Clinical trial NCT07015567: Treatment of Complex Post-traumatic Stress Disorder Among Displaced People in Switzerland
Official title: Contextualised, Culture-sensitive Diagnosis and Psychotherapy for the Treatment of Complex Post-traumatic Stress Disorder Among Displaced People in Switzerland: A Two-step Multicentric Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Complex Post-Traumatic Stress Disorder
Keywords: Refugee populations
Cultural adaptation
Factorial experiment
Culturally sensitive psychotherapy
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 288
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: In this single-blind randomised trial, we will use a Balanced Incomplete Block Design (BIBD), which corresponds to an incomplete factorial experiment. Our design encompasses 48 experimental conditions, where all participants will receive three out of four modules of the adapted ESTAIR manual and will have one waiting period (at the start or at the end of their treatment). We will test all possible combinations and sequences of these modules. Assessments (between modules and after the last module) will be conducted by assessors. Assessors will not have access to the experimental condition to which the participant is assigned, nor to any information related to the therapy process.
Primary purpose: TREATMENT

Brief 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, we 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 criteria: Inclusion Criteria:

* Informed consent signature
* Refugees and asylum seekers with a valid residence permit (N, F, B, or C status in Switzerland)
* Speaking one of the four mentioned languages (Arabic, Farsi/Dari, Kurdish, and Turkish)
* A psychotherapy is indicated and was prescribed
* Participated to the part 1 of the study and was diagnosed with CPTSD on the basis of the standard ITI and the 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

Primary outcomes:
measure: CPTSD symptom reduction
timeFrame: 8 months
Secondary outcomes:
measure: Depression
timeFrame: 8 months
measure: Anxiety
timeFrame: 8 months
measure: Somatic symptoms
timeFrame: 8 months
measure: Well-being
timeFrame: 8 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Centra
state: HH
city: Aarau
country: Switzerland
facility: Psy4Asyl
state: AG
city: Wabern
country: Switzerland
facility: SRK Ambulatorium für Folter- und Kriegsopfer
state: BE
city: Liestal
country: Switzerland
facility: Psychiatrie Basel-Land
state: BL
city: Basel
country: Switzerland
facility: UPK Transkulturelle Ambulanz
state: BS
city: Lausanne
country: Switzerland
facility: Association Appartenances
state: VD
Study officials:
References:
citation: Heim E, Karatzias T, Maercker A. Cultural concepts of distress and complex PTSD: Future directions for research and treatment. Clin Psychol Rev. 2022 Apr;93:102143. doi: 10.1016/j.cpr.2022.102143. Epub 2022 Mar 7.