recruited from October through December 2020" 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 critical secular events specifically related to availability of internet resources occurred during the study. Secular events pertaining to COVID-19 are described.
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is not applicable to this study.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " 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.
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 "There were 3486 individuals assessed for eligibility, 1569 were excluded for not meeting good-actor criteria (n= 988) or not meeting RCT inclusion criteria (n=581). A total of 1,717 individuals were randomized to Beautiful Mood (n=425), COVID Coach (n=431), Calm (n=424), or 7 Cups of Tea (n=437). Among those allocated to a condition, 838 participants completed the RCT baseline assessment while 643 participants completed the follow-up assessment. 581 individuals reported using the assigned app and 62 reported using a nonassigned app. For this intention to treat trial, all randomized participants were included in the primary analysis."

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).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-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 "For this intention to treat trial, all randomized participants were included in the primary analysis." 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 "An ANOVA found a significant difference on the IUS among the conditions (mean(Beautiful Mood) 72.9, SD 16.7; mean(Covid Coach) 71.2, SD 15.4; mean(Calm) 66.8, SD 17.3; mean(7 Cups) 65.2, SD 17.7). Tukey HSD post hoc tests indicated Beautiful Mood was significantly more usable than Calm (mean difference = 6.0, 95% CI 1.2-10.8; P = .007) and 7 Cups of Tea (mean difference = 7.7, 95% CI 2.9-2.5; P < .001). COVID Coach was significantly more usable than 7 Cups of Tea (mean difference = 6.1, 95% CI 1.2-10.9; P = .007). We found no significant differences on app acceptability (overall AIM mean = 3.5, SD = 1.0, 95% CI 3.4-3.6; P = .22) or appropriateness (overall IAM mean = 3.6, SD = 0.9, 95% CI 3.6-3.7; P = .48)." " Table 3 displays the reporting sample size, mean scores, and standard deviation at each timepoint for the PHQ-9, GAD-7, SBQ-R, and DERS-SF for each app...From baseline to followup, participants improved an estimated -1.5 points on the PHQ-9 (SE 0.2; 95% CI -1.1--1.8; P < .001) and -1.3 points on the GAD-7 (SE 0.2; 95% CI -1.0--1.6; P < .001)." 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 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).

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 "App use A crosstabulation with chi-square test found significant differences among the apps in the amount of use participants reported; participants used Beautiful Mood more frequently and Covid Coach and 7 Cups of Tea less frequently (see Table 2)." "Dosage Mixed effects models were computed to examine the relation of frequency of app use with change over time on the PHQ-9, GAD-7, SBQ-R, and DERS-SF, over all conditions, controlling for condition, for a condition x app use interaction, and for condition x time." 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 brie y explain why the item is not applicable/relevant for your study "At follow-up, 62/643 (9.6%) participants reported being non-adherent to condition assignment and reported that they use a different app than the one they were randomly assigned to use." Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable to this study

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

19) All important harms or unintended effects in each group
(for speci c guidance see CONSORT for harms) 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 brie y explain why the item is not applicable/relevant for your study This is not applicable to this study.
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 reported.

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2]. Does your paper address subitem 19-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 Only quantitative feedback on usability, acceptability, and appropriateness was obtained. Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is done. For example, "Our primary findings are that commercial mobile mental health apps are found to be usable, acceptable and had a positive impact on depression and anxiety, but not emotional regulation or suicide risk.: Copy and paste relevant sections from the manuscript (include quotes in quotation 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 done. For example, "Understanding the risks of using commercial apps is as important as determining their impacts and should be explored in future studies."

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

21) Generalisability (external validity, applicability) of the trial findings
NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is done. For example, "Study limitations include the following: (1) our sample consisted of participants from Prolific, and thus may be most representative of essential workers or COVID-19 unemployed persons who are proactively seeking other sources of income to offset financial stress......
(2) because we did not partner with the technology companies who created the study apps, we relied on self-reported app use, which may be subject to self-report bias......(3) While we justify our timeline for measuring outcomes after 4 weeks of intervention use based on what is typical for most mental health app users, we do not have information on the lasting effects of treatment outcome or on continued app use.....(4) we did not ask about potential adverse events related to app use. This is an interesting area of research that to date has not been explored. Understanding the risks of using commercial apps is as important as determining their impacts and should be explored in future studies."

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 Copy and paste relevant sections from the manuscript (include quotes in quotation 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 described in the study strengths and conclusion sections 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 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

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Conflict of Interest: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest." 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?
We added increased detail about the web-based assessment protocols.
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