Mindfulness-SOS: Stress Reduction for Refugees

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2021-01-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stress Disorders, Post-Traumatic Stress Related Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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 - 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes