Implementation of Group Problem Management Plus (PM+) in Adult Syrian Refugees in Turkey: RCT (STRENGTHS)
NCT ID: NCT03960892
Last Updated: 2021-12-14
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
369 participants
INTERVENTIONAL
2018-12-29
2021-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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E-CAU with Group Problem Management Plus (PM+)
190 participants will be randomly assigned to E-CAU with Group PM+. The PM+ is developed by the World Health Organization (WHO) especially for the communities who are exposed to adversity. PM+ (Dawson et al., 2015) belongs to a set of programs which are low-intensity, shorter, less expensive and trans-diagnostic (i.e., not condition-specific, but targeted at a broader set of symptoms of common mental disorders) programs to reduce common mental health symptoms (including depression, anxiety and stress symptoms) and improve psychosocial functioning.
The participants in the experimental arm will receive Group PM+ by trained, non-specialist peer-refugees in addition to E-CAU.
Problem Management Plus (PM+)
This intervention is based on the WHO treatment guidelines for conditions related to stress (WHO, 2013). It is a 5-session intervention that is delivered by trained non-specialists, and is available in individual and group delivery formats for both children and adults. PM+ includes evidence-based techniques such as; problem solving, stress management, behavioral activation, and accessing social support. It has proved to be effective by two randomized controlled trials (RCTs) in Kenya and Pakistan (Bryant, Dawson, Schafer, Sijbrandij, \& van Ommeren, 2016; Rahman, Hamdani, Awan, Bryant, Dawson, Khan, Mukhtar-ul-Haq Azeemi, et al., 2016).
Enhanced care as usual (E-CAU) only
190 participants will be randomly assigned to E-CAU group. CAU ranges from the free health services government provides to Refugee and Asylum Seekers Assistance and Solidarity Association's (RASASA) mental health services which are provided by the Psychological Support Unit (MHPSS Support Unit) which includes counselling as well. The enhanced care arm (CAU, with the addition of a leaflet which will include information on the services that they can get from RASASA and other public services. ), is to be used as a benchmark for measuring the effectiveness of STRENGTHS's intervention, which is Problem Management Plus (PM+).
No interventions assigned to this group
Interventions
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Problem Management Plus (PM+)
This intervention is based on the WHO treatment guidelines for conditions related to stress (WHO, 2013). It is a 5-session intervention that is delivered by trained non-specialists, and is available in individual and group delivery formats for both children and adults. PM+ includes evidence-based techniques such as; problem solving, stress management, behavioral activation, and accessing social support. It has proved to be effective by two randomized controlled trials (RCTs) in Kenya and Pakistan (Bryant, Dawson, Schafer, Sijbrandij, \& van Ommeren, 2016; Rahman, Hamdani, Awan, Bryant, Dawson, Khan, Mukhtar-ul-Haq Azeemi, et al., 2016).
Eligibility Criteria
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Inclusion Criteria
* Syrian under temporary protection status
* Arabic-speaking
* Elevated levels of psychological distress (K10 \>15) and reduced psychosocial functioning (WHODAS 2.0 \>16)
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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European Commission
OTHER
Istanbul Sehir University
OTHER
Responsible Party
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Principal Investigators
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Zeynep Ceren Acartürk, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Koç University
Locations
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Refugee and Asylum Seekers Assistance and Solidarity Association's (RASASA)
Istanbul, Sultanbeyli, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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10/2017No:2
Identifier Type: -
Identifier Source: org_study_id