Actively Recruiting

Phase Not Applicable
Age: 17Years +
All Genders
NCT07015567

Treatment of Complex Post-traumatic Stress Disorder Among Displaced People in Switzerland and Germany

Led by Eva Heim · Updated on 2026-05-12

288

Participants Needed

7

Research Sites

253 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In WHO ICD-11 (its latest edition), the diagnostic criteria for post-traumatic stress disorder (PTSD) were revised, and a new sibling disorder, complex post-traumatic stress disorder (CPTSD) was introduced. CPTSD is a debilitating condition associated with severe, prolonged, or chronic trauma. Refugee populations are affected by high prevalence of CPTSD because of high rates of such trauma (e.g. torture). Untreated CPTSD has negative consequences for quality of life and for integration into the host society. Evidence indicates cultural variation in the phenomenology of CPTSD. Modular approaches, e.g., the Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR/MPE), have been recommended for the treatment of CPTSD. However, they have not been tested in a clinical trial among refugees so far and there are no available publications about their effectiveness in CPTSD symptom reduction among this population. Research suggests a higher symptom reduction of trauma-focused techniques, such as Narrative Exposure Therapy (NET), among refugee population. In a previous study, the investigators pilot tested a version of ESTAIR/NET that was adapted to sociocultural and structural aspects related to psychopathology in refugee populations. The performance of these culturally adapted modules in CPTSD symptom reduction among the refugee population remains to be assessed. The present clinical trial seeks to assess the effect of the culturally adapted modules of the ESTAIR manual on symptom reduction among refugees and asylum seekers diagnosed with CPTSD.

CONDITIONS

Official Title

Treatment of Complex Post-traumatic Stress Disorder Among Displaced People in Switzerland and Germany

Who Can Participate

Age: 17Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Refugees and asylum seekers with a valid residence permit (N, F, B, or C status)
  • Speak Arabic, Farsi/Dari, Pashtu, Kurdish (different dialects), or Turkish
  • Psychotherapy is indicated and prescribed
  • Diagnosed with CPTSD based on International Trauma Interview and Socio-cultural and structural addendum, confirmed by local therapist
Not Eligible

You will not qualify if you...

  • Acute psychosis
  • Imminent risk of suicide
  • Severe alcohol and/or substance abuse
  • Currently enrolled in another psychotherapy
  • Unable to follow study procedures due to cognitive impairment
  • Unable to give informed consent
  • Known pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Centra

Hamburg, Free and Hanseatic City of Hamburg, Germany, 20097

Not Yet Recruiting

2

Psychiatrie Basel-Land

Liestal, Basel-Landschaft, Switzerland, 4410

Actively Recruiting

3

Psy4Asyl

Aarau, Canton of Aargau, Switzerland, 5000

Actively Recruiting

4

UPK Transkulturelle Ambulanz

Basel, Canton of Basel-City, Switzerland, 4051

Actively Recruiting

5

SRK Ambulatorium für Folter- und Kriegsopfer

Wabern, Canton of Bern, Switzerland, 3084

Not Yet Recruiting

6

Appartenances - CPM Lausanne

Lausanne, Canton of Vaud, Switzerland, 1003

Actively Recruiting

7

Appartenances - CPM Yverdon-les-Bains

Yverdon-les-Bains, Canton of Vaud, Switzerland, 1400

Actively Recruiting

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Research Team

E

Eva Heim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

48

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