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Mechanisms of Mindfulness Training and Stress Reduction

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ClinicalTrials.gov Identifier: NCT02502227
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : February 1, 2017
Sponsor:
Collaborators:
University of Pittsburgh
Penn State University
Information provided by (Responsible Party):
Carnegie Mellon University

Brief Summary:
This study is a three-arm randomized controlled trial of a mindfulness stress reduction intervention, with the aim of dismantling the experience-monitoring and nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment component. In addition to enhancing understanding of mechanisms underlying the effects of mindfulness interventions, identifying the therapeutic constituent(s) could inform development of targeted interventions as well as provide strategies to optimize adherence.

Condition or disease Intervention/treatment Phase
Psychological Stress Mindfulness Behavioral: Mindfulness Not Applicable

Detailed Description:
There is a growing body of randomized controlled trial (RCT) evidence indicating that mindfulness training interventions may reduce stress and improve stress-related disease outcomes. Yet little is known about the underlying active training mechanisms of mindfulness training. Although it is generally believed that mindfulness training interventions foster a capacity to monitor and accept present moment experience, debate currently focuses on whether it is the capacity to both monitor and non-judgmentally accept experience that drives the salutary effects observed in mindfulness training interventions. This project will test these putative active mechanisms by comparing two different types of mindfulness meditation training programs. N=135 stressed community adults will be recruited and randomized to either two different types of 8-week Mindfulness-Based Stress Reduction (MBSR) programs or a No Treatment Control (assessment only) comparison condition. Participants will complete 3 days of daily experience sampling (Ecological Momentary Assessment) immediately before and after the 8-week intervention period to measure attentional control and stress perceptions in daily life. In order to measure psychological and HPA-axis stress reactivity to a controlled stressor, participants will also complete a standardized acute stress challenge task (the Trier Social Stress Test, TSST) immediately following the 3-day post-intervention assessment period. This project provides the first dismantling study of mindfulness meditation training, it utilizes cutting-edge daily experience sampling of real life stress (using EMA) and stress biomarkers (salivary cortisol), and will provide important initial information for designing more effective (and efficient) mindfulness training interventions in at-risk stressed patient populations.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Mechanisms of Mindfulness Training and Stress Reduction
Study Start Date : July 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arm Intervention/treatment
Active Comparator: Mindfulness Training
Mindfulness training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation
Behavioral: Mindfulness
Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience

Active Comparator: Mindful Attention Only Training
Mindful attention only training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation
Behavioral: Mindfulness
Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience

No Intervention: No Treatment Control Condition
No treatment participants will be informed that their participation is important and that they are requested to not seek out similar treatments during this waiting period.



Primary Outcome Measures :
  1. Daily life stress assessed via Ecological Momentary Assessment [ Time Frame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks ]

Secondary Outcome Measures :
  1. Daily life state attention and acceptance assessed via Ecological Momentary Assessment [ Time Frame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks ]
  2. Subjective stress in response to social evaluative threat [ Time Frame: assessed at post-intervention, which is an average of 14 weeks ]
  3. Salivary Cortisol in response to social evaluative threat [ Time Frame: assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge ]
  4. Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure) [ Time Frame: assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session ]
  5. Sustained attention measured by the Dichotic Listening Task [ Time Frame: change from baseline to post-intervention, which is an average of 14 weeks ]
  6. Sustained inattentional blindness measured by the Inattentional Blindness Task [ Time Frame: post-intervention only ]

Other Outcome Measures:
  1. Daily life affect assessed via Ecological Momentary Assessment [ Time Frame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks ]
  2. Daily life social interactions assessed via Ecological Momentary Assessment [ Time Frame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks ]
  3. Perceived stress using the Perceived Stress Scale [ Time Frame: change from baseline to post-intervention, which is an average of 14 weeks ]
  4. Attentional control using the Attentional Control Scale [ Time Frame: change from baseline to post-intervention, which is an average of 14 weeks ]
  5. Treatment expectancies [ Time Frame: post-intervention an average of 14 weeks after the baseline ]
  6. Subjective responses to the training program intervention [ Time Frame: composite of ratings made after each intervention lesson, an average of 10 weeks following baseline ]
  7. Mindfulness using the Mindful Attention Awareness Scale [ Time Frame: change from baseline to post-intervention, which is an average of 14 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English speaking
  • Moderate- to high-stress
  • Owns an internet-enabled smart phone

Exclusion Criteria:

  • Diagnosis of chronic mental (e.g. recurrent depression, schizophrenia, personality disorder) or physical disease (e.g. cancer, HIV, diabetes)
  • Hospitalization in past 3 months
  • Medication use that interferes with cortisol activity (e.g. corticosteroids)
  • Current oral contraceptive use
  • Pregnancy
  • Current antibiotic, antiviral, or antimicrobial treatment
  • Travel outside the country within the past 6 months to any country on the Center for Disease Control travel alert list
  • Recreational drug use, excessive alcohol or tobacco use
  • Significant experience with or daily practice of mindfulness meditation or related mind-body practice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502227


Locations
United States, Pennsylvania
Carnegie Mellon University
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Medical Center- Center for Integrative Medicine
Pittsburgh, Pennsylvania, United States, 15232
Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Carnegie Mellon University
University of Pittsburgh
Penn State University
Investigators
Study Chair: Wendy Weber, Ph.D. National Center for Complementary and Integrative Health, National Institutes of Health

Responsible Party: Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT02502227     History of Changes
Other Study ID Numbers: 1R21AT008493-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by Carnegie Mellon University:
mindfulness
psychological stress
wellness programs
cortisol

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms