AzTrials
AzTrials

Complex Post-Traumatic Stress DisorderESTAIR_REFUGEENCT07015567

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

A study testing 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) and Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET) in people with Complex Post-Traumatic Stress Disorder, run by Eva Heim at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 years and older
Conditions the study is for
Complex Post-Traumatic Stress Disorder
What is being tested?
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) and Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
8 sitesin 2 countries
Study dates
21 Jan 2026to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

8 sites in 2 countries

Switzerland7 sites, 7 recruiting
  • Psy4Asyl

    Aarau, Canton of Aargau, 5000

    Sara Michalik, +62 521 01 11, leitung@psy4asyl.ch

    Sara Michalik

    Recruiting
  • UPK Transkulturelle Ambulanz

    Basel, Canton of Basel-City, 4051

    Serena Galli, +41 61 325 81 05, Serena.Galli@upk.ch

    Serena Galli

    Recruiting
  • Appartenances - CPM Lausanne

    Lausanne, Canton of Vaud, 1003

    Felicia Dutray, +41 21 341 12 50, f.dutray@appartenances.ch

    Felicia Dutray

    Recruiting
  • Psychiatrie Basel-Land

    Liestal, Basel-Landschaft, 4410

    Daniel Sollberger, +41 61 553 51 15, daniel.sollberger@pbl.ch

    Daniel Sollberger

    Recruiting
  • SRK Ambulatorium für Folter- und Kriegsopfer

    Wabern, Canton of Bern, 3084

    Christoph Engel, +41 58 400 40 85, christoph.engel@redcross.ch

    Christoph Engel

    Not yet recruiting
  • Integrierten Psychiatrie Winterthur

    Winterthur, Canton of Zurich, 8400

    Jochen Binder, +41 52 264 38 60, Jochen.Binder@ipw.ch

    Jochen Binder

    Recruiting
  • Appartenances - CPM Yverdon-les-Bains

    Yverdon-les-Bains, Canton of Vaud, 1400

    Felicia Dutray, +41 24 425 06 65, f.dutray@appartenances.ch

    Felicia Dutray

    Recruiting

Other trials in Switzerland

Germany1 site, 1 recruiting
  • Centra

    Hamburg, Free and Hanseatic City of Hamburg, 20097

    Ingo Schäfer, +49-176-21631798, i.schaefer@uke.de

    Ingo Schäfer

    Not yet recruiting

Other trials in Germany

About this study

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

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.

Being tested
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)
Keywords
Refugee populations, Cultural adaptation, Factorial experiment, Culturally sensitive psychotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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)Behavioural

    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)Behavioural

    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)Behavioural

    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.

