Stress Disorders, Post-TraumaticNCT05616286
Mindfulness-SOS for Refugees
A study testing Mindfulness-SOS for Refugees 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 research group therefore developed, and initially piloted in a single-site open trial, a novel mindfulness- and compassion-based digital intervention program - Mindfulness-SOS for refugees… 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-SOS for Refugees
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Dec 2022to Aug 2023
- Phase
- Interventional
- 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
- East African refugee or asylum seeker living in Israel
- Tigrinya fluency and literacy
- Owns a personal smartphone
Who cannot join
- Active suicidal ideation or/and past suicide attempt in the last year or/and passive suicidal ideation with clinical indicators of imminent suicide risk (e.g. severe paranoia)
- Current mental health treatment (i.e. psychotherapy or/and group therapy at least twice a month)
- Participation in the MBTR-R group in a previous study
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Central Bus Station
Tel Aviv
Anna Aizik, phD, 053-2249339, anna.aizikreebs@gmail.com
About this study
Official title: Mindfulness-SOS for Refugees: Randomized Controlled Trial
Worldwide, refugees and asylum seekers suffer at high rates from trauma and stress-related mental health problems. The research group therefore developed, and initially piloted in a single-site open trial, a novel mindfulness- and compassion-based digital intervention program - Mindfulness-SOS for refugees (Mindfulness-SOS). The pilot study had promising preliminary findings of utilization, feasibility and related dose-response effects of intervention program engagement with mental health outcomes. The digital intervention program was developed based on randomized control trial data of a group-based mindfulness- and compassion-based program for forcibly displaced people.
To address common limitations of mobile health interventions such as attrition, engagement and adherence, the investigators will implement a personalized stepped-care adaptation and augmentation of Mindfulness-SOS, that entails providing intensified (remote) guidance for FDPs that do not respond to the intervention, to optimize capacity to therapeutically benefit from Mindfulness-SOS. To do so, the investigators propose to carry out a randomized controlled Sequential Multiple Assignment Randomized Trial (SMART) study to test and optimize the therapeutic outcomes of Mindfulness-SOS, using an adaptive intervention sequence of guidance format intensities among N ≅ 170 (50% female) adult trauma-affected Eritrean asylum-seekers residing in Israel.
Read the detailed description
Over 100 million Forcibly Displaced Persons (FDPs), including refugees and asylum-seekers, are forcibly displaced due to conflict, persecution, and natural disaster. Forced displacement is often associated with severe and chronic forms of trauma- and stress-related mental health difficulties, with destructive generational and inter-generational consequences for forcibly displaced families including spouses or partners, children, as well as communities.
To address this fast-growing crisis and the public health challenge, field-wide efforts have emerged to develop and test interventions tailored to the complex needs and post-displacement settings of FDPs. Among such efforts, the research group developed Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) - a Mindfulness-Based Intervention (MBI) that is group-based, trauma-sensitive and socio-culturally adapted for diverse populations of FDPs. MBTR-R demonstrated waitlist-controlled evidence of efficacy and safety to improve stress- and trauma-related mental health outcomes among African asylum-seekers in Israel.
Yet, the potential reach, access, scalability, and therefore impact of such interventions is systematically limited by their relatively rigid, group-based in-person delivery format. Behavioral Intervention Technologies (BITs), notably via mobile health interventions (mHealth), may be one promising implementation approach to help facilitate the dissemination and scalability of MBTR-R among FDPs. The research group therefore developed, and initially piloted a novel mHealth adaptation of MBTR-R - Mindfulness-SOS for refugees (Mindfulness-SOS) with promising preliminary findings of utilization, related feasibility and effects of engagement with the program on several individual mental health outcomes (i.e., modest protective dose-response effects).
Yet, to improve their impact and efficacy, the development and delivery of BIT adaptations of MBIs broadly, and among FDPs specifically, must address well-documented limitations of BITs, most notably, high attrition, low engagement and adherence. One way to do so is through personalized stepped-care adaptation and augmentation of Mindfulness-SOS, that entails providing intensified (remote) guidance for FDPs that do not respond to the intervention, as a means of reducing attrition, increasing engagement and adherence, and optimizing capacity to therapeutically benefit from Mindfulness-SOS. The research group argues that a Sequential Multiple Assignment Randomized Trial (SMART), a multistage randomized trials design, is particularly well-suited to experimentally deliver, test, and optimize such a personalized adaptive stepped-care approach to Mindfulness-SOS for FDPs.
