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Completed

NCT Number: NCT02433431

Mechanisms of Mindfulness and Stress Resilience: A Mobile App Mindfulness Training Study

The purpose of this study is to test the active components of mindfulness meditation for reducing psychological stress and improving biomarkers of health. This study compares the effects of three brief trainings: (1) training in both present-moment attention and mindful acceptance, (2) training in present-focused attention, and (3) an active psychological training with no mindfulness content.

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Key information

Conditions

Psychological Stress Behavior Behavioral Symptoms Mindfulness Stress, Psychological

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

About this study

Mindfulness meditation practices are widely used among the general public, with people seeking to reduce stress, pain, inflammation, depression, and disease symptoms. Moreover, randomized controlled trials have shown mindfulness training programs to be effective in improving a broad range of psychological and physical health outcomes, particularly among populations with high stress burdens. Still, little is known about the mechanisms underlying mindfulness training that drive these effects. This study tests the active components of mindfulness that impact stress responding and health biomarkers.

The study separates attention and acceptance mindfulness instructions into three 14-day training programs delivered to a stressed adult population: (1) attention and acceptance instructions, (2) attentional monitoring instructions only, or (3) analytic thinking with no mindfulness instruction. Intervention programs are delivered on participants' own smartphones, providing a platform for maximal experimental control in testing the active ingredients of mindfulness training.

Participants are recruited from the Pittsburgh community. At a baseline laboratory session, they complete psychosocial questionnaires and tasks and provide a dried blood spot sample. On their own, they complete pre- and post-intervention Ecological Momentary Assessment measures of stress, attention, and acceptance in daily life. Between these assessments, participants have 14 days to complete their randomly assigned 14-lesson intervention program. Participants return to the lab for post-intervention assessments (questionnaires, tasks, dried blood sample), listen to a final training session from their intervention program, and complete the Trier Social Stress Test. Participants are compensated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • English speaking
  • Moderate- to high-stress (4-item Perceived Stress Scale score of 6 or higher)

Exclusion criteria

  • Diagnosis of chronic mental (e.g., recurrent depression, schizophrenia, personality disorder) or physical disease (e.g., cancer, HIV, heart disease, diabetes, bleeding disorder)
  • Hospitalization in past 3 months
  • Medication use that interferes with HPA-axis activity (e.g., corticosteroids)
  • Current oral contraceptive use
  • Current antibiotic, antiviral, or antimicrobial treatment
  • Travel outside the country within the past 6 months to any country on the CDC 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 Training

Behavioral

Mindfulness training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.

Mindful Attention Only Training

Behavioral

Mindful attention training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.

Analytic Thinking Training

Behavioral

Comparison analytic thinking intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.

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 2.5 weeks

  2. Inflammatory Biomarkers assessed via Dried Blood Spot

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

    Five Dried Blood Spot samples are obtained from participants' finger for assessment of circulating markers of inflammation (CRP, IL-6).

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 2.5 weeks

  2. Subjective stress in response to social evaluative threat (TSST)

    Time frame: assessed at post-intervention, which is an average of 3.5 weeks

  3. Salivary Cortisol AUC in response to social evaluative threat (TSST)

    Time frame: assessed at post-intervention, which is an average of 3.5 weeks, at time 0, and 25, 35, and 60 minutes post-TSST

  4. Blood Pressure reactivity to social evaluative threat (TSST)

    Time frame: assessed at post-intervention, which is an average of 3.5 weeks, at 2-minute intervals during session

  5. Evening salivary cortisol

    Time frame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks

  6. Sustained attention measured by the Dichotic Listening Task

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

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 2.5 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 2.5 weeks

  3. Perceived stress measured by the PSS

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  4. Mindfulness facets measured by the FFMQ-sf

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  5. Mindfulness measured by the PHLMS

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  6. Attentional control measured by the ACS

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  7. Nonattachment measured by Nonattachment Scale

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  8. Subjective health measured by the SF-12

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  9. Sleep quality measured by the PSQI-sf

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  10. Loneliness measured by the UCLA Loneliness Scale

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  11. Interpersonal support measured by the ISEL-12

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  12. Social network measured by the SNI

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  13. Depression measured by the CES-D-10

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  14. Mind-wandering measured by the RRQ

    Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks

  15. Treatment expectancies measured by Credibility/Expectancy Questionnaire

    Time frame: post-intervention, which is an average of 3.5 weeks

  16. Alerting, orienting, and executive control measured by the ANT task

    Time frame: post-intervention, which is an average of 3.5 weeks

  17. Subjective responses to the training program intervention

    Time frame: composite of ratings made after each of 14 intervention lessons, an average of 2 weeks following baseline

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Collaborators

  • 01 Expert Systems, LLC
  • Mind and Life Institute, Hadley, Massachusetts
  • Penn State University
  • University of Pittsburgh
  • Virginia Commonwealth University
  • Yoga Science Foundation

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 5, 2015
Registry last updated
May 17, 2016

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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