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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03912077
Enrollment
23
Registered
2019-04-11
Start date
2019-03-09
Completion date
2019-06-20
Last updated
2019-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Distress, Psychological Trauma

Keywords

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

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.

Interventions

BEHAVIORALCulturally Adapted Cognitive Behavioural Therapy

7-session psychosocial intervention

Sponsors

Istanbul Sehir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessors will be blind to the study conditions; while participants and facilitators will be aware of the study conditions.

Intervention model description

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).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Psychological distress symptoms1-week post-interventionHopkins 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

MeasureTime frameDescription
Psychological trauma symptoms1-week post-interventionHarvard 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).
Depression symptoms1-week post-interventionBeck 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).
Distress symptoms related with post-migration events1-week post-intervention; 6-month and 12-month follow-upsPost-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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026