Efficacy of a Text-Based Mental Health Coaching App in Improving the Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial

Background Stress, anxiety, and depression are major mental health concerns worldwide. A wide variety of digital mental health interventions have demonstrated efficacy in improving one’s mental health status, and digital interventions that involve some form of human involvement have been shown to demonstrate greater efficacy than self-guided digital interventions. Studies demonstrating the efficacy of digital mental health interventions within the Asian region are scarce. Objective This study aimed to investigate the potential efficacy of the digital mental health intervention, ThoughtFullChat, which consists of one-on-one, asynchronous, text-based coaching with certified mental health professionals and self-guided tools, in improving self-reported symptoms of depression, anxiety, and stress. The study also aims to examine the potential differences in efficacy among occupational subgroups and between sexes. Methods A randomized controlled study was conducted among housemen (trainee physicians), students, faculty members, and corporate staff at International Medical University, Malaysia. A total of 392 participants were enrolled and randomized to the intervention (n=197, 50.3%) and control (n=195, 49.7%) groups. Depression, anxiety, and stress symptoms were measured using the Depression, Anxiety, and Stress Scale–21 items at baseline and after the 3-month intervention period. The Satisfaction with Life Scale and Brief Resilience Scale were also included, along with a questionnaire about demographics. Results Significant decrease was observed in depression (P=.02) and anxiety (P=.002) scores in the intervention group. A subgroup (corporate staff) also demonstrated significant decrease in stress (P=.005) alongside depression (P=.006) and anxiety (P=.002). Females showed significant improvements in depression (P=.02) and anxiety (P<.001) when compared with males. Conclusions This study provides evidence that the ThoughtFullChat app is effective in improving the symptoms of depression, anxiety, and stress in individuals, particularly among corporate staff from the educational field. It also supports the notion that mobile mental health apps that connect users to mental health professionals in a discreet and cost-efficient manner can make important contributions to the improvement of mental health outcomes. The differential improvements among occupational subgroups and between sexes in this study indicate the need for future digital mental health app designs to consider an element of personalization focused on systemic components relating to occupation. Trial Registration Clinicaltrials.gov NCT04944277; https://classic.clinicaltrials.gov/ct2/show/NCT04944277

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)

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. 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 While the item is applicable, we have made mention of the term "application" in the title and then specified "asynchronous text-based digital mental health mobile application" in the objectives section of the abstract. This was to allow for brevity in the title and compensating with details in the abstract.

