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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02433431
Enrollment
153
Registered
2015-05-05
Start date
2015-02-28
Completion date
2016-04-30
Last updated
2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mindfulness, Psychological Stress

Keywords

mindfulness, psychological stress, immune marker, wellness programs, mobile applications, cortisol

Brief summary

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

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.

Interventions

BEHAVIORALMindfulness 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.

BEHAVIORALMindful 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.

BEHAVIORALAnalytic 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.

Sponsors

Mind and Life Institute, Hadley, Massachusetts
CollaboratorOTHER
Yoga Science Foundation
CollaboratorOTHER
Penn State University
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
Virginia Commonwealth University
CollaboratorOTHER
01 Expert Systems, LLC
CollaboratorINDUSTRY
Carnegie Mellon University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Daily life stress assessed via Ecological Momentary Assessmentchange 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 Spotchange from baseline to post-intervention, which is an average of 3.5 weeksFive Dried Blood Spot samples are obtained from participants' finger for assessment of circulating markers of inflammation (CRP, IL-6).

Secondary

MeasureTime frame
Salivary Cortisol AUC in response to social evaluative threat (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)assessed at post-intervention, which is an average of 3.5 weeks, at 2-minute intervals during session
Daily life state attention and acceptance assessed via Ecological Momentary Assessmentchange 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 Taskchange from baseline to post-intervention, which is an average of 3.5 weeks
Evening salivary cortisolchange 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)assessed at post-intervention, which is an average of 3.5 weeks

Other

MeasureTime frame
Sleep quality measured by the PSQI-sfchange from baseline to post-intervention, which is an average of 3.5 weeks
Loneliness measured by the UCLA Loneliness Scalechange from baseline to post-intervention, which is an average of 3.5 weeks
Interpersonal support measured by the ISEL-12change from baseline to post-intervention, which is an average of 3.5 weeks
Social network measured by the SNIchange from baseline to post-intervention, which is an average of 3.5 weeks
Daily life affect assessed via Ecological Momentary Assessmentchange from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
Mind-wandering measured by the RRQchange from baseline to post-intervention, which is an average of 3.5 weeks
Treatment expectancies measured by Credibility/Expectancy Questionnairepost-intervention, which is an average of 3.5 weeks
Alerting, orienting, and executive control measured by the ANT taskpost-intervention, which is an average of 3.5 weeks
Subjective responses to the training program interventioncomposite of ratings made after each of 14 intervention lessons, an average of 2 weeks following baseline
Depression measured by the CES-D-10change from baseline to post-intervention, which is an average of 3.5 weeks
Daily life social interactions assessed via Ecological Momentary Assessmentchange from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
Perceived stress measured by the PSSchange from baseline to post-intervention, which is an average of 3.5 weeks
Mindfulness facets measured by the FFMQ-sfchange from baseline to post-intervention, which is an average of 3.5 weeks
Mindfulness measured by the PHLMSchange from baseline to post-intervention, which is an average of 3.5 weeks
Attentional control measured by the ACSchange from baseline to post-intervention, which is an average of 3.5 weeks
Nonattachment measured by Nonattachment Scalechange from baseline to post-intervention, which is an average of 3.5 weeks
Subjective health measured by the SF-12change from baseline to post-intervention, which is an average of 3.5 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026