Clinical trial 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Complex Post-Traumatic Stress Disorder
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility ESTAIR manual
timeFrame: 7 months
measure: Feasibility International Trauma Interview (ITI)
timeFrame: 1 month
measure: Feasibility research procedures
timeFrame: 7 months
measure: Acceptability International Trauma Interview (ITI)
timeFrame: 1 month
measure: Acceptability ESTAIR/MPE
timeFrame: 7 months
measure: Acceptability research procedures
timeFrame: 7 months
Secondary outcomes:
measure: Complex post-traumatic stress disorder
timeFrame: 7 months
measure: Depression
timeFrame: 7 months
measure: Anxiety
timeFrame: 7 months
measure: Somatic Symptoms
timeFrame: 7 months
measure: Wellbeing
timeFrame: 7 Months
Other outcomes:
Locations:
city: Wabern
country: Switzerland
facility: Ambulatorium für Folter- und Kriegsopfer
state: BE
city: Lausanne
country: Switzerland
facility: Appartenances
Study officials:
References: