Clinical trial NCT04380259: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stress Disorders, Post-Traumatic
Stress Related Disorder
Keywords: Asylum Seekers, Anxiety, Compassion, Depression, Mindfulness, PTSD, Post-Migration Stress, Refugees, Trauma
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Harvard Trauma Questionnaire (HTQ)
timeFrame: Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention
measure: Brief Patient Health Questionnaire (PHQ-9)
timeFrame: Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention
measure: Beck's Anxiety Inventory (BAI)
timeFrame: 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:
measure: Brief Inventory of Thriving (BIT)
timeFrame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
measure: Post-Migration Living Difficulties Checklist (PMLD)
timeFrame: 1-week pre-intervention
measure: The State Shame and Guilt Scale (SSGS)
timeFrame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
measure: The Short Self Compassion Scale (SSCS)
timeFrame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
measure: The Five Facets Mindfulness Questionnaire (FFMQ)
timeFrame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
measure: Moral Injury Event Scale
timeFrame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
measure: Trauma Cue Exposure Task
timeFrame: 1-week pre-intervention, 1-week post-intervention
measure: Autobiographical Memory Recall Task
timeFrame: 1-week pre-intervention, 1-week post-intervention
measure: Adapted Sternberg Working Memory Task
timeFrame: 1-week pre-intervention, 1-week post-intervention
measure: Self-Referential Encoding Task (SRET) of Self-Compassion and Self-Criticism
timeFrame: 1-week pre-intervention, 1-week post-intervention
measure: Single Experience and Self-Implicit Association Task (SES-IAT)
timeFrame: 1-week pre-intervention, 1-week post-intervention
measure: Experience Sampling of State Mindfulness
timeFrame: 15-minutes pre-intervention session and 15-minutes post-intervention session
measure: Experience Sampling of Cognitive Avoidance
timeFrame: 15-minutes pre-intervention session
measure: Experience Sampling of Negative Repetitive Thinking
timeFrame: 15-minutes pre-intervention session
measure: Experience Sampling of Emotion
timeFrame: 15-minutes pre-intervention session and 15-minutes post-intervention session
measure: Experience Sampling of Formal and Informal Mindfulness Practice
timeFrame: 15-minutes pre-intervention session
measure: Experience Sampling of Self-Compassion
timeFrame: 15-minutes pre-intervention session
measure: Experience Sampling of Depression
timeFrame: 15-minutes pre-intervention session
measure: Experience Sampling of Anxiety
timeFrame: 15-minutes pre-intervention session
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Kuchinate
state: Merkaz
Study officials:
affiliation: University of Haifa
name: Amit Bernstein
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.