The research group therefore propose to carry out a SMART study to test and optimize the therapeutic outcomes of Mindfulness-SOS, using an adaptive intervention sequence of guidance format intensities among N ≅ 170 (50% female) adult Eritrean asylum-seekers residing in Israel. Following baseline assessment (pre-intervention), participants will be randomly assigned to Minimally-Guided Mindfulness-SOS (MG-Mindfulness-SOS) or to Wait-List Control. Mid-intervention, 3-weeks following randomization, all participants will be re-assessed. Participants initially randomized to MG-Mindfulness-SOS will be identified as either responders or non-responders. Responders will be assigned to continue MG-Mindfulness-SOS. Non-responders will be re-randomized to either Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS), an adaptive intervention sequence condition, or to continue with the MG-Mindfulness-SOS, a non-adaptive intervention sequence condition. Following the 7-week wait-list period and after re-assessment, Wait-List Control participants will initiate MG-Mindfulness-SOS intervention, receive MG-Mindfulness-SOS. Then, like participants initially randomized to MG-Mindfulness-SOS, 3-weeks following the wait-list period, participants will be re-randomized to either Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS), the adaptive intervention sequence condition, or to continue with the MG-Mindfulness-SOS, the non-adaptive intervention sequence condition. All participants will be re-assessed at post-intervention, and then at 8-week follow-up assessment. Primary outcomes will include subjective self-report measures of individual mental health outcomes. Secondary outcomes will include subjective self-report and/or parental report measures of pro-social family outcomes, child outcomes, inter-personal and community outcomes.
- Being tested
- Mindfulness-SOS for Refugees
- Keywords
- Forcibly Displaced Persons, Post-Migration Stress, Trauma, Depression, Anxiety, Stress, Online Mental Health Intervention Program, Mindfulness, Compassion, Treatment Adherence
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries, Depression, Anxiety Disorders, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-SOS for RefugeesBehavioural
Mindfulness-SOS for Refugees is a brief internet-based mobile-supported intervention program which is a mobile health adaptation of MBTR-R, mindfulness- and compassion-based, trauma-sensitive, and socio-culturally adapted group intervention program designed for FDPs. Mindfulness-SOS for Refugees entails 8 brief sessions and 9 mindfulness meditation practice exercises - delivered via audio recordings using participants' smartphones. The Mindfulness-SOS for Refugees intervention program is specifically designed to mitigate acute stress and related mental health symptoms among FDPs.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-SOS | Experimental | Mindfulness-SOS for Refugees is a brief internet-based mobile-supported intervention program which is a mobile health adaptation of MBTR-R, mindfulness- and compassion-based, trauma-sensitive, and socio-culturally adapted group intervention program designed for FDPs. Mindfulness-SOS for Refugees entails 8 brief sessions and 9 mindfulness meditation practice exercises - delivered via audio recordings using participants' smartphones. Mid-intervention, 3-weeks following randomization, all participants will be re-assessed. Participants initially randomized to MG-Mindfulness-SOS will be identified as either responders or non-responders. Responders will be assigned to continue MG-Mindfulness-SOS. Non-responders will be re-randomized to either Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS), an adaptive intervention sequence condition, or to continue with the MG-Mindfulness-SOS, a non-adaptive intervention sequence condition. Receives: Behavioral: Mindfulness-SOS for Refugees |
| Waitlist-Control | No intervention | Following the 7-week waitlist period and another assessment, participants randomized to waitlist-control will be assigned to Minimally-Guided Mindfulness-SOS (MG-Mindfulness-SOS) and then re-assessed following 3-weeks and, as described above, assigned to either continue in the MG-Mindfulness-SOS group or to move to the Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harvard Trauma Questionnaire
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 immediately pre-intervention to 1-week post-intervention
Brief Patient Health Questionnaire (PHQ-9)
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 immediately pre-intervention to 1-week 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 immediately pre-intervention to 1-week post-intervention
Positive and Negative Affect Schedule (PANAS)
PANAS-SF is a 10-item self-report questionnaire measuring state positive and negative affect (5-point Likert scale ranging from 1 to 5) with higher scores indicating greater state positive and negative affect. The PANAS-SF includes 2 subscales, one measuring positive affect and the other measuring negative affect. Each subscale score is the sum of its items.
