Acceptability and feasibility of Reframe-IT+U for suicidal ideation in university students: protocol of a quasi-experimental pilot study

Abstract

Background: 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 to explore its impact on reducing suicidal ideation. Methods: A quasi-experimental before-and-after design will be used with a sample of students from a private university who present mild to moderate suicidal risk. As this is a pilot study, a sample size calculation is not required; however, we expect to recruit 18 participants, which will enable 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 2 and 4 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 min each will be held, focusing on emotional regulation, cognitive restructuring, and problem-solving. Trained psychologists will facilitate the intervention under the supervision of a trained psychologist or psychiatrist. To assess acceptability and satisfaction, the Client Satisfaction Questionnaire (CSQ-8) will be primarily used. To assess secondary 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-Behavioral Therapy Skills Questionnaire (CBTSQ) for cognitive-behavioral skills. Reduction in suicidal ideation, satisfaction with the intervention, and program adherence will be measured. Discussion: The study aims to determine whether the proposed prevention program, along with the accompanying assessments and procedures, is 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. Trial registration: Clinical Trials NCT07001202, June 2nd, 2025. [https://www.clinicaltrials.gov/study/ NCT07001202]