Implementation of Group Problem Management Plus (PM+) in Adult Syrian Refugees in Turkey: RCT (STRENGTHS)

NCT03960892 | Completed DMC

• 1 other identifier: 10/2017No:2
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Posttraumatic Stress Disorder; Psychological Distress

Keywords

Refugees; Mental Health

Outcome Measures

Primary Outcomes (1)

• Hopkins Symptom Checklist-25 (HSCL-25)

  The aim is to measure the change in psychological distress. Sub-scales can be calculated for depression (13 items) and anxiety symptoms (10 items). There are two items related to somatic symptoms. The items are rated on a 1-4 point Likert scale, with a well-validated cut-off score of 1.75. The current study will primarily look at the total score in which the lower values represent a better outcome. Furthermore, aim is to examine changes in caseness in depression, a cut-off score for the depression sub-scale of 2.1 will be used.

  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 (5)

• PTSD Checklist for DSM-5 (PCL-5)

  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

• Psychological Outcome Measures (PSYCHLOPS)

  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

• Client Service Receipt Inventory (CSRI)

  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

• Access to health care: own questionnaire

  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

• Socio-demographic information and disability: WHODAS

  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 (1)

• Traumatic experiences questionnaire: own questionnaire

  Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from at 12 month post intervention assessment

Study Arms (2)

E-CAU with Group Problem Management Plus (PM+)

EXPERIMENTAL

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.

Behavioral: Problem Management Plus (PM+)

Enhanced care as usual (E-CAU) only

NO INTERVENTION

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+).

Interventions

Problem Management Plus (PM+) BEHAVIORAL

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).

E-CAU with Group Problem Management Plus (PM+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul Sehir University: lead
• European Commission: collaborator

Study Sites (1)

Refugee and Asylum Seekers Assistance and Solidarity Association's (RASASA)

Istanbul, Sultanbeyli, 34930, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 26407793 BACKGROUND

• 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.

  PMID: 27863515 BACKGROUND

• 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.

  PMID: 27837602 BACKGROUND

• 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.

  PMID: 32192539 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

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

Study Officials

• Zeynep Ceren Acartürk, Assoc. Prof.

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: December 29, 2018
• Primary Completion: June 12, 2021
• Study Completion: November 30, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The STRENGTHS project is a five year project which started in 2017. The individual participant data will be available for the other partners during the project which is between 2017 and 2022.
• Access Criteria: The criteria for access is to be a partner of the STRENGTHS project.

Locations

TU (1)