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").
C l e a r s e l e c t i o n 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 co-interventions were used. 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 C l e a r s e l e c t i o n 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 The primary condition was symptoms of depression, anxiety and stress present before any official diagnosis as measured by the DASS-21. This was specified in the title as "Symptoms of Stress, Anxiety and Depression". 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 main feature is an asynchronous text-based mobile application and this is specified in the objective in the abstract, with details provided in the main text. There were no particular key features, functionalities or components that were directly relevant to the intervention other than its text-based nature, with the self-guided tools present as a secondary factor. The study also did not account for any differential effectiveness between the text-based platform and self-guided tools, viewing the entire application as one general intervention instead subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) C l e a r s e l e c t i o n 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 This item was not reported in the abstract but clearly elaborated in the methods section of the main text. The platform connected users to mental health professionals (counsellors or clinical psychologists) via asynchronous texting. 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 study does not involve the use of drugs or symptom specific interventions, and instead relied on text-based talk therapy conducted by professionals. Outcomes were self-assessed through questionnaires as mentioned in the methods: "using the DASS-21 scale at baseline and after a 3-month intervention period. Other measures of life satisfaction and resilience were also included, along with a questionnaire on 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 The following can be found in the RESULTS section in the ABSTRACT: "A significant decrease was observed in depression (P=.015) and anxiety (P=.002) scores in the intervention group. One subgroup (corporate staff) also demonstrated a significant decrease in stress scores (P =.005) alongside depression (P=.006) and anxiety (P=.002). In our subgroup analysis, the corporate staff showed significantly greater improvements in depression, anxiety, and stress scores. Females showed significant improvements in depression (P=.024) and anxiety (P<.001) when compared to males"  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 Trial outcomes were not negative. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Problem and type of solution as discussed : "Most people experiencing mental health problems are unable to access treatment due to a variety of reasons that include the lack of availability of services, time constraints, transportation problems, high costs and stigma . Digital mental health interventions, commonly defined as mental health interventions that make use of digital tools (i.e., mobile applications or artificial intelligence based software) to augment mental healthcare and improve its delivery, access and effectiveness, have been known to be particularly useful in overcoming the barrier of stigma due to increased privacy and anonymity. Such interventions also improve access to preventive care, thus enabling a proactive approach to mental wellbeing." What is known about the system is stated as follows: "In terms of efficacy, digital mental health interventions has been shown to be as effective as traditional approaches [17], but without the typical barriers to accessibility that are linked to these latter approaches." Motivation and context are as follows: 1. "While many studies look at efficacy of digital mental health interventions among different occupational groups independently [5,6,7,8,10], very few emphasize the differential impact of these interventions between occupational groups or even between gender" 2. "Most studies on digital mental health interventions are conducted in the West, with very little available data from Asia or other non-western populations." From 1, it follows that the present study's approach of performing a comparison between occupational groups may yield helpful information that may aid in personalisation of interventions according to the needs of these occupational groups.
From 2, it follows that the present study may add to the scarce data on context-specificity of the intervention within the Asian region.
METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Objectives are stated in the Objectives section as follows: 1. "This study examined the potential efficacy of the ThoughtFullChat mobile application among physicians in training (housemen), students, faculty members (academic staff) and corporate staff, in reducing symptoms of self-reported depression, anxiety and stress as measured by the DASS-21 scale." 2. "Scores on the Satisfaction With Life Scale (SWLS) and Brief Resilience Scale (BRS) were also measured." 3. "We also analysed the gender differences in improvements and sought feedback on user satisfaction." Hypotheses are stated in the same section as follows: "The first hypothesis that was proposed was that there would be an improvement in depression, anxiety and stress symptoms in the general sample and the subgroups post intervention, in line with previous observations in research. The second hypothesis was that women would show more significant improvement than men given that the nature of the application that involved asynchronous texting with a mental health professional and other self-guided tools have been previously observed to be more engaging with women." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This item is addressed as follows: 1. "This trial used a 1X1 factorial design (intervention group with free usage of coaching app vs control group with no introduction of the app).' 2. "The ThoughtFullChat Application had an odds ratio change of 0.5-0.6, based on past data provided by ThoughtFull. Thus, an odds ratio of 0.54 was selected for use. This is based on individuals with anxiety moving into the normal range of scores or improving one grade of severity. The sample size calculator obtained from OpenEpi®© provided a sample size of 384, with 192 in each arm. The current study had 197 participants in the intervention group and 195 in the control group, satisfying the sample size estimation." 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 changes to methods were done. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 major disruptive bug fixes were apparent. 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 "The inclusion criteria include medical practitioners who undergo internship training in any Malaysian hospitals, current International Medical University faculty members, students and corporate staff who are competent in English, and experiencing none to severe stress, anxiety or depression based on their DASS-21 score"

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
C l e a r s e l e c t i o n 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 This was not explicitly stated by implied by the type of occupation, educational attainment subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. 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.
C l e a r s e l e c t i o n 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 stated as follows: "The inclusion criteria include medical practitioners who undergo internship training in any Malaysian hospitals, current International Medical University faculty members, students and corporate staff who are competent in English, and experiencing none to severe stress, anxiety or depression based on their DASS-21 score. All participants were above 18 years 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.
C l e a r s e l e c t i o n 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 A webinar was conducted to introduce participants to the project and the app. This is stated as follows: "A webinar on mental health resilience was carried out jointly by the ThoughtFull team and 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 This is clearly addressed as follows: "The inclusion criteria include medical practitioners who undergo internship training in any Malaysian hospitals, current International Medical University faculty members, students and corporate staff who are competent in English, and experiencing none to severe stress, anxiety or depression based on their DASS-21 score." This implies that participants for the housemen group were primarily located in hospitals throughout Malaysia and the rest were located primarily in the main campus of the International Medical University, Malaysia in Kuala Lumpur. Since data was collected

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 This is clearly stated in the instruments subsection in detail. The following phrase emphasizes this: "The instruments used in the questionnaire are DASS-21, Satisfaction With Life Scale (SWLS) and Brief Resilience Scale (BRS)." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 participants were affiliated with the International Medical University as stated in the Methods section.

