Mindfulness-SOS: Stress Reduction for Refugees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Harvard Trauma Questionnaire according to DSM-5 (HTQ-5)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •East African refugee or asylum seeker living in Israel
- •Tigrinya fluency and literacy
- •Owns a personal smartphone
排除标准
- •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
结局指标
主要结局
Harvard Trauma Questionnaire according to DSM-5 (HTQ-5)
时间窗: Change from immediately pre-intervention to 1-week post-intervention
The Harvard Trauma Questionnaire according to DSM-5 (HTQ-5) is a 25-item self-report questionnaire to assess post-traumatic stress symptom severity (4-point Likert scale), with higher scores indicating greater levels of post-traumatic stress severity (minimum scale score 1 and maximum scale score 4), HTQ-5 mean cut-off score ≥ 2 is commonly used to identify categorical (diagnostic) symptom status of post-traumatic stress disorder
Beck's Anxiety Inventory (BAI)
时间窗: Change from immediately pre-intervention to 1-week post-intervention
6 Items of the Beck's Anxiety Inventory (BAI) self-report questionnaire will be used to assess anxiety symptom severity (4-point Likert scale), with higher scores indicating greater levels of anxiety symptom severity
Brief Patient Health Questionnaire (PHQ-9)
时间窗: Change from immediately pre-intervention to 1-week post-intervention
The brief Patient Health Questionnaire (PHQ-9) is a 9-item self-report questionnaire to assess depression symptom severity (4-point Likert scale), with higher scores indicating greater levels of depression symptom severity (minimum scale score 0 and maximum scale score 27), PHQ-9 mean cut-off score ≥10 is commonly used to identify categorical (diagnostic) symptom status of depression
次要结局
- Brief Inventory of Thriving (BIT)(Change from immediately pre-intervention to 1-week post-intervention)
- Parenting Scale (PS)(Change from immediately pre-intervention to 1-week post-intervention)
- Modified 5-item Extended-Hurt/Insult/Threaten/Scream (Modified E-HITS)(Change from immediately pre-intervention to 1-week post-intervention)
- Positive and Negative Affect Schedule (PANAS)(Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks)
- Brief weekly assessment of formal and informal mindfulness practice(Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks)
- Dimensions of Anger Reactions-5 (DAR-5)(Change from immediately pre-intervention to 1-week post-intervention)
- Brief assessment of mindful awareness(Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks)
- Brief weekly assessment of post-traumatic stress(Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks)
- Brief weekly assessment of depression(Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks)
- Brief weekly assessment of anxiety(Weekly change from week 1 of intervention to 1-week post-intervention, up to 8 weeks)
- Post-Migration Living Difficulties Checklist (PMLD)(Change from immediately pre-intervention to 1-week post-intervention)
- Brief assessment of self-compassion(Change from immediately pre-intervention to 1-week post-intervention, measured weekly up to 8 weeks)