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

Implementation of Problem Management Plus in Syrian refugees: a randomized controlled trial RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11862037

Enrollment

184

Registered

2022-08-23

Start date

2019-03-07

Completion date

Unknown

Last updated

2023-02-13

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

Conditions

Common mental disorders

Interventions

Problem Management Plus (PM+): PM+ consists of five weekly in-person sessions of 90 minutes each with a non-specialist helper. The intervention is based on cognitive-behavioral therapy

session 1), problem-solving (session 2), behavioural activation (re-engaging with pleasant and task-oriented activities

session 3), and accessing social support (session 4). Homework practice is scheduled following each session and discussed in the next session. Psychoeducation is delivered in session 1 and relapse pre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults of 18 years or above 2. Syrian refugee 3. Arabic-speaking 4. Elevated levels of psychological distress (K10 >15) and reduced psychosocial functioning (WHODAS 2.0 >16)

Exclusion criteria

Exclusion criteria: 1. Acute medical conditions 2. 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) 3. Severe mental disorder (psychotic disorders, substance-dependence) 4. Severe cognitive impairment (e.g., severe intellectual disability or dementia) 5. Currently enrolled in a specialized psychological treatment program (e.g., EMDR, CBT)

Design outcomes

Primary

Measure	Time frame
Psychological distress (Hopkins Symptom Checklist; HSCL-25) at screening/baseline, 1-week post-assessment, 3-month follow-up, 12-month follow-up	—

Secondary

Measure	Time frame
Measured at screening/baseline, 1-week post-assessment, 3-month follow-up, 12-month follow-up unless noted: 1. Depression (HSCL-25 subscale) 2. Anxiety (HSCL-25 subscale) 3. Symptoms of post traumatic stress disorder (PTSD Checklist DSM-5; PCL-5) 4. Functional impairment (WHO Disability Assessment Schedule; WHODAS 2.0) 5. Self-identified problems (Psychological Outcomes Profiles; PSYCHLOPS) 6. Cost of care (Client Service Receipt Inventory; adapted CSRI) 7. Anger (Trait Anger Scale; STAS) at baseline and 1-week post assessment 8. Cortisol (hair cortisol concentrations) at baseline and 3-month follow up	—

Measure

Time frame

Measured at screening/baseline, 1-week post-assessment, 3-month follow-up, 12-month follow-up unless noted: 1. Depression (HSCL-25 subscale) 2. Anxiety (HSCL-25 subscale) 3. Symptoms of post traumatic stress disorder (PTSD Checklist DSM-5; PCL-5) 4. Functional impairment (WHO Disability Assessment Schedule; WHODAS 2.0) 5. Self-identified problems (Psychological Outcomes Profiles; PSYCHLOPS) 6. Cost of care (Client Service Receipt Inventory; adapted CSRI) 7. Anger (Trait Anger Scale; STAS) at baseline and 1-week post assessment 8. Cortisol (hair cortisol concentrations) at baseline and 3-month follow up

—

Countries

Netherlands

Contacts

Public ContactAnne de Graaff

a.m.de.graaff@vu.nl+31 (0)205983833

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026