Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

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

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.

Study Overview

• Status: Completed
• Conditions: Trauma
• Intervention / Treatment: Behavioral: Skills training of Affect-Regulation - A culture-sensitive approach: STARK

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • REFUGIO München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotion Regulation Group Therapy; Participants assigned to this condition will receive treatment immediately after assignment.	Behavioral: Skills training of Affect-Regulation - A culture-sensitive approach: STARK; Emotion Regulation Group Therapy, 14 sessions, 1.5 hour sessions, group therapy, meeting weekly.; Other Names: German title: Skills-Training der Affektregulation: Ein kultursensibler Ansatz: STARK
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: REFUGIO Munich
• Investigators: Principal Investigator: Alexandra Liedl, PhD, REFUGIO München; Study Director: Theresa Koch, M.Sc., Ludwig-Maximilians-Universität München/ REFUGIO München; Study Chair: Thomas Ehring, Professor, Ludwig-Maximilians-Universität München

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: PTSD; Group therapy; trauma treatment; Refugees; Emotion regulation; randomized controlled
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 022ERT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No