Psychological Distress Clinical Trial
Official title:
War and Immigration: Implementing Psychosocial Interventions to Syrian Refugee Women Who Are Exposed to Psychological Trauma
NCT number | NCT03912077 |
Other study ID # | 16/2018No:1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2019 |
Est. completion date | June 20, 2019 |
Verified date | August 2019 |
Source | Istanbul Sehir University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | June 20, 2019 |
Est. primary completion date | June 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Turkey | Refugees and Asylum Seekers Assistance and Solidarity Association | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul Sehir University |
Turkey,
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. — View Citation
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. — View Citation
Beck, A. T., Steer, R. A., & Brown, G. K. Manual for Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation. 1996.
Ghareeb, A. G. Manual of the Arabic BDI-II. Cairo, Egypt: Angle Press. 2000.
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. — View Citation
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. — View Citation
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. — View Citation
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.
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 (Hasanovic 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 | Psychological trauma symptoms | 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 | |
Secondary | Depression symptoms | 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 | |
Secondary | Distress symptoms related with post-migration events | 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 |
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