Mindfulness-SOS: Stress Reduction for Refugees
Condition: Stress Disorders, Post-Traumatic; Stress Related Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mindfulness-SOS for Refugees
Intervention type(s): Behavioral
Intervention description(s): 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 model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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