Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

NCT03162679 | Completed

• 1 other identifier: 022ERT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma

Keywords

trauma treatment; Refugees; Emotion regulation; Group therapy; randomized controlled; PTSD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Study Arms (2)

Emotion Regulation Group Therapy

EXPERIMENTAL

Participants assigned to this condition will receive treatment immediately after assignment.

Behavioral: Skills training of Affect-Regulation - A culture-sensitive approach: STARK

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.

Interventions

Skills training of Affect-Regulation - A culture-sensitive approach: STARK BEHAVIORAL

Emotion Regulation Group Therapy, 14 sessions, 1.5 hour sessions, group therapy, meeting weekly.

Also known as: German title: Skills-Training der Affektregulation: Ein kultursensibler Ansatz: STARK

Emotion Regulation Group Therapy

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• REFUGIO Munich: collaborator

Study Sites (1)

REFUGIO München

Munich, Germany

Location

MeSH Terms

Conditions

Wounds and Injuries; Emotional Regulation; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Alexandra Liedl, PhD

  REFUGIO München

  PRINCIPAL INVESTIGATOR

• Theresa Koch, M.Sc.

  Ludwig-Maximilians-Universität München/ REFUGIO München

  STUDY DIRECTOR

• Thomas Ehring, Professor

  Ludwig-Maximilians-Universität München

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Student

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 22, 2017
• Study Start: June 1, 2017
• Primary Completion: December 21, 2018
• Study Completion: February 1, 2019
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

DE (1)