Clinical trial Recruiting at 6 sites Interventional Ages 17 and up

Therapy program for refugees and asylum seekers with complex PTSD in Switzerland and Germany

Official title: 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

Run by University of Lausanne · NCT07015567 · Data updated 2026-11-12

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

Study typeInterventional
Ages17 Years and up
SexAll
Enrollment288 (estimated)
SponsorUniversity of Lausanne
Academic / other
Locations8 sites (Hamburg, Free and Hanseatic City of Hamburg and 7 other locations)
StatusRecruiting
StartedJanuary 21, 2026
Main results expectedDecember 2030
Study endsDecember 2030
Registry record updatedJuly 31, 2026
Trial IDNCT07015567 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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), Turkish, English, German, or French
* Originating from Middle East, Northern Africa, or Sub-Sahara Africa
* 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 it's running

  • 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
  • Appartenances - CPM Lausanne
    Lausanne, Canton of Vaud, Switzerland
    Recruiting
  • Appartenances - CPM Yverdon-les-Bains
    Yverdon-les-Bains, Canton of Vaud, Switzerland
    Recruiting
  • Integrierten Psychiatrie Winterthur
    Winterthur, Canton of Zurich, Switzerland
    Recruiting
Show 2 more locations
  • Centra
    Hamburg, Free and Hanseatic City of Hamburg, Germany
    Not yet recruiting
  • SRK Ambulatorium für Folter- und Kriegsopfer
    Wabern, Canton of Bern, Switzerland
    Not yet recruiting

Study contacts

Similar studies

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  • Trauma-Focused Cognitive-Behavioral Therapy for PTSD Treatment

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.