Culturally Adapted Cognitive Behavioral Therapy to Reduce Psychological Distress of Individuals Affected by the Earthquake: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Kessler Psychological Distress Scale (K-10) over time
研究概览
简要总结
Earthquakes in Türkiye cause survivors to develop serious and prolonged mental health issues and adapted versions of cognitive behavioral therapy has proven to be successful in addressing these concerns.The main goal of this pilot randomized control trial (RCT) is to test potential effectiveness of Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) in reducing psychological distress and depressive symptoms and increasing well-being of earthquake survivors.
详细描述
Türkiye was struck by two large earthquakes with moment magnitudes 7.7. and 7.6, on the 6th of February 2023. The disaster resulted in more than 50 thousand people losing their lives, more than 107 thousand people getting injured and more than 84 thousand buildings being demolished, severely damaged or slated for demolition. After the earthquakes, various mental health issues can emerge among the survivors such as depression, anxiety disorders, posttraumatic stress disorder, sleep problems, prolonged grief disorder, decrease in quality of life, increase in suicidality and substance use, and their effects can be prolonged if not treated.
An effective treatment method for the mental health issues that the earthquake survivors may experience is cognitive behavioral therapy (CBT) which is effective both in individual and group formats. Moreover, culturally adapted versions of CBT demonstrated higher effectiveness. One such adaptation, developed as a transdiagnostic intervention by Devon Hinton, is known as Culturally Adapted CBT (CA-CBT), which has shown effectiveness across various cultures and countries. It has been successfully applied to depressed and traumatized women in Türkiye, reducing depressive symptoms and PTSD. CA-CBT incorporates emotion regulation techniques, mindfulness and stretching exercises as well as cognitive-behavioral approach principles. Some advantages of the CA-CBT are: (1) as a transdiagnostic intervention, it can be applied to treat various psychopathologies (2) as a group intervention, it can be applied to multiple individuals simultaneously, (3) as an 8-session intervention, it can improve mental health in the short term.
CA-CBT has not been tested with a population specifically consisting of individuals affected by earthquakes before. This pilot randomized control trial (RCT) aims to assess the potential effectiveness and feasibility of CA-CBT, specifically tailored for the earthquake survivors, and their mental health issues following the disaster. The main research questions of the study are whether the group CA-CBT is effective in decreasing psychological distress and depressive symptoms and increasing well-being among earthquake survivors one month after post-assessment.
The study is planned to be conducted with the collaboration with non-governmental organizations giving services to earthquake survivors. After the baseline assessment, eligible 60 participants will be randomized to two arms according to the 1:1 principle with automatized randomization software. 30 randomly allocated participants will receive CA-CBT and 30 randomly allocated participants will receive Enhanced Care as Usual (E-CAU) as the control group. One week after the completion of the sessions, all participants including control group participants will have post-assessments consisting of the same questionnaires as baseline assessment. One month after the post-assessment, all participants including control group participants will have follow-up assessments consisting of the same questionnaires as baseline and post-assessments.
If CA-CBT proves effective for individuals affected by earthquakes, it can be disseminated among mental health care professionals. Consequently, more earthquake survivors can access this high-quality evidence-based intervention adapted to their culture.
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
- Single (Outcomes Assessor)
盲法说明
Participants will not be blinded to their study arm due to the nature of the intervention, but outcome assessors will be blinded.
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
- •Being 18 years old or older.
- •Having experienced the earthquake.
- •Having a considerable amount of psychological distress: scoring 16 or higher on the Kessler Psychological Distress Scale (K10).
排除标准
- •Having a severe mental disorder (conducted by a trained assessor).
- •Presenting suicidality (assessed by the Problem Management Plus Suicidality Tool).
结局指标
主要结局
Change in Kessler Psychological Distress Scale (K-10) over time
时间窗: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
K-10 is a 10-item scale that measures psychological distress. Each item is scored from 1 (none of the time) to 5 (all of the time) and ranges between 10 and 50. Higher scores indicate higher levels of psychological distress.
次要结局
- Change in Prolonged Grief Disorder-13 (PG-13) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))
- Change in Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))
- Change in World Health Organization Quality of Life (WHOQOL-BREF) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))
- Change in The Emotion Regulation Questionnaire (ERQ) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))
- Change in Acceptance and Action Questionnaire - version 2 (AAQ-2) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))
- Change in Patient Health Questionnaire-9 (PHQ-9) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))
- Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))
- Change in Multidimensional Scale of Perceived Social Support (MSPSS) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))
- Change in Dispositional Hope Scale (DHS) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))
- Change in Generalized Anxiety Disorder-7 (GAD-7) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))
- Change in World Health Organization-Five Well-Being Index (WHO-5) (1998) over time(Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment))