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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05917613
Other study ID # 2023-00464
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date June 30, 2024

Study information

Verified date November 2023
Source University of Lausanne
Contact Eva Heim, PhD
Phone +41 21 692 31 75
Email eva.heim@unil.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Enhanced Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR/MPE)
Psychotherapeutic manual for the treatment of Complex Post-Traumatic Stress Disorder (CPTSD)

Locations

Country Name City State
Switzerland Appartenances Lausanne
Switzerland Ambulatorium für Folter- und Kriegsopfer Wabern BE

Sponsors (1)

Lead Sponsor Collaborator
Eva Heim

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Complex post-traumatic stress disorder 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. 7 months
Secondary 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. 7 months
Secondary 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. 7 months
Secondary 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 anxiety. 7 months
Secondary Wellbeing WHO-5 questionnaire. Scores range from 0-25, with higher scores reflecting higher levels of well-being 7 Months
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