Assessing MB-Spirit: A Novel Intervention for Promoting Spiritual Development and Psychological Well-being
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- FACIT-SP meaning and peace subscale
研究概览
简要总结
The goal of this clinical trial is to test two new behavioral interventions designed to reduce stress and improve spiritual well-being in stressed adults. The main questions it aims to answer are:
- Can the program decrease stress and improve spiritual well-being?
- What brain changes accompany participation in the programs?
Participants will:
- Be randomized to either a live online course that meets for 90 minutes every week for 8-weeks, or to a self-paced program. In the self-paced program, participants will receive materials once a week and can work through them at their own pace. Both programs are designed to decrease stress and improve well-being.
- Complete questionnaires before and after the course.
- Complete and interview before and after the course.
- A subset of people will be randomized to complete an MRI scan of their brain before and after the course.
Participants will be randomized to either take the course right away, or be put on a wait-list. Those on the wait-list will undergo the testing at 2 timepoints before they start the program.
详细描述
Forty-four individuals with high stress will be randomized 1:1, stratified by sex, to either the live or self-paced course. Participants will receive daily email with a link to a REDCap database to record minutes of homework practice. Pre and post testing will occur within a 21-day testing period before or after the courses. We will assess changes in spiritual well-being (Primary outcome), mindfulness, and use of character/virtue strengths (secondary outcomes). Changes in clinical symptoms will be explored. Participants will also complete a structured interview to assess developmental stage. A subset of participants will be randomized to undergo functional magnetic resonance imaging (fMRI) scanning before and after their program. Scans consist of a high-resolution gray matter scan, a 10-minute resting state scan and two 10-minute guided spiritual experience scans. Participants will rate the 'depth' of each spiritual state they experience while they are in the scanner on a 5-point scale. As a manipulation check, after exiting the scanner they will be asked to describe the states that arose. We will also assess the acceptability of the task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Understands English
- •Able to attend all 8 classes
- •Able to travel to Boston for MRI scans
排除标准
- •claustrophobia, pregnancy, head trauma, metallic implants or devices contraindicating MRI, left-handed, conditions that alter cerebral blood flow or metabolism (e.g. stroke), current use of psychotropic medications, lifetime history of suicidality, homicidally, self-destructive acts, schizophrenia or psychosis.
研究组 & 干预措施
MB-Spirit
8-week online course that combines mindfulness with character strengths to promote well-being
干预措施: MB-Spirit (Behavioral)
Strong Behaviors for Stress Reduction
self-paced program. Participants receive materials once a week to complete at their own pace
干预措施: Strong Behaviors for Stress Reduction (Behavioral)
结局指标
主要结局
FACIT-SP meaning and peace subscale
时间窗: 8 weeks
The meaning and peace subscale of the widely used and well-validated FACIT-SP-non-illness (Functional assessment of chronic illness therapy spiritual wellbeing - non illness) is our primary outcome metric. It has very good reliability (alpha=.81) and has high discriminate validity.
次要结局
- Duke University Religion Index(8-weeks)
- Brief Signature Strengths Use Scale (BSSUS)(8 weeks)
- Metacognitive Processes of Decentering Scale (MPoD-t)(8 weeks)
- PROMIS-29(8 weeks)
研究者
Sara W Lazar
Associate Research Scientist
Massachusetts General Hospital