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

NCT03912077 | Completed DMC

• 1 other identifier: 16/2018No:1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Psychological Trauma

Keywords

Refugees; Psychological distress; Psychological trauma; Anxiety; CA-CBT; Depression; Post-traumatic stress disorder; Intervention; Turkey; Migration

Outcome Measures

Primary Outcomes (1)

• Psychological distress symptoms

  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 Outcomes (3)

• Psychological trauma symptoms

  1-week post-intervention

• Depression symptoms

  1-week post-intervention

• Distress symptoms related with post-migration events

  1-week post-intervention; 6-month and 12-month follow-ups

Study Arms (2)

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.

Behavioral: Culturally Adapted Cognitive Behavioural Therapy

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.

Interventions

Culturally Adapted Cognitive Behavioural Therapy BEHAVIORAL

7-session psychosocial intervention

Culturally Adapted Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Sehir University: lead

Study Sites (1)

Refugees and Asylum Seekers Assistance and Solidarity Association

Istanbul, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 25195765 BACKGROUND

• 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.

  PMID: 22508639 BACKGROUND

• 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.

  PMID: 21864414 BACKGROUND

• 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.

  PMID: 23771261 BACKGROUND

• 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.

  PMID: 18827753 BACKGROUND

• Ghareeb, A. G. Manual of the Arabic BDI-II. Cairo, Egypt: Angle Press. 2000.

  BACKGROUND

• Beck, A. T., Steer, R. A., & Brown, G. K. Manual for Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation. 1996.

  BACKGROUND

• 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.

  PMID: 9246254 BACKGROUND

• 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.

  PMID: 18018666 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34618479 DERIVED

MeSH Terms

Conditions

Psychological Trauma; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blind to the study conditions; while participants and facilitators will be aware of the study conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It is a randomized, parallel-group trial that enroll Syrian refugee women with psychological distress, according to the Hopkins Symptom Checklist - 25 (HSCL-25) who will be randomly assigned to the Culturally Adapted Cognitive Behavioural Therapy (CA-CBT) intervention or to treatment as usual (TAU).

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 11, 2019
• Study Start: March 9, 2019
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)