Clinical trial NCT03960892: Implementation of Group Problem Management Plus (PM+) in Adult Syrian Refugees in Turkey: RCT (STRENGTHS)
Official title: Syrian REfuGees MeNTal HealTH Care Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Posttraumatic Stress Disorder
Psychological Distress
Keywords: Refugees
Mental Health
Lead sponsor: Istanbul Sehir University
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2019-05-23
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To implement Group Problem Management Plus (PM+) in Syrian refugees with this RCT to evaluate feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted Group PM+ intervention for adult Syrian refugees in Turkey.

Detailed description: The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study is a 5-year study that started in January 2017 with funding from the European Commission Horizon 2020 scheme. Turkey is one of the eight sites in STRENGTHS project that this study will be conducted. The main aim of STRENGTHS in Turkey is to evaluate the feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted psychological intervention Group Problem Management Plus (PM+) intervention for adult Syrian refugees in Turkey.

Study participants (n=380) will consist of adult Syrian refugees (18 years and older) in Turkey with self-reported functional impairment (WHODAS 2.0 \>16) and elevated psychological distress (K10 \>15.9). Participants will be randomly allocated either to the treatment group who will receive five sessions of PM+ or to the enhanced care-as-usual (E-CAU) group. Participants in the comparison group will receive E-CAU only. The primary outcome will be the decrease in psychological distress from baseline to three-month post-intervention assessment, measured through the Hopkins Symptoms Checklist (HSCL-25).

Eligibility criteria: Inclusion Criteria:

* Adults of 18 years or above
* Syrian under temporary protection status
* Arabic-speaking
* Elevated levels of psychological distress (K10 \>15) and reduced psychosocial functioning (WHODAS 2.0 \>16)

Exclusion Criteria:

* Acute medical conditions
* Imminent suicide risk or expressed acute needs/protection risks (e.g., a young woman who expresses that she is at acute risk of being assaulted or killed)
* Severe mental disorder (psychotic disorders, substance-dependence)
* Severe cognitive impairment (e.g., severe intellectual disability or dementia)

Primary outcomes:
measure: Hopkins Symptom Checklist-25 (HSCL-25)
timeFrame: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment
Secondary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment
measure: Psychological Outcome Measures (PSYCHLOPS)
timeFrame: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment
measure: Access to health care: own questionnaire
timeFrame: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment
measure: Socio-demographic information and disability: WHODAS
timeFrame: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment
Other outcomes:
measure: Traumatic experiences questionnaire: own questionnaire
timeFrame: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from at 12 month post intervention assessment
Locations:
city: Istanbul
country: Turkey
facility: Refugee and Asylum Seekers Assistance and Solidarity Association's (RASASA)
state: Sultanbeyli
Study officials:
affiliation: Koç University
name: Zeynep Ceren Acartürk, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.
citation: Dawson KS, Schafer A, Anjuri D, Ndogoni L, Musyoki C, Sijbrandij M, van Ommeren M, Bryant RA. Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi. BMC Psychiatry. 2016 Nov 18;16(1):410. doi: 10.1186/s12888-016-1117-x.
citation: Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, Azeemi MM, Akhtar P, Nazir H, Chiumento A, Sijbrandij M, Wang D, Farooq S, van Ommeren M. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2609-2617. doi: 10.1001/jama.2016.17165.
citation: Uygun E, Ilkkursun Z, Sijbrandij M, Aker AT, Bryant R, Cuijpers P, Fuhr DC, de Graaff AM, de Jong J, McDaid D, Morina N, Park AL, Roberts B, Ventevogel P, Yurtbakan T, Acarturk C; STRENGHTS consortium. Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey. Trials. 2020 Mar 20;21(1):283. doi: 10.1186/s13063-020-4166-x.