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临床试验/NCT03162679
NCT03162679已完成不适用

Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees: A Randomized Controlled Trial

Ludwig-Maximilians - University of Munich1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

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

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

Experimental

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

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Theresa Koch

Phd Student

Ludwig-Maximilians - University of Munich

研究点 (1)

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