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

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Carnegie Mellon University

Status

Completed

Conditions

Psychological Stress
Mindfulness

Treatments

Behavioral: Analytic Thinking Training
Behavioral: Mindful Attention Only Training
Behavioral: Mindfulness Training

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02433431
IRBSTUDY2015_00000122

Details and patient eligibility

About

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.

Full 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.

Enrollment

153 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

153 participants in 3 patient groups

Mindfulness Training
Active Comparator group
Description:
14-lesson audio-guided mindfulness training program instructing present-moment attention and an orientation of acceptance
Treatment:
Behavioral: Mindfulness Training
Mindful Attention Only Training
Active Comparator group
Description:
14-lesson audio-guided mindfulness training program instructing present-moment attention only
Treatment:
Behavioral: Mindful Attention Only Training
Analytic Thinking Training
Active Comparator group
Description:
14-lesson audio-guided analytic thinking program encouraging reflection on one's thoughts, feelings, and behaviors, but not instructing mindfulness
Treatment:
Behavioral: Analytic Thinking Training

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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