Stress Disorders, Post-TraumaticNCT04761510
Mindfulness-SOS: Stress Reduction 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
The COVID-19 pandemic crisis is associated with a wide range of stressors for the general population. For forcibly displaced persons (FDPs), the turmoil of this crisis is magnified significantly, and elevated pre-existing post-migration stressors and trauma-related mental health problems are acutely amplified. 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
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Sep 2020to 14 Jan 2021
- 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.
About this study
The COVID-19 pandemic crisis is associated with a wide range of stressors for the general population. For forcibly displaced persons (FDPs), the turmoil of this crisis is magnified significantly, and elevated pre-existing post-migration stressors and trauma-related mental health problems are acutely amplified. In a recent randomized control trial, Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) led to large acute stress-buffering effects among Eritrean asylum seekers in Israel. The investigators thus developed Mindfulness-SOS for Refugees - a brief internet-based mobile-supported adaptation of the MBTR-R mental health intervention program - specifically designed to mitigate acute stress and related mental health symptoms among FDPs. The investigators will conduct a nonrandomized single-group intervention trial of the efficacy, safety, utilization, and related feasibility of Mindfulness-SOS for Refugees among a traumatized chronically stressed sample of East African asylum seekers in an urban post-displacement setting in the Middle East (Israel). The study will be carried out during an acutely stressful period of time for this population due to a COVID-19 pandemic national lockdown.
Read the detailed description
Brief Background:
The COVID-19 pandemic is associated with a range of stressors and consequent mental health problems. For tens of millions of FDPs, stressors and sequelae of the pandemic are particularly magnified and severe, as their preexisting stress-related mental health problems are acutely exacerbated. In a recent randomized control trial prior to the COVID-19 pandemic, the investigators found significant therapeutic effects of MBTR-R - a 9-week, mindfulness- and compassion-based, trauma-sensitive, and socio-culturally adapted group intervention program designed for FDPs - for stress- and trauma-related mental health outcomes among Eritrean asylum seekers in Israel. In light of the COVID-19 pandemic, and to facilitate access, reach, and flexibility of mental health care among FDPs, the investigators developed Mindfulness-SOS for Refugees - a brief internet-based mobile-supported adaptation of the MBTR-R mental health intervention program - specifically designed to mitigate acute stress and related mental health symptoms among FDPs.
Study Aims:
Broadly, the study aims are: I) to test the efficacy of the Mindfulness-SOS for Refugees intervention program on stress- and trauma-related mental health outcomes (e.g. posttraumatic stress, depression), II) to test intervention safety - including rates of clinically significant deterioration in primary outcomes in response to the intervention, III) to assess participant utilization of the Mindfulness-SOS for Refugees intervention program, IV) to test whether Mindfulness-SOS for Refugees will lead to changes in targeted processes or mechanisms of change including mindful awareness and self-compassion, and V) to test whether expected pre-to-post intervention change in the targeted processes will predict expected pre-to-post intervention change in stress- and trauma-related mental health outcomes.
Study Overview:
Accordingly, the investigators will conduct a nonrandomized single-group intervention trial among a community sample of traumatized and chronically stressed East African asylum seekers (N=60, 50% female), residing in Israel in an urban post-displacement setting, during the COVID-19 pandemic. Over the course of three successive months, participants will be recruited from the community via public flyers, social networks, local non-governmental- (NGOs), and municipal- organizations working with FDPs. Participants will be assigned to Mindfulness-SOS for Refugees - a brief internet-based mobile-supported intervention program, entailing 8 brief sessions as well as 9 mindfulness meditation practice exercises - delivered via audio recordings using participants' personal smartphones. Over the course of the Mindfulness-SOS for Refugees intervention program, participants will receive administrative guidance (e.g. technical support in case of mobile phone and internet platform-related difficulties and relevant information of the internet-based mobile-supported intervention program and assessment); as well as adherence-focused guidance (e.g. adherence monitoring including weekly brief check-in telephone calls and smartphone text-based nudges to remind and prompt weekly adherence and assessment), in the participants' mother tongue, Tigrinya. Stress- and trauma-related mental health outcomes and targeted change processes will be assessed via self-report questionnaires pre-intervention, brief weekly assessments, and post-intervention. In addition to participants' self-report, participant-level utilization of the Mindfulness-SOS for Refugees intervention program will be digitally monitored. Participants will be encouraged to complete 2 sessions per week and practice each day for 4 weeks but can choose to extend this up to 8 weeks. Post-intervention assessments will be carried out when participants will complete the 8 sessions of the internet-based mobile-supported intervention program (recommended 4 weeks, a maximum of 8 weeks post-baseline, or when participants will indicate that they are no longer interested in participating in the intervention program). The intervention program and assessments will be completed on participants' smartphones.
