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Acceptability and Feasibility of Reframe-IT+U for Suicidality in University Students.

NCT07001202 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-03

No results posted yet for this study

Summary

Mental health in university students is a growing concern worldwide. In Chile, previous studies have shown high rates of depressive symptoms, anxiety, and suicidal risk in this population. This study seeks to evaluate the acceptability and feasibility of a Cognitive Behavioral Therapy (CBT)-based intervention for the indicated prevention of suicidality in undergraduate students, and also to explore its impact on reducing suicidal ideation. A quasi-experimental before-and-after design will be used with a sample of students from the Universidad de los Andes who present mild to moderate suicidal risk. As this is a pilot study, a sample size calculation is not required, but we expect to recruit 20 subjects, which will allow us to conduct acceptability and feasibility assessments and collect data for a larger-scale study. A follow-up will consist of repeating the initial assessment questionnaire, which will be completed two and four months after the intervention. The methodology includes an initial interview to assess inclusion and exclusion criteria, signing informed consent, and developing a safety plan with the students. Following this, six weekly sessions (three in-person and three with digital components) of 60 minutes each will be held, focusing on emotional regulation, cognitive restructuring, and problem-solving. The intervention will be facilitated by trained psychologists, under the supervision of a trained psychologist or psychiatrist. To assess acceptability, the Client Satisfaction Questionnaire (CSQ-8) will be primarily used.

To assess outcomes, validated instruments will be applied, such as the Columbia Suicide Risk Scale (C-SSRS), the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms, the Generalized Anxiety Disorder 7 (GAD-7) for anxiety symptoms, the Short Form-12 Health Survey (SF-12) for quality of life, the Distress Tolerance Scale (DTS) for stress tolerance, the Community Assessment of Psychic Experiences-Positive (CAPE-P15) for psychotic symptoms, the Difficulties in Emotion Regulation Scale (DERS-E) for emotional regulation, the Social Problem-Solving Inventory-Revised (SPSI-R) for problem-solving, and the Cognitive-behavioural Therapy Skills Questionnaire (CBTSQ) for cognitive-behavioral skills. Reduction in suicidal ideation, satisfaction with the intervention, and program adherence will be measured.

The study hopes that the prevention program, along with the proposed assessments and procedures, will be appropriate and feasible in a university setting. This will allow progress toward a larger randomized controlled trial. Furthermore, it is expected that students in the intervention group will experience a reduction in suicidal ideation.

Conditions

Interventions

BEHAVIORAL

Indicated Prevention for suicidality

The Reframe-IT+U program is an individualized preventive intervention based on cognitive behavioral therapy, with a problem-solving and help-seeking approach, delivered within the University with psychologists and supervision. The program consists of six weekly sessions of 60-90 minutes each.

Sponsors & Collaborators

  • Universidad de los Andes, Chile

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-10-31
Completion
2025-10-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07001202 on ClinicalTrials.gov