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Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

Primary Purpose

Trauma

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Trauma focused on measuring trauma treatment, Refugees, Emotion regulation, Group therapy, randomized controlled, PTSD

Eligibility Criteria

15 Years - 21 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

REFUGIO München

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Emotion Regulation Group Therapy

Wait List Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in Difficulties in Emotion Regulation

Scale: Emotion Regulation Scale (DERS)

Change in General Health

Scale General Health Questionnaire -28 (GHQ-28)

Secondary Outcome Measures

Change in posttraumatic stress

Scale: PTSD Checklist for DSM-5 (PCL-5)

Change in Anger Reactions

Scale: Dimensions of Anger Reactions-5 (DAR-5)

Treatment Experience Scale - Patient (TESP)

Change in emotional competence (Third party assessment by caregiver)

Scale: Emotional Competence Questionnaire (German: Emotionale-Kompetenz-Fragebogen - Fremdbeurteilung (EKF))

Full Information

NCT ID

NCT03162679

First Posted

May 18, 2017

Last Updated

April 2, 2019

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

REFUGIO Munich

1. Study Identification

Unique Protocol Identification Number

NCT03162679

Brief Title

Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

December 21, 2018 (Actual)

Study Completion Date

February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

REFUGIO Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Emotion Regulation Group Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Wait List Control

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

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

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Difficulties in Emotion Regulation

Description

Scale: Emotion Regulation Scale (DERS)

Time Frame

baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)

Title

Change in General Health

Description

Scale General Health Questionnaire -28 (GHQ-28)

Time Frame

baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)

Secondary Outcome Measure Information:

Title

Change in posttraumatic stress

Description

Scale: PTSD Checklist for DSM-5 (PCL-5)

Time Frame

baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)

Title

Change in Anger Reactions

Description

Scale: Dimensions of Anger Reactions-5 (DAR-5)

Time Frame

baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)

Title

Treatment Experience Scale - Patient (TESP)

Time Frame

after 14 weeks (= post-treatment)

Title

Change in emotional competence (Third party assessment by caregiver)

Description

Scale: Emotional Competence Questionnaire (German: Emotionale-Kompetenz-Fragebogen - Fremdbeurteilung (EKF))

Time Frame

baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandra Liedl, PhD

Organizational Affiliation

REFUGIO München

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Theresa Koch, M.Sc.

Organizational Affiliation

Ludwig-Maximilians-Universität München/ REFUGIO München

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Thomas Ehring, Professor

Organizational Affiliation

Ludwig-Maximilians-Universität München

Official's Role

Study Chair

Facility Information:

Facility Name

REFUGIO München

City

Munich

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

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