Measured: Change from immediately pre-intervention to mid-assessment (3 weeks in) to 1-week post-intervention
Secondary outcomes (13)
Post-Migration Living Difficulties (PMLD) scale
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: Change from immediately pre-intervention to 1-week post-intervention
Brief Inventory of Thriving (BIT)
One item of the 9-item self-report questionnaire Brief Inventory of Thriving (BIT) was used to assess subjective wellbeing (5-point Likert scale) with higher scores indicating greater subjective well-being (minimum score 1 and maximum score 5).
Measured: Change from immediately pre-intervention to 1-week post-intervention
The State Shame and Guilt Scale
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: Change from immediately pre-intervention to 1-week post-intervention
Brief Five-Facet-Mindfulness Scale
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: Change from immediately pre-intervention to 1-week post-intervention
Short Form of the Conflict Tactic Scale
The Conflict Tactics Scales (CTS2) is the most widely used instrument for measuring intimate partner violence. The scale presents various cases of intimate partner violence and measures the frequency of these instances. The scale consists of 16 items measured on a 5-point scale ranging from (1)This has never happened to (5) 3-5 times in the last week.
Measured: Change from immediately pre-intervention to 1-week post-intervention
Revised Social Capital Scale
The social capital scale is used to measure the resources available to an individual through relational networks. The scale consists of 11 items on a 5-point Likert scale ( 1- Not at all - 5-Very often).
Measured: Change from immediately pre-intervention to 1-week post-intervention
Sussex-Oxford Compassion for Self Scale
The Self-Compassion Scale SOCS is a 20-item self-report questionnaire to assess different facets of compassion for others (5-point Likert scale) with higher scores indicating greater levels of compassion for others (minimum scale score 1 and maximum scale score 5).
Measured: Change from immediately pre-intervention to 1-week post-intervention
Challenged Sense of Belonging Scale (CSBS)
The CSBS assess a challenged or eroded sense of belonging that provides insight into how individuals relate to their environment and how socially connected they feel. The scale consists of four key elements connection, participation, identification, and congruence. The CSBS is a 4-item scale measured in a 5-point Likert scale ranging from 1(Strongly agree)-5(Strongly disagree).
Measured: Change from immediately pre-intervention to 1-week post-intervention
Metacognitive Processes of Decentering Scale-Trait (MPoD-T)
MPod-s is a 3-item self-report questionnaire measuring state levels of the 3 metacognitive processes of decentering (11-point Likert scale ranging from 0 to 10) with higher scores indicating greater levels of decentering (minimum scale score 0 and maximum scale score 10). Each of the 3 MPoD-s items measures a metacognitive process of decentering: meta-awareness, disidentification from internal experience, and non-reactivity to internal experience. MPod-s will be used to measure change, from pre-to post-intervention, instate decentering during the MAT mindfulness meditation.
Measured: Change from immediately pre-intervention to 1-week post-intervention
Alliance with an Unguided Smartphone App
The measure consists of 6 items on a 5-point Likert scale 1(strongly agree)-5(strongly disagree). The measure aims to determine the quality of the alliance between the app-user and the smartphone app.
Measured: Change from immediately pre-intervention to 1-week post-intervention
Child Behavior Checklist (CBCL)
The CBCL includes 21 items measured on a 3-point Likert scale (0-Never true - 2-Often true). The measure is used to detect behavioral and emotional problems in children and adolescents.
Measured: Change from immediately pre-intervention to 1-week post-intervention
Hostile/Warm Parenting styles
This measure consists of items that measure parental warmth and parental hostility. The measure consists of 11 items on a 5-point Likert scale 1(never)-5(always).
Measured: Change from immediately pre-intervention to 1-week post-intervention
Brief Problem monitoring (BPM)
The BPM provides a uniformed problem scale to assess attentional, behavioral, and internalizing problems in children and adolescents aged from 6-18 years old. The BPM includes 19 items measured on a 3-point Likert scale (0-Not true - 2-Very true).
Measured: Change from immediately pre-intervention to 1-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start15 Dec 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616286
- Sponsor's protocol ID
- Mindfulness-SOS RCT
- Status last verified
- Sep 2022
- First submitted
- 6 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-SOS for Refugees: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05616286
- Acronym / sponsor ID
- Mindfulness-SOS RCT
- Keywords
- Forcibly Displaced Persons, Post-Migration Stress, Trauma, Depression, Anxiety, Stress, Online Mental Health Intervention Program, Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 15 Nov 2022 (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 research group therefore developed, and initially piloted in a single-site open trial, a novel mindfulness- and compassion-based digital intervention program - Mindfulness-SOS for refugees (Mindfulness-SOS). The pilot study had promising preliminary findings of utilization, feasibility and related dose-response effects of intervention program engagement with mental health outcomes. The digital intervention program was developed based on randomized control trial data of a group-based mindfulness- and compassion-based program for forcibly displaced people.
