Clinical trial NCT03162679: 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
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: trauma treatment
Refugees
Emotion regulation
Group therapy
randomized controlled
PTSD
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: REFUGIO Munich
First posted: 2017-05-22
Enrollment: 44
Sex: MALE
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Difficulties in Emotion Regulation
timeFrame: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
measure: Change in General Health
timeFrame: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
Secondary outcomes:
measure: Change in posttraumatic stress
timeFrame: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
measure: Change in Anger Reactions
timeFrame: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
measure: Treatment Experience Scale - Patient (TESP)
timeFrame: after 14 weeks (= post-treatment)
measure: Change in emotional competence (Third party assessment by caregiver)
timeFrame: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: REFUGIO München
Study officials:
affiliation: REFUGIO München
name: Alexandra Liedl, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ludwig-Maximilians-Universität München/ REFUGIO München
name: Theresa Koch, M.Sc.
role: STUDY_DIRECTOR
affiliation: Ludwig-Maximilians-Universität München
name: Thomas Ehring, Professor
role: STUDY_CHAIR
References: