The Stress Reduction Intervention Study

April 3, 2018 updated by: Ohio University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale
Time Frame: 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.
Baseline and 6-weeks after baseline.
Salivary cortisol response to repeated acute psychosocial stress
Time Frame: 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.
Post-intervention (approximately 7-14 weeks after baseline assessment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular response to repeated acute psychosocial stress
Time Frame: 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.
Post-intervention (approximately 7-14 weeks after baseline assessment)
Autonomic response to repeated acute psychosocial stress
Time Frame: 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.
Post-intervention (approximately 7-14 weeks after baseline assessment)
Dispositional Mindfulness
Time Frame: Baseline and 6-weeks
Five Facet Mindfulness Questionnaire
Baseline and 6-weeks
Equanimity
Time Frame: Baseline and 6-weeks
The Non-Attachment Scale
Baseline and 6-weeks
Smoking
Time Frame: Baseline and 6-weeks
Fagerstrom Test for Nicotine Dependence
Baseline and 6-weeks
Alcohol
Time Frame: Baseline and 6-weeks
Alcohol Use Disorders Identification Test - Consumption items
Baseline and 6-weeks
Marijuana
Time Frame: Baseline and 6-weeks
Single item assessing frequency of marijuana use
Baseline and 6-weeks
Perceived control over thoughts
Time Frame: Baseline and 6 weeks
Thought Control Ability Questionnaire
Baseline and 6 weeks
Coping Skills
Time Frame: Baseline and 6-weeks
Brief-COPE measure
Baseline and 6-weeks
Depressed mood
Time Frame: Baseline and 6-weeks
Center for Epidemiologic Studies Depression Scale
Baseline and 6-weeks
Anxiety
Time Frame: Baseline and 6-weeks later
Spielberger State-Trait Anxiety Inventory
Baseline and 6-weeks later
Social Connectedness
Time Frame: Baseline and 6-weeks
Social Connectedness Scale-Revised
Baseline and 6-weeks
Optimism
Time Frame: Baseline and 6-weeks
Life Orientation Test
Baseline and 6-weeks
Worry
Time Frame: Baseline and 6-weeks
Penn State Worry Questionnaire
Baseline and 6-weeks
Experiential Avoidance
Time Frame: Baseline and 6-weeks
Acceptance and Action Questionnaire-II
Baseline and 6-weeks
Emotion Regulation
Time Frame: Baseline and 6-weeks
Difficulties in Emotion Regulation Scale
Baseline and 6-weeks
Negative Urgency
Time Frame: Baseline and 6-weeks
UPPS-P Impulsive Behavior Scale: Negative Urgency Items
Baseline and 6-weeks
Chronic Stress
Time Frame: Baseline and 6-weeks
Trier Inventory for Chronic Stress
Baseline and 6-weeks
Sleep
Time Frame: Baseline and 6-weeks
Pittsburgh Sleep Quality Index
Baseline and 6-weeks
State Affect
Time Frame: 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.
Post-intervention (approximately 7-14 weeks after baseline assessment)
State mindfulness
Time Frame: 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.
Post-intervention (approximately 7-14 weeks after baseline assessment)
Implicit association between self and shame
Time Frame: 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.
Post-intervention (approximately 7-14 weeks after baseline assessment)
State rumination
Time Frame: 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.
Post-intervention (approximately 7-14 weeks after baseline assessment)
Stress appraisals
Time Frame: 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.
Post-intervention (approximately 7-14 weeks after baseline assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16F18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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