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Recruiting NCT07015567

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

No phase Interventional Complex Post-Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET), Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET), Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET), Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET).
Who it may be relevant to
Registry conditions: Complex Post-Traumatic Stress Disorder. Basic parameters: from 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Behavioral Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
    ESTAIR is a psychotherapeutic manual for the treatment of CPTSD. The manual was adapted to the target population. It contains 24 sessions which are organised in four modules, including a module about emotion regulation. This module contains exercises for emotional awareness and emotion regulation with different focuses (on body, thoughts and behaviour).
  • Behavioral Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
    ESTAIR is a psychotherapeutic manual for the treatment of CPTSD. The manual was adapted to the target population. It contains 24 sessions which are organised in four modules, including a module about negative self-concept. In this module, the manual tackles topics such as what is the self, thinking about the self through cognitive restructuring, criticism and compassion and the self in relation to others.
  • Behavioral Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
    ESTAIR is a psychotherapeutic manual for the treatment of CPTSD. The manual was adapted to the target population. It contains 24 sessions which are organised in four modules, including a module about interpersonal relationships. This module includes exercises to understand relationship patterns, increasing assertiveness, practicing assertiveness, and managing power.
  • Behavioral Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
    ESTAIR is a psychotherapeutic manual for the treatment of CPTSD. It contains 24 sessions which are organised in four modules. The manual was adapted to the target population. In this context, the module "modified prolonged exposure" was replaced with Narrative Exposure Therapy (NET). NET is a standardised approach for the treatment of PTSD that has been tested across diverse social and cultural contexts. In this intervention, patients and therapists elaborate together a chronological timeline (c

Primary outcome measures

  • CPTSD symptom change [Time frame: 8 months]
Secondary outcome measures (5)
  • Depression [Time frame: 8 months]
  • Anxiety [Time frame: 8 months]
  • Somatic symptoms [Time frame: 8 months]
  • Well-being [Time frame: 8 months]
  • Dissociative symptoms (Shut-D) [Time frame: 8 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Treatment

Study locations

Switzerland · 7 centers
  • Psychiatrie Basel-Land — Liestal
  • Psy4Asyl — Aarau
  • UPK Transkulturelle Ambulanz — Basel
  • SRK Ambulatorium für Folter- und Kriegsopfer — Wabern
  • Appartenances - CPM Lausanne — Lausanne
  • Appartenances - CPM Yverdon-les-Bains — Yverdon-les-Bains
  • Integrierten Psychiatrie Winterthur — Winterthur
Germany · 1 center
  • Centra — Hamburg

Publications

  • 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. PMID 35313215

Identifiers

NCT: NCT07015567 · BASEC 2025-00450 · 10001G_212438

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