TraumaNCT03162679
Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees
A study testing Skills training of Affect-Regulation - A culture-sensitive approach: STARK in people with Trauma, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 15 to 21 years, men only
- Conditions the study is for
- Trauma
- What is being tested?
- Skills training of Affect-Regulation - A culture-sensitive approach: STARK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2017to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Psychosis
- Serious suicidal ideations
- Currently receiving psychotherapy elsewhere
- Serious dissociation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees: A Randomized Controlled Trial
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.
- Conditions
- Trauma
- Being tested
- Skills training of Affect-Regulation - A culture-sensitive approach: STARK
- Keywords
- trauma treatment, Refugees, Emotion regulation, Group therapy, randomized controlled, PTSD
- Medical subject headings
- Wounds and Injuries, Emotional Regulation, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills training of Affect-Regulation - A culture-sensitive approach: STARKBehavioural
Also called German title: Skills-Training der Affektregulation: Ein kultursensibler Ansatz: STARK
Emotion Regulation Group Therapy, 14 sessions, 1.5 hour sessions, group therapy, meeting weekly.
| Study group | Role | What they receive |
|---|---|---|
| Emotion Regulation Group Therapy | Experimental | Participants assigned to this condition will receive treatment immediately after assignment. Receives: Behavioral: Skills training of Affect-Regulation - A culture-sensitive approach: STARK |
| Wait List Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Difficulties in Emotion Regulation
Scale: Emotion Regulation Scale (DERS)
Measured: 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)
Measured: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
Secondary outcomes (4)
Change in posttraumatic stress
Scale: PTSD Checklist for DSM-5 (PCL-5)
Measured: 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)
Measured: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
Treatment Experience Scale - Patient (TESP)
Measured: after 14 weeks (= post-treatment)
Change in emotional competence (Third party assessment by caregiver)
Scale: Emotional Competence Questionnaire (German: Emotionale-Kompetenz-Fragebogen - Fremdbeurteilung (EKF))
Measured: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Jun 2017
- Primary completion21 Dec 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- REFUGIO Munich
- Responsible party
- Principal investigator, Theresa Koch, Ludwig-Maximilians - University of Munich
- Investigators
- Alexandra Liedl, PhD, Principal investigator, REFUGIO MünchenTheresa Koch, M.Sc., Study director, Ludwig-Maximilians-Universität München/ REFUGIO MünchenThomas Ehring, Professor, Study chair, Ludwig-Maximilians-Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162679
- Sponsor's protocol ID
- 022ERT
- Status last verified
- Apr 2019
- First submitted
- 18 May 2017
- Last updated
- 3 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03162679
- Acronym / sponsor ID
- 022ERT
- Conditions
- Trauma
- Keywords
- trauma treatment, Refugees, Emotion regulation, Group therapy, randomized controlled, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- REFUGIO Munich
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotion Regulation Group Therapy | Experimental | Behavioral: Skills training of Affect-Regulation - A culture-sensitive approach: STARKParticipants assigned to this condition will receive treatment immediately after assignment. |
| Wait List Control | No intervention | –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. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Psychosis
- Serious suicidal ideations
- Currently receiving psychotherapy elsewhere
- Serious dissociation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skills training of Affect-Regulation - A culture-sensitive approach: STARKAlso: German title: Skills-Training der Affektregulation: Ein kultursensibler Ansatz: STARKEmotion Regulation Group Therapy, 14 sessions, 1.5 hour sessions, group therapy, meeting weekly. | Behavioural | Emotion Regulation Group Therapy |
Primary outcome
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)
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)
4 secondary outcomes
Change in posttraumatic stress
Time frame: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
Change in Anger Reactions
Time frame: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)
Treatment Experience Scale - Patient (TESP)
Time frame: after 14 weeks (= post-treatment)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Liedl, PhD principal investigator
REFUGIO München
Theresa Koch, M.Sc. study director
Ludwig-Maximilians-Universität München/ REFUGIO München
Thomas Ehring, Professor study chair
Ludwig-Maximilians-Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skills training of Affect-Regulation - A culture-sensitive approach: STARK in people with Trauma, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Difficulties in Emotion Regulation (time frame: baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.