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NCT Number: NCT07015567

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

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.

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Key information

Conditions

Complex Post-Traumatic Stress Disorder

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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), 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.

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

Treatment and study plan

Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)

Behavioral

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).

Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)

Behavioral

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.

Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)

Behavioral

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.

Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)

Behavioral

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 (called "the lifeline") of patient's life and the traumatic events, using a rope, stones for traumatic events, and flowers for positive events. Thereafter, the traumatic events are discussed in detail, one in each session. At the end of each session, patients receive a written form of these narrations, co-signed by patient and the therapist.

Primary outcomes

  1. CPTSD symptom change

    Time frame: 8 months

    CPTSD symptom change will be assessed with the International Trauma Questionnaire (ITQ-28). This questionnaire contains 28 items on symptoms that are self-rated on a Likert scale of 0-4, with a maximum total score of 112.

Secondary outcomes

  1. Depression

    Time frame: 8 months

    Patient Health Questionnaire (PHQ-9). The PHQ-9 score may range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). Higher scores mean higher levels of depression.

  2. Anxiety

    Time frame: 8 months

    General Anxiety Disorder Questionnaire (GAD-7). The GAD-7 score may range from 0 to 21, since each of the 7 items can be scored from 0 (not at all) to 3 (nearly every day). Higher scores mean higher levels of anxiety.

  3. Somatic symptoms

    Time frame: 8 months

    Somatic Symptoms Scale (SSS-8). The SSS-8 score may range from 0 to 32, since each of the 8 items can be scored from 0 (not at all) to 4 (severely). Higher scores mean higher levels of somatic symptoms.

  4. Well-being

    Time frame: 8 months

    WHO-5 questionnaire. Scores range from 0-25, with higher scores reflecting higher levels of well-being.

  5. Dissociative symptoms (Shut-D)

    Time frame: 8 months

    The Shut-D contains 13 items measuring dissociative symptoms such as fainting or analgesia. Each item is rated on a scale from 0 to 3. The total score ranges from 0 to 39.

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Heim

CONTACT

[email protected]

+41 21 692 31 75

Sponsors and collaborators

Lead sponsor

Eva Heim

Other

Registry information

Official study 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

Acronym: ESTAIR_REFUGEE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 11, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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