- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04380259
Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)
May 5, 2020 updated by: University of Haifa
Mindfulness-Based Trauma Recovery for Refugees (MBTR-R): Efficacy, Safety and Mechanisms
Worldwide, refugees and asylum seekers suffer at high rates from trauma- and stress-related mental health problems.
The investigators thus developed Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) - a 9-week, mindfulness- and compassion-based, trauma-sensitive and socio-culturally adapted, group intervention for refugees and asylum seekers.
The overarching aims of the study were to, first, test whether MBTR-R is an efficacious and safe mental health intervention for traumatized refugees and asylum seekers with respect to stress- and trauma-related mental health outcomes; and, second, to test theorized mechanisms of action of MBTR-R.
Accordingly, the investigators conducted a randomized waitlist-controlled trial among a community sample of female and male Eritrean asylum seekers in an urban post-displacement setting in the Middle East (Israel).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Broadly, the investigators aimed to assess whether MBTR-R is an efficacious and safe mental health intervention for traumatized asylum seekers.
Aim I: The investigators predicted that, relative to a waitlist control condition, MBTR-R will lead to improved stress-and trauma-related mental health outcomes, including lower levels and rates of posttraumatic stress, depression, anxiety, and improved subjective well-being at post-intervention and 5-week follow-up.
Aim II: The investigators aimed to test, whether relative to the waitlist-control condition, MBTR-R was safe and thus not associated with participant-level clinically significant deterioration in any of the monitored primary mental health outcomes at post-intervention or at follow-up.
In the event of adverse responding, the investigators planned to test whether key demographic factors or pre-existing vulnerability factors at pre-intervention that may predict participant-level deterioration or adverse responding to the intervention - so as to identify candidate contraindications for MBTR-R.
Aim III: The investigators predicted that, relative to a waitlist control condition, MBTR-R will lead to changes in psycho-behavioral processes targeted by the intervention and implicated in vulnerability at pre-intervention, from pre-to-post intervention, measured in controlled behavioral and cognitive-experimental lab tasks or experience sampling measures, including measures of (a) self-compassion and self-criticism, (b) self-referential processing of fear, (c) avoidance, (d) emotional reactivity to trauma-related information and autobiographical memory, (e) impaired executive functions of trauma-related information processing in working memory.
Aim IV: The investigators aimed to test whether, among the MBTR-R group, pre-to-post-intervention change and pre-intervention to follow-up change in mental health outcomes (Aim I) will be predicted or mediated by pre-to-post intervention change in the targeted psycho-behavioral processes.
Study Type
Interventional
Enrollment (Actual)
158
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Merkaz
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Tel Aviv, Merkaz, Israel, 637909
- Kuchinate
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Eritrean refugee or asylum seeker living in Israel
Exclusion Criteria:
- active suicidality
- current psychotic symptoms
- current mental health treatment (e.g. psychotherapy, participation in psycho-social support group)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MBTR-R (Mindfulness-Based Trauma Recovery for Refugees)
Mindfulness-based group intervention consisting of nine 2.5-hour weekly sessions.
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MBTR-R is a mindfulness-based group intervention of nine 2.5-hour weekly sessions.
MBTR-R format and structure parallel MBSR (mindfulness-based stress reduction) and MBCT (mindfulness-based cognitive therapy).
MBTR-R includes systematic training in formal and informal mindfulness practices with trauma-sensitive adaptations and home practice.
Trauma-sensitive adaptations include a "safe place" practice, psychoeducation about posttraumatic stress, stress reactivity, as well as self-compassion practices to cope with fear, self-judgement, guilt and shame.
Socio-cultural adaptations include real-time linguistic translation of each session by a cultural mediator from the refugee community and use of socio-culturally specific metaphors.
MBTR-R groups were conducted for men and women separately and delivered in an accessible, "safe space" in the local refugee community.
Group meetings included a shared meal of traditional Eritrean food and female participants were offered free child care.
