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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Acceptability research procedures
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •imminent risk of suicide;
- •acute psychosis;
- •severe alcohol and/or drug addiction.
结局指标
主要结局
Acceptability research procedures
时间窗: 7 months
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.
Acceptability International Trauma Interview (ITI)
时间窗: 1 month
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
时间窗: 7 months
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.
Feasibility ESTAIR manual
时间窗: 7 months
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)
时间窗: 1 month
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
时间窗: 7 months
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.
次要结局
- Depression(7 months)
- Somatic Symptoms(7 months)
- Wellbeing(7 Months)
- Complex post-traumatic stress disorder(7 months)
- Anxiety(7 months)
研究者
Eva Heim
Associate professor
University of Lausanne