The Stress Reduction Intervention Study

Study Overview
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Brief Summary
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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.

Official Title
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The Mindfulness Intervention and Repeated Acute Stress (MIRAS) Study

Conditions
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Stress, Physiological, Stress, Psychological

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction
* Behavioral: Cognitive-Behavioral Therapy (CBT) Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention wait-list<br>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 | |
| Active Comparator: Mindfulness Based Stress Reduction(MBSR)<br>This arm will receive 6 weekly, 2-hour groups that focuses on mindfulness meditation for stress reduction | Behavioral: Mindfulness Based Stress Reduction<br>* A modified version of traditional MBSR. The current study's version of MBSR is shortened to 6-weeks.<br>|
| Active Comparator: Cognitive Behavioral Therapy (CBT) Group<br>This are will receive 6 weekly, 2-hour groups that focus on cognitive-behavioral skills for stress | Behavioral: Cognitive-Behavioral Therapy (CBT) Group<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | 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. | Baseline and 6-weeks after baseline. | 
| Salivary cortisol response to repeated acute psychosocial stress | 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. | Post-intervention (approximately 7-14 weeks after baseline assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular response to repeated acute psychosocial stress | 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. | Post-intervention (approximately 7-14 weeks after baseline assessment) | 
| Autonomic response to repeated acute psychosocial stress | 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. | Post-intervention (approximately 7-14 weeks after baseline assessment) | 
| Dispositional Mindfulness | Five Facet Mindfulness Questionnaire | Baseline and 6-weeks | 
| Equanimity | The Non-Attachment Scale | Baseline and 6-weeks | 
| Smoking | Fagerstrom Test for Nicotine Dependence | Baseline and 6-weeks | 
| Alcohol | Alcohol Use Disorders Identification Test - Consumption items | Baseline and 6-weeks | 
| Marijuana | Single item assessing frequency of marijuana use | Baseline and 6-weeks | 
| Perceived control over thoughts | Thought Control Ability Questionnaire | Baseline and 6 weeks | 
| Coping Skills | Brief-COPE measure | Baseline and 6-weeks | 
| Depressed mood | Center for Epidemiologic Studies Depression Scale | Baseline and 6-weeks | 
| Anxiety | Spielberger State-Trait Anxiety Inventory | Baseline and 6-weeks later | 
| Social Connectedness | Social Connectedness Scale-Revised | Baseline and 6-weeks | 
| Optimism | Life Orientation Test | Baseline and 6-weeks | 
| Worry | Penn State Worry Questionnaire | Baseline and 6-weeks | 
| Experiential Avoidance | Acceptance and Action Questionnaire-II | Baseline and 6-weeks | 
| Emotion Regulation | Difficulties in Emotion Regulation Scale | Baseline and 6-weeks | 
| Negative Urgency | UPPS-P Impulsive Behavior Scale: Negative Urgency Items | Baseline and 6-weeks | 
| Chronic Stress | Trier Inventory for Chronic Stress | Baseline and 6-weeks | 
| Sleep | Pittsburgh Sleep Quality Index | Baseline and 6-weeks | 
| State Affect | 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. | Post-intervention (approximately 7-14 weeks after baseline assessment) | 
| State mindfulness | Mindful Attention Awareness Scale (MAAS) - state version. The investigators will measure the change in state mindfulness from the first stressor exposure to the second. | Post-intervention (approximately 7-14 weeks after baseline assessment) | 
| Implicit association between self and shame | 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. | Post-intervention (approximately 7-14 weeks after baseline assessment) | 
| State rumination | Thoughts Questionnaire (TQ). The investigators will measure the change in state rumination from the first stressor exposure to the second. | Post-intervention (approximately 7-14 weeks after baseline assessment) | 
| Stress appraisals | 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. | Post-intervention (approximately 7-14 weeks after baseline assessment) |