Mechanisms of Mindfulness Training and Stress Reduction

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.

Study Overview

• Status: Completed
• Conditions: Psychological Stress; Mindfulness
• Intervention / Treatment: Behavioral: Mindfulness

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
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Carnegie Mellon University
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center- Center for Integrative Medicine
    • University Park, Pennsylvania, United States, 16802
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Daily life stress assessed via Ecological Momentary Assessment	change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Carnegie Mellon University
• Collaborators: University of Pittsburgh; Penn State University
• Investigators: Study Chair: Wendy Weber, Ph.D., National Center for Complementary and Integrative Health, National Institutes of Health

Publications and helpful links

General Publications

• Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Mindfulness interventions improve momentary and trait measures of attentional control: Evidence from a randomized controlled trial. J Exp Psychol Gen. 2021 Apr;150(4):686-699. doi: 10.1037/xge0000969. Epub 2020 Sep 24.
• Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Psychological mechanisms driving stress resilience in mindfulness training: A randomized controlled trial. Health Psychol. 2019 Aug;38(8):759-768. doi: 10.1037/hea0000763. Epub 2019 May 23.
• Lindsay EK, Chin B, Greco CM, Young S, Brown KW, Wright AGC, Smyth JM, Burkett D, Creswell JD. How mindfulness training promotes positive emotions: Dismantling acceptance skills training in two randomized controlled trials. J Pers Soc Psychol. 2018 Dec;115(6):944-973. doi: 10.1037/pspa0000134.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: mindfulness; cortisol; psychological stress; wellness programs
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 1R21AT008493-01A1 (U.S. NIH Grant/Contract)