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NCT Number: NCT04380259

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

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).

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Key information

Conditions

Stress Disorders, Post-Traumatic Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Traumatic Stress Related Disorder Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kuchinate

Tel Aviv, Central District, 637909, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

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

Behavioral

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 outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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 outcomes

  1. Brief Inventory of Thriving (BIT)

    Time frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention

    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)

  2. Post-Migration Living Difficulties Checklist (PMLD)

    Time frame: 1-week pre-intervention

    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)

  3. The State Shame and Guilt Scale (SSGS)

    Time frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention

    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)

  4. The Short Self Compassion Scale (SSCS)

    Time frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention

    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)

  5. The Five Facets Mindfulness Questionnaire (FFMQ)

    Time frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention

    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)

  6. Moral Injury Event Scale

    Time frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention

    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)

  7. Trauma Cue Exposure Task

    Time frame: 1-week pre-intervention, 1-week post-intervention

    The Trauma Cue Exposure Task measures behavioral avoidance in response to trauma cues

  8. Autobiographical Memory Recall Task

    Time frame: 1-week pre-intervention, 1-week post-intervention

    The Autobiographical Memory Recall Task measures avoidance in response to recalling a traumatic autobiographical memory

  9. Adapted Sternberg Working Memory Task

    Time frame: 1-week pre-intervention, 1-week post-intervention

    The Adapted Sternberg Working Memory Task measures working memory processing of trauma- and stress-related words versus positive words

  10. Self-Referential Encoding Task (SRET) of Self-Compassion and Self-Criticism

    Time frame: 1-week pre-intervention, 1-week post-intervention

    The SRET measures self-referential processing of self-criticism and self-compassion

  11. Single Experience and Self-Implicit Association Task (SES-IAT)

    Time frame: 1-week pre-intervention, 1-week post-intervention

    The SES-IAT measures self-referential processing of fear

  12. Experience Sampling of State Mindfulness

    Time frame: 15-minutes pre-intervention session and 15-minutes post-intervention session

    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

  13. Experience Sampling of Cognitive Avoidance

    Time frame: 15-minutes pre-intervention session

    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

  14. Experience Sampling of Negative Repetitive Thinking

    Time frame: 15-minutes pre-intervention session

    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. Experience Sampling of Emotion

    Time frame: 15-minutes pre-intervention session and 15-minutes post-intervention session

    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

  16. Experience Sampling of Formal and Informal Mindfulness Practice

    Time frame: 15-minutes pre-intervention session

    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

  17. Experience Sampling of Self-Compassion

    Time frame: 15-minutes pre-intervention session

    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

  18. Experience Sampling of Depression

    Time frame: 15-minutes pre-intervention session

    1-item experience sample (5-point Likert scale) of depression (minimum score 1 maximum score 5), higher scores indicate greater levels of depression

  19. Experience Sampling of Anxiety

    Time frame: 15-minutes pre-intervention session

    1-item experience sample (5-point Likert scale) of anxiety (minimum score 1 maximum score 5), higher scores indicate greater levels of anxiety

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 8, 2020
Registry last updated
May 8, 2020

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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