NCT05770388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 4, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

January 30, 2023

Last Update Submit

October 3, 2024

Conditions

Keywords

Suicide PreventionHelp-Seeking BehaviorApp-based InterventionUniversity Students

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • Willingness to change

    3 months post-randomization

  • Intention to help-seeking

    3 months post-randomization

  • Access to treatment

    3 and 6 months post-randomization

  • Barriers to accessing treatment

    3 months post-randomization

  • Suicidal risk

    3 months post-randomization

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Intervention Group

EXPERIMENTAL

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 MoodBehavioral: Reminder messages and counseling

Interventions

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.

Control GroupIntervention Group

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Currently undergoing mental health treatment (psychological or psychiatric)
  • High suicidal risk during the last 30 days and/or 3 months \[answer "yes" to questions 4 and 5 (last 30 days) and/or question 6 (last 3 months) of the C-SSRS\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Álvaro Jiménez-Molina

Santiago, Santiago Metropolitan, 8370128, Chile

Location

Related Publications (6)

  • 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.

    PMID: 30211576BACKGROUND
  • 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.

    PMID: 30663193BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 30456814BACKGROUND
  • 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.

    PMID: 28805169BACKGROUND
  • 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.

    PMID: 34574553BACKGROUND

MeSH Terms

Conditions

Suicidal IdeationSuicide PreventionHelp-Seeking Behavior

Interventions

Counseling

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Álvaro Jiménez-Molina, PhD

    University Diego Portales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

March 15, 2023

Study Start

December 15, 2022

Primary Completion

December 30, 2023

Study Completion

July 30, 2024

Last Updated

October 4, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations