The Stress Reduction Intervention Study

Stress, Psychological Clinical Trial

Official title:

The Mindfulness Intervention and Repeated Acute Stress (MIRAS) Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02894229
• Other study ID #: 16F18
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 5, 2016
• Last updated: April 3, 2018
• Start date: August 2016
• Est. completion date: July 2019

Study information

• Verified date: April 2018
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress, Physiological
• Stress, Psychological

Intervention

Behavioral:
• Mindfulness Based Stress Reduction
A modified version of traditional MBSR. The current study's version of MBSR is shortened to 6-weeks.
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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)
Secondary	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)
Secondary	Dispositional Mindfulness	Five Facet Mindfulness Questionnaire	Baseline and 6-weeks
Secondary	Equanimity	The Non-Attachment Scale	Baseline and 6-weeks
Secondary	Smoking	Fagerstrom Test for Nicotine Dependence	Baseline and 6-weeks
Secondary	Alcohol	Alcohol Use Disorders Identification Test - Consumption items	Baseline and 6-weeks
Secondary	Marijuana	Single item assessing frequency of marijuana use	Baseline and 6-weeks
Secondary	Perceived control over thoughts	Thought Control Ability Questionnaire	Baseline and 6 weeks
Secondary	Coping Skills	Brief-COPE measure	Baseline and 6-weeks
Secondary	Depressed mood	Center for Epidemiologic Studies Depression Scale	Baseline and 6-weeks
Secondary	Anxiety	Spielberger State-Trait Anxiety Inventory	Baseline and 6-weeks later
Secondary	Social Connectedness	Social Connectedness Scale-Revised	Baseline and 6-weeks
Secondary	Optimism	Life Orientation Test	Baseline and 6-weeks
Secondary	Worry	Penn State Worry Questionnaire	Baseline and 6-weeks
Secondary	Experiential Avoidance	Acceptance and Action Questionnaire-II	Baseline and 6-weeks
Secondary	Emotion Regulation	Difficulties in Emotion Regulation Scale	Baseline and 6-weeks
Secondary	Negative Urgency	UPPS-P Impulsive Behavior Scale: Negative Urgency Items	Baseline and 6-weeks
Secondary	Chronic Stress	Trier Inventory for Chronic Stress	Baseline and 6-weeks
Secondary	Sleep	Pittsburgh Sleep Quality Index	Baseline and 6-weeks
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)