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)
Primary Purpose
Complex Post-Traumatic Stress Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR/MPE)
Sponsored by
About this trial
This is an interventional treatment trial for Complex Post-Traumatic Stress Disorder
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Psychotherapy
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Wellbeing
WHO-5 questionnaire. Scores range from 0-25, with higher scores reflecting higher levels of well-being
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05917613
Brief 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)
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eva Heim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Post-Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR/MPE)
Intervention Description
Psychotherapeutic manual for the treatment of Complex Post-Traumatic Stress Disorder (CPTSD)
Primary Outcome Measure Information:
Title
Feasibility ESTAIR manual
Description
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.
Time Frame
7 months
Title
Feasibility International Trauma Interview (ITI)
Description
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.
Time Frame
1 month
Title
Feasibility research procedures
Description
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.
Time Frame
7 months
Title
Acceptability International Trauma Interview (ITI)
Description
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.
Time Frame
1 month
Title
Acceptability ESTAIR/MPE
Description
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.
Time Frame
7 months
Title
Acceptability research procedures
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Complex post-traumatic stress disorder
Description
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.
Time Frame
7 months
Title
Depression
Description
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
7 months
Title
Anxiety
Description
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
7 months
Title
Somatic Symptoms
Description
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.
Time Frame
7 months
Title
Wellbeing
Description
WHO-5 questionnaire. Scores range from 0-25, with higher scores reflecting higher levels of well-being
Time Frame
7 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
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)
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