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

August 8, 2019 updated by: Halime Sevde Eskici, Istanbul Sehir University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Refugees and Asylum Seekers Assistance and Solidarity Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Culturally Adapted Cognitive Behavioural Therapy

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.
Behavioral: Culturally Adapted Cognitive Behavioural Therapy
7-session psychosocial intervention
No Intervention: Treatment as Usual
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-week post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological trauma symptoms
Time Frame: 1-week post-intervention
Harvard Trauma Questionnaire (HTQ) assesses the traumatic events that one experienced during his/her lifetime (Part I of the questionnaire) and measures the severity of post-traumatic stress disorder symptoms (Part IV of the questionnaire) (Mollica et al., 2004). The first part of the HTQ consists of 43 traumatic events and participants are asked to answer whether they have experienced such traumatic event or not, by choosing 'Yes' or 'No'. The fourth part of the HTQ has 45 items and participants are asked to rate each item from 1 (not at all) to 4 (extremely).
1-week post-intervention
Depression symptoms
Time Frame: 1-week post-intervention
Beck Depression Inventory II (BDI-II) measures depression symptoms and has 21 items. The total score of BDI-II varies from 0 to 63 and higher scores indicate more severe depressive symptoms (Beck et al., 1996). The Arabic version of the BDI-II has been developed by Ghareeb (2000).
1-week post-intervention
Distress symptoms related with post-migration events
Time Frame: 1-week post-intervention; 6-month and 12-month follow-ups
Post-Migration Living Difficulties (PMLD) assesses adverse events that one experienced after migration and measures the distress level induced by such events. Participants are asked to evaluate their experiences regarding the problems they had in the last 12 months. PMLD has 17 items and participants are asked to rate each item from 0 (was not a problem/did not happen) to 4 (a very serious problem).
1-week post-intervention; 6-month and 12-month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Sehir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2019

Primary Completion (Actual)

June 20, 2019

Study Completion (Actual)

June 20, 2019

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/2018No:1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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