mindfulness-sos for refugees

Conditions: Stress Disorders, Post-Traumatic; Stress Related Disorder

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.

over 100 million forcibly displaced persons (fdps), including refugees and asylum-seekers, are forcibly displaced due to conflict, persecution, and natural disaster. forced displacement is often associated with severe and chronic forms of trauma- and stress-related mental health difficulties, with destructive generational and inter-generational consequences for forcibly displaced families including spouses or partners, children, as well as communities. to address this fast-growing crisis and the public health challenge, field-wide efforts have emerged to develop and test interventions tailored to the complex needs and post-displacement settings of fdps. among such efforts, the research group developed mindfulness-based trauma recovery for refugees (mbtr-r) - a mindfulness-based intervention (mbi) that is group-based, trauma-sensitive and socio-culturally adapted for diverse populations of fdps. mbtr-r demonstrated waitlist-controlled evidence of efficacy and safety to improve stress- and trauma-related mental health outcomes among african asylum-seekers in israel. yet, the potential reach, access, scalability, and therefore impact of such interventions is systematically limited by their relatively rigid, group-based in-person delivery format. behavioral intervention technologies (bits), notably via mobile health interventions (mhealth), may be one promising implementation approach to help facilitate the dissemination and scalability of mbtr-r among fdps. the research group therefore developed, and initially piloted a novel mhealth adaptation of mbtr-r - mindfulness-sos for refugees (mindfulness-sos) with promising preliminary findings of utilization, related feasibility and effects of engagement with the program on several individual mental health outcomes (i.e., modest protective dose-response effects). yet, to improve their impact and efficacy, the development and delivery of bit adaptations of mbis broadly, and among fdps specifically, must address well-documented limitations of bits, most notably, high attrition, low engagement and adherence. one way to do so is through personalized stepped-care adaptation and augmentation of mindfulness-sos, that entails providing intensified (remote) guidance for fdps that do not respond to the intervention, as a means of reducing attrition, increasing engagement and adherence, and optimizing capacity to therapeutically benefit from mindfulness-sos. the research group argues that a sequential multiple assignment randomized trial (smart), a multistage randomized trials design, is particularly well-suited to experimentally deliver, test, and optimize such a personalized adaptive stepped-care approach to mindfulness-sos for fdps. the research group therefore propose to carry out a 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 eritrean asylum-seekers residing in israel. following baseline assessment (pre-intervention), participants will be randomly assigned to minimally-guided mindfulness-sos (mg-mindfulness-sos) or to wait-list control. mid-intervention, 3-weeks following randomization, all participants will be re-assessed. participants initially randomized to mg-mindfulness-sos will be identified as either responders or non-responders. responders will be assigned to continue mg-mindfulness-sos. non-responders will be re-randomized to either intensified-guidance mindfulness-sos (ig-mindfulness-sos), an adaptive intervention sequence condition, or to continue with the mg-mindfulness-sos, a non-adaptive intervention sequence condition. following the 7-week wait-list period and after re-assessment, wait-list control participants will initiate mg-mindfulness-sos intervention, receive mg-mindfulness-sos. then, like participants initially randomized to mg-mindfulness-sos, 3-weeks following the wait-list period, participants will be re-randomized to either intensified-guidance mindfulness-sos (ig-mindfulness-sos), the adaptive intervention sequence condition, or to continue with the mg-mindfulness-sos, the non-adaptive intervention sequence condition. all participants will be re-assessed at post-intervention, and then at 8-week follow-up assessment. primary outcomes will include subjective self-report measures of individual mental health outcomes. secondary outcomes will include subjective self-report and/or parental report measures of pro-social family outcomes, child outcomes, inter-personal and community outcomes.

Eligibility criteria:
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

Keywords: forcibly displaced persons post-migration stress trauma depression anxiety stress online mental health intervention program mindfulness compassion treatment adherence