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

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: Completed
• Conditions: Psychological Stress; Mindfulness
• Intervention / Treatment: Behavioral: Mindfulness Training; Behavioral: Mindful Attention Only Training; Behavioral: Analytic Thinking Training

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: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Daily life stress 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
Inflammatory Biomarkers assessed via Dried Blood Spot	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

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Daily life affect 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
Daily life social interactions 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
Perceived stress measured by the PSS	change from baseline to post-intervention, which is an average of 3.5 weeks
Mindfulness facets measured by the FFMQ-sf	change from baseline to post-intervention, which is an average of 3.5 weeks
Mindfulness measured by the PHLMS	change from baseline to post-intervention, which is an average of 3.5 weeks
Attentional control measured by the ACS	change from baseline to post-intervention, which is an average of 3.5 weeks
Nonattachment measured by Nonattachment Scale	change from baseline to post-intervention, which is an average of 3.5 weeks
Subjective health measured by the SF-12	change from baseline to post-intervention, which is an average of 3.5 weeks
Sleep quality measured by the PSQI-sf	change from baseline to post-intervention, which is an average of 3.5 weeks
Loneliness measured by the UCLA Loneliness Scale	change from baseline to post-intervention, which is an average of 3.5 weeks
Interpersonal support measured by the ISEL-12	change from baseline to post-intervention, which is an average of 3.5 weeks
Social network measured by the SNI	change from baseline to post-intervention, which is an average of 3.5 weeks
Depression measured by the CES-D-10	change from baseline to post-intervention, which is an average of 3.5 weeks
Mind-wandering measured by the RRQ	change from baseline to post-intervention, which is an average of 3.5 weeks
Treatment expectancies measured by Credibility/Expectancy Questionnaire	post-intervention, which is an average of 3.5 weeks
Alerting, orienting, and executive control measured by the ANT task	post-intervention, which is an average of 3.5 weeks
Subjective responses to the training program intervention	composite of ratings made after each of 14 intervention lessons, an average of 2 weeks following baseline

Collaborators and Investigators

• Sponsor: Carnegie Mellon University
• Collaborators: University of Pittsburgh; Penn State University; Virginia Commonwealth University; Mind and Life Institute, Hadley, Massachusetts; Yoga Science Foundation; 01 Expert Systems, LLC
• Investigators: Principal Investigator: Emily K Lindsay, MS, Carnegie Mellon University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: mindfulness; cortisol; mobile applications; psychological stress; wellness programs; immune marker
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: IRBSTUDY2015_00000122