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

NCT07001202 | Not Yet Recruiting

• 2 other identifiers: FDI UAN23102 - Reframe-IT+UFDI UAN23102
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Suicidal Ideation; Depression Disorders; Anxiety

Keywords

Suicidal ideation prevention; Indicated prevention; Depression prevention; Anxiety prevention; University students; College students

Outcome Measures

Primary Outcomes (5)

• Client Satisfaction Questionnaire (CSQ-8)

  It is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which rates each of the 9 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria from "0" (Never) to "3" (Almost Every Day). In Chile, it has been validated among people aged 20 years and over, with a sensitivity of 92% and a specificity of 89%, compared to the Hamilton Depression Scale. In addition, it has construct validity and concurrent predictive validity with the The International Classification of Diseases, 10th Revision (CIE-10) criteria for depression. The interpretation is made by adding the total of the first nine questions: 0-4 points, without depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression.

  End of intervention at 6 weeks

• Feasibility Assessment: Number of participants recruited

  Initially, inclusion and exclusion criteria will be defined to ensure that participants are representatives of the target group. A tracking system will be implemented to monitor the number of people recruited.

  through study completion, an average of 1 year

• Feasibility Assessment: Recruitment time for completion

  A tracking system will be implemented to monitor the time needed to complete the recruitment process.

  through study completion, an average of 1 year

• Feasibility Assessment: Evaluation of data collection and results.

  Clear protocols will be established for data collection and analysis, ensuring accuracy and consistency. Statistical analyzes will be used to check the validity and reliability of the results.

  through study completion, an average of 1 year

• Feasibility Assessment: Level of progress of the participants in the sessions.

  The completion and the time needed for completion of each module of the intervention will be registered.

  through study completion, an average of 1 yea

Secondary Outcomes (9)

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Through study completion, an average of 1 year

• Patient Health Questionnaire-9 (PHQ-9)

  Through study completion, an average of 1 year

• Generalized Anxiety Disorder (GAD-7)

  Through study completion, an average of 1 year

• Distress Tolerance Scale (DTS)

  Through study completion, an average of 1 year

• The Cognitive-behavioral Therapy Skills Questionnaire (CBTSQ)

  Through study completion, an average of 1 year

Study Arms (1)

Reframe-IT+U

EXPERIMENTAL

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.

Behavioral: Indicated Prevention for suicidality

Interventions

Indicated Prevention for suicidality BEHAVIORAL

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.

Reframe-IT+U

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older.
• Undergraduate students at Universidad de los Andes.
• Able to read and speak Spanish.
• Mild to moderate suicide risk in the past month, defined as having answered "Yes" to items 1, 2, 3, and/or 4 on the Columbia Suicide Severity Rating Scale (C-SSRS).

You may not qualify if:

• Severe suicide risk, defined as having answered "Yes" to item 5 (past month) or item 6 (past 3 months) on the Columbia Suicide Severity Rating Scale (C-SSRS).
• Presence of a severe, untreated psychiatric condition during the past year or history of psychiatric hospitalization in the last two years.
• Determination by the University Wellness Team that the participant is not in a suitable condition to participate due to a severe psychiatric condition or need for hospitalization.
• High severity of psychotic symptoms (score equal to or greater than 2 on any of items 13, 14, and/or 15 of the Community Assessment of Psychic Experiences - Positive Scale (CAPE, P15)).

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead

Related Publications (38)

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MeSH Terms

Conditions

Suicidal Ideation; Anxiety Disorders

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Jorge Gaete, MD PhD

CONTACT

+56226182277; jgaete@uandes.cl

Valentina Romo, MSc

CONTACT

+56226181000; vromo@uandes.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Quasi-experimental study pre and post.

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: June 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share