Therapy program for refugees and asylum seekers with complex PTSD in Switzerland and Germany
Contextualised, Culture-sensitive Diagnosis and Psychotherapy for the Treatment of Complex Post-traumatic Stress Disorder Among Displaced People in Switzerland and Germany: A Two-step Multicentric Randomised Clinical Trial
This trial will test whether a culturally adapted modular therapy (ESTAIR combined with Narrative Exposure Therapy) can reduce complex PTSD symptoms in refugees and asylum seekers treated in Germany and Switzerland.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 17 Years and up |
| Sex | All |
| Sponsor | University of Lausanne Academic / other |
| Locations | 7 sites (Hamburg, Free and Hanseatic City of Hamburg and 6 other locations) |
| Trial ID | NCT07015567 on ClinicalTrials.gov |
What this trial studies
The trial uses a factorial, modular design to compare four ESTAIR/NET modules (emotion regulation, negative self-concept, interpersonal relationships, and narrative exposure) delivered in culturally adapted formats for displaced people. Participants who completed the initial screening and were diagnosed with CPTSD using the International Trauma Interview plus a socio-cultural addendum receive module-based psychotherapy in their language. Therapy is provided at clinical sites in Hamburg, Liestal, and Aarau with outcomes focused on CPTSD symptom reduction and functioning. The study aims to identify which module or combinations work best and to test feasibility of a culturally sensitive modular approach in refugee populations.
Who should consider this trial
Good fit: Ideal participants are refugees or asylum seekers in Germany or Switzerland who have a clinical CPTSD diagnosis after part 1, speak Arabic, Farsi/Dari, Pashto, Kurdish, or Turkish, have psychotherapy indicated, and can give informed consent.
Not a fit: People with acute psychosis, imminent suicide risk, severe alcohol or substance abuse, inability to follow procedures or give consent, current enrollment in another psychotherapy, or known pregnancy are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could reduce CPTSD symptoms and improve daily functioning and social integration for refugees and asylum seekers.
How similar studies have performed: Narrative Exposure Therapy has shown benefits for trauma-affected refugees, but the combined modular ESTAIR/NET approach for CPTSD in displaced populations is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent signature * Refugees and asylum seekers with a valid residence permit (N, F, B, or C status) * Speaking Arabic, Farsi/Dari, Pashtu, Kurdish (different dialects), or Turkish * A psychotherapy is indicated and was prescribed * Participated to part 1 of the study and was diagnosed with CPTSD on the basis of the standard International Trauma Interview and the Socio-cultural and structural addendum (SCSA). The diagnosis is done based on the clinical judgement by the local therapist. Exclusion Criteria: * Acute psychosis * Imminent risk of suicide * Severe alcohol and/or substance abuse * Being enrolled in another psychotherapy * Inability to follow study procedures (i.e., cognitive impairment) * Inability to give informed consent * Known pregnancy
Where this trial is running
Hamburg, Free and Hanseatic City of Hamburg and 6 other locations
- Centra — Hamburg, Free and Hanseatic City of Hamburg, Germany (Not_yet_recruiting)
- Psychiatrie Basel-Land — Liestal, Basel-Landschaft, Switzerland (Recruiting)
- Psy4Asyl — Aarau, Canton of Aargau, Switzerland (Recruiting)
- UPK Transkulturelle Ambulanz — Basel, Canton of Basel-City, Switzerland (Recruiting)
- SRK Ambulatorium für Folter- und Kriegsopfer — Wabern, Canton of Bern, Switzerland (Not_yet_recruiting)
- Appartenances - CPM Lausanne — Lausanne, Canton of Vaud, Switzerland (Recruiting)
- Appartenances - CPM Yverdon-les-Bains — Yverdon-les-Bains, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Study coordinator: Eva Heim
- Email: eva.heim@unil.ch
- Phone: +41 21 692 31 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.