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

Phase 3
Recruiting
Conditions
depression
Psychological symptoms of anxiety, (posttraumatic) stress and depression, anger, hair biomarkers
anxiety
Psychological symptoms
distress
10027946
Registration Number
NL-OMON53148
Lead Sponsor
Vrije Universiteit
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
510
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

(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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameter will be the decrease in psychological distress from<br /><br>baseline to three-month follow-up, measured through the Hopkins Symptoms<br /><br>Checklist (HSCL-25), a self-report measure for symptoms of psychological<br /><br>distress. We expect a difference of Cohen*s d effect size of .4 between the PM+<br /><br>group and controls.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary parameters include functional impairment (WHODAS 2.0), posttraumatic<br /><br>stress reactions (PCL-5), self-identified problems (PSYCHLOPS), cost of care<br /><br>(CSRI schedule), anger (STAS-T), and hair biomarkers</p><br>
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