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Suicidal IdeationNCT05770388

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

A study testing App Take Care of Your Mood and Reminder messages and counseling in people with Suicidal Ideation and Suicidal Behavior, run by University of Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicidal Ideation, Suicidal Behavior
What is being tested?
App Take Care of Your Mood and Reminder messages and counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChile
Study dates
15 Dec 2022to 30 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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]

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Álvaro Jiménez-Molina

    Santiago, Santiago Metropolitan, 8370128

Other trials in Chile

About this study

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)

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:

Read more
  • 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.

Being tested
App Take Care of Your Mood, Reminder messages and counseling
Keywords
Suicide Prevention, Help-Seeking Behavior, App-based Intervention, University Students
Medical subject headings
Suicidal Ideation, Suicide Prevention, Help-Seeking Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App Take Care of Your MoodDevice

    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.

  • Reminder messages and counselingBehavioural

    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.

Study groups in NCT05770388
Study groupRoleWhat they receive
Control GroupActive comparatorParticipants 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.
Receives: Device: App Take Care of Your Mood
Intervention GroupExperimentalParticipants 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.
Receives: Device: App Take Care of Your Mood; Behavioral: Reminder messages and counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months post-randomization

  2. 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.

    Measured: 3 months post-randomization

  3. 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.

    Measured: 3 months post-randomization

  4. 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.

    Measured: 3 months post-randomization

Secondary outcomes (5)

  1. 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.

    Measured: 3 months post-randomization

  2. 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.

    Measured: 3 months post-randomization

  3. 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).

    Measured: 3 and 6 months post-randomization

  4. 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).

    Measured: 3 months post-randomization

  5. 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.

    Measured: 3 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2023
  2. Study start15 Dec 2022
  3. Primary completion30 Dec 2023
  4. Study completion30 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05770388
Sponsor's protocol ID
FONDECYT Postdoctorado 3200944
Status last verified
Aug 2024
First submitted
30 Jan 2023
Last updated
4 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30211576

  • 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.

    PubMed 30663193

  • 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.

    PubMed 30456814

  • 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.

    PubMed 28805169

  • 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.

    PubMed 34574553

Questions about this trial

What is this clinical trial studying?

A study testing App Take Care of Your Mood and Reminder messages and counseling in people with Suicidal Ideation and Suicidal Behavior, run by University of Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response, drop-out and adherence rates (time frame: 3 months post-randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05770388, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.

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