Clinical Trials Directory

Trials / Completed

CompletedNCT03567083

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

STRENGTHS: Fostering Responsive Mental Health Systems in the Syrian Refugee Crisis - The Turkey Site

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Istanbul Sehir University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALProblem 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).

Timeline

Start date
2018-06-23
Primary completion
2019-01-21
Completion
2019-01-21
First posted
2018-06-25
Last updated
2021-05-19

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03567083. Inclusion in this directory is not an endorsement.