Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

NCT ID: NCT03162679

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Emotion Regulation Group Therapy

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: BEHAVIORAL

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

REFUGIO Munich

UNKNOWN

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Theresa Koch

Phd Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra Liedl, PhD

Role: PRINCIPAL_INVESTIGATOR

REFUGIO München

Theresa Koch, M.Sc.

Role: STUDY_DIRECTOR

Ludwig-Maximilians-Universität München/ REFUGIO München

Thomas Ehring, Professor

Role: STUDY_CHAIR

Ludwig-Maximilians-Universität München

Locations

REFUGIO München

Munich, , Germany

Countries

Germany

Other Identifiers

022ERT

Identifier Type: -

Identifier Source: org_study_id