Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-26 @ 7:38 AM
Study NCT ID:
NCT04380259
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2020-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-05', 'studyFirstSubmitDate': '2020-04-26', 'studyFirstSubmitQcDate': '2020-05-05', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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'}, {'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', 'description': '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'}, {'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', 'description': "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"}], 'secondaryOutcomes': [{'measure': 'Brief Inventory of Thriving (BIT)', 'timeFrame': '1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention', 'description': '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)'}, {'measure': 'Post-Migration Living Difficulties Checklist (PMLD)', 'timeFrame': '1-week pre-intervention', 'description': '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)'}, {'measure': 'The State Shame and Guilt Scale (SSGS)', 'timeFrame': '1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention', 'description': '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)'}, {'measure': 'The Short Self Compassion Scale (SSCS)', 'timeFrame': '1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention', 'description': '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)'}, {'measure': 'The Five Facets Mindfulness Questionnaire (FFMQ)', 'timeFrame': '1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention', 'description': '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)'}, {'measure': 'Moral Injury Event Scale', 'timeFrame': '1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention', 'description': '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)'}, {'measure': 'Trauma Cue Exposure Task', 'timeFrame': '1-week pre-intervention, 1-week post-intervention', 'description': 'The Trauma Cue Exposure Task measures behavioral avoidance in response to trauma cues'}, {'measure': 'Autobiographical Memory Recall Task', 'timeFrame': '1-week pre-intervention, 1-week post-intervention', 'description': 'The Autobiographical Memory Recall Task measures avoidance in response to recalling a traumatic autobiographical memory'}, {'measure': 'Adapted Sternberg Working Memory Task', 'timeFrame': '1-week pre-intervention, 1-week post-intervention', 'description': 'The Adapted Sternberg Working Memory Task measures working memory processing of trauma- and stress-related words versus positive words'}, {'measure': 'Self-Referential Encoding Task (SRET) of Self-Compassion and Self-Criticism', 'timeFrame': '1-week pre-intervention, 1-week post-intervention', 'description': 'The SRET measures self-referential processing of self-criticism and self-compassion'}, {'measure': 'Single Experience and Self-Implicit Association Task (SES-IAT)', 'timeFrame': '1-week pre-intervention, 1-week post-intervention', 'description': 'The SES-IAT measures self-referential processing of fear'}, {'measure': 'Experience Sampling of State Mindfulness', 'timeFrame': '15-minutes pre-intervention session and 15-minutes post-intervention session', 'description': '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'}, {'measure': 'Experience Sampling of Cognitive Avoidance', 'timeFrame': '15-minutes pre-intervention session', 'description': '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'}, {'measure': 'Experience Sampling of Negative Repetitive Thinking', 'timeFrame': '15-minutes pre-intervention session', 'description': '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'}, {'measure': 'Experience Sampling of Emotion', 'timeFrame': '15-minutes pre-intervention session and 15-minutes post-intervention session', 'description': '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'}, {'measure': 'Experience Sampling of Formal and Informal Mindfulness Practice', 'timeFrame': '15-minutes pre-intervention session', 'description': '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'}, {'measure': 'Experience Sampling of Self-Compassion', 'timeFrame': '15-minutes pre-intervention session', 'description': '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'}, {'measure': 'Experience Sampling of Depression', 'timeFrame': '15-minutes pre-intervention session', 'description': '1-item experience sample (5-point Likert scale) of depression (minimum score 1 maximum score 5), higher scores indicate greater levels of depression'}, {'measure': 'Experience Sampling of Anxiety', 'timeFrame': '15-minutes pre-intervention session', 'description': '1-item experience sample (5-point Likert scale) of anxiety (minimum score 1 maximum score 5), higher scores indicate greater levels of anxiety'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asylum Seekers, Anxiety, Compassion, Depression, Mindfulness, PTSD, Post-Migration Stress, Refugees, Trauma'], 'conditions': ['Stress Disorders, Post-Traumatic', 'Stress Related Disorder']}, 'referencesModule': {'references': [{'pmid': '35925708', 'type': 'DERIVED', '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.'}, {'pmid': '35833254', 'type': 'DERIVED', 'citation': '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': '35343723', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eritrean refugee or asylum seeker living in Israel\n\nExclusion Criteria:\n\n* active suicidality\n* current psychotic symptoms\n* current mental health treatment (e.g. psychotherapy, participation in psycho-social support group)'}, 'identificationModule': {'nctId': 'NCT04380259', 'briefTitle': 'Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': 'Mindfulness-Based Trauma Recovery for Refugees (MBTR-R): Efficacy, Safety and Mechanisms', 'orgStudyIdInfo': {'id': 'MBTR-R Tel Aviv'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBTR-R (Mindfulness-Based Trauma Recovery for Refugees)', 'description': 'Mindfulness-based group intervention consisting of nine 2.5-hour weekly sessions.', 'interventionNames': ['Behavioral: Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist-Control', 'description': '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': [{'name': 'Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['MBTR-R (Mindfulness-Based Trauma Recovery for Refugees)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '637909', 'city': 'Tel Aviv', 'state': 'Central District', 'country': 'Israel', 'facility': 'Kuchinate'}], 'overallOfficials': [{'name': 'Amit Bernstein', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Haifa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Haifa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}