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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127982
• Other study ID #: COLCIENCIAS 644-2014
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 20, 2021

Study information

• Verified date: November 2022
• Source: University of Los Andes, Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Disorder

Intervention

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).

Locations

Country	Name	City	State
Colombia	Laboratorio de Psicología Clínica Uniandes - Universidad de Los Andes	Bogotá	DC

Sponsors (1)

Lead Sponsor	Collaborator
University of Los Andes, Columbia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.