The Stress Reduction Intervention Study

The Mindfulness Intervention and Repeated Acute Stress (MIRAS) Study

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 Overview

• Status: Unknown
• Conditions: Stress, Psychological; Stress, Physiological
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction; Behavioral: Cognitive-Behavioral Therapy (CBT) Group

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Ohio University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 16F18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO