Unified Protocol for Emotional Problems in Victims of the Armed Conflict in Colombia

Emotional Disorder Clinical Trial

Official title: Effects of the Adaptation of the Unified Protocol for Emotional Problems in Victims of the Armed Conflict in Colombia: A Randomized Clinical Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Specific objectives

• To translate and adapt the UP, taking into account the cultural, social, economic and political context of individuals exposed to political violence in Colombia.

• Develop and adapt a set of assessment tools to identify victim's symptoms of anxiety, depression, and related disorders.

• Conduct a randomized clinical trial comparing outcomes of 12 biweekly sessions of the culturally adapted UP in a group participants randomized to immediate treatment to a waiting list control receiving delayed (6-week) treatment.

• To identify potential variables that mediate or moderate the effects of treatment with the UP.

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). ;

Related Conditions & MeSH terms

• Emotional Disorder

• NCT number: NCT03127982
• Study type: Interventional
• Source: University of Los Andes, Columbia
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Completion date: December 20, 2021