To address common limitations of mobile health interventions such as attrition, engagement and adherence, the investigators will implement a personalized stepped-care adaptation and augmentation of Mindfulness-SOS, that entails providing intensified (remote) guidance for FDPs that do not respond to the intervention, to optimize capacity to therapeutically benefit from Mindfulness-SOS. To do so, the investigators propose to carry out a randomized controlled Sequential Multiple Assignment Randomized Trial (SMART) study to test and optimize the therapeutic outcomes of Mindfulness-SOS, using an adaptive intervention sequence of guidance format intensities among N ≅ 170 (50% female) adult trauma-affected Eritrean asylum-seekers residing in Israel.
Detailed description
Over 100 million Forcibly Displaced Persons (FDPs), including refugees and asylum-seekers, are forcibly displaced due to conflict, persecution, and natural disaster. Forced displacement is often associated with severe and chronic forms of trauma- and stress-related mental health difficulties, with destructive generational and inter-generational consequences for forcibly displaced families including spouses or partners, children, as well as communities.
To address this fast-growing crisis and the public health challenge, field-wide efforts have emerged to develop and test interventions tailored to the complex needs and post-displacement settings of FDPs. Among such efforts, the research group developed Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) - a Mindfulness-Based Intervention (MBI) that is group-based, trauma-sensitive and socio-culturally adapted for diverse populations of FDPs. MBTR-R demonstrated waitlist-controlled evidence of efficacy and safety to improve stress- and trauma-related mental health outcomes among African asylum-seekers in Israel.
Yet, the potential reach, access, scalability, and therefore impact of such interventions is systematically limited by their relatively rigid, group-based in-person delivery format. Behavioral Intervention Technologies (BITs), notably via mobile health interventions (mHealth), may be one promising implementation approach to help facilitate the dissemination and scalability of MBTR-R among FDPs. The research group therefore developed, and initially piloted a novel mHealth adaptation of MBTR-R - Mindfulness-SOS for refugees (Mindfulness-SOS) with promising preliminary findings of utilization, related feasibility and effects of engagement with the program on several individual mental health outcomes (i.e., modest protective dose-response effects).
Yet, to improve their impact and efficacy, the development and delivery of BIT adaptations of MBIs broadly, and among FDPs specifically, must address well-documented limitations of BITs, most notably, high attrition, low engagement and adherence. One way to do so is through personalized stepped-care adaptation and augmentation of Mindfulness-SOS, that entails providing intensified (remote) guidance for FDPs that do not respond to the intervention, as a means of reducing attrition, increasing engagement and adherence, and optimizing capacity to therapeutically benefit from Mindfulness-SOS. The research group argues that a Sequential Multiple Assignment Randomized Trial (SMART), a multistage randomized trials design, is particularly well-suited to experimentally deliver, test, and optimize such a personalized adaptive stepped-care approach to Mindfulness-SOS for FDPs.
