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Recruiting
NCT05616286
Mindfulness-SOS for Refugees
Conditions: Stress Disorders, Post-Traumatic, Stress Related Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 170
Sponsor: University of Haifa
Location: Israel
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.
Eligibility Criteria
Inclusion Criteria:East African refugee or asylum seeker living in IsraelTigrinya fluency and literacyOwns a personal smartphoneExclusion Criteria: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
Source: ClinicalTrials.gov (NCT05616286). StuddyBuddy aggregates publicly available trial information.