Clinical trial NCT02894229: The Stress Reduction Intervention Study
Official title: The Mindfulness Intervention and Repeated Acute Stress (MIRAS) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Physiological
Stress, Psychological
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline and 6-weeks after baseline.
measure: Salivary cortisol response to repeated acute psychosocial stress
timeFrame: Post-intervention (approximately 7-14 weeks after baseline assessment)
Secondary outcomes:
measure: Cardiovascular response to repeated acute psychosocial stress
timeFrame: Post-intervention (approximately 7-14 weeks after baseline assessment)
measure: Autonomic response to repeated acute psychosocial stress
timeFrame: Post-intervention (approximately 7-14 weeks after baseline assessment)
measure: Dispositional Mindfulness
timeFrame: Baseline and 6-weeks
measure: Equanimity
timeFrame: Baseline and 6-weeks
measure: Smoking
timeFrame: Baseline and 6-weeks
measure: Alcohol
timeFrame: Baseline and 6-weeks
measure: Marijuana
timeFrame: Baseline and 6-weeks
measure: Perceived control over thoughts
timeFrame: Baseline and 6 weeks
measure: Coping Skills
timeFrame: Baseline and 6-weeks
measure: Depressed mood
timeFrame: Baseline and 6-weeks
measure: Anxiety
timeFrame: Baseline and 6-weeks later
measure: Social Connectedness
timeFrame: Baseline and 6-weeks
measure: Optimism
timeFrame: Baseline and 6-weeks
measure: Worry
timeFrame: Baseline and 6-weeks
measure: Experiential Avoidance
timeFrame: Baseline and 6-weeks
measure: Emotion Regulation
timeFrame: Baseline and 6-weeks
measure: Negative Urgency
timeFrame: Baseline and 6-weeks
measure: Chronic Stress
timeFrame: Baseline and 6-weeks
measure: Sleep
timeFrame: Baseline and 6-weeks
measure: State Affect
timeFrame: Post-intervention (approximately 7-14 weeks after baseline assessment)
measure: State mindfulness
timeFrame: Post-intervention (approximately 7-14 weeks after baseline assessment)
measure: Implicit association between self and shame
timeFrame: Post-intervention (approximately 7-14 weeks after baseline assessment)
measure: State rumination
timeFrame: Post-intervention (approximately 7-14 weeks after baseline assessment)
measure: Stress appraisals
timeFrame: Post-intervention (approximately 7-14 weeks after baseline assessment)
Other outcomes:
Locations:
Study officials:
References:
citation: Manigault AW, Shorey RC, Decastro G, Appelmann HM, Hamilton KR, Scanlin MC, France CR, Zoccola PM. Standardized stress reduction interventions and blood pressure habituation: Secondary results from a randomized controlled trial. Health Psychol. 2021 Mar;40(3):196-206. doi: 10.1037/hea0000954.