Clinical trial NCT05770388: 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
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Suicidal Behavior
Keywords: Suicide Prevention
Help-Seeking Behavior
App-based Intervention
University Students
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: University Diego Portales
name: Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay), ANID - NCS2021_081
name: Millennium Institute on Immunology and Immunotherapy
First posted: 2023-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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 \[answer "yes" to questions 4 and 5 (last 30 days) and/or question 6 (last 3 months) of the C-SSRS\]

Primary outcomes:
measure: Response, drop-out and adherence rates
timeFrame: 3 months post-randomization
measure: Acceptance
timeFrame: 3 months post-randomization
measure: User Satisfaction
timeFrame: 3 months post-randomization
measure: User Experience
timeFrame: 3 months post-randomization
Secondary outcomes:
measure: Willingness to change
timeFrame: 3 months post-randomization
measure: Intention to help-seeking
timeFrame: 3 months post-randomization
measure: Access to treatment
timeFrame: 3 and 6 months post-randomization
measure: Barriers to accessing treatment
timeFrame: 3 months post-randomization
measure: Suicidal risk
timeFrame: 3 months post-randomization
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Álvaro Jiménez-Molina
state: Metropolitana
Study officials:
affiliation: University Diego Portales
name: Álvaro Jiménez-Molina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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
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.
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.
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.