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

Primary Purpose

Suicidal Ideation, Suicidal Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
App Take Care of Your Mood
Reminder messages and counseling
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring Suicide Prevention, Help-Seeking Behavior, App-based Intervention, University Students

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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]

Sites / Locations

  • Álvaro Jiménez-MolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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).
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).
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.

Full Information

First Posted
January 30, 2023
Last Updated
March 3, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05770388
Brief Title
App-based Intervention to Promote Mental Health Help-seeking Among University Students
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicidal Behavior
Keywords
Suicide Prevention, Help-Seeking Behavior, App-based Intervention, University Students

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
App Take Care of Your Mood
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reminder messages and counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response, drop-out and adherence rates
Description
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.
Time Frame
3 months post-randomization
Title
Acceptance
Description
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.
Time Frame
3 months post-randomization
Title
User Satisfaction
Description
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.
Time Frame
3 months post-randomization
Title
User Experience
Description
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.
Time Frame
3 months post-randomization
Secondary Outcome Measure Information:
Title
Willingness to change
Description
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.
Time Frame
3 months post-randomization
Title
Intention to help-seeking
Description
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.
Time Frame
3 months post-randomization
Title
Access to treatment
Description
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).
Time Frame
3 and 6 months post-randomization
Title
Barriers to accessing treatment
Description
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).
Time Frame
3 months post-randomization
Title
Suicidal risk
Description
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.
Time Frame
3 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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]
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Álvaro Jiménez-Molina, PhD
Phone
56983536140
Email
alvaro.jimenez@udp.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Álvaro Jiménez-Molina, PhD
Organizational Affiliation
University Diego Portales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Álvaro Jiménez-Molina
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8370128
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Álvaro Jiménez-Molina, PhD
Phone
56983536140
Email
alvaro.jimenez@udp.cl
First Name & Middle Initial & Last Name & Degree
Álvaro Jiménez-Molina, PhD
First Name & Middle Initial & Last Name & Degree
Vania Martínez, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30211576
Citation
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.
Results Reference
background
PubMed Identifier
30663193
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
30456814
Citation
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.
Results Reference
background
PubMed Identifier
28805169
Citation
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.
Results Reference
background
PubMed Identifier
34574553
Citation
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.
Results Reference
background

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

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