Mindfulness-Based Trauma Recovery for Refugees (MBTR-R): Efficacy, Safety and Mechanisms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Brief Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
Worldwide, refugees and asylum seekers suffer at high rates from trauma- and stress-related mental health problems. The investigators thus developed Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) - a 9-week, mindfulness- and compassion-based, trauma-sensitive and socio-culturally adapted, group intervention for refugees and asylum seekers. The overarching aims of the study were to, first, test whether MBTR-R is an efficacious and safe mental health intervention for traumatized refugees and asylum seekers with respect to stress- and trauma-related mental health outcomes; and, second, to test theorized mechanisms of action of MBTR-R. Accordingly, the investigators conducted a randomized waitlist-controlled trial among a community sample of female and male Eritrean asylum seekers in an urban post-displacement setting in the Middle East (Israel).
详细描述
Broadly, the investigators aimed to assess whether MBTR-R is an efficacious and safe mental health intervention for traumatized asylum seekers. Aim I: The investigators predicted that, relative to a waitlist control condition, MBTR-R will lead to improved stress-and trauma-related mental health outcomes, including lower levels and rates of posttraumatic stress, depression, anxiety, and improved subjective well-being at post-intervention and 5-week follow-up. Aim II: The investigators aimed to test, whether relative to the waitlist-control condition, MBTR-R was safe and thus not associated with participant-level clinically significant deterioration in any of the monitored primary mental health outcomes at post-intervention or at follow-up. In the event of adverse responding, the investigators planned to test whether key demographic factors or pre-existing vulnerability factors at pre-intervention that may predict participant-level deterioration or adverse responding to the intervention - so as to identify candidate contraindications for MBTR-R. Aim III: The investigators predicted that, relative to a waitlist control condition, MBTR-R will lead to changes in psycho-behavioral processes targeted by the intervention and implicated in vulnerability at pre-intervention, from pre-to-post intervention, measured in controlled behavioral and cognitive-experimental lab tasks or experience sampling measures, including measures of (a) self-compassion and self-criticism, (b) self-referential processing of fear, (c) avoidance, (d) emotional reactivity to trauma-related information and autobiographical memory, (e) impaired executive functions of trauma-related information processing in working memory. Aim IV: The investigators aimed to test whether, among the MBTR-R group, pre-to-post-intervention change and pre-intervention to follow-up change in mental health outcomes (Aim I) will be predicted or mediated by pre-to-post intervention change in the targeted psycho-behavioral processes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Eritrean refugee or asylum seeker living in Israel
排除标准
- •active suicidality
- •current psychotic symptoms
- •current mental health treatment (e.g. psychotherapy, participation in psycho-social support group)
结局指标
主要结局
Brief Patient Health Questionnaire (PHQ-9)
时间窗: Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks post-intervention
The brief Patient Health Questionnaire (PHQ-9) is 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
Beck's Anxiety Inventory (BAI)
时间窗: Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks 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
Harvard Trauma Questionnaire (HTQ)
时间窗: Change from 1-week pre-intervention to 1-week post-intervention and change from 1-week pre-intervention to 5-weeks 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
次要结局
- Autobiographical Memory Recall Task(1-week pre-intervention, 1-week post-intervention)
- Post-Migration Living Difficulties Checklist (PMLD)(1-week pre-intervention)
- Moral Injury Event Scale(1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention)
- Adapted Sternberg Working Memory Task(1-week pre-intervention, 1-week post-intervention)
- Self-Referential Encoding Task (SRET) of Self-Compassion and Self-Criticism(1-week pre-intervention, 1-week post-intervention)
- Single Experience and Self-Implicit Association Task (SES-IAT)(1-week pre-intervention, 1-week post-intervention)
- Experience Sampling of State Mindfulness(15-minutes pre-intervention session and 15-minutes post-intervention session)
- The State Shame and Guilt Scale (SSGS)(1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention)
- The Five Facets Mindfulness Questionnaire (FFMQ)(1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention)
- Experience Sampling of Depression(15-minutes pre-intervention session)
- Brief Inventory of Thriving (BIT)(1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention)
- Trauma Cue Exposure Task(1-week pre-intervention, 1-week post-intervention)
- Experience Sampling of Negative Repetitive Thinking(15-minutes pre-intervention session)
- Experience Sampling of Emotion(15-minutes pre-intervention session and 15-minutes post-intervention session)
- The Short Self Compassion Scale (SSCS)(1-week pre-intervention, 1-week post-intervention and 5-weeks post-intervention)
- Experience Sampling of Cognitive Avoidance(15-minutes pre-intervention session)
- Experience Sampling of Self-Compassion(15-minutes pre-intervention session)
- Experience Sampling of Formal and Informal Mindfulness Practice(15-minutes pre-intervention session)
- Experience Sampling of Anxiety(15-minutes pre-intervention session)