Mindfulness-SOS for Refugees: Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Disorders, Post-Traumatic
- Sponsor
- University of Haifa
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Brief Patient Health Questionnaire (PHQ-9)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Brief Patient Health Questionnaire (PHQ-9)
Time Frame: Change from immediately pre-intervention to 1-week post-intervention
A 9-item self-report questionnaire to assess depression symptom severity (5-point Likert scale) with higher scores indicating greater depression symptom severity (minimum scale score 0 and maximum scale score 36), PHQ-9 mean cut-off score ≥10 is commonly used to identify categorical (diagnostic) symptom status of depression.
Positive and Negative Affect Schedule (PANAS)
Time Frame: Change from immediately pre-intervention to mid-assessment (3 weeks in) to 1-week post-intervention
PANAS-SF is a 10-item self-report questionnaire measuring state positive and negative affect (5-point Likert scale ranging from 1 to 5) with higher scores indicating greater state positive and negative affect. The PANAS-SF includes 2 subscales, one measuring positive affect and the other measuring negative affect. Each subscale score is the sum of its items.
Harvard Trauma Questionnaire
Time Frame: Change from immediately pre-intervention to 1-week post-intervention
The Harvard Trauma Questionnaire (HTQ) is a 16-item self-report questionnaire to assess post-traumatic stress symptom severity (5-point Likert scale) with higher scores indicating greater post-traumatic stress severity (minimum scale score 1 and maximum scale score 5), HTQ mean cut-off score ≥ 2 is commonly used to identify categorical (diagnostic) symptom status of post-traumatic stress disorder
Beck's Anxiety Inventory (BAI)
Time Frame: Change from immediately pre-intervention to 1-week post-intervention
The Beck's Anxiety Inventory (BAI) is a 21-item self-report questionnaire to assess anxiety symptom severity (4-point Likert scale) with higher scores indicating greater anxiety symptom severity (minimum scale score 0 and maximum scale score 63), BAI total cut-off score ≥ 16 is commonly used to identify categorical (diagnostic) symptom status of anxiety disorder.
Secondary Outcomes
- Sussex-Oxford Compassion for Self Scale(Change from immediately pre-intervention to 1-week post-intervention)
- Brief Inventory of Thriving (BIT)(Change from immediately pre-intervention to 1-week post-intervention)
- Post-Migration Living Difficulties (PMLD) scale(Change from immediately pre-intervention to 1-week post-intervention)
- The State Shame and Guilt Scale(Change from immediately pre-intervention to 1-week post-intervention)
- Brief Five-Facet-Mindfulness Scale(Change from immediately pre-intervention to 1-week post-intervention)
- Short Form of the Conflict Tactic Scale(Change from immediately pre-intervention to 1-week post-intervention)
- Revised Social Capital Scale(Change from immediately pre-intervention to 1-week post-intervention)
- Challenged Sense of Belonging Scale (CSBS)(Change from immediately pre-intervention to 1-week post-intervention)
- Child Behavior Checklist (CBCL)(Change from immediately pre-intervention to 1-week post-intervention)
- Hostile/Warm Parenting styles(Change from immediately pre-intervention to 1-week post-intervention)
- Brief Problem monitoring (BPM)(Change from immediately pre-intervention to 1-week post-intervention)
- Metacognitive Processes of Decentering Scale-Trait (MPoD-T)(Change from immediately pre-intervention to 1-week post-intervention)
- Alliance with an Unguided Smartphone App(Change from immediately pre-intervention to 1-week post-intervention)