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NCT Number: NCT05917613

Complex-Posttraumatic Stress Disorder - Cultural Adaptation of a Therapeutic Manual and Development of a Culture-specific Diagnostic Module for Refugee Populations in Switzerland (Pilot Trial)

In January 2022, the World Health Organization (WHO) launched the 11th edition of the International Classification of Diseases (ICD-11). This diagnostic manual includes the new diagnosis of complex post-traumatic stress disorder (CPTSD). This new diagnostic category describes difficulties that may arise as a result of multiple, prolonged or repeated trauma, from which it is difficult or impossible to escape, such as torture, domestic violence or childhood sexual abuse. People affected by CPTSD often have difficulty regulating their emotions and maintaining relationships with others, and they often show a negative self-concept.

Evidence from the field of cultural clinical psychology indicates cultural variation in the CPTSD symptoms across different cultural groups. In addition, psychopathology is shaped by structural factors such as inequality and/or discrimination.

This research project aims to highlight such cultural and structural aspects related to PTSD and CPTSD among refugee populations in Switzerland. A diagnostic interview and a therapeutic manual will be culturally adapted and pilot tested with a small sample (n = 24).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ambulatorium für Folter- und Kriegsopfer, Wabern, Canton of Bern, Switzerland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Refugees and asylum seekers from the greater Middle Eastern and Northern Africa (MENA) region, regardless of their residence permit. The four languages that will be used for the planned project are: Farsi/Dari, Arabic, Turkish, and Kurdish (Kurmanji).
  • "High risk" (i.e., minimally 8 points) on the questionnaire Process of Recognition and Orientation of Torture Victims in European Countries to facilitate Care and Treatment (PROTECT);
  • age 18 or older;
  • informed consent signed

Exclusion criteria

  • imminent risk of suicide;
  • acute psychosis;
  • severe alcohol and/or drug addiction.

Treatment and study plan

Enhanced Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR/MPE)

Behavioral

Psychotherapeutic manual for the treatment of Complex Post-Traumatic Stress Disorder (CPTSD)

Primary outcomes

  1. Feasibility ESTAIR manual

    Time frame: 7 months

    Feasibility of the ESTAIR manual will be evaluated via the percentage of users who who adhere to the therapy until the end (out of those who start the therapy). As general rule, 80-90% adherence is considered as excellent, 70-80% as satisfactory, and 60-70% as acceptable.

  2. Feasibility International Trauma Interview (ITI)

    Time frame: 1 month

    Feasibility will be examined based on the percentage of participants who complete the ITI. As general rule, 80-90% participation and adherence is considered as excellent, 70-80% as satisfactory, and 60-70% as acceptable.

  3. Feasibility research procedures

    Time frame: 7 months

    Feasibility will be evaluated based on the percentage of participants who give their informed consent (out of those invited) and based on the percentage of participants who adhere to the study until the end (out of those who sign the informed consent). As general rule, 80-90% participation and adherence is considered as excellent, 70-80% as satisfactory, and 60-70% as acceptable.

  4. Acceptability International Trauma Interview (ITI)

    Time frame: 1 month

    Acceptability of the ITI will be assessed through qualitative interviews after the diagnostic interview. Content analysis will be used to extract the most important information related to acceptability.

  5. Acceptability ESTAIR/MPE

    Time frame: 7 months

    Acceptability will be assessed through the qualitative interviews after each of the four modules. Content analysis will be used to extract the most important information related to acceptability.

  6. Acceptability research procedures

    Time frame: 7 months

    Acceptability of the research procedures will be assessed through qualitative interviews at the end of the study. Content analysis will be used to extract the most important information related to acceptability.

Secondary outcomes

  1. Complex post-traumatic stress disorder

    Time frame: 7 months

    International Trauma Interview. This interview evaluates 12 symptoms (6 for post-traumatic stress disorder and another 6 for disturbances in self-organisation). A diagnosis of complex post-traumatic stress disorder requires that the post-traumatic stress disorder criteria are satisfied (with a diminished startle response if hypervigilance or exaggerated startle are not present), and the endorsement of one of two symptoms from each of the three "disturbances in self-organisation" symptom clusters, plus endorsement of functional impairment associated with these symptoms. Endorsement of a symptom requires that it is trauma related, has been present for at least a year and scores > 2.

  2. Depression

    Time frame: 7 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.

  3. Anxiety

    Time frame: 7 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.

  4. Somatic Symptoms

    Time frame: 7 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 anxiety.

  5. Wellbeing

    Time frame: 7 Months

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

Sponsors and collaborators

Lead sponsor

Eva Heim

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2023
Registry last updated
Dec 9, 2024

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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