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Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)

Primary Purpose

Stress Disorders, Post-Traumatic, Stress Related Disorder

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Asylum Seekers, Anxiety, Compassion, Depression, Mindfulness, PTSD, Post-Migration Stress, Refugees, Trauma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Kuchinate

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MBTR-R (Mindfulness-Based Trauma Recovery for Refugees)

Waitlist-Control

Arm Description

Mindfulness-based group intervention consisting of nine 2.5-hour weekly sessions.

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).

Outcomes

Primary Outcome Measures

Harvard Trauma Questionnaire (HTQ)
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
Brief Patient Health Questionnaire (PHQ-9)
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
Beck's Anxiety Inventory (BAI)
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

Secondary Outcome Measures

Brief Inventory of Thriving (BIT)
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)
Post-Migration Living Difficulties Checklist (PMLD)
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)
The State Shame and Guilt Scale (SSGS)
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)
The Short Self Compassion Scale (SSCS)
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)
The Five Facets Mindfulness Questionnaire (FFMQ)
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)
Moral Injury Event Scale
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)
Trauma Cue Exposure Task
The Trauma Cue Exposure Task measures behavioral avoidance in response to trauma cues
Autobiographical Memory Recall Task
The Autobiographical Memory Recall Task measures avoidance in response to recalling a traumatic autobiographical memory
Adapted Sternberg Working Memory Task
The Adapted Sternberg Working Memory Task measures working memory processing of trauma- and stress-related words versus positive words
Self-Referential Encoding Task (SRET) of Self-Compassion and Self-Criticism
The SRET measures self-referential processing of self-criticism and self-compassion
Single Experience and Self-Implicit Association Task (SES-IAT)
The SES-IAT measures self-referential processing of fear
Experience Sampling of State Mindfulness
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
Experience Sampling of Cognitive Avoidance
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
Experience Sampling of Negative Repetitive Thinking
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
Experience Sampling of Emotion
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
Experience Sampling of Formal and Informal Mindfulness Practice
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
Experience Sampling of Self-Compassion
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
Experience Sampling of Depression
1-item experience sample (5-point Likert scale) of depression (minimum score 1 maximum score 5), higher scores indicate greater levels of depression
Experience Sampling of Anxiety
1-item experience sample (5-point Likert scale) of anxiety (minimum score 1 maximum score 5), higher scores indicate greater levels of anxiety

Full Information

First Posted
April 26, 2020
Last Updated
May 5, 2020
Sponsor
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT04380259
Brief Title
Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)
Official Title
Mindfulness-Based Trauma Recovery for Refugees (MBTR-R): Efficacy, Safety and Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
May 18, 2019 (Actual)
Study Completion Date
May 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Stress Related Disorder
Keywords
Asylum Seekers, Anxiety, Compassion, Depression, Mindfulness, PTSD, Post-Migration Stress, Refugees, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBTR-R (Mindfulness-Based Trauma Recovery for Refugees)
Arm Type
Experimental
Arm Description
Mindfulness-based group intervention consisting of nine 2.5-hour weekly sessions.
Arm Title
Waitlist-Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Harvard Trauma Questionnaire (HTQ)
Description
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
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
Title
Brief Patient Health Questionnaire (PHQ-9)
Description
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
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
Title
Beck's Anxiety Inventory (BAI)
Description
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
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
Secondary Outcome Measure Information:
Title
Brief Inventory of Thriving (BIT)
Description
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)
Time Frame
1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
Title
Post-Migration Living Difficulties Checklist (PMLD)
Description
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)
Time Frame
1-week pre-intervention
Title
The State Shame and Guilt Scale (SSGS)
Description
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)
Time Frame
1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
Title
The Short Self Compassion Scale (SSCS)
Description
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)
Time Frame
1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
Title
The Five Facets Mindfulness Questionnaire (FFMQ)
Description
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)
Time Frame
1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
Title
Moral Injury Event Scale
Description
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)
Time Frame
1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
Title
Trauma Cue Exposure Task
Description
The Trauma Cue Exposure Task measures behavioral avoidance in response to trauma cues
Time Frame
1-week pre-intervention, 1-week post-intervention
Title
Autobiographical Memory Recall Task
Description
The Autobiographical Memory Recall Task measures avoidance in response to recalling a traumatic autobiographical memory
Time Frame
1-week pre-intervention, 1-week post-intervention
Title
Adapted Sternberg Working Memory Task
Description
The Adapted Sternberg Working Memory Task measures working memory processing of trauma- and stress-related words versus positive words
Time Frame
1-week pre-intervention, 1-week post-intervention
Title
Self-Referential Encoding Task (SRET) of Self-Compassion and Self-Criticism
Description
The SRET measures self-referential processing of self-criticism and self-compassion
Time Frame
1-week pre-intervention, 1-week post-intervention
Title
Single Experience and Self-Implicit Association Task (SES-IAT)
Description
The SES-IAT measures self-referential processing of fear
Time Frame
1-week pre-intervention, 1-week post-intervention
Title
Experience Sampling of State Mindfulness
Description
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
Time Frame
15-minutes pre-intervention session and 15-minutes post-intervention session
Title
Experience Sampling of Cognitive Avoidance
Description
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
Time Frame
15-minutes pre-intervention session
Title
Experience Sampling of Negative Repetitive Thinking
Description
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
Time Frame
15-minutes pre-intervention session
Title
Experience Sampling of Emotion
Description
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
Time Frame
15-minutes pre-intervention session and 15-minutes post-intervention session
Title
Experience Sampling of Formal and Informal Mindfulness Practice
Description
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
Time Frame
15-minutes pre-intervention session
Title
Experience Sampling of Self-Compassion
Description
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
Time Frame
15-minutes pre-intervention session
Title
Experience Sampling of Depression
Description
1-item experience sample (5-point Likert scale) of depression (minimum score 1 maximum score 5), higher scores indicate greater levels of depression
Time Frame
15-minutes pre-intervention session
Title
Experience Sampling of Anxiety
Description
1-item experience sample (5-point Likert scale) of anxiety (minimum score 1 maximum score 5), higher scores indicate greater levels of anxiety
Time Frame
15-minutes pre-intervention session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Bernstein
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuchinate
City
Tel Aviv
State/Province
Merkaz
ZIP/Postal Code
637909
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35925708
Citation
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. 2023 Apr;23(3):622-632. doi: 10.1037/emo0001126. Epub 2022 Aug 4.
Results Reference
derived
PubMed Identifier
35343723
Citation
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.
Results Reference
derived

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Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)

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