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

Sponsor

Carnegie Mellon University (Other)

Overall Status

Completed

CT.gov ID

NCT02433431

Collaborator

Mind and Life Institute, Hadley, Massachusetts (Other), Yoga Science Foundation (Other), Penn State University (Other), University of Pittsburgh (Other), Virginia Commonwealth University (Other), 01 Expert Systems, LLC (Industry)

153

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Stress Mindfulness	Behavioral: Mindfulness Training Behavioral: Mindful Attention Only Training Behavioral: Analytic Thinking Training	N/A

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

Actual Enrollment :

153 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 [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 Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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