The Mindfulness Intervention and Repeated Acute Stress (MIRAS) Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- Perceived Stress Scale
研究概览
简要总结
The primary purpose of the present study is to investigate the relationship between mindfulness and stress habituation. The investigators propose to measure the effect of mindfulness on stress habituation by randomly assigning participants to a 6-week mindfulness-based stress reduction group intervention, a cognitive-behavioral skills group comparison intervention, or a waitlist control condition followed by repeated acute psychosocial stress testing (2 laboratory sessions on 2 separate days). Saliva will be collected from participants throughout both laboratory testing sessions to measure HPA axis activation (an essential stress-responsive system), along with other measures of physiological and psychological stress (e.g., heart rate, blood pressure, emotions). Mediators and moderators of treatment outcome will be examined. The cognitive-behavioral skills group condition is an appropriate comparison group due to the well-documented efficacy of cognitive-behavioral interventions on stress.
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
- 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
- •English-speaking adults who are between the ages of 18-50, who are in general good health
- •Perceived stress scores (PSS) > 3 on a screening survey
排除标准
- •reported previous completion of a Mindfulness-Based Stress Reduction or Cognitive Behavioral Therapy program.
- •reported pregnancy
- •reported use of steroid medication
- •presence of a major psychiatric or endocrine disorder (e.g., Major Depression, Cushings Disease; self-reported)
- •reported regular wake time after 10:00 AM on a weekday
研究组 & 干预措施
No intervention wait-list
This arm will receive no intervention for approximately the first 4 months. At the conclusion of the 4-month period, this group will receive a 6-week cognitive-behavioral therapy (CBT) group
Mindfulness Based Stress Reduction(MBSR)
This arm will receive 6 weekly, 2-hour groups that focuses on mindfulness meditation for stress reduction
干预措施: Mindfulness Based Stress Reduction (Behavioral)
Cognitive Behavioral Therapy (CBT) Group
This are will receive 6 weekly, 2-hour groups that focus on cognitive-behavioral skills for stress
干预措施: Cognitive-Behavioral Therapy (CBT) Group (Behavioral)
结局指标
主要结局
Perceived Stress Scale
时间窗: Baseline and 6-weeks after baseline.
A 10-item self-report measure that examines perceived stress. The measure produces one total score. The investigators will measure the change in total score from baseline to the 6-week assessment.
Salivary cortisol response to repeated acute psychosocial stress
时间窗: Post-intervention (approximately 7-14 weeks after baseline assessment)
4 saliva samples will be collected before and after a psychosocial stressor task, which will be administered on two separate occasions separated in time by at least 48 hours. All saliva samples will be assayed for salivary cortisol using enzyme-linked immunoassays. The investigators will measure the change in cortisol stress profiles from the first stressor exposure to the second.
次要结局
- Sleep(Baseline and 6-weeks)
- Equanimity(Baseline and 6-weeks)
- Smoking(Baseline and 6-weeks)
- Alcohol(Baseline and 6-weeks)
- Marijuana(Baseline and 6-weeks)
- Perceived control over thoughts(Baseline and 6 weeks)
- Coping Skills(Baseline and 6-weeks)
- Anxiety(Baseline and 6-weeks later)
- Cardiovascular response to repeated acute psychosocial stress(Post-intervention (approximately 7-14 weeks after baseline assessment))
- Autonomic response to repeated acute psychosocial stress(Post-intervention (approximately 7-14 weeks after baseline assessment))
- Dispositional Mindfulness(Baseline and 6-weeks)
- Depressed mood(Baseline and 6-weeks)
- Social Connectedness(Baseline and 6-weeks)
- Optimism(Baseline and 6-weeks)
- Worry(Baseline and 6-weeks)
- Experiential Avoidance(Baseline and 6-weeks)
- Emotion Regulation(Baseline and 6-weeks)
- Negative Urgency(Baseline and 6-weeks)
- Chronic Stress(Baseline and 6-weeks)
- State Affect(Post-intervention (approximately 7-14 weeks after baseline assessment))
- State mindfulness(Post-intervention (approximately 7-14 weeks after baseline assessment))
- Implicit association between self and shame(Post-intervention (approximately 7-14 weeks after baseline assessment))
- State rumination(Post-intervention (approximately 7-14 weeks after baseline assessment))
- Stress appraisals(Post-intervention (approximately 7-14 weeks after baseline assessment))