The Mindfulness Intervention and Repeated Acute Stress (MIRAS) Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ohio University
- Enrollment
- 150
- Primary Endpoint
- Perceived Stress Scale
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: 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
Intervention: Cognitive-Behavioral Therapy (CBT) Group (Behavioral)
Outcomes
Primary Outcomes
Perceived Stress Scale
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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))
- 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)
- 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)
- Anxiety(Baseline and 6-weeks later)
- 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)