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STRENGTHS: Fostering responsive mental health systems in the Syrian refugee crisis

STRENGTHS: Fostering responsive mental health systems in the Syrian refugee crisis - Implementation of Problem Management Plus in Syrian refugees

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53148
Enrollment
510
Registered
2017-09-05
Start date
2018-05-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological symptoms of anxiety, (posttraumatic) stress and depression, anger, hair biomarkers anxiety depression distress Psychological symptoms

Interventions

Participants in the treatment group will receive five sessions of Problem Management Plus (PM+), and treatment as usual (TAU). PM+ is an evidence-based, low-intensity, psychological intervention and

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: (Phase 2 and 4B, Exploratory randomized controlled trial (RCT) and Definite RCT) - 18 years or above - refugee - Arabic-speaking - Elevated levels of psychological distress (K10 >15.9) and reduced psychosocial functioning (WHODAS 2.0 >16)

Exclusion criteria

Exclusion criteria: (for participants in phase 2 and 4B) - Acute medical conditions - Imminent suicide risk or with 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) - Currently enrolled in a specialized psychological treatment program (e.g., EMDR, CBT)

Design outcomes

Primary

MeasureTime frame
The main study parameter will be the decrease in psychological distress from baseline to three-month follow-up, measured through the Hopkins Symptoms Checklist (HSCL-25), a self-report measure for symptoms of psychological distress. We expect a difference of Cohen*s d effect size of .4 between the PM+ group and controls.

Secondary

MeasureTime frame
Secondary parameters include functional impairment (WHODAS 2.0), posttraumatic stress reactions (PCL-5), self-identified problems (PSYCHLOPS), cost of care (CSRI schedule), anger (STAS-T), and hair biomarkers

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)