Clinical trial NCT04761510: Mindfulness-SOS: Stress Reduction for Refugees
Official title: Mindfulness-SOS: Stress Reduction for Refugees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Stress Related Disorder
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
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 according to DSM-5 (HTQ-5)
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
Secondary outcomes:
measure: Post-Migration Living Difficulties Checklist (PMLD)
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: Dimensions of Anger Reactions-5 (DAR-5)
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Parenting Scale (PS)
timeFrame: Change from immediately pre-intervention to 1-week post-intervention
measure: Modified 5-item Extended-Hurt/Insult/Threaten/Scream (Modified E-HITS)
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 1-week post-intervention, measured weekly up to 8 weeks
measure: Brief assessment of mindful awareness
timeFrame: Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks
measure: Brief assessment of self-compassion
timeFrame: Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks
measure: Brief weekly assessment of formal and informal mindfulness practice
timeFrame: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
measure: Brief weekly assessment of post-traumatic stress
timeFrame: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
measure: Brief weekly assessment of depression
timeFrame: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
measure: Brief weekly assessment of anxiety
timeFrame: Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assaf
state: Merkaz
Study officials:
References: