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

NCT03127982 | Completed DMC

• 1 other identifier: COLCIENCIAS 644-2014
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emotional Disorder

Keywords

Anxiety Depression Emotion PTSD Randomized Clinical Trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

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

• Anxiety measure.

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

• Depression measure.

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

• Current level of functioning.

  Baseline, and 3-month follow-up.

Study Arms (2)

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.

Behavioral: Unified Protocol

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).

Behavioral: Unified Protocol

Interventions

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).

Also known as: UP for the Transdiagnostic Treatment of Emotional Disorders

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on self-representation.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Los Andes, Columbia: lead

Study Sites (1)

Laboratorio de Psicología Clínica Uniandes - Universidad de Los Andes

Bogotá, DC, Colombia

Location

Related Publications (1)

• 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.

  PMID: 37466983 DERIVED

Study Officials

• Leonidas Castro-Camacho, Ph.D.

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The clinical staff participating in the intervention are unaware of the group membership of the subjects; either experimental or wait-list.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Allocation: Randomized Intervention Model: Parallel Assignment Single Blind

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 25, 2017
• Study Start: January 1, 2015
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2021
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)