Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162679
• Other study ID #: 022ERT
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2019
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 1, 2019
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma

Intervention

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.

Locations

Country	Name	City	State
Germany	REFUGIO München	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	REFUGIO Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	Treatment Experience Scale - Patient (TESP)		after 14 weeks (= post-treatment)
Secondary	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)