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No Intervention: Waitlist-Control
Following the 9-week waitlist period and 1-week post-intervention assessment, participants randomized to waitlist-control were offered an equivalent group intervention (i.e., 22.5 total hours, group instructor and cultural mediator, psychoeducation and low-intensity cognitive behavior therapy skill training, relaxation techniques).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Harvard Trauma Questionnaire (HTQ)
Time Frame: Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention
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The Harvard Trauma Questionnaire (HTQ) is a 16-item self-report questionnaire to assess post-traumatic stress symptom severity (5-point Likert scale) with higher scores indicating greater post-traumatic stress severity (minimum scale score 1 and maximum scale score 5), HTQ mean cut-off score ≥ 2 is commonly used to identify categorical (diagnostic) symptom status of post-traumatic stress disorder
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Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention
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Brief Patient Health Questionnaire (PHQ-9)
Time Frame: Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention
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The brief Patient Health Questionnaire (PHQ-9) is a 9-item self-report questionnaire to assess depression symptom severity (5-point Likert scale) with higher scores indicating greater depression symptom severity (minimum scale score 0 and maximum scale score 36), PHQ-9 mean cut-off score ≥10 is commonly used to identify categorical (diagnostic) symptom status of depression
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Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention
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Beck's Anxiety Inventory (BAI)
Time Frame: Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention
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The Beck's Anxiety Inventory (BAI) is a 21-item self-report questionnaire to assess anxiety symptom severity (4-point Likert scale) with higher scores indicating greater anxiety symptom severity (minimum scale score 0 and maximum scale score 63), BAI total cut-off score ≥ 16 is commonly used to identify categorical (diagnostic) symptom status of anxiety disorder
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Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Inventory of Thriving (BIT)
Time Frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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One item of the 9-item self-report questionnaire Brief Inventory of Thriving (BIT) was used to assess subjective well-being (5-point Likert scale) with higher scores indicating greater subjective well-being (minimum score 1 and maximum score 5)
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1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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Post-Migration Living Difficulties Checklist (PMLD)
Time Frame: 1-week pre-intervention
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The Post-Migration-Living-Difficulties Checklist (PMLD) is a 9-item self-report questionnaire to assess post-migration stress (5-point Likert scale) with higher scores indicating greater post-migration stress (minimum scale score 1 and maximum scale score 5)
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1-week pre-intervention
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The State Shame and Guilt Scale (SSGS)
Time Frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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The State Shame and Guilt Scale (SSGS) is a 15-item self-report questionnaire to assess state shame and guilt (5-point Likert scale) with higher scores indicating greater levels of state shame, guilt and pride (minimum scale score 15 and maximum scale score 75)
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1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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The Short Self Compassion Scale (SSCS)
Time Frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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The Short Self-Compassion Scale SSCS is a 12-item self-report questionnaire to assess different facets of self-compassion (5-point Likert scale) with higher scores indicating greater levels of self-compassion (minimum scale score 1 and maximum scale score 5)
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1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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The Five Facets Mindfulness Questionnaire (FFMQ)
Time Frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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The Five Facets of Mindfulness Questionnaire (FFMQ) is a self-report questionnaire to assess different facets of trait mindfulness (5-point Likert scale) with higher scores indicating greater levels of trait mindfulness (minimum scale score 1 and maximum scale score 5)
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1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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Moral Injury Event Scale
Time Frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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The Moral Injury Event Scale is a self-report questionnaire to assess moral injury (6-point Likert scale) with higher scores indicating greater levels of moral injury (minimum scale score 1 and maximum scale score 6)
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1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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Trauma Cue Exposure Task
Time Frame: 1-week pre-intervention, 1-week post-intervention
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The Trauma Cue Exposure Task measures behavioral avoidance in response to trauma cues
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1-week pre-intervention, 1-week post-intervention
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Autobiographical Memory Recall Task
Time Frame: 1-week pre-intervention, 1-week post-intervention
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The Autobiographical Memory Recall Task measures avoidance in response to recalling a traumatic autobiographical memory
