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)

NCT05917613 | Active Not Recruiting

• 1 other identifier: 2023-00464
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Complex Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (6)

• Feasibility ESTAIR manual

  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.

  7 months

• Feasibility International Trauma Interview (ITI)

  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.

  1 month

• Feasibility research procedures

  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.

  7 months

• Acceptability International Trauma Interview (ITI)

  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.

  1 month

• Acceptability ESTAIR/MPE

  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.

  7 months

• Acceptability research procedures

  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.

  7 months

Secondary Outcomes (5)

• Complex post-traumatic stress disorder

  7 months

• Depression

  7 months

• Anxiety

  7 months

• Somatic Symptoms

  7 months

• Wellbeing

  7 Months

Study Arms (1)

Intervention

EXPERIMENTAL

Psychotherapy

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

Interventions

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)

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eva Heim: lead

Study Sites (2)

Ambulatorium für Folter- und Kriegsopfer

Wabern, Canton of Bern, 3084, Switzerland

Location

Appartenances

Lausanne, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: Pilot

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: June 26, 2023
• Study Start: November 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CH (2)