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临床试验/NCT03912077
NCT03912077已完成不适用

War and Immigration: Implementing Psychosocial Interventions to Syrian Refugee Women Who Are Exposed to Psychological Trauma

Istanbul Sehir University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年3月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
Psychological distress symptoms

研究概览

简要总结

This study assesses severity of trauma, depression and anxiety symptoms of Syrian women under temporary protection who reside in Istanbul and types of exposed trauma that they have experienced. This study also evaluates the effectiveness of the Culturally Adapted Cognitive Behavioural Therapy (CA-CBT) in Syrian women under temporary protection who are with psychological distress in Turkey. Half of participants will receive Culturally Adapted Cognitive Behavioural Therapy (CA-CBT), while the other half will receive treatment as usual.

详细描述

Background: Due to the ongoing conflict in Syria, Syrian people have faced with various atrocities. Many of them were displaced from their home, causing them to experience difficulties during and after the immigration. Being exposed to such stressors makes refugees susceptible to psychological distress and put them at risk to develop psychological disorders such as post-traumatic stress disorder, anxiety disorders, depression and so on (Alpak et al., 2015).

Culturally Adapted Cognitive Behavioural Therapy (CA-CBT) is an evidence-based psychological intervention manual developed by Devon Hinton, MD from Harvard University and Baland Jalal from University of Cambridge. It is a group therapy protocol that consists of 7 sessions. CA-CBT is a brief intervention that adopts a transdiagnostical approach and can be delivered by trained facilitators to people who are psychologically distressed. Several RCTs has been conducted to evaluate effectiveness of CA-CBT and demonstrated positive results. (Hinton et al., 2012).

Objectives: This study has two aims. First aim of the study is to assess severity of trauma, depression and anxiety symptoms and types of exposed trauma of Syrian refugee women who reside in Istanbul. Second aim of the study is to evaluate the effectiveness of the Culturally Adapted Cognitive Behavioural Therapy in Syrian refugee women with psychological distress resettled in Turkey, as compared with treatment as usual (TAU). The primary outcome is the decrease in psychological distress symptoms. Secondary outcomes are depression, anxiety and psychological trauma symptoms along with post-migration living difficulties and related distress symptoms.

Design: This is a parallel-group randomized controlled trial, therefore participants will have an equal probability (1:1) of being randomly allocated to the CA-CBT intervention or the TAU.

Methodology: Screening will be conducted before randomization. Syrian refugee women who score 1.75 or above (≥ 1.75) at the Hopkins Symptom Checklist - 25 (HSCL-25) will enter the study. After randomization they will receive the 7- session CA-CBT or the TAU. The CA-CBT intervention phase will last 7 weeks (1 session per week). After intervention, post-assessments will be performed.

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

Outcomes assessors will be blind to the study conditions; while participants and facilitators will be aware of the study conditions.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being 18 years old and older
  • Being a Syrian woman under temporary protection who resides in Istanbul
  • Being able to speak and understand Arabic
  • Having psychological distress symptoms, as shown by a score of 1.75 or more at the Hopkins Symptoms Checklist-25 (HSCL-25 ≥ 1.75 )

排除标准

  • Imminent risk of suicide
  • Severe mental disorder (psychotic disorders, substance dependence)
  • Severe cognitive impairment (severe intellectual disability or dementia)

研究组 & 干预措施

Culturally Adapted Cognitive Behavioural Therapy

Experimental

Culturally Adapted Cognitive Behavioural Therapy (CA-CBT) is an evidence-based psychological intervention manual developed by Devon Hinton, MD from Harvard University and Baland Jalal from University of Cambridge. It is a group therapy protocol that consists of 7 sessions.

It is a brief, feasible and culturally sensitive intervention that has a transdiagnostical approach. Detailed information about Syrian culture, idioms of stress, cultural differences, and psychological problems that Syrian refugee women have been facing and their needs, expectations and sensitivities are considered in the adaptation process. Examples, cultural metaphors and imageries that take part in the manual are adapted according to Syrian culture.

干预措施: Culturally Adapted Cognitive Behavioural Therapy (Behavioral)

Treatment as Usual

No Intervention

Control arm participants will receive routine social support and/or care according to ordinary practice of the non-governmental organization (treatment as usual). Also, they will receive baseline and post assessments according to the study schedule.

结局指标

主要结局

Psychological distress symptoms

时间窗: 1-week post-intervention

Hopkins Symptoms Checklist - 25 (HSCL-25) measures psychological distress symptoms and has 25 items. Participants rate each item from 1 (not at all) to 4 (extremely). First 10 items measure anxiety symptoms, whereas the following 15 items measure depression symptoms. There are many studies, which demonstrate that the Arabic version of HSCL-25 is statistically reliable and valid (Kobeissi et al., 2011). HSCL-25 has been used in several intercultural studies (Aragona et al., 2013) and cut-off score has been assigned as 1.75 in many studies (Hasanović and Herenda, 2008). The current study will primarily look at the total score in which the lower values represent a better outcome.

次要结局

  • Distress symptoms related with post-migration events(1-week post-intervention; 6-month and 12-month follow-ups)
  • Psychological trauma symptoms(1-week post-intervention)
  • Depression symptoms(1-week post-intervention)

研究者

发起方
Istanbul Sehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Halime Sevde Eskici

Principal Investigator

Istanbul Sehir University

研究点 (1)

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