Effects of the Adaptation of the Unified Protocol for Emotional Problems in Victims of the Armed Conflict in Colombia: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Changes in diagnostic criteria for depression, anxiety, as assessed by the Patient Health Questionnaire.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The clinical staff participating in the intervention are unaware of the group membership of the subjects; either experimental or wait-list.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 1
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.
干预措施: Unified Protocol (Behavioral)
Group 2
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).
干预措施: Unified Protocol (Behavioral)
结局指标
主要结局
Changes in diagnostic criteria for depression, anxiety, as assessed by the Patient Health Questionnaire.
时间窗: 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)
时间窗: 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).
次要结局
- 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.)
- 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.)
- Current level of functioning.(Baseline, and 3-month follow-up.)
研究者
Leonidas Castro Camacho, Ph.D.,ABPP
Associate Professor
University of Los Andes, Columbia