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1-week pre-intervention, 1-week post-intervention
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Adapted Sternberg Working Memory Task
Time Frame: 1-week pre-intervention, 1-week post-intervention
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The Adapted Sternberg Working Memory Task measures working memory processing of trauma- and stress-related words versus positive words
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1-week pre-intervention, 1-week post-intervention
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Self-Referential Encoding Task (SRET) of Self-Compassion and Self-Criticism
Time Frame: 1-week pre-intervention, 1-week post-intervention
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The SRET measures self-referential processing of self-criticism and self-compassion
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1-week pre-intervention, 1-week post-intervention
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Single Experience and Self-Implicit Association Task (SES-IAT)
Time Frame: 1-week pre-intervention, 1-week post-intervention
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The SES-IAT measures self-referential processing of fear
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1-week pre-intervention, 1-week post-intervention
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Experience Sampling of State Mindfulness
Time Frame: 15-minutes pre-intervention session and 15-minutes post-intervention session
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3-item experience sample (5-point Likert scale) of state mindfulness (minimum score 3 maximum score 15), higher scores indicate greater levels of state mindfulness
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15-minutes pre-intervention session and 15-minutes post-intervention session
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Experience Sampling of Cognitive Avoidance
Time Frame: 15-minutes pre-intervention session
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1-item experience sample (5-point Likert scale) of cognitive avoidance (minimum score 1 maximum score 5), higher scores indicate greater levels of cognitive avoidance
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15-minutes pre-intervention session
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Experience Sampling of Negative Repetitive Thinking
Time Frame: 15-minutes pre-intervention session
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1-item experience sample (5-point Likert scale) of negative repetitive thinking (minimum score 1 maximum score 5), higher scores indicate greater levels of negative repetitive thinking
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15-minutes pre-intervention session
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Experience Sampling of Emotion
Time Frame: 15-minutes pre-intervention session and 15-minutes post-intervention session
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4-item experience sample (5-point Likert scale) of the emotions happy, calm, sad and nervous/tense (minimum score 4 maximum score 20), higher scores indicate greater levels of the emotions happy, calm, sad and nervous/tense
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15-minutes pre-intervention session and 15-minutes post-intervention session
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Experience Sampling of Formal and Informal Mindfulness Practice
Time Frame: 15-minutes pre-intervention session
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2-item experience sample number of formal and informal mindfulness practice during the past week, higher scores indicate greater number of mindfulness practices during the past week
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15-minutes pre-intervention session
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Experience Sampling of Self-Compassion
Time Frame: 15-minutes pre-intervention session
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1-item experience sample (5-point Likert scale) of negative self-compassion (minimum score 1 maximum score 5), higher scores indicate greater levels of self-compassion
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15-minutes pre-intervention session
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Experience Sampling of Depression
Time Frame: 15-minutes pre-intervention session
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1-item experience sample (5-point Likert scale) of depression (minimum score 1 maximum score 5), higher scores indicate greater levels of depression
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15-minutes pre-intervention session
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Experience Sampling of Anxiety
Time Frame: 15-minutes pre-intervention session
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1-item experience sample (5-point Likert scale) of anxiety (minimum score 1 maximum score 5), higher scores indicate greater levels of anxiety
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15-minutes pre-intervention session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amit Bernstein, University of Haifa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Oren-Schwartz R, Aizik-Reebs A, Yuval K, Hadash Y, Bernstein A. Effect of mindfulness-based trauma recovery for refugees on shame and guilt in trauma recovery among African asylum-seekers. Emotion. 2022 Aug 4. doi: 10.1037/emo0001126. Online ahead of print.
- Aizik-Reebs A, Amir I, Yuval K, Hadash Y, Bernstein A. Candidate mechanisms of action of mindfulness-based trauma recovery for refugees (MBTR-R): Self-compassion and self-criticism. J Consult Clin Psychol. 2022 Feb;90(2):107-122. doi: 10.1037/ccp0000716.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2018
Primary Completion (Actual)
May 18, 2019
Study Completion (Actual)
May 18, 2019
Study Registration Dates
First Submitted
April 26, 2020
First Submitted That Met QC Criteria
May 5, 2020
First Posted (Actual)
May 8, 2020
Study Record Updates
Last Update Posted (Actual)
May 8, 2020
Last Update Submitted That Met QC Criteria
May 5, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBTR-R Tel Aviv
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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