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NCT Number: NCT03127982

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

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.

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Key information

Conditions

Emotional Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratorio de Psicología Clínica Uniandes - Universidad de Los Andes

Bogotá, DC, Colombia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: UP for the Transdiagnostic Treatment of Emotional Disorders

Primary outcomes

  1. Changes in diagnostic criteria for depression, anxiety, as assessed by the Patient Health Questionnaire.

    Time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.

    PHQ - complete.

  2. Change in symptoms of post-traumatic stress as measured by the Post-Traumatic Stress Disorder (PTSD)

    Time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.

    Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).

Secondary outcomes

  1. Quality of Life. Self-reported measure assessing the physical health, subjective feelings, leisure activities, social relationships, general activities, satisfaction with medications and life satisfaction.

    Time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.

    Quality of Life Enjoyment Questionnaire, Q-LES-Q.

  2. Anxiety measure.

    Time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.

    Overall Anxiety Severity and Impairment Scale (OASIS)

  3. Depression measure.

    Time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.

    Overall Depression Severity and Impairment Scale. (ODSIS).

  4. Current level of functioning.

    Time frame: Baseline, and 3-month follow-up.

    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.

Sponsors and collaborators

Lead sponsor

University of Los Andes, Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Apr 25, 2017
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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