The research group therefore propose to carry out a SMART study to test and optimize the therapeutic outcomes of Mindfulness-SOS, using an adaptive intervention sequence of guidance format intensities among N ≅ 170 (50% female) adult Eritrean asylum-seekers residing in Israel. Following baseline assessment (pre-intervention), participants will be randomly assigned to Minimally-Guided Mindfulness-SOS (MG-Mindfulness-SOS) or to Wait-List Control. Mid-intervention, 3-weeks following randomization, all participants will be re-assessed. Participants initially randomized to MG-Mindfulness-SOS will be identified as either responders or non-responders. Responders will be assigned to continue MG-Mindfulness-SOS. Non-responders will be re-randomized to either Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS), an adaptive intervention sequence condition, or to continue with the MG-Mindfulness-SOS, a non-adaptive intervention sequence condition. Following the 7-week wait-list period and after re-assessment, Wait-List Control participants will initiate MG-Mindfulness-SOS intervention, receive MG-Mindfulness-SOS. Then, like participants initially randomized to MG-Mindfulness-SOS, 3-weeks following the wait-list period, participants will be re-randomized to either Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS), the adaptive intervention sequence condition, or to continue with the MG-Mindfulness-SOS, the non-adaptive intervention sequence condition. All participants will be re-assessed at post-intervention, and then at 8-week follow-up assessment. Primary outcomes will include subjective self-report measures of individual mental health outcomes. Secondary outcomes will include subjective self-report and/or parental report measures of pro-social family outcomes, child outcomes, inter-personal and community outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-SOS | Experimental | Behavioral: Mindfulness-SOS for RefugeesMindfulness-SOS for Refugees is a brief internet-based mobile-supported intervention program which is a mobile health adaptation of MBTR-R, mindfulness- and compassion-based, trauma-sensitive, and socio-culturally adapted group intervention program designed for FDPs. Mindfulness-SOS for Refugees entails 8 brief sessions and 9 mindfulness meditation practice exercises - delivered via audio recordings using participants' smartphones. Mid-intervention, 3-weeks following randomization, all participants will be re-assessed. Participants initially randomized to MG-Mindfulness-SOS will be identified as either responders or non-responders. Responders will be assigned to continue MG-Mindfulness-SOS. Non-responders will be re-randomized to either Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS), an adaptive intervention sequence condition, or to continue with the MG-Mindfulness-SOS, a non-adaptive intervention sequence condition. |
| Waitlist-Control | No intervention | –Following the 7-week waitlist period and another assessment, participants randomized to waitlist-control will be assigned to Minimally-Guided Mindfulness-SOS (MG-Mindfulness-SOS) and then re-assessed following 3-weeks and, as described above, assigned to either continue in the MG-Mindfulness-SOS group or to move to the Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- East African refugee or asylum seeker living in Israel
- Tigrinya fluency and literacy
- Owns a personal smartphone
Key exclusion criteria (3 listed)
- Active suicidal ideation or/and past suicide attempt in the last year or/and passive suicidal ideation with clinical indicators of imminent suicide risk (e.g. severe paranoia)
- Current mental health treatment (i.e. psychotherapy or/and group therapy at least twice a month)
- Participation in the MBTR-R group in a previous study
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-SOS for RefugeesMindfulness-SOS for Refugees is a brief internet-based mobile-supported intervention program which is a mobile health adaptation of MBTR-R, mindfulness- and compassion-based, trauma-sensitive, and socio-culturally adapted group intervention program designed for FDPs. Mindfulness-SOS for Refugees entails 8 brief sessions and 9 mindfulness meditation practice exercises - delivered via audio recordings using participants' smartphones. The Mindfulness-SOS for Refugees intervention program is specifically designed to mitigate acute stress and related mental health symptoms among FDPs. | Behavioural | Mindfulness-SOS |
Primary outcome
Harvard Trauma Questionnaire
Time frame: Change from immediately pre-intervention to 1-week 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 immediately pre-intervention to 1-week post-intervention
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 immediately pre-intervention to 1-week 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.
Positive and Negative Affect Schedule (PANAS)
Time frame: Change from immediately pre-intervention to mid-assessment (3 weeks in) to 1-week post-intervention
PANAS-SF is a 10-item self-report questionnaire measuring state positive and negative affect (5-point Likert scale ranging from 1 to 5) with higher scores indicating greater state positive and negative affect. The PANAS-SF includes 2 subscales, one measuring positive affect and the other measuring negative affect. Each subscale score is the sum of its items.
13 secondary outcomes
Post-Migration Living Difficulties (PMLD) scale
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Brief Inventory of Thriving (BIT)
Time frame: Change from immediately pre-intervention to 1-week post-intervention
The State Shame and Guilt Scale
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Brief Five-Facet-Mindfulness Scale
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Short Form of the Conflict Tactic Scale
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Revised Social Capital Scale
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Sussex-Oxford Compassion for Self Scale
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Challenged Sense of Belonging Scale (CSBS)
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Metacognitive Processes of Decentering Scale-Trait (MPoD-T)
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Alliance with an Unguided Smartphone App
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Child Behavior Checklist (CBCL)
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Hostile/Warm Parenting styles
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Brief Problem monitoring (BPM)
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-SOS for Refugees 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 3 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: status not confirmed, as of the sponsor's last update on 2 Dec 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harvard Trauma Questionnaire (time frame: Change from immediately pre-intervention to 1-week post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2022.