- Being tested
- Mindfulness-SOS for Refugees
- Keywords
- Forcibly Displaced Persons, Post-migration Stress, Trauma, Post-traumatic Stress Disorder, Depression, Anxiety, COVID-19 Pandemic, Stress, Online Mental Health Intervention Program, Treatment Adherence, Mindfulness, Compassion
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries, Depression, Anxiety Disorders, COVID-19, 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 - a 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 intervention program is specifically designed to mitigate acute stress and related mental health symptoms among FDPs. During participation in the Mindfulness-SOS for Refugees intervention program, participants will be encouraged to complete 2 sessions per week and practice each day for 4 weeks but can choose to extend this up to 8 weeks. Delivery of Mindfulness-SOS for Refugees entails administrative guidance as well as adherence-focused guidance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Harvard Trauma Questionnaire according to DSM-5 (HTQ-5)
The Harvard Trauma Questionnaire according to DSM-5 (HTQ-5) is a 25-item self-report questionnaire to assess post-traumatic stress symptom severity (4-point Likert scale), with higher scores indicating greater levels of post-traumatic stress severity (minimum scale score 1 and maximum scale score 4), HTQ-5 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)
The brief Patient Health Questionnaire (PHQ-9) is a 9-item self-report questionnaire to assess depression symptom severity (4-point Likert scale), with higher scores indicating greater levels of depression symptom severity (minimum scale score 0 and maximum scale score 27), 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)
6 Items of the Beck's Anxiety Inventory (BAI) self-report questionnaire will be used to assess anxiety symptom severity (4-point Likert scale), with higher scores indicating greater levels of anxiety symptom severity
Measured: Change from immediately pre-intervention to 1-week post-intervention
Secondary outcomes (12)
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 levels of 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 Brief Inventory of Thriving (BIT) self-report questionnaire will be used to assess subjective well-being (5-point Likert scale), with higher scores indicating greater levels of subjective well-being
Measured: Change from immediately pre-intervention to 1-week post-intervention
Dimensions of Anger Reactions-5 (DAR-5)
One item of the Dimensions of Anger Reactions-5 (DAR-5) self-report questionnaire will be used to assess anger duration (5-point Likert scale), with higher scores indicating greater levels of anger duration
Measured: Change from immediately pre-intervention to 1-week post-intervention
Parenting Scale (PS)
One item of the Parenting Scale (PS) self-report questionnaire will be used to assess parental discipline strategies (5-point Likert scale), with higher scores indicating less effective discipline strategies
Measured: Change from immediately pre-intervention to 1-week post-intervention
Modified 5-item Extended-Hurt/Insult/Threaten/Scream (Modified E-HITS)
One adapted item of the Modified 5-item Extended-Hurt/Insult/Threaten/Scream (Modified E-HITS) self-report questionnaire will be used to assess intimate partner violence (IPV) perpetration (5-point Likert scale), with higher scores indicating greater levels of perpetration of IPV
Measured: Change from immediately pre-intervention to 1-week post-intervention
Positive and Negative Affect Schedule (PANAS)
The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire to assess positive and negative affect (5-point Likert scale), with higher scores indicating greater levels of activation of positively and negatively valanced affects
Measured: Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks
Brief assessment of mindful awareness
4 self-report Items will be used to assess mindful awareness (5-point Likert scale), with higher scores indicating greater levels of mindful awareness
Measured: Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks
Brief assessment of self-compassion
3 self-report Items will be used to assess self-compassion (5-point Likert scale), with higher scores indicating greater levels of self-compassion
Measured: Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks
Brief weekly assessment of formal and informal mindfulness practice
2 self-report Items will be used to assess number of formal and informal mindfulness practice during the past week, with higher scores indicating greater number of mindfulness practices during the past week
Measured: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
Brief weekly assessment of post-traumatic stress
4 self-report Items will be used to assess post-traumatic stress (5-point Likert scale), with higher scores indicating greater levels of post-traumatic stress
Measured: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
Brief weekly assessment of depression
One self-report item will be used to assess depression (5-point Likert scale), with higher scores indicating greater levels of depression
Measured: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
Brief weekly assessment of anxiety
One self-report item will be used to assess anxiety (5-point Likert scale), with higher scores indicating greater levels of anxiety
Measured: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start14 Sep 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761510
- Sponsor's protocol ID
- Mindfulness-SOS for Refugees
- Status last verified
- Feb 2020
- First submitted
- 12 Jan 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zohar Puris S, Yuval K, Gebremariam G, Goldberg SB, Aviad N, Baldwin SA, Bernstein A. Nonrandomized Open Trial of a Mindfulness- and Compassion-Based Selective Preventive Mobile Health Intervention for Forcibly Displaced People. Mindfulness (N Y). 2025 Oct 2;16(10):2845-62. doi: 10.1007/s12671-025-02675-9. Online ahead of print.
