Stress Disorders, Post-TraumaticPhase 1/2NCT04380259
Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)
A Phase 1/2 study testing Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) in people with Stress Disorders, Post-Traumatic and Stress Related Disorder, run by University of Haifa at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Stress Related Disorder
- What is being tested?
- Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteIsrael
- Study dates
- 10 May 2018to 18 May 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eritrean refugee or asylum seeker living in Israel
Who cannot join
- active suicidality
- current psychotic symptoms
- current mental health treatment (e.g. psychotherapy, participation in psycho-social support group)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-Based Trauma Recovery for Refugees (MBTR-R): Efficacy, Safety and Mechanisms
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).
Read the 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.
- Being tested
- Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)
- Keywords
- Asylum Seekers, Anxiety, Compassion, Depression, Mindfulness, PTSD, Post-Migration Stress, Refugees, Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBTR-R (Mindfulness-Based Trauma Recovery for Refugees) | Experimental | Mindfulness-based group intervention consisting of nine 2.5-hour weekly sessions. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
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)
Measured: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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)
Measured: 1-week pre-intervention
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)
Measured: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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)
Measured: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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)
Measured: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
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)
Measured: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
Trauma Cue Exposure Task
The Trauma Cue Exposure Task measures behavioral avoidance in response to trauma cues
Measured: 1-week pre-intervention, 1-week post-intervention
Autobiographical Memory Recall Task
The Autobiographical Memory Recall Task measures avoidance in response to recalling a traumatic autobiographical memory
Measured: 1-week pre-intervention, 1-week post-intervention
Adapted Sternberg Working Memory Task
The Adapted Sternberg Working Memory Task measures working memory processing of trauma- and stress-related words versus positive words
Measured: 1-week pre-intervention, 1-week post-intervention
Self-Referential Encoding Task (SRET) of Self-Compassion and Self-Criticism
The SRET measures self-referential processing of self-criticism and self-compassion
Measured: 1-week pre-intervention, 1-week post-intervention
Single Experience and Self-Implicit Association Task (SES-IAT)
The SES-IAT measures self-referential processing of fear
Measured: 1-week pre-intervention, 1-week post-intervention
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
Measured: 15-minutes pre-intervention session and 15-minutes post-intervention session
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
Measured: 15-minutes pre-intervention session
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
Measured: 15-minutes pre-intervention session
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
Measured: 15-minutes pre-intervention session and 15-minutes post-intervention session
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
Measured: 15-minutes pre-intervention session
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
Measured: 15-minutes pre-intervention session
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
Measured: 15-minutes pre-intervention session
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
Measured: 15-minutes pre-intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start10 May 2018
- Primary completion18 May 2019
- Study completion18 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Bernstein, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380259
- Sponsor's protocol ID
- MBTR-R Tel Aviv
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35925708Blay 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.
PubMed 35833254Aizik-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.
PubMed 35343723
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Trauma Recovery for Refugees (MBTR-R): Efficacy, Safety and Mechanisms
- ClinicalTrials.gov ID
- NCT04380259
- Acronym / sponsor ID
- MBTR-R Tel Aviv
- Keywords
- Asylum Seekers, Anxiety, Compassion, Depression, Mindfulness, PTSD, Post-Migration Stress, Refugees, Trauma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 18 May 2019 (actual)
- Study completion
- 18 May 2019 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBTR-R (Mindfulness-Based Trauma Recovery for Refugees) | Experimental | Behavioral: Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)Mindfulness-based group intervention consisting of nine 2.5-hour weekly sessions. |
| 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eritrean refugee or asylum seeker living in Israel
Key exclusion criteria (3 listed)
- active suicidality
- current psychotic symptoms
- current mental health treatment (e.g. psychotherapy, participation in psycho-social support group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MBTR-R (Mindfulness-Based Trauma Recovery for Refugees) |
Primary outcome
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
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
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
19 secondary outcomes
Brief Inventory of Thriving (BIT)
Time frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
Post-Migration Living Difficulties Checklist (PMLD)
Time frame: 1-week pre-intervention
The State Shame and Guilt Scale (SSGS)
Time frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
The Short Self Compassion Scale (SSCS)
Time frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
The Five Facets Mindfulness Questionnaire (FFMQ)
Time frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
Moral Injury Event Scale
Time frame: 1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention
Trauma Cue Exposure Task
Time frame: 1-week pre-intervention, 1-week post-intervention
Autobiographical Memory Recall Task
Time frame: 1-week pre-intervention, 1-week post-intervention
Adapted Sternberg Working Memory Task
Time frame: 1-week pre-intervention, 1-week post-intervention
Self-Referential Encoding Task (SRET) of Self-Compassion and Self-Criticism
Time frame: 1-week pre-intervention, 1-week post-intervention
Single Experience and Self-Implicit Association Task (SES-IAT)
Time frame: 1-week pre-intervention, 1-week post-intervention
Experience Sampling of State Mindfulness
Time frame: 15-minutes pre-intervention session and 15-minutes post-intervention session
Experience Sampling of Cognitive Avoidance
Time frame: 15-minutes pre-intervention session
Experience Sampling of Negative Repetitive Thinking
Time frame: 15-minutes pre-intervention session
Experience Sampling of Emotion
Time frame: 15-minutes pre-intervention session and 15-minutes post-intervention session
Experience Sampling of Formal and Informal Mindfulness Practice
Time frame: 15-minutes pre-intervention session
Experience Sampling of Self-Compassion
Time frame: 15-minutes pre-intervention session
Experience Sampling of Depression
Time frame: 15-minutes pre-intervention session
Experience Sampling of Anxiety
Time frame: 15-minutes pre-intervention session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Derived from this study: PubMed 35925708Oren-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.
- Derived from this study: PubMed 35833254Blay 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.
- Derived from this study: PubMed 35343723Aizik-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Bernstein principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) in people with Stress Disorders, Post-Traumatic and Stress Related Disorder, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380259, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.