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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
Eva Heim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Post-Traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 13, 2023
    Last Updated
    June 14, 2023
    Sponsor
    Eva Heim
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    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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