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Clinical Trials/NCT02433431
NCT02433431CompletedNot Applicable

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

Carnegie Mellon University1 site in 1 country153 target enrollmentStarted: February 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
153
Locations
1
Primary Endpoint
Daily life stress assessed via Ecological Momentary Assessment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Mindfulness Training

Active Comparator

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

Intervention: Mindfulness Training (Behavioral)

Mindful Attention Only Training

Active Comparator

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

Intervention: Mindful Attention Only Training (Behavioral)

Analytic Thinking Training

Active Comparator

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

Intervention: Analytic Thinking Training (Behavioral)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Daily life state attention and acceptance assessed via Ecological Momentary Assessment(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)(assessed at post-intervention, which is an average of 3.5 weeks)
  • 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)
  • Evening salivary cortisol(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(change from baseline to post-intervention, which is an average of 3.5 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emily Lindsay

Doctoral Student

Carnegie Mellon University

Study Sites (1)

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