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

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)

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Suicidal Behavior
• Intervention / Treatment: Device: App Take Care of Your Mood; Behavioral: Reminder messages and counseling

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 8370128
      • Álvaro Jiménez-Molina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; 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; 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.
Experimental: Intervention Group; 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; 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.; Behavioral: Reminder messages and counseling; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: University Diego Portales; Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay), ANID - NCS2021_081; Millennium Institute for Research in Depression and Personality (MIDAP), ANID - ICS13_005
• Investigators: Principal Investigator: Álvaro Jiménez-Molina, PhD, University Diego Portales

Publications and helpful links

General Publications

• Auerbach RP, Mortier P, Bruffaerts R, Alonso J, Benjet C, Cuijpers P, Demyttenaere K, Ebert DD, Green JG, Hasking P, Murray E, Nock MK, Pinder-Amaker S, Sampson NA, Stein DJ, Vilagut G, Zaslavsky AM, Kessler RC; WHO WMH-ICS Collaborators. WHO World Mental Health Surveys International College Student Project: Prevalence and distribution of mental disorders. J Abnorm Psychol. 2018 Oct;127(7):623-638. doi: 10.1037/abn0000362. Epub 2018 Sep 13.
• Bruffaerts R, Mortier P, Auerbach RP, Alonso J, Hermosillo De la Torre AE, Cuijpers P, Demyttenaere K, Ebert DD, Green JG, Hasking P, Stein DJ, Ennis E, Nock MK, Pinder-Amaker S, Sampson NA, Vilagut G, Zaslavsky AM, Kessler RC; WHO WMH-ICS Collaborators. Lifetime and 12-month treatment for mental disorders and suicidal thoughts and behaviors among first year college students. Int J Methods Psychiatr Res. 2019 Jun;28(2):e1764. doi: 10.1002/mpr.1764. Epub 2019 Jan 20.
• Jiménez-Molina A, Franco P, Mac-Ginty S, and Martínez V (2023) Internet-based interventions for prevention and early treatment of depression in higher education students. En Martínez V. y Miranda C. (eds) Prevention and early treatment of depression through the life course. Springer, 97-119. https://doi.org/10.1007/978-3-031-13029-8_6
• Ebert DD, Franke M, Kahlke F, Kuchler AM, Bruffaerts R, Mortier P, Karyotaki E, Alonso J, Cuijpers P, Berking M, Auerbach RP, Kessler RC, Baumeister H; WHO World Mental Health - International College Student collaborators. Increasing intentions to use mental health services among university students. Results of a pilot randomized controlled trial within the World Health Organization's World Mental Health International College Student Initiative. Int J Methods Psychiatr Res. 2019 Jun;28(2):e1754. doi: 10.1002/mpr.1754. Epub 2018 Nov 20.
• Mortier P, Cuijpers P, Kiekens G, Auerbach RP, Demyttenaere K, Green JG, Kessler RC, Nock MK, Bruffaerts R. The prevalence of suicidal thoughts and behaviours among college students: a meta-analysis. Psychol Med. 2018 Mar;48(4):554-565. doi: 10.1017/S0033291717002215. Epub 2017 Aug 14.
• Martinez V, Espinosa-Duque D, Jimenez-Molina A, Rojas G, Vohringer PA, Fernandez-Arcila M, Luttges C, Irarrazaval M, Bauer S, Moessner M. Feasibility and Acceptability of "Cuida tu Animo" (Take Care of Your Mood): An Internet-Based Program for Prevention and Early Intervention of Adolescent Depression in Chile and Colombia. Int J Environ Res Public Health. 2021 Sep 13;18(18):9628. doi: 10.3390/ijerph18189628.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Suicide Prevention; University Students; Help-Seeking Behavior; App-based Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: FONDECYT Postdoctorado 3200944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No