PubMed 41050629Blay 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 35833254
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-SOS: Stress Reduction for Refugees
- ClinicalTrials.gov ID
- NCT04761510
- Acronym / sponsor ID
- Mindfulness-SOS for Refugees
- Keywords
- Forcibly Displaced Persons, Post-migration Stress, Trauma, Post-traumatic Stress Disorder, Depression, Anxiety, COVID-19 Pandemic, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 21 Feb 2021 (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.
The COVID-19 pandemic crisis is associated with a wide range of stressors for the general population. For forcibly displaced persons (FDPs), the turmoil of this crisis is magnified significantly, and elevated pre-existing post-migration stressors and trauma-related mental health problems are acutely amplified. In a recent randomized control trial, Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) led to large acute stress-buffering effects among Eritrean asylum seekers in Israel. The investigators thus developed Mindfulness-SOS for Refugees - a brief internet-based mobile-supported adaptation of the MBTR-R mental health intervention program - specifically designed to mitigate acute stress and related mental health symptoms among FDPs. The investigators will conduct a nonrandomized single-group intervention trial of the efficacy, safety, utilization, and related feasibility of Mindfulness-SOS for Refugees among a traumatized chronically stressed sample of East African asylum seekers in an urban post-displacement setting in the Middle East (Israel). The study will be carried out during an acutely stressful period of time for this population due to a COVID-19 pandemic national lockdown.
Detailed description
Brief Background:
The COVID-19 pandemic is associated with a range of stressors and consequent mental health problems. For tens of millions of FDPs, stressors and sequelae of the pandemic are particularly magnified and severe, as their preexisting stress-related mental health problems are acutely exacerbated. In a recent randomized control trial prior to the COVID-19 pandemic, the investigators found significant therapeutic effects of MBTR-R - a 9-week, mindfulness- and compassion-based, trauma-sensitive, and socio-culturally adapted group intervention program designed for FDPs - for stress- and trauma-related mental health outcomes among Eritrean asylum seekers in Israel. In light of the COVID-19 pandemic, and to facilitate access, reach, and flexibility of mental health care among FDPs, the investigators developed Mindfulness-SOS for Refugees - a brief internet-based mobile-supported adaptation of the MBTR-R mental health intervention program - specifically designed to mitigate acute stress and related mental health symptoms among FDPs.
Study Aims:
Broadly, the study aims are: I) to test the efficacy of the Mindfulness-SOS for Refugees intervention program on stress- and trauma-related mental health outcomes (e.g. posttraumatic stress, depression), II) to test intervention safety - including rates of clinically significant deterioration in primary outcomes in response to the intervention, III) to assess participant utilization of the Mindfulness-SOS for Refugees intervention program, IV) to test whether Mindfulness-SOS for Refugees will lead to changes in targeted processes or mechanisms of change including mindful awareness and self-compassion, and V) to test whether expected pre-to-post intervention change in the targeted processes will predict expected pre-to-post intervention change in stress- and trauma-related mental health outcomes.
