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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380259
• Other study ID #: MBTR-R Tel Aviv
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 10, 2018
• Est. completion date: May 18, 2019

Study information

• Verified date: April 2020
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 18, 2019
• Est. primary completion date: May 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Stress Disorders, Post-Traumatic
• Stress Related Disorder

Intervention

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

Locations

Country	Name	City	State
Israel	Kuchinate	Tel Aviv	Merkaz

Sponsors (1)

Lead Sponsor	Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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