Implementing Psychosocial Interventions to Syrian Refugee Women Who Are Exposed to Psychological Trauma

Psychological Distress Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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.

Expected outcomes: The expected outcome is decrease in the depression, anxiety and psychological trauma symptoms and general improvement in distress symptoms caused by post-migration living difficulties, in refugees in the CA-CBT intervention arm, as compared to TAU. ;

Related Conditions & MeSH terms

• Psychological Distress
• Psychological Trauma
• Wounds and Injuries

• NCT number: NCT03912077
• Study type: Interventional
• Source: Istanbul Sehir University
• Status: Completed
• Phase: N/A
• Start date: March 9, 2019
• Completion date: June 20, 2019