4b-ii) Report how institutional affiliations are displayed
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

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 ThoughtFull is the brand name of the application used as intervention. They are also accredited in the acknowledgement. The nature of the application is explained as follows in the Methods: "The intervention group were given a 3-month free usage of the ThoughtFullChat application, a text-based mental health coaching application. Participants can communicate with their mental health professionals (licensed counsellors or clinical psychologists) through unlimited asynchronous texting anytime, anywhere. The application also includes goal setting, mood tracking, guided psychoeducational materials, exercises and other learning materials. Mental health professionals used a provider version of the app through their

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 These were not explained as the intervention has not been previously tested in an academic or research setting.

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 The nature of the development and updating were not described as no major self-serve functions were disrupted. Also, the presence of a professional is implied to be the major active component in the application, as it largely centres around mental health coaching via text.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
C l e a r s e l e c t i o n 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 This is not relevant to the study due to the emphasis of the app, which is digitally supported text-based coaching involving a human professional. subitem not at all important 1 2 3 4 5 essential 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.
C l e a r s e l e c t i o n 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 ThoughFullChat is a commercial solution and elements of its technology are deemed proprietary.

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.
C l e a r s e l e c t i o n 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 application is commercially available on the app store or online.

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).
C l e a r s e l e c t i o n 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 The relevant components for this item are addressed as follows: "The intervention group were given a 3-month free usage of the ThoughtFullChat application, a text-based mental health coaching application. Participants can communicate with their mental health professionals (licensed counsellors or clinical psychologists) through unlimited asynchronous texting anytime, anywhere." "Mental health professionals used a provider version of the app through their smartphone to chat with participants and monitor participant engagement." 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 Since the intervention largely centres on the professional, only a brief description of the selfguided features are provided in the article: "The application also includes goal setting, mood tracking, guided psychoeducational materials, exercises and other learning materials."

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.
C l e a r s e l e c t i o n 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 This is an asynchronous application and the present article does not report optimal timing

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).
C l e a r s e l e c t i o n 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 It was clearly indicated that it is a text-based mobile application involving mental health professionals as follows: "Participants can communicate with their mental health professionals (licensed counsellors or clinical psychologists) through unlimited asynchronous texting anytime, anywhere." 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 This is not directly relevant to the present article given the asynchronous nature of the intervention. Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
This was not deemed to be relevant at this stage of the study. However, a pilot study was conducted to test the comprehensibility of instruments: "A pilot study of the questionnaire was done amongst the research team and academic staff who were not included in the study population to ensure the questions were understood and perceived correctly. All participants understood the context well and could answer the questionnaires without any obstructions."

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.
C l e a r s e l e c t i o n Does your paper address subitem 6a-ii?

