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

NCT04380259 | Completed Phase 1

• 1 other identifier: MBTR-R Tel Aviv
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress Disorders, Post-Traumatic; Stress Related Disorder

Keywords

Asylum Seekers, Anxiety, Compassion, Depression, Mindfulness, PTSD, Post-Migration Stress, Refugees, Trauma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (19)

• Brief Inventory of Thriving (BIT)

  1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention

• Post-Migration Living Difficulties Checklist (PMLD)

  1-week pre-intervention

• The State Shame and Guilt Scale (SSGS)

  1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention

• The Short Self Compassion Scale (SSCS)

  1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention

• The Five Facets Mindfulness Questionnaire (FFMQ)

  1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention

Study Arms (2)

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

EXPERIMENTAL

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

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

Waitlist-Control

NO INTERVENTION

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).

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eritrean refugee or asylum seeker living in Israel

You may not qualify if:

• active suicidality
• current psychotic symptoms
• current mental health treatment (e.g. psychotherapy, participation in psycho-social support group)

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

Kuchinate

Tel Aviv, Central District, 637909, Israel

Location

Related Publications (3)

• 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.

  PMID: 35925708 DERIVED

• Blay Benzaken Y, Zohar S, Yuval K, Aizik-Reebs A, Gebremariam SG, Bernstein A. COVID-19 and Mental Health Among People Who Are Forcibly Displaced: The Role of Socioeconomic Insecurity. Psychiatr Serv. 2023 Feb 1;74(2):158-165. doi: 10.1176/appi.ps.202200052. Epub 2022 Jul 14.

  PMID: 35833254 DERIVED

• 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.

  PMID: 35343723 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Amit Bernstein

  University of Haifa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: May 8, 2020
• Study Start: May 10, 2018
• Primary Completion: May 18, 2019
• Study Completion: May 18, 2019
• Last Updated: May 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)