App-based Intervention to Promote Mental Health Help-seeking Among University Students

Study Overview
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Brief Summary
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It is estimated that approximately one in three university students has a mental health problem and between 5-10% have active suicidal ideation. Most college students do not receive professional treatment, which has been associated with structural and attitudinal barriers to help-seeking. Given that young people regularly use the internet to seek information about health problems, internet and digital technology-based interventions could represent an effective approach to overcome attitudinal barriers. The goal of this study is to evaluate the feasibility of a mobile app-based intervention for the promotion of help-seeking in mental health services for university students at risk of suicide. The main questions it aims to answer are: Is it feasible to implement a mobile app-based intervention for the promotion of mental health help-seeking in a university context? Is it possible to increase the likelihood of help-seeking in mental health services among university students at risk of suicide through an app-based intervention? Participants will receive a brief contact intervention (via phone call or chat) where they will be assessed by a clinical psychologist, receive information on available support services and instructions to download and use a mobile app called Take Care of Your Mood. In addition, the participants can request a counseling session with a clinical psychologist. Participants will also receive reminder messages (by email and chat) motivating them to use the app or request a counseling session with a psychologist if they deem it necessary. Researchers will compare this intervention with a brief contact intervention (control group) where participants will be assessed by a clinical psychologist, will receive instructions to download and use the app, but will not receive reminder messages or be able to access a counseling session with a psychologist.

Official Title
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Development and Evaluation of a Digital Technology-based Programme for Detecting Suicidal Risk and Promoting Help-seeking Among University Students: a Feasibility Study (Pilot RCT)

Conditions
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Suicidal Ideation, Suicidal Behavior

Intervention / Treatment
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* Device: App Take Care of Your Mood
* Behavioral: Reminder messages and counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: University students who have completed the Longitudinal Survey of University Student Mental Health (ELSAM), based on The WHO World Mental Health International College Student (WMH-ICS) initiative Suicidal ideation during the last 12 months Have access to Internet, email and Smartphone Agree to participate in the research through informed consent. Exclusion Criteria: Currently undergoing mental health treatment (psychological or psychiatric) High suicidal risk during the last 30 days and/or 3 months [answer yes to questions 4 and 5 (last 30 days) and/or question 6 (last 3 months) of the C-SSRS]

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Participants will receive a brief contact intervention (via phone call or chat) in which a clinical psychologist will assess their general mental health status and level of suicidal risk, and will provide an intervention based on the principles of motivational interviewing and psycho-educational information along with a list of mental health services available within and outside the University. Participants will also receive instructions on how to download and use a mobile app. | Device: App Take Care of Your Mood<br>* The app provides psychoeducational information, contains several thematic modules (mindfulness, emotional regulation, healthy lifestyle habits, safety plan for crisis management, among others), allows mood monitoring, contains motivational messages and videos aimed at promoting help-seeking in mental health, and information on available support services.<br>|
| Experimental: Intervention Group<br>Participants will receive a brief contact intervention (via phone call or chat) in which a clinical psychologist will assess their mental health status and level of suicidal risk and will provide an intervention based on the principles of motivational interviewing and psycho-educational information along with a list of mental health services available within and outside the University. Participants will also receive instructions on how to download and use a mobile app. Additionally, participants will also receive reminder messages (by email and chat) encouraging them to use the app and to request a counseling session (via phone call, videoconference or chat) with a clinical psychologist if they think it is necessary. After two months, this group will receive a new contact with a clinical psychologist via phone call or chat. In this contact, mood and level of suicidal risk will be assessed, and participants will be encouraged to seek mental health help if they have not already done so. | Device: App Take Care of Your Mood<br>* The app provides psychoeducational information, contains several thematic modules (mindfulness, emotional regulation, healthy lifestyle habits, safety plan for crisis management, among others), allows mood monitoring, contains motivational messages and videos aimed at promoting help-seeking in mental health, and information on available support services.<br>Behavioral: Reminder messages and counseling<br>* Participants receive reminder messages (by email and chat) encouraging them to use the app and to request a counseling session (via phone call, videoconference or chat) with a clinical psychologist if they think it is necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response, drop-out and adherence rates | Data will be collected on the number of eligible individuals and those who enter the study. The response rate of participants and the adherence and dropout levels of participants during follow-up will also be evaluated. | 3 months post-randomization | 
| Acceptance | Acceptance will be assessed through 7 questions on perceived usefulness and relevance of the intervention, degree of engagement and participation, among others. The responses are made in a Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores indicate more acceptance of the program. | 3 months post-randomization | 
| User Satisfaction | Semi-structured interviews (n=15) will be conducted to explore participants' experience, evaluation of the app content, and opinions on potential changes to be included in the intervention. | 3 months post-randomization | 
| User Experience | The Standardized User Experience Percentile Rank Questionnaire for Mobile Apps (SUPR-Qm) will be used. The SUPR-Qm is a 16-item instrument that assesses a user's experience of a mobile application. The questionnaire has 16 items with responses on a 5-point Likert scale (1 = strongly disagree and 5 = strongly agree). Higher scores indicate a better evaluation of the app. | 3 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Willingness to change | Participants will answer the following question: How would you rate your willingness or readiness to change emotional problems you may be having right now? Answers can range from 1 (I don't have any problems that need to change) to 5 (I had a problem, but I have done something about it and things are going better now). A higher score indicates a greater willingness to change. | 3 months post-randomization | 
| Intention to help-seeking | Participants will answer the following question: Within the next 30 days, how likely do you think it is that you will seek help from a mental health service? (1=very likely and 5=not at all likely). A lower score indicates a higher likelihood of seeking mental health help. | 3 months post-randomization | 
| Access to treatment | It will be assessed on the basis of a question on the use of mental health services (counselling, psychotherapy, pharmacotherapy or other) during the last 3 months (1=Yes, 2=No). | 3 and 6 months post-randomization | 
| Barriers to accessing treatment | It will be assessed on the basis of the Seeking treatment section of The WHO World Mental Health International College Student (WMH-ICS) Initiative questionnaire, which contains 10 items aimed at assessing attitudes towards seeking help and barriers to accessing treatment (Ebert et al. 2019). Responses to each item can range from 1 (very important) to 5 (not important). | 3 months post-randomization | 
| Suicidal risk | The Columbia Suicide Severity Rating Scale (C-SSRS) is an interviewer-rated measure of suicidal thoughts and behaviors. The abbreviated version of the scale contains 6 questions and classifies people into three groups (no risk or slight risk, moderate risk, high risk). Scores can range from 0 to 6. Higher scores represent a higher risk of suicide. | 3 months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide Prevention, Help-Seeking Behavior, App-based Intervention, University Students