Health TrialsbyHealthPanel

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

ConditionComplex Post-Traumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17+
SponsorEva Heim

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Acute psychosis

Imminent risk of suicide

Severe alcohol and/or substance abuse

Being enrolled in another psychotherapy

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

288 Participants
are divided into 48 treatment groups

48

Treatment groups

See each treatment group below.

Group A: 1. Waiting period, emotion regulation, negative self-concept, interpersonal relationshipsExperimental treatment 3 interventions
Group B: 2. Waiting period, emotion regulation, negative self-concept, narrative exposure therapyExperimental treatment 3 interventions
Group C: 3. Waiting period, emotion regulation, interpersonal relationships, negative self-conceptExperimental treatment 3 interventions
Group D: 4. Waiting period, emotion regulation, interpersonal relationships, narrative exposure therapyExperimental treatment 3 interventions
Group E: 5. Waiting period, emotion regulation, narrative exposure therapy, negative self-conceptExperimental treatment 3 interventions
Group F: 6. Waiting period, emotion regulation, narrative exposure therapy, interpersonal relationshipsExperimental treatment 3 interventions
Group G: 7. Waiting period, negative self-concept, emotion regulation, interpersonal relationshipsExperimental treatment 3 interventions
Group H: 8. Waiting period, negative self-concept, emotion regulation, narrative exposure therapyExperimental treatment 3 interventions
Group I: 9. Waiting period, negative self-concept, interpersonal relationships, emotion regulationExperimental treatment 3 interventions
Group J: 10. Waiting period, negative self-concept, interpersonal relationships, narrative exposure therapyExperimental treatment 3 interventions
Group K: 11. Waiting period, negative self-concept, narrative exposure therapy, emotion regulationExperimental treatment 3 interventions
Group L: 12. Waiting period, negative self-concept, narrative exposure therapy, interpersonal relationshipsExperimental treatment 3 interventions
Group M: 13. Waiting period, interpersonal relationships, emotion regulation, negative self-conceptExperimental treatment 3 interventions
Group N: 14. Waiting period, interpersonal relationships, emotion regulation, narrative exposure therapyExperimental treatment 3 interventions
Group O: 15. Waiting period, interpersonal relationships, negative self-concept, emotion regulationExperimental treatment 3 interventions
Group P: 16. Waiting period, interpersonal relationships, negative self-concept, narrative exposure therapyExperimental treatment 3 interventions
Group Q: 17. Waiting period, interpersonal relationships, narrative exposure therapy, emotion regulationExperimental treatment 3 interventions
Group R: 18. Waiting period, interpersonal relationships, narrative exposure therapy, negative self-conceptExperimental treatment 3 interventions
Group S: 19. Waiting period, narrative exposure therapy, emotion regulation, negative self-conceptExperimental treatment 3 interventions
Group T: 20. Waiting period, narrative exposure therapy, emotion regulation, interpersonal relationshipsExperimental treatment 3 interventions
Group U: 21. Waiting period, narrative exposure therapy, negative self-concept, emotion regulationExperimental treatment 3 interventions
Group V: 22. Waiting period, narrative exposure therapy, negative self-concept, interpersonal relationshipsExperimental treatment 3 interventions
Group W: 23. Waiting period, narrative exposure therapy, interpersonal relationships, emotion regulationExperimental treatment 3 interventions
Group X: 24. Waiting period, narrative exposure therapy, interpersonal relationships, negative self-conceptExperimental treatment 3 interventions
Group Y: 25. Emotion regulation, negative self-concept, interpersonal relationships, waiting periodExperimental treatment 3 interventions
Group Z: 26. Emotion regulation, negative self-concept, narrative exposure therapy, waiting periodExperimental treatment 3 interventions
Group [: 27. Emotion regulation, interpersonal relationships, negative self-concept, waiting periodExperimental treatment 3 interventions
Group \: 28. Emotion regulation, interpersonal relationships, narrative exposure therapy, waiting periodExperimental treatment 3 interventions
Group ]: 29. Emotion regulation, narrative exposure therapy, negative self-concept, waiting periodExperimental treatment 3 interventions
Group ^: 30. Emotion regulation, narrative exposure therapy, interpersonal relationships, waiting periodExperimental treatment 3 interventions
Group _: 31. Negative self-concept, emotion regulation, interpersonal relationships, waiting periodExperimental treatment 3 interventions
Group `: 32. Negative self-concept, emotion regulation, narrative exposure therapy, waiting periodExperimental treatment 3 interventions
Group a: 33. Negative self-concept, interpersonal relationships, emotion regulation, waiting periodExperimental treatment 3 interventions
Group b: 34. Negative self-concept, interpersonal relationships, narrative exposure therapy, waiting periodExperimental treatment 3 interventions
Group c: 35. Negative self-concept, narrative exposure therapy, emotion regulation, waiting periodExperimental treatment 3 interventions
Group d: 36. Negative self-concept, narrative exposure therapy, interpersonal relationships, waiting periodExperimental treatment 3 interventions
Group e: 37. Interpersonal relationships, emotion regulation, negative self-concept, waiting periodExperimental treatment 3 interventions
Group f: 38. Interpersonal relationships, emotion regulation, narrative exposure therapy, waiting periodExperimental treatment 3 interventions
Group g: 39. Interpersonal relationships, negative self-concept, emotion regulation, waiting periodExperimental treatment 3 interventions
Group h: 40. Interpersonal relationships, negative self-concept, narrative exposure therapy, waiting periodExperimental treatment 3 interventions
Group i: 41. Interpersonal relationships, narrative exposure therapy, emotion regulation, waiting periodExperimental treatment 3 interventions
Group j: 42. Interpersonal relationships, narrative exposure therapy, negative self-concept, waiting periodExperimental treatment 3 interventions
Group k: 43. Narrative exposure therapy, emotion regulation, negative self-concept, waiting periodExperimental treatment 3 interventions
Group l: 44. Narrative exposure therapy, emotion regulation, interpersonal relationships, waiting periodExperimental treatment 3 interventions
Group m: 45. Narrative exposure therapy, negative self-concept, emotion regulation, waiting periodExperimental treatment 3 interventions
Group n: 46. Narrative exposure therapy, negative self-concept, interpersonal relationships, waiting periodExperimental treatment 3 interventions
Group o: 47. Narrative exposure therapy, interpersonal relationships, emotion regulation, waiting periodExperimental treatment 3 interventions
Group p: 48. Narrative exposure therapy, interpersonal relationships, negative self-concept, waiting periodExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
8 months

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
8 months
4

Well-being

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

Time frame
8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eva Heim

Lead sponsor

University of Lausanne

Sponsor institution

Source ClinicalTrials.gov
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