Copy and paste relevant sections from manuscript text
This does not apply due to the nature of the intervention which involves asynchronous texting and not a drug or symptom specific tool. 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 The trial outcome measures were not changed after commencement. 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 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 This is stated as follows in the subsection Sample Size: "This interventional study with ThoughtFullChat involves the measuring of five variables: Depression, Anxiety and Stress (DASS-21), Resilience and Satisfaction of Life scores. We used anxiety as the primary outcome for our sample size estimation.
The ThoughtFullChat Application had an odds ratio change of 0.5-0.6, based on past data provided by ThoughtFull. Thus, an odds ratio of 0.54 was selected for use. This is based on individuals with anxiety moving into the normal range of scores or improving one grade of severity. The sample size calculator obtained from OpenEpi© provided a sample size of 384, with 192 in each arm. The current study had 197 participants in the intervention group and 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 This is not applicable to the current report.
8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is not applicable to the current report.
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 This is stated in detail as follows: "Block randomization was chosen to allocate participants into intervention and control groups for our study. Before the start of the trial, we used Research Randomizer, an online software to assign participants to intervention and control groups. We randomised 5 participants from every 10 respondents to our questionnaire. Five unique sets of numbers were generated, and the corresponding participants were allocated to the intervention group. The procedure was repeated for every 10 respondents." 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 This is stated as follows: "Before the start of the trial, we used Research Randomizer, an online software to assign participants to intervention and control groups. " 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 The randomization was done by the authors using a software as mentioned: "...we used Research Randomizer, an online software to assign participants to intervention and control groups." 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any).
C l e a r s e l e c t i o n 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 Professionals did not know the identity of participants: However, the following was done: "Enrolled participants were assigned a code which was used as the sole identifier during this study. The identity of the participants was not revealed to the mental health professionals that served them. The emergency contact details of each participant were requested and stored by ThoughtFull's internal clinical team to be used in case of an emergency. All participants were informed of the limits to privacy and the confidentiality policy prior to joining the study." However, blinding of assessor was unnecessary as assessment was based on self-reported measures.

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) 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".
C l e a r s e l e c t i o n 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 Participants were informed if they were in the control or intervention group: "Participants in the control group were not given free access to the ThoughtFullChat application but were not restricted from using other apps or obtaining other forms of intervention during the study period." Further elaborations are given in the subsections entitled "Intervention Group" and "Control Group".
12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is not relevant as this is a eHealth trial.
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 Statistical methods were described in detail in the "Statistical Analysis" subsection: "The collected data was exported from Microsoft Forms to Excel Sheets and analysed using the IBM Statistical Package for the Social Sciences (SPSS) Version 28.0.0.0 (190). Descriptive statistics were calculated for the participant's socio-demographic factors and user experience of the app among intervention group. The mean and standard deviation for the DASS-21, SWLS and BRS before and after the intervention are presented. Wilcoxon signed-rank test was used to calculate the significant differences in the mean of the 3 metrics (DASS-21, SWLS, and BRS) of the 2 groups. A p-value <0.05 is considered statistically significant. Cohen's d value was used to calculate the effect size of each result." 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]).
C l e a r s e l e c t i o n 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 "There were 495 respondents who responded to our pre-interventional questionnaire. Upon screening the participant's DASS-21 scores, 392 (79%) were enrolled and randomised to the intervention and control groups. The remaining 63 respondents did not fit the inclusion criteria due to severe DASS-21 scores. We could not identify and exclude 35 respondents due to incomplete questionnaires. During the study, 30 (15%) participants from the intervention group requested to quit the study. In the control group, 28 participants (14%) did not complete the follow-up questionnaire. After 3 months, there were 167 participants in each arm who completed the studies." This is also indicated in the CONSORT diagram. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This was stated as follows: "All procedures were approved by the Research Ethics committee of International Medical University. Consolidated Standards of Reporting Trials (CONSORT) guidelines were followed, and the study was conducted in adherence to the Declaration of Helsinki. The study was also registered on clinicaltrials.gov (ID: NCT04944277)."

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 "Enrolled participants were assigned a code which was used as the sole identifier during this study. The identity of the participants was not revealed to the mental health professionals that served them. The emergency contact details of each participant were requested and stored by ThoughtFull's internal clinical team to be used in case of an emergency. All participants were informed of the limits to privacy and the confidentiality policy prior to joining the study."

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 "The emergency contact details of each participant were requested and stored by ThoughtFull's internal clinical team to be used in case of an emergency. All participants were informed of the limits to privacy and the confidentiality policy prior to joining the study.
Also, participants in the control group were given access to helplines and other resources: "They were also provided with other non-digital resources such as helplines or 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 " Figure 1 explains the flow of the present study. There were 495 respondents who responded to our pre-interventional questionnaire. Upon screening the participant's DASS-21 scores, 392 (79%) were enrolled and randomised to the intervention and control groups. The remaining 63 respondents did not fit the inclusion criteria due to severe DASS-21 scores. We could not identify and exclude 35 respondents due to incomplete questionnaires. During the study, 30 (15%) participants from the intervention group requested to quit the study. In the control group, 28 participants (14%) did not complete the follow-up questionnaire. After 3 * Copy and paste relevant sections from the manuscript (include quotes in quotation 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 could not identify and exclude 35 respondents due to incomplete questionnaires. During the study, 30 (15%) participants from the intervention group requested to quit the study. In the control group, 28 participants (14%) did not complete the follow-up questionnaire. After 3 months, there were 167 participants in each arm who completed the studies."

