Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Centra
NOT_YET_RECRUITING
Hamburg
Switzerland
Psy4Asyl
RECRUITING
Aarau
UPK Transkulturelle Ambulanz
RECRUITING
Basel
Appartenances - CPM Lausanne
NOT_YET_RECRUITING
Lausanne
Psychiatrie Basel-Land
RECRUITING
Liestal
SRK Ambulatorium für Folter- und Kriegsopfer
NOT_YET_RECRUITING
Wabern
Appartenances - CPM Yverdon-les-Bains
NOT_YET_RECRUITING
Yverdon-les-bains
Contact Information
Primary
Eva Heim
eva.heim@unil.ch
+41 21 692 31 75
Time Frame
Start Date: 2026-01-21
Estimated Completion Date: 2030-12
Participants
Target number of participants: 288
Treatments
Experimental: 1. Waiting period, emotion regulation, negative self-concept, interpersonal relationships
Experimental: 2. Waiting period, emotion regulation, negative self-concept, narrative exposure therapy
Experimental: 3. Waiting period, emotion regulation, interpersonal relationships, negative self-concept
Experimental: 4. Waiting period, emotion regulation, interpersonal relationships, narrative exposure therapy
Experimental: 5. Waiting period, emotion regulation, narrative exposure therapy, negative self-concept
Experimental: 6. Waiting period, emotion regulation, narrative exposure therapy, interpersonal relationships
Experimental: 7. Waiting period, negative self-concept, emotion regulation, interpersonal relationships
Experimental: 8. Waiting period, negative self-concept, emotion regulation, narrative exposure therapy
Experimental: 9. Waiting period, negative self-concept, interpersonal relationships, emotion regulation
Experimental: 10. Waiting period, negative self-concept, interpersonal relationships, narrative exposure therapy
Experimental: 11. Waiting period, negative self-concept, narrative exposure therapy, emotion regulation
Experimental: 12. Waiting period, negative self-concept, narrative exposure therapy, interpersonal relationships
Experimental: 13. Waiting period, interpersonal relationships, emotion regulation, negative self-concept
Experimental: 14. Waiting period, interpersonal relationships, emotion regulation, narrative exposure therapy
Experimental: 15. Waiting period, interpersonal relationships, negative self-concept, emotion regulation
Experimental: 16. Waiting period, interpersonal relationships, negative self-concept, narrative exposure therapy
Experimental: 17. Waiting period, interpersonal relationships, narrative exposure therapy, emotion regulation
Experimental: 18. Waiting period, interpersonal relationships, narrative exposure therapy, negative self-concept
Experimental: 19. Waiting period, narrative exposure therapy, emotion regulation, negative self-concept
Experimental: 20. Waiting period, narrative exposure therapy, emotion regulation, interpersonal relationships
Experimental: 21. Waiting period, narrative exposure therapy, negative self-concept, emotion regulation
Experimental: 22. Waiting period, narrative exposure therapy, negative self-concept, interpersonal relationships
Experimental: 23. Waiting period, narrative exposure therapy, interpersonal relationships, emotion regulation
Experimental: 24. Waiting period, narrative exposure therapy, interpersonal relationships, negative self-concept
Experimental: 25. Emotion regulation, negative self-concept, interpersonal relationships, waiting period
Experimental: 26. Emotion regulation, negative self-concept, narrative exposure therapy, waiting period
Experimental: 27. Emotion regulation, interpersonal relationships, negative self-concept, waiting period
Experimental: 28. Emotion regulation, interpersonal relationships, narrative exposure therapy, waiting period
Experimental: 29. Emotion regulation, narrative exposure therapy, negative self-concept, waiting period
Experimental: 30. Emotion regulation, narrative exposure therapy, interpersonal relationships, waiting period
Experimental: 31. Negative self-concept, emotion regulation, interpersonal relationships, waiting period
Experimental: 32. Negative self-concept, emotion regulation, narrative exposure therapy, waiting period
Experimental: 33. Negative self-concept, interpersonal relationships, emotion regulation, waiting period
Experimental: 34. Negative self-concept, interpersonal relationships, narrative exposure therapy, waiting period
Experimental: 35. Negative self-concept, narrative exposure therapy, emotion regulation, waiting period
Experimental: 36. Negative self-concept, narrative exposure therapy, interpersonal relationships, waiting period
Experimental: 37. Interpersonal relationships, emotion regulation, negative self-concept, waiting period
Experimental: 38. Interpersonal relationships, emotion regulation, narrative exposure therapy, waiting period
Experimental: 39. Interpersonal relationships, negative self-concept, emotion regulation, waiting period
Experimental: 40. Interpersonal relationships, negative self-concept, narrative exposure therapy, waiting period
Experimental: 41. Interpersonal relationships, narrative exposure therapy, emotion regulation, waiting period
Experimental: 42. Interpersonal relationships, narrative exposure therapy, negative self-concept, waiting period
Experimental: 43. Narrative exposure therapy, emotion regulation, negative self-concept, waiting period
Experimental: 44. Narrative exposure therapy, emotion regulation, interpersonal relationships, waiting period
Experimental: 45. Narrative exposure therapy, negative self-concept, emotion regulation, waiting period
Experimental: 46. Narrative exposure therapy, negative self-concept, interpersonal relationships, waiting period
Experimental: 47. Narrative exposure therapy, interpersonal relationships, emotion regulation, waiting period
Experimental: 48. Narrative exposure therapy, interpersonal relationships, negative self-concept, waiting period
Related Therapeutic Areas
Post-Traumatic Stress Disorder (PTSD)
Sponsors
Leads: Eva Heim

This content was sourced from clinicaltrials.gov

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