Psychological symptoms of anxiety, (posttraumatic) stress and depression, anger, hair biomarkers anxiety depression distress Psychological symptoms
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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