Study Overview:
Accordingly, the investigators will conduct a nonrandomized single-group intervention trial among a community sample of traumatized and chronically stressed East African asylum seekers (N=60, 50% female), residing in Israel in an urban post-displacement setting, during the COVID-19 pandemic. Over the course of three successive months, participants will be recruited from the community via public flyers, social networks, local non-governmental- (NGOs), and municipal- organizations working with FDPs. Participants will be assigned to Mindfulness-SOS for Refugees - a brief internet-based mobile-supported intervention program, entailing 8 brief sessions as well as 9 mindfulness meditation practice exercises - delivered via audio recordings using participants' personal smartphones. Over the course of the Mindfulness-SOS for Refugees intervention program, participants will receive administrative guidance (e.g. technical support in case of mobile phone and internet platform-related difficulties and relevant information of the internet-based mobile-supported intervention program and assessment); as well as adherence-focused guidance (e.g. adherence monitoring including weekly brief check-in telephone calls and smartphone text-based nudges to remind and prompt weekly adherence and assessment), in the participants' mother tongue, Tigrinya. Stress- and trauma-related mental health outcomes and targeted change processes will be assessed via self-report questionnaires pre-intervention, brief weekly assessments, and post-intervention. In addition to participants' self-report, participant-level utilization of the Mindfulness-SOS for Refugees intervention program will be digitally monitored. Participants will be encouraged to complete 2 sessions per week and practice each day for 4 weeks but can choose to extend this up to 8 weeks. Post-intervention assessments will be carried out when participants will complete the 8 sessions of the internet-based mobile-supported intervention program (recommended 4 weeks, a maximum of 8 weeks post-baseline, or when participants will indicate that they are no longer interested in participating in the intervention program). The intervention program and assessments will be completed on participants' smartphones.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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 - a 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 intervention program is specifically designed to mitigate acute stress and related mental health symptoms among FDPs. During participation in the Mindfulness-SOS for Refugees intervention program, participants will be encouraged to complete 2 sessions per week and practice each day for 4 weeks but can choose to extend this up to 8 weeks. Delivery of Mindfulness-SOS for Refugees entails administrative guidance as well as adherence-focused guidance. | Behavioural | – |
Primary outcome
Harvard Trauma Questionnaire according to DSM-5 (HTQ-5)
Time frame: Change from immediately pre-intervention to 1-week post-intervention
The Harvard Trauma Questionnaire according to DSM-5 (HTQ-5) is a 25-item self-report questionnaire to assess post-traumatic stress symptom severity (4-point Likert scale), with higher scores indicating greater levels of post-traumatic stress severity (minimum scale score 1 and maximum scale score 4), HTQ-5 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
The brief Patient Health Questionnaire (PHQ-9) is a 9-item self-report questionnaire to assess depression symptom severity (4-point Likert scale), with higher scores indicating greater levels of depression symptom severity (minimum scale score 0 and maximum scale score 27), 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
6 Items of the Beck's Anxiety Inventory (BAI) self-report questionnaire will be used to assess anxiety symptom severity (4-point Likert scale), with higher scores indicating greater levels of anxiety symptom severity
12 secondary outcomes
Post-Migration Living Difficulties Checklist (PMLD)
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
Dimensions of Anger Reactions-5 (DAR-5)
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Parenting Scale (PS)
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Modified 5-item Extended-Hurt/Insult/Threaten/Scream (Modified E-HITS)
Time frame: Change from immediately pre-intervention to 1-week post-intervention
Positive and Negative Affect Schedule (PANAS)
Time frame: Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks
Brief assessment of mindful awareness
Time frame: Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks
Brief assessment of self-compassion
Time frame: Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks
Brief weekly assessment of formal and informal mindfulness practice
Time frame: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
Brief weekly assessment of post-traumatic stress
Time frame: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
Brief weekly assessment of depression
Time frame: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
Brief weekly assessment of anxiety
Time frame: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
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 21 Feb 2021.
- Derived from this study: PubMed 41050629Zohar Puris S, Yuval K, Gebremariam G, Goldberg SB, Aviad N, Baldwin SA, Bernstein A. Nonrandomized Open Trial of a Mindfulness- and Compassion-Based Selective Preventive Mobile Health Intervention for Forcibly Displaced People. Mindfulness (N Y). 2025 Oct 2;16(10):2845-62. doi: 10.1007/s12671-025-02675-9. Online ahead of print.
- 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.
- Mindfulness-SOS for Refugees intervention program study websiteLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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: finished, as of the sponsor's last update on 21 Feb 2021. 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?
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 according to DSM-5 (HTQ-5) (time frame: Change from immediately pre-intervention to 1-week 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 NCT04761510, which also lists 2 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 21 Feb 2021.