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The Stress Reduction Intervention Study

The Mindfulness Intervention and Repeated Acute Stress (MIRAS) Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02894229
Enrollment
150
Registered
2016-09-09
Start date
2016-08-31
Completion date
2019-07-31
Last updated
2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Physiological, Stress, Psychological

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.

Interventions

BEHAVIORALMindfulness Based Stress Reduction

A modified version of traditional MBSR. The current study's version of MBSR is shortened to 6-weeks.

BEHAVIORALCognitive-Behavioral Therapy (CBT) Group

A 6-week, 2-hour per group, skills group that focuses on various cognitive-behavioral skills for stress reduction (e.g., progressive muscle relaxation; cognitive restructuring).

Sponsors

Ohio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Perceived Stress ScaleBaseline 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 stressPost-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

MeasureTime frameDescription
Dispositional MindfulnessBaseline and 6-weeksFive Facet Mindfulness Questionnaire
State ruminationPost-intervention (approximately 7-14 weeks after baseline assessment)Thoughts Questionnaire (TQ). The investigators will measure the change in state rumination from the first stressor exposure to the second.
EquanimityBaseline and 6-weeksThe Non-Attachment Scale
SmokingBaseline and 6-weeksFagerstrom Test for Nicotine Dependence
AlcoholBaseline and 6-weeksAlcohol Use Disorders Identification Test - Consumption items
MarijuanaBaseline and 6-weeksSingle item assessing frequency of marijuana use
Perceived control over thoughtsBaseline and 6 weeksThought Control Ability Questionnaire
Coping SkillsBaseline and 6-weeksBrief-COPE measure
Depressed moodBaseline and 6-weeksCenter for Epidemiologic Studies Depression Scale
AnxietyBaseline and 6-weeks laterSpielberger State-Trait Anxiety Inventory
Social ConnectednessBaseline and 6-weeksSocial Connectedness Scale-Revised
Cardiovascular response to repeated acute psychosocial stressPost-intervention (approximately 7-14 weeks after baseline assessment)Heart rate and blood pressure will be assessed non-invasively and periodically before, during, and after non-invasively a psychosocial stressor task, with an Omron Health Care HEM-907XL Professional Blood Pressure Monitor. The investigators will measure the change in heart rate and blood pressure stress profiles from the first stressor exposure to the second.
WorryBaseline and 6-weeksPenn State Worry Questionnaire
Experiential AvoidanceBaseline and 6-weeksAcceptance and Action Questionnaire-II
Emotion RegulationBaseline and 6-weeksDifficulties in Emotion Regulation Scale
Negative UrgencyBaseline and 6-weeksUPPS-P Impulsive Behavior Scale: Negative Urgency Items
Chronic StressBaseline and 6-weeksTrier Inventory for Chronic Stress
SleepBaseline and 6-weeksPittsburgh Sleep Quality Index
State AffectPost-intervention (approximately 7-14 weeks after baseline assessment)Positive and Negative Affect Schedule (PANAS) will be used to assess state affect and specific emotions several times before and after a psychosocial stressor task. The investigators will measure the change in emotion response profiles from the first stressor exposure to the second.
State mindfulnessPost-intervention (approximately 7-14 weeks after baseline assessment)Mindful Attention Awareness Scale (MAAS) - state version. The investigators will measure the change in state mindfulness from the first stressor exposure to the second.
Implicit association between self and shamePost-intervention (approximately 7-14 weeks after baseline assessment)A shame experience and self implicit association test will be used to measure experiential self-referential processing of present moment shame. The investigators will measure the change in implicit association between self and shame from the first stressor exposure to the second.
Stress appraisalsPost-intervention (approximately 7-14 weeks after baseline assessment)Cognitive task appraisals will be assessed before and after a psychosocial stressor task. The investigators will measure the change in appraisals from the first stressor exposure to the second.
OptimismBaseline and 6-weeksLife Orientation Test
Autonomic response to repeated acute psychosocial stressPost-intervention (approximately 7-14 weeks after baseline assessment)Heart rate variability will be assessed continuously before, during, and after non-invasively a psychosocial stressor task, with a MP150 device manufactured by BIOPAC. The investigators will measure the change in heart rate variability stress profiles from the first stressor exposure to the second.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026