Implementation of Problem Management Plus (PM+) in Adult Syrian Refugees in Turkey: Pilot

NCT ID: NCT03567083

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-23
• Study Completion Date: 2019-01-21

Brief Summary

To implement Problem Management Plus (PM+) in Syrian refugees with this pilot study in Turkey with the aim of informing the definitive RCT about drop-out rates and estimated effect sizes.

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 and Turkey is one of the sites 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 Problem Management Plus (PM+) intervention for adult Syrian refugees in Turkey.

The current trial registration is for the pilot trial to investigate the feasibility and acceptability (e.g., obtain estimates of drop-out rates), to inform a full-scale, definitive randomized controlled trial. Study participants (n=60) 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

Anxiety; Depression; Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

E-CAU with Problem Management Plus (PM+)

30 participants will be randomly assigned to E-CAU with PM+ group. 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.

Group Type: EXPERIMENTAL

Problem Management Plus (PM+)

Intervention Type: 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-specialized workers or lay people, 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

30 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 referral document), is to be used as a benchmark for measuring the effectiveness of STRENGTHS's intervention, which is Problem Management Plus (PM+).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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-specialized workers or lay people, 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults of 18 years or above
• Syrian under temporary protection status
• Arabic-speaking
• Elevated levels of psychological distress (K10 >15.9) 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Istanbul Sehir University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeynep Ceren Acartürk

Role: PRINCIPAL_INVESTIGATOR

Istanbul Sehir University

Locations

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

Istanbul, Sultanbeyli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 26407793 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27863515 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27837602 (View on PubMed)

Acarturk C, Uygun E, Ilkkursun Z, Yurtbakan T, Kurt G, Adam-Troian J, Senay I, Bryant R, Cuijpers P, Kiselev N, McDaid D, Morina N, Nisanci Z, Park AL, Sijbrandij M, Ventevogel P, Fuhr DC. Group problem management plus (PM+) to decrease psychological distress among Syrian refugees in Turkey: a pilot randomised controlled trial. BMC Psychiatry. 2022 Jan 4;22(1):8. doi: 10.1186/s12888-021-03645-w.

Reference Type: DERIVED

PMID: 34983461 (View on PubMed)

Other Identifiers

10/2017No:1

Identifier Type: -

Identifier Source: org_study_id