Emotional Disorder
Conditions
Keywords
Anxiety Depression Emotion PTSD Randomized Clinical Trial
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).
Interventions
BEHAVIORALUnified 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).
Sponsors
University of Los Andes, Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The clinical staff participating in the intervention are unaware of the group membership of the subjects; either experimental or wait-list.
Intervention model description
Allocation: Randomized Intervention Model: Parallel Assignment Single Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in diagnostic criteria for depression, anxiety, as assessed by the Patient Health Questionnaire. | Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up. | PHQ - complete. |
| Change in symptoms of post-traumatic stress as measured by the Post-Traumatic Stress Disorder (PTSD) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Quality of Life Enjoyment Questionnaire, Q-LES-Q. |
| Anxiety measure. | 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) |
| Depression measure. | 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). |
| Current level of functioning. | 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. |
Countries
Colombia
Outcome results
None listed