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Completed

NCT Number: NCT02502227

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carnegie Mellon University, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Collaborators

  • Penn State University
  • University of Pittsburgh

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2015
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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