Clinical trial NCT03127982: Unified Protocol for Emotional Problems in Victims of the Armed Conflict in Colombia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Disorder
Keywords: Anxiety Depression Emotion PTSD Randomized Clinical Trial
Lead sponsor: University of Los Andes, Columbia
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment Single Blind
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in diagnostic criteria for depression, anxiety, as assessed by the Patient Health Questionnaire.
timeFrame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
measure: Change in symptoms of post-traumatic stress as measured by the Post-Traumatic Stress Disorder (PTSD)
timeFrame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
Secondary outcomes:
measure: Quality of Life. Self-reported measure assessing the physical health, subjective feelings, leisure activities, social relationships, general activities, satisfaction with medications and life satisfaction.
timeFrame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
measure: Anxiety measure.
timeFrame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
measure: Depression measure.
timeFrame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
measure: Current level of functioning.
timeFrame: Baseline, and 3-month follow-up.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Laboratorio de Psicología Clínica Uniandes - Universidad de Los Andes
state: DC
Study officials:
affiliation: Universidad de Los Andes
name: Leonidas Castro-Camacho, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: