Effectiveness of a CBT Online-based Program to Reduce Suicide Ideation Among School Adolescents
NCT05229302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2024-05-08
Summary
This is a single-blind two armed cluster randomized controlled trial (cRCT) aimed to determine the effectiveness of an integrated blended intervention (online a face-to face sessions) to reduce suicidal ideation (primary outcome). Additionally, the effect of the program on the following secondary outcomes will be assessed: suicidal attempts, depressive symptoms, hopelessness and problem-solving skills. On the other side, given its probable role as underlying mechanism in SI reduction, the effect of the intervention on emotional regulation will be assessed. Moreover, the study will evaluate whether the effects of the cRCT on primary and secondary outcomes remain at post-intervention and at 3-month, 6-month and 12-month follow-up.
Conditions
Interventions
- BEHAVIORAL
-
Reframet IT
The online intervention comprises 8 modules of cognitive behavioral therapy (CBT) delivered at schools by psychologists over 10 weeks. Contents: engagement and problem identification, emotional recognition and distress tolerance, identification of negative automatic thinking, help seeking and activity scheduling, problem solving, and cognitive restructuring, and a wrap up session. Two activities per module. Using a message board, the participant could communicate with research therapists who also check completed activities and respond with personalized messages. The face-to-face intervention comprises 4 CBT-based sessions to help the students in three aspects: i) close support and monitoring in case of an increase of symptomatology; ii) motivation to persist with the CBT; and iii) support the interaction between the students and CBT. Additionally, participants will be referred to a primary care clinic to receive treatment as usual.
- BEHAVIORAL
-
Usual care
Treatment as usual consists of identification and assisted referral to a primary care clinic where trained psychologists will assess the symptomatology and propose a course of actions, from initiation of psychotherapy to referral to a General practitioner to initiate medication if needed. Psychoterapy in primary care clinics consists of a range of 4-8 sessions twice a month. Most of the content of the psychotherapy are based on Cognitive-Behavioral Model. When needed, general practioners may suggest using medication, which normally are SSRI anditepressant (e.g., Fluoxetine, Sertraline). Medical check-up is conducted every month or every two months.
Sponsors & Collaborators
-
Universidad de los Andes, Chile
collaborator OTHER -
Centre for Youth Mental Health, University of Melbourne, Australia
collaborator UNKNOWN -
University of Talca
lead OTHER
Principal Investigators
-
Daniel Nuñez, PhD · University of Talca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2024-03-30
- Completion
- 2024-03-30
Countries
- Chile
Study Locations
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