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Completed

NCT Number: NCT03162679

Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees

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.

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Key information

Age range

15 year–21 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

REFUGIO München

Munich, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

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

Primary outcomes

  1. Change in Difficulties in Emotion Regulation

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

    Scale: Emotion Regulation Scale (DERS)

  2. Change in General Health

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

    Scale General Health Questionnaire -28 (GHQ-28)

Secondary outcomes

  1. Change in posttraumatic stress

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

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

  2. Change in Anger Reactions

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

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

  3. Treatment Experience Scale - Patient (TESP)

    Time frame: after 14 weeks (= post-treatment)

  4. Change in emotional competence (Third party assessment by caregiver)

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

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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • REFUGIO Munich

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 22, 2017
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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