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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness-Based Trauma Recovery for Refugees (MBTR-R): Efficacy, Safety and Mechanisms

Conditions
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Stress Disorders, Post-Traumatic, Stress Related Disorder

Intervention / Treatment
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* Behavioral: Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBTR-R (Mindfulness-Based Trauma Recovery for Refugees)<br>Mindfulness-based group intervention consisting of nine 2.5-hour weekly sessions. | Behavioral: Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)<br>* 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.<br>|
| No Intervention: Waitlist-Control<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention | 
| 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 | Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention | 
| 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 | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention | 
| 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) | 1-week pre-intervention | 
| 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) | 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention | 
| 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) | 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention | 
| 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) | 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention | 
| 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) | 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention | 
| Trauma Cue Exposure Task | The Trauma Cue Exposure Task measures behavioral avoidance in response to trauma cues | 1-week pre-intervention, 1-week post-intervention | 
| Autobiographical Memory Recall Task | The Autobiographical Memory Recall Task measures avoidance in response to recalling a traumatic autobiographical memory | 1-week pre-intervention, 1-week post-intervention | 
| Adapted Sternberg Working Memory Task | The Adapted Sternberg Working Memory Task measures working memory processing of trauma- and stress-related words versus positive words | 1-week pre-intervention, 1-week post-intervention | 
| Self-Referential Encoding Task (SRET) of Self-Compassion and Self-Criticism | The SRET measures self-referential processing of self-criticism and self-compassion | 1-week pre-intervention, 1-week post-intervention | 
| Single Experience and Self-Implicit Association Task (SES-IAT) | The SES-IAT measures self-referential processing of fear | 1-week pre-intervention, 1-week post-intervention | 
| 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 | 15-minutes pre-intervention session and 15-minutes post-intervention session | 
| 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 | 15-minutes pre-intervention session | 
| 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 | 15-minutes pre-intervention session | 
| 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 | 15-minutes pre-intervention session and 15-minutes post-intervention session | 
| 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 | 15-minutes pre-intervention session | 
| 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 | 15-minutes pre-intervention session | 
| 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 | 15-minutes pre-intervention session | 
| 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 | 15-minutes pre-intervention session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asylum Seekers, Anxiety, Compassion, Depression, Mindfulness, PTSD, Post-Migration Stress, Refugees, Trauma