Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Difficulties in Emotion Regulation
研究概览
简要总结
There is a lack of studies on treatment effect in traumatised refugees. Recent findings indicate that emotion regulation deficits play a key role in PTSD also among traumatized refugees and highlight the importance and potential directions for the development of an emotion regulation training for refugees. In this study, the investigators therefore want to examine the effectiveness of a new, transdiagnostic, cultural-sensitive group therapy, which systematically teaches specific emotion regulation strategies. Participants will be randomly assigned to either the emotion regulation training, delivered in group format or a wait list control condition. The study takes place in cooperation with REFUGIO Munich, which is a treatment centre specialised in the treatment of traumatised refugees. Clinicians will deliver the treatment to traumatized asylum seekers and refugees that report difficulties in emotion regulation. The investigators will examine if refugees and asylum seekers in the intervention group will show improvements in psychological symptoms, social functioning as well as in emotion regulation in comparison to a wait list control group which will receive the treatment after the intervention group has completed. The group therapy covers 14 sessions and has a cognitive-behavioural background. It focuses on conveying strategies to cope with intense feelings and the patients should gain a sense of self-efficacy and control over their trauma-relevant feelings and symptoms. Qualified interpreters will be used in the assessments as well as group therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 21 Years(Child, Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Refugee or asylum seeker from Afghanistan, speaking Dari
- •reporting at least one traumatic event on a trauma list
- •reporting difficulties in emotion regulation
- •between the age of 15 and 21 years
排除标准
- •Psychosis
- •Serious suicidal ideations
- •Currently receiving psychotherapy elsewhere
- •Serious dissociation
研究组 & 干预措施
Emotion Regulation Group Therapy
Participants assigned to this condition will receive treatment immediately after assignment.
干预措施: Skills training of Affect-Regulation - A culture-sensitive approach: STARK (Behavioral)
Wait List Control
This condition is a wait-list control and receives no intervention during the study period, but is offered treatment after the final assessment directly after the treatment phase of the intervention group.
结局指标
主要结局
Change in Difficulties in Emotion Regulation
时间窗: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
Scale: Emotion Regulation Scale (DERS)
Change in General Health
时间窗: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
Scale General Health Questionnaire -28 (GHQ-28)
次要结局
- Change in posttraumatic stress(baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment))
- Change in Anger Reactions(baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment))
- Treatment Experience Scale - Patient (TESP)(after 14 weeks (= post-treatment))
- Change in emotional competence (Third party assessment by caregiver)(baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment))
研究者
Theresa Koch
Phd Student
Ludwig-Maximilians - University of Munich
