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

May 13, 2016 updated by: Emily Lindsay, Carnegie Mellon University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Carnegie Mellon University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Mindfulness Training
14-lesson audio-guided mindfulness training program instructing present-moment attention and an orientation of acceptance
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.
Active Comparator: Mindful Attention Only Training
14-lesson audio-guided mindfulness training program instructing present-moment attention only
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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).
change from baseline to post-intervention, which is an average of 3.5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
change from baseline to post-intervention, which is an average of 3.5 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
composite of ratings made after each of 14 intervention lessons, an average of 2 weeks following baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carnegie Mellon University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pittsburgh
Penn State University
Virginia Commonwealth University
Mind and Life Institute, Hadley, Massachusetts
Yoga Science Foundation
01 Expert Systems, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily K Lindsay, MS, Carnegie Mellon University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRBSTUDY2015_00000122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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