Implementing Psychosocial Interventions to Syrian Refugee Women Who Are Exposed to Psychological Trauma
NCT ID: NCT03912077
Last Updated: 2019-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2019-03-09
2019-06-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Culturally Adapted Cognitive Behavioural Therapy
7-session psychosocial 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.
No interventions assigned to this group
Interventions
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Culturally Adapted Cognitive Behavioural Therapy
7-session psychosocial intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe mental disorder (psychotic disorders, substance dependence)
* Severe cognitive impairment (severe intellectual disability or dementia)
18 Years
FEMALE
Yes
Sponsors
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Istanbul Sehir University
OTHER
Responsible Party
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Halime Sevde Eskici
Principal Investigator
Locations
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Refugees and Asylum Seekers Assistance and Solidarity Association
Istanbul, , Turkey (Türkiye)
Countries
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References
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Alpak G, Unal A, Bulbul F, Sagaltici E, Bez Y, Altindag A, Dalkilic A, Savas HA. Post-traumatic stress disorder among Syrian refugees in Turkey: a cross-sectional study. Int J Psychiatry Clin Pract. 2015 Mar;19(1):45-50. doi: 10.3109/13651501.2014.961930. Epub 2014 Oct 6.
Hinton DE, Rivera EI, Hofmann SG, Barlow DH, Otto MW. Adapting CBT for traumatized refugees and ethnic minority patients: examples from culturally adapted CBT (CA-CBT). Transcult Psychiatry. 2012 Apr;49(2):340-65. doi: 10.1177/1363461512441595.
Kobeissi L, Araya R, El Kak F, Ghantous Z, Khawaja M, Khoury B, Mahfoud Z, Nakkash R, Peters TJ, Ramia S, Zurayk H. The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial. BMC Psychiatry. 2011 Aug 25;11:142. doi: 10.1186/1471-244X-11-142.
Aragona M, Pucci D, Mazzetti M, Maisano B, Geraci S. Traumatic events, post-migration living difficulties and post-traumatic symptoms in first generation immigrants: a primary care study. Ann Ist Super Sanita. 2013;49(2):169-75. doi: 10.4415/ANN_13_02_08.
Hasanovic M, Herenda S. Post traumatic stress disorder, depression and anxiety among family medicine residents after 1992-95 war in Bosnia and Herzegovina. Psychiatr Danub. 2008 Sep;20(3):277-85.
Ghareeb, A. G. Manual of the Arabic BDI-II. Cairo, Egypt: Angle Press. 2000.
Beck, A. T., Steer, R. A., & Brown, G. K. Manual for Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation. 1996.
Silove D, Sinnerbrink I, Field A, Manicavasagar V, Steel Z. Anxiety, depression and PTSD in asylum-seekers: assocations with pre-migration trauma and post-migration stressors. Br J Psychiatry. 1997 Apr;170:351-7. doi: 10.1192/bjp.170.4.351.
Shoeb M, Weinstein H, Mollica R. The Harvard trauma questionnaire: adapting a cross-cultural instrument for measuring torture, trauma and posttraumatic stress disorder in Iraqi refugees. Int J Soc Psychiatry. 2007 Sep;53(5):447-63. doi: 10.1177/0020764007078362.
Mollica, R. F., McDonald, L. S., Massagli, M. P., & Silove, D. Measuring trauma, measuring torture: instructions and guidance on the utilization of the Harvard Program in Refugee Trauma's Versions of the Hopkins Symptom Checklist-25 (HSCL-25) & The Harvard Trauma Questionnaire (HTQ). Harvard Program in Refugee Trauma. 2004.
Eskici HS, Hinton DE, Jalal B, Yurtbakan T, Acarturk C. Culturally adapted cognitive behavioral therapy for Syrian refugee women in Turkey: A randomized controlled trial. Psychol Trauma. 2023 Feb;15(2):189-198. doi: 10.1037/tra0001138. Epub 2021 Oct 7.
Other Identifiers
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16/2018No:1
Identifier Type: -
Identifier Source: org_study_id
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