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

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

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.

Study Overview

• Status: Completed
• Conditions: Emotional Disorder
• Intervention / Treatment: Behavioral: Unified Protocol

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • DC
    • Bogotá, DC, Colombia
      • Laboratorio de Psicología Clínica Uniandes - Universidad de Los Andes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria. Individuals registered as victims in Colombian Victims Unit, 18 years or older, who meet the diagnostic criteria for one or more anxiety disorder(s), depressive disorder(s) or post-traumatic stress and related disorder(s) according to the Diagnostic and Statistical Manual (DSM-5, 2013) as determined by the International Neuro-Psychiatric Interview M.I.N.I.

Exclusion Criteria:

• Exclusion criteria. Individuals diagnosed with psychotic disorders, bipolar affective disorders, intellectual disability, dementia, substance abuse (as primary diagnoses, with hospitalization requirement for treatment) as well as individuals who endorse acute suicidal risk. Those that do not meet the inclusion criteria, but are in need of mental health attention, will be referred to entities of the Health System, so that they receive the pertinent treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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.	Behavioral: Unified Protocol; 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).; Other Names: UP for the Transdiagnostic Treatment of Emotional Disorders
Active Comparator: Group 2; 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).	Behavioral: Unified Protocol; 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).; Other Names: UP for the Transdiagnostic Treatment of Emotional Disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.	Baseline, and 3-month follow-up.

Collaborators and Investigators

• Sponsor: University of Los Andes, Columbia
• Investigators: Principal Investigator: Leonidas Castro-Camacho, Ph.D., Universidad de Los Andes

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Anxiety Depression Emotion PTSD Randomized Clinical Trial
• Other Study ID Numbers: COLCIENCIAS 644-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No