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Clinical Trials/NCT03912077
NCT03912077
Completed
Not Applicable

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

Istanbul Sehir University1 site in 1 country23 target enrollmentMarch 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychological Distress
Sponsor
Istanbul Sehir University
Enrollment
23
Locations
1
Primary Endpoint
Psychological distress symptoms
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 9, 2019
End Date
June 20, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Istanbul Sehir University
Responsible Party
Principal Investigator
Principal Investigator

Halime Sevde Eskici

Principal Investigator

Istanbul Sehir University

Eligibility Criteria

Inclusion Criteria

  • 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 )

Exclusion Criteria

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

Outcomes

Primary Outcomes

Psychological distress symptoms

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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