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Mindfulness-SOS for Refugees

NCT05616286 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2022-12-02

No results posted yet for this study

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 (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.

Conditions

  • Stress Disorders, Post-Traumatic
  • Stress Related Disorder

Interventions

BEHAVIORAL

Mindfulness-SOS for Refugees

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.

Sponsors & Collaborators

  • University of Haifa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05616286 on ClinicalTrials.gov