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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02433431
First Posted: May 5, 2015
Last Update Posted: May 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mind and Life Institute, Hadley, Massachusetts
Yoga Science Foundation
Penn State University
University of Pittsburgh
Virginia Commonwealth University
01 Expert Systems, LLC
Information provided by (Responsible Party):
Emily Lindsay, Carnegie Mellon University
April 23, 2015
May 5, 2015
May 17, 2016
February 2015
April 2016   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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).
Same as current
Complete list of historical versions of study NCT02433431 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Subjective stress in response to social evaluative threat (TSST) [ Time Frame: assessed at post-intervention, which is an average of 3.5 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Sustained attention measured by the Dichotic Listening Task [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
Same as current
  • 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 ]
  • 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 ]
  • Perceived stress measured by the PSS [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Mindfulness facets measured by the FFMQ-sf [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Mindfulness measured by the PHLMS [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Attentional control measured by the ACS [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Nonattachment measured by Nonattachment Scale [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Subjective health measured by the SF-12 [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Sleep quality measured by the PSQI-sf [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Loneliness measured by the UCLA Loneliness Scale [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Interpersonal support measured by the ISEL-12 [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Social network measured by the SNI [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Depression measured by the CES-D-10 [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Mind-wandering measured by the RRQ [ Time Frame: change from baseline to post-intervention, which is an average of 3.5 weeks ]
  • Treatment expectancies measured by Credibility/Expectancy Questionnaire [ Time Frame: post-intervention, which is an average of 3.5 weeks ]
  • Alerting, orienting, and executive control measured by the ANT task [ Time Frame: post-intervention, which is an average of 3.5 weeks ]
  • 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 ]
Same as current
 
Mechanisms of Mindfulness and Stress Resilience: A Mobile App Mindfulness Training Study
Not Provided
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
  • Psychological Stress
  • Mindfulness
  • Behavioral: Mindfulness Training
    Mindfulness training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.
  • Behavioral: Mindful Attention Only Training
    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.
  • Behavioral: Analytic Thinking Training
    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.
  • Active Comparator: Mindfulness Training
    14-lesson audio-guided mindfulness training program instructing present-moment attention and an orientation of acceptance
    Intervention: Behavioral: Mindfulness Training
  • Active Comparator: Mindful Attention Only Training
    14-lesson audio-guided mindfulness training program instructing present-moment attention only
    Intervention: Behavioral: Mindful Attention Only Training
  • Active Comparator: Analytic Thinking Training
    14-lesson audio-guided analytic thinking program encouraging reflection on one's thoughts, feelings, and behaviors, but not instructing mindfulness
    Intervention: Behavioral: Analytic Thinking Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02433431
IRBSTUDY2015_00000122
No
Not Provided
Not Provided
Emily Lindsay, Carnegie Mellon University
Carnegie Mellon University
  • Mind and Life Institute, Hadley, Massachusetts
  • Yoga Science Foundation
  • Penn State University
  • University of Pittsburgh
  • Virginia Commonwealth University
  • 01 Expert Systems, LLC
Principal Investigator: Emily K Lindsay, MS Carnegie Mellon University
Principal Investigator: J. David Creswell, PhD Carnegie Mellon University
Carnegie Mellon University
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP