Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

Not Applicable

Completed

• Conditions: Trauma

• Registration Number: NCT03162679
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Study Start: 2017-06-01
• Primary Completion: 2018-12-21
• Study Completion: 2019-02-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

Inclusion Criteria

• 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

Exclusion Criteria

• Psychosis
• Serious suicidal ideations
• Currently receiving psychotherapy elsewhere
• Serious dissociation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Difficulties in Emotion Regulation	baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)	Scale: Emotion Regulation Scale (DERS)
Change in General Health	baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)	Scale General Health Questionnaire -28 (GHQ-28)

Secondary Outcome Measures

Name	Time	Method
Change in posttraumatic stress	baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)	Scale: PTSD Checklist for DSM-5 (PCL-5)
Change in Anger Reactions	baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)	Scale: Dimensions of Anger Reactions-5 (DAR-5)
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)	Scale: Emotional Competence Questionnaire (German: Emotionale-Kompetenz-Fragebogen - Fremdbeurteilung (EKF))

Trial Locations

Locations (1)

REFUGIO München; 🇩🇪 Munich, Germany