Mindfulness-SOS: Stress Reduction for Refugees

NCT04761510 | Completed

• 1 other identifier: Mindfulness-SOS for Refugees
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stress Disorders, Post-Traumatic; Stress Related Disorder

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Change from immediately pre-intervention to 1-week post-intervention

Secondary Outcomes (12)

• Post-Migration Living Difficulties Checklist (PMLD)

  Change from immediately pre-intervention to 1-week post-intervention

• Brief Inventory of Thriving (BIT)

  Change from immediately pre-intervention to 1-week post-intervention

• Dimensions of Anger Reactions-5 (DAR-5)

  Change from immediately pre-intervention to 1-week post-intervention

• Parenting Scale (PS)

  Change from immediately pre-intervention to 1-week post-intervention

• Modified 5-item Extended-Hurt/Insult/Threaten/Scream (Modified E-HITS)

  Change from immediately pre-intervention to 1-week post-intervention

Interventions

Mindfulness-SOS for Refugees BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• East African refugee or asylum seeker living in Israel
• Tigrinya fluency and literacy
• Owns a personal smartphone

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

Assaf

Tel Aviv, Central District, 6617141, Israel

Location

Related Publications (2)

• 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.

  PMID: 41050629 DERIVED

• Blay Benzaken Y, Zohar S, Yuval K, Aizik-Reebs A, Gebremariam SG, Bernstein A. COVID-19 and Mental Health Among People Who Are Forcibly Displaced: The Role of Socioeconomic Insecurity. Psychiatr Serv. 2023 Feb 1;74(2):158-165. doi: 10.1176/appi.ps.202200052. Epub 2022 Jul 14.

  PMID: 35833254 DERIVED

Related Links

• Mindfulness-SOS for Refugees intervention program study website

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries; Depression; Anxiety Disorders; COVID-19; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 21, 2021
• Study Start: September 14, 2020
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: February 21, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)