Evaluation of Two Mental Health Interventions Based on the Community for Violence-Displaced Afro-Descendants in Colombia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 521
- 试验地点
- 2
- 主要终点
- Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders.
研究概览
简要总结
This study is a community prevention randomized trial with three parallel groups: two intervention groups and one control group in Buenaventura and Quibdó.
The aim of the trial is to evaluate the impact of two community interventions on mental health; the intervention groups are designed to decrease depression, anxiety, post-traumatic stress disorders symptoms as well as the level of dysfunctionality in Afro-Colombian victims of violence.
Adult people (equal or more than 18 years old) belonging to Afro-Colombian communities in both cities will participate in the enter survey. The subjects will be selected based on the severity of symptoms, traumatic experiences and a level of dysfunction identified using the instruments of this research (i.e. those obtaining an score equal or higher than 49 in symptoms (25% of the total of symptoms)).
The fieldwork and the interventions will be conducted by people belonging to the community; they are called Lay Psychosocial Community Workers (LPCW). After six (6) weeks of formal training, they will be able to perform two kinds of interventions, Common Elements Treatment Approach (CETA) based on a cognitive behavioral intervention and Narrative Community Group Therapy (NCGT), for the people affected by violence and displacement that were pre-selected according to the baseline instrument.
The LPCW will be under the constant supervision by psychologists of the project, and under weekly supervision by a group of experts from Johns Hopkins University, the Heartland Alliance and The Institute for Research and Development in Violence Prevention and Promotion of Peaceful Coexistence Social (CISALVA) by means of phone calls or monthly visits to the cities. Selected subjects will be randomly allocated to any study branch: CETA, NCGT or the waiting control group.
The study subjects will follow their allocated treatment, or waiting in the control group, for 8 to 12 weeks; then they will be re-assessed using the project instrument two weeks after the last session of therapy.
The study outcome is the differences in instrument scores between the follow-up and the baseline among the interventions (CETA or NCGT) and control group.
Control subjects will be assessed by the project psychologist after the follow-up, and they will receive treatment when necessary.
详细描述
Colombian armed conflict predominantly affects rural communities; armed conflict has caused thousands of deaths and the displacement of a vast amount of people from rural areas. A considerable amount of the displacement comes from the two most important cities in Pacific coast region: Buenaventura in Valle del Cauca province and Quibdó in Chocó province.
This project will assess treatments, Common Elements Treatment Approach (CETA) and Narrative Community Group Therapy (NCGT), to reduce mental symptoms triggered by violence and will develop mechanisms for a sustainable supply of mental health services in the region.
Adult Afro-Colombian persons who have responded to the study survey but present symptoms of severe mental illness like schizophrenic, psychotic, suicidal attempters, those who can potentially harm others, or who require specialized treatment will not be included in the study.
They will be referred to a project psychologist who will determine whether they require psychiatric treatment, in which case, they will be referred to health institutions through social workers who will ensure treatment is given. Finally, anyone who is related to the LPCW will be excluded.
For the CETA arm, new clients will be enrolled as long as a treatment position becomes available (i.e., as long as previous clients have completed the treatment) to keep the providers (LPCW) running at full capacity. These new clients will be chosen from those randomly allocated to receive the CETA treatment; within fifteen (15) days of the completion of treatment the participants will be reassessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years of age or older) Afro-Colombian victims of violence and torture who have expressed sadness, suffering psychological trauma caused by violence and when the situation was known by the leaders of Afro-Colombian Displaced Association (AFRODES) or the community leaders contacted by the research team.
- •Persons with a total symptomatic value greater than or equal to 49 points in the study instrument, with the presence of trauma from violence, and a loss of functionality score greater than zero.
- •Individuals who signed the informed consent.
排除标准
- •People of ethnicities other than Afro-Colombian.
- •Children under 18 years old.
- •Persons who present symptoms of severe mental illness such as schizophrenia, psychotic episodes, suicidal attempters, and those who potentially could harm others.
- •Anyone who is related with the counselors (LPCW).
结局指标
主要结局
Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders.
时间窗: Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.
Symptoms, ranging from 0 for "never" to 3 for "all the time" being three the worst score, were assessed with adapted versions of Hopkins Symptom Checklist and Harvard Trauma Questionnaire. Constructs of depression (n=15 symptoms), anxiety (n=10 symptoms), and post-traumatic stress symptoms (n=16 symptoms) were extracted and analyzed out of the mentioned surveys. Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ). For each scale, the mean was calculated in order to use it as the measure for comparisons. Mean difference in scores of symptoms of anxiety, depression, and post-traumatic stress disorders between the subject's baseline and the final assessments were calculated.
次要结局
- Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction(Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.)
研究者
Maria Isabel Gutiérrez Martínez
Professor
Universidad del Valle, Colombia