The Stress Reduction Intervention Study
- Conditions
- Stress, PhysiologicalStress, Psychological
- Interventions
- Behavioral: Cognitive-Behavioral Therapy (CBT) GroupBehavioral: Mindfulness Based Stress Reduction
- Registration Number
- NCT02894229
- Lead Sponsor
- Ohio University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behavioral Therapy (CBT) Group Cognitive-Behavioral Therapy (CBT) Group This are will receive 6 weekly, 2-hour groups that focus on cognitive-behavioral skills for stress Mindfulness Based Stress Reduction(MBSR) Mindfulness Based Stress Reduction This arm will receive 6 weekly, 2-hour groups that focuses on mindfulness meditation for stress reduction
- Primary Outcome Measures
Name Time Method Perceived Stress Scale 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 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 Outcome Measures
Name Time Method Depressed mood Baseline and 6-weeks Center for Epidemiologic Studies Depression Scale
Anxiety Baseline and 6-weeks later Spielberger State-Trait Anxiety Inventory
Equanimity Baseline and 6-weeks The Non-Attachment Scale
Smoking Baseline and 6-weeks Fagerstrom Test for Nicotine Dependence
Alcohol Baseline and 6-weeks Alcohol Use Disorders Identification Test - Consumption items
Marijuana Baseline and 6-weeks Single item assessing frequency of marijuana use
Sleep Baseline and 6-weeks Pittsburgh Sleep Quality Index
Perceived control over thoughts Baseline and 6 weeks Thought Control Ability Questionnaire
Coping Skills Baseline and 6-weeks Brief-COPE measure
Cardiovascular response to repeated acute psychosocial stress Post-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.
Autonomic response to repeated acute psychosocial stress Post-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.
Dispositional Mindfulness Baseline and 6-weeks Five Facet Mindfulness Questionnaire
Social Connectedness Baseline and 6-weeks Social Connectedness Scale-Revised
Optimism Baseline and 6-weeks Life Orientation Test
Worry Baseline and 6-weeks Penn State Worry Questionnaire
Experiential Avoidance Baseline and 6-weeks Acceptance and Action Questionnaire-II
Emotion Regulation Baseline and 6-weeks Difficulties in Emotion Regulation Scale
Negative Urgency Baseline and 6-weeks UPPS-P Impulsive Behavior Scale: Negative Urgency Items
Chronic Stress Baseline and 6-weeks Trier Inventory for Chronic Stress
State Affect Post-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 mindfulness Post-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 shame Post-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.
State rumination Post-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.
Stress appraisals Post-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.