Clinical trial NCT05616286: Mindfulness-SOS for Refugees
Official title: Mindfulness-SOS for Refugees: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Stress Related Disorder
Keywords: Forcibly Displaced Persons
Post-Migration Stress
Trauma
Depression
Anxiety
Stress
Online Mental Health Intervention Program
Mindfulness
Compassion
Treatment Adherence
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Primary outcomes:
measure: Harvard Trauma Questionnaire
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Brief Patient Health Questionnaire (PHQ-9)
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Beck's Anxiety Inventory (BAI)
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Change from immediately pre-intervention to mid-assessment (3 weeks in) to 1-week post-intervention
Secondary outcomes:
measure: Post-Migration Living Difficulties (PMLD) scale
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Brief Inventory of Thriving (BIT)
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: The State Shame and Guilt Scale
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Brief Five-Facet-Mindfulness Scale
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Short Form of the Conflict Tactic Scale
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Revised Social Capital Scale
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Sussex-Oxford Compassion for Self Scale
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Challenged Sense of Belonging Scale (CSBS)
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Metacognitive Processes of Decentering Scale-Trait (MPoD-T)
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Alliance with an Unguided Smartphone App
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Child Behavior Checklist (CBCL)
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Hostile/Warm Parenting styles
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Brief Problem monitoring (BPM)
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Central Bus Station
Study officials:
References: