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

NCT ID: NCT02433431

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psychological Stress Mindfulness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mindfulness Training

14-lesson audio-guided mindfulness training program instructing present-moment attention and an orientation of acceptance

Group Type ACTIVE_COMPARATOR

Mindfulness Training

Intervention Type 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

14-lesson audio-guided mindfulness training program instructing present-moment attention only

Group Type ACTIVE_COMPARATOR

Mindful Attention Only Training

Intervention Type 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

14-lesson audio-guided analytic thinking program encouraging reflection on one's thoughts, feelings, and behaviors, but not instructing mindfulness

Group Type ACTIVE_COMPARATOR

Analytic Thinking Training

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mind and Life Institute, Hadley, Massachusetts

OTHER

Sponsor Role collaborator

Yoga Science Foundation

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role collaborator

01 Expert Systems, LLC

INDUSTRY

Sponsor Role collaborator

Carnegie Mellon University

OTHER

Sponsor Role lead

Responsible Party

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Emily Lindsay

Doctoral Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily K Lindsay, MS

Role: PRINCIPAL_INVESTIGATOR

Carnegie Mellon University

J. David Creswell, PhD

Role: PRINCIPAL_INVESTIGATOR

Carnegie Mellon University

Locations

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Carnegie Mellon University

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Lindsay EK, Young S, Creswell JD. Mindfulness training fosters a positive outlook during acute stress: A randomized controlled trial. Emotion. 2025 Jun;25(4):815-826. doi: 10.1037/emo0001452. Epub 2024 Nov 21.

Reference Type DERIVED
PMID: 39570681 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30550321 (View on PubMed)

Other Identifiers

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IRBSTUDY2015_00000122

Identifier Type: -

Identifier Source: org_study_id

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