Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

Study Overview
=================
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.

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

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Behavioral: Skills training of Affect-Regulation - A culture-sensitive approach: STARK


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, trauma treatment, Refugees, Emotion regulation, Group therapy, randomized controlled