Study groups in NCT07015567
Study groupRoleWhat they receive
1. Waiting period, emotion regulation, negative self-concept, interpersonal relationshipsExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
2. Waiting period, emotion regulation, negative self-concept, narrative exposure therapyExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
3. Waiting period, emotion regulation, interpersonal relationships, negative self-conceptExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
4. Waiting period, emotion regulation, interpersonal relationships, narrative exposure therapyExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
5. Waiting period, emotion regulation, narrative exposure therapy, negative self-conceptExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
6. Waiting period, emotion regulation, narrative exposure therapy, interpersonal relationshipsExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
7. Waiting period, negative self-concept, emotion regulation, interpersonal relationshipsExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
8. Waiting period, negative self-concept, emotion regulation, narrative exposure therapyExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
9. Waiting period, negative self-concept, interpersonal relationships, emotion regulationExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
10. Waiting period, negative self-concept, interpersonal relationships, narrative exposure therapyExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
11. Waiting period, negative self-concept, narrative exposure therapy, emotion regulationExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
12. Waiting period, negative self-concept, narrative exposure therapy, interpersonal relationshipsExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
13. Waiting period, interpersonal relationships, emotion regulation, negative self-conceptExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
14. Waiting period, interpersonal relationships, emotion regulation, narrative exposure therapyExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
15. Waiting period, interpersonal relationships, negative self-concept, emotion regulationExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
16. Waiting period, interpersonal relationships, negative self-concept, narrative exposure therapyExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
17. Waiting period, interpersonal relationships, narrative exposure therapy, emotion regulationExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
18. Waiting period, interpersonal relationships, narrative exposure therapy, negative self-conceptExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
19. Waiting period, narrative exposure therapy, emotion regulation, negative self-conceptExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
20. Waiting period, narrative exposure therapy, emotion regulation, interpersonal relationshipsExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
21. Waiting period, narrative exposure therapy, negative self-concept, emotion regulationExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
22. Waiting period, narrative exposure therapy, negative self-concept, interpersonal relationshipsExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
23. Waiting period, narrative exposure therapy, interpersonal relationships, emotion regulationExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
24. Waiting period, narrative exposure therapy, interpersonal relationships, negative self-conceptExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
25. Emotion regulation, negative self-concept, interpersonal relationships, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
26. Emotion regulation, negative self-concept, narrative exposure therapy, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
27. Emotion regulation, interpersonal relationships, negative self-concept, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
28. Emotion regulation, interpersonal relationships, narrative exposure therapy, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
29. Emotion regulation, narrative exposure therapy, negative self-concept, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
30. Emotion regulation, narrative exposure therapy, interpersonal relationships, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
31. Negative self-concept, emotion regulation, interpersonal relationships, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
32. Negative self-concept, emotion regulation, narrative exposure therapy, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
33. Negative self-concept, interpersonal relationships, emotion regulation, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
34. Negative self-concept, interpersonal relationships, narrative exposure therapy, waiting periodExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
35. Negative self-concept, narrative exposure therapy, emotion regulation, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
36. Negative self-concept, narrative exposure therapy, interpersonal relationships, waiting periodExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
37. Interpersonal relationships, emotion regulation, negative self-concept, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
38. Interpersonal relationships, emotion regulation, narrative exposure therapy, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
39. Interpersonal relationships, negative self-concept, emotion regulation, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
40. Interpersonal relationships, negative self-concept, narrative exposure therapy, waiting periodExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
41. Interpersonal relationships, narrative exposure therapy, emotion regulation, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
42. Interpersonal relationships, narrative exposure therapy, negative self-concept, waiting periodExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
43. Narrative exposure therapy, emotion regulation, negative self-concept, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
44. Narrative exposure therapy, emotion regulation, interpersonal relationships, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
45. Narrative exposure therapy, negative self-concept, emotion regulation, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
46. Narrative exposure therapy, negative self-concept, interpersonal relationships, waiting periodExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
47. Narrative exposure therapy, interpersonal relationships, emotion regulation, waiting periodExperimentalNot described
Receives: Behavioral: Emotion regulation module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)
48. Narrative exposure therapy, interpersonal relationships, negative self-concept, waiting periodExperimentalNot described
Receives: Behavioral: Negative self-concept module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET); Behavioral: Narrative exposure therapy module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CPTSD symptom change

    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.

    Measured: 8 months

Secondary outcomes (5)
  1. Depression

    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.

    Measured: 8 months

  2. Anxiety

    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.

    Measured: 8 months

  3. Somatic symptoms

    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.

    Measured: 8 months

  4. Well-being

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

    Measured: 8 months

  5. Dissociative symptoms (Shut-D)

    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.

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start21 Jan 2026
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
In this single-blind randomised trial, the study team will use a Balanced Incomplete Block Design (BIBD), which corresponds to an incomplete factorial experiment. The 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). The investigators 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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
288 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015567
Sponsor's protocol ID
BASEC 2025-00450
Other IDs
10001G_212438
Acronym
ESTAIR_REFUGEE
Status last verified
Jul 2026
First submitted
3 Jun 2025
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 35313215

Questions about this trial

What is this clinical trial studying?

A study testing 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) and Interpersonal relationships module of Enhanced Skills Training in Affective and Interpersonal Regulation combined with Narrative Exposure Therapy (ESTAIR/NET) in people with Complex Post-Traumatic Stress Disorder, run by Eva Heim at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eva Heim (+41 21 692 31 75, eva.heim@unil.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CPTSD symptom change (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07015567, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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