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The present study aims at evaluating the effects of a CBT intervention, a cultural adaptation of the Unified Protocol for the Trans-diagnostic Treatment of Emotional Disorders (UP) in victims of the Colombian armed conflict.
A randomized clinical trial aimed at evaluating the effects of the UP in a group of 100 internally displaced victims of armed conflict living in Bogotá is being implemented. Participants are recruited from several governmental, non-governmental agencies as well as community organizations of victims. Participants are being randomly assigned to treatment condition (N=50) or to waiting-list control (N=50). Treatment consists in 12 biweekly sessions covering the 8 modules of the original UP. The effects of the UP is evaluated through Patient Health Questionnaire (PHQ) and several measures of co-morbid emotional disorders, Anxiety, Depression, PTSD as well as level of functioning and quality of life.
Specific objectives
Methodology Design. Allocation randomized Participants. 100 individuals presenting emotional sequelae of exposure to violent events of armed conflict in Colombia, 50 of which are being randomly assigned to treatment group and 50 to control group (waiting list).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Immediately following randomization, participants in this condition attend 12-13 biweekly face-to face individual sessions that last approximately 1.5 hrs each of the cultural adaptation of the Unified Protocol trans diagnostic treatment comprising the following modules: motivation enhancement, psycho-education of emotion, emotion awareness training, cognitive reappraisal, emotion avoidance and emotion-driven behavior, tolerance training for physical sensations, emotion exposure, and relapse prevention. Treatment is provided by graduate students in clinical psychology who have been trained in the UP and receive weekly supervision by experienced clinicians and use a Workbook for homework assigned between sessions. |
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| Group 2 | Active Comparator | Participants randomly assigned to this condition do not receive any active intervention during a six-week wait period after randomization, while completing assessment evaluation at the beginning and end of wait list period, after which they receive the same intervention (Unified Protocol) provided to the treatment condition (Group 1). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unified Protocol | Behavioral | The Unified Protocol (UP) is a trans-diagnostic cognitive-behavioral therapy (tCBT) for individuals diagnosed with anxiety disorders, depression and related disorders (which we refer to as emotional disorders). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in diagnostic criteria for depression, anxiety, as assessed by the Patient Health Questionnaire. | PHQ - complete. | Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up. |
| Change in symptoms of post-traumatic stress as measured by the Post-Traumatic Stress Disorder (PTSD) | Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5). | Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life. Self-reported measure assessing the physical health, subjective feelings, leisure activities, social relationships, general activities, satisfaction with medications and life satisfaction. | Quality of Life Enjoyment Questionnaire, Q-LES-Q. | Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
Based on self-representation.
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| Name | Affiliation | Role |
|---|---|---|
| Leonidas Castro-Camacho, Ph.D. | Universidad de Los Andes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorio de Psicología Clínica Uniandes - Universidad de Los Andes | Bogotá | DC | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37466983 | Derived | Castro-Camacho L, Barlow DH, Garcia N, Farchione TJ, Idrobo F, Rattner M, Quant DM, Gonzalez L, Moreno JD. Effects of a Contextual Adaptation of the Unified Protocol in Multiple Emotional Disorders in Individuals Exposed to Armed Conflict in Colombia: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Oct 1;80(10):991-999. doi: 10.1001/jamapsychiatry.2023.2392. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 19, 2022 | |
| Reset | Oct 25, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 19, 2022 | Oct 25, 2023 |
Allocation: Randomized Intervention Model: Parallel Assignment Single Blind
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The clinical staff participating in the intervention are unaware of the group membership of the subjects; either experimental or wait-list.
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| Anxiety measure. | Overall Anxiety Severity and Impairment Scale (OASIS) | Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up. |
| Depression measure. | Overall Depression Severity and Impairment Scale. (ODSIS). | Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up. |
| Current level of functioning. | Current level of functioning measure. Adapted from ACOPLE. (Santaella-Tenorio J, Bonilla- Escobar FJ, Fandiño-Losada A, Bass J, Gutiérrez-Martínez MI, Bolton P. Validating an Instrument for victims of violence in Colombia: Evaluation of Two Community-based Mental Health Interventions for Violence-Displaced Afro-Descendants in Colombia. [Unpublished manuscript]. Colombia: University of Valle, Instituto CISALVA; 2013). -[Time Frame: Baseline, and 3-month follow-up.](streamdown:incomplete-link) | Baseline, and 3-month follow-up. |