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. 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 CONSORT diagram provided in figure 1.
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 This was stated in the "recruitment" section: This cross-sectional study was conducted among housemen, university students, faculty members and corporate staff at International Medical University (IMU) from 26th July 2021 to 26th October 2021." Note: No follow ups were done post-intervention. 14b) Why the trial ended or was stopped (early) 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" C l e a r s e l e c t i o n 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 This is not relevant to this study.
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 relevant to this study. 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 This was included in Table 2 15-i) Report demographics associated with digital divide issues

15) A
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 Not relevant to the present demographic group.

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 This is given in the CONSORT diagram and all other figures

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).
C l e a r s e l e c t i o n 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 The primary analysis outcomes involve comparison with control and is stated in the "Overall outcomes" subsection. The secondary analysis compares subgroups within the intervention group. This is explained in the "Housemen Group", "Medical Students", "Faculty Group', "Corporate Staff", "Age" and "Gender" subsections of the Results.
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 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 These are explained in the respective subsections of the "Results". They are also clearly explained in " Table 3" and " Table 4" 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 This is not included in the present study.
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 This is not relevant to the present study.
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 Results of subgroup analysis are presented in " Table 4" and within the subsections pertaining to each subgroup in the "Results" section.

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).
C l e a r s e l e c t i o n 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 The relevant subgroup analyses are presented under the subsections pertaining to each subgroup in the "Results" 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 Although a questionnaire on quality of user experience was done and reported in "User Experience with ThoughtFullChat App" subsection, no qualitative data was requested. 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).
C l e a r s e l e c t i o n 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 "The goal of this study was to examine the potential effectiveness of a text-based mental health coaching application in improving mental well-being among adults without any known diagnosis of mental health problems. The results demonstrated partial support for the first hypothesis, that the use of the ThoughtFullChat application would result in reduced DASS-21. There was a significant decrease in scores of anxiety and depression in the overall sample but the decrease in stress was not significant, possibly indicating a pathway to the reduction of depression and anxiety that is independent of stress scores." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 are stated as follows: 1. "It is likely that the nature of the workplace environment (i.e. a fixed schedule and with arguably greater predictability as compared to students and housemen) may have contributed independently to the increased effectiveness observed. However, further studies particularly of a qualitative nature may be required to further confirm this speculation." 2." The overall positive feedback on user experience in this study goes beyond merely demonstrating the user-friendliness of the application and may likely imply an openness towards digital-based mental health strategies at least among Malaysians, and likely among Asians. However, further studies are required to corroborate this." 3. "Keeping in mind that different subgroups within a population respond differently to a uniform intervention, understanding how these differences in response emerge through the interaction of systemic factors is likely to provide useful information that could guide efforts towards effective personalisation of intervention design."

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.
C l e a r s e l e c t i o n 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 These are addressed in the "Strengths and Limitations" subsection. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 not explicitly discussed although implied through in the discussions. The study is largely of a preliminary and formative nature. 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.
C l e a r s e l e c t i o n 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 was not relevant to the study at this stage given its preliminary and formative nature. 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 "The study was registered on clinicaltrials.gov (ID: NCT04944277)." 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 This is not relevant. However further questions may be directed to the corresponding author where needed.
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 These were stated in the "Acknowledgement" About the CONSORT EHEALTH checklist 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.
C l e a r s e l e c t i o n 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 yes, major changes yes, minor changes no Your answer must have a minimum of 25 characters.
Your answer must have a minimum of 25 characters. yes no Other: 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?
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