Clinical trial NCT02433431: Mechanisms of Mindfulness and Stress Resilience: A Mobile App Mindfulness Training Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Mindfulness
Keywords: mindfulness
psychological stress
immune marker
wellness programs
mobile applications
cortisol
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: Mind and Life Institute, Hadley, Massachusetts
name: Yoga Science Foundation
name: Penn State University
name: University of Pittsburgh
name: Virginia Commonwealth University
name: 01 Expert Systems, LLC
First posted: 2015-05-05
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily life stress assessed via Ecological Momentary Assessment
timeFrame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
measure: Inflammatory Biomarkers assessed via Dried Blood Spot
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
Secondary outcomes:
measure: Daily life state attention and acceptance assessed via Ecological Momentary Assessment
timeFrame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
measure: Subjective stress in response to social evaluative threat (TSST)
timeFrame: assessed at post-intervention, which is an average of 3.5 weeks
measure: Salivary Cortisol AUC in response to social evaluative threat (TSST)
timeFrame: assessed at post-intervention, which is an average of 3.5 weeks, at time 0, and 25, 35, and 60 minutes post-TSST
measure: Blood Pressure reactivity to social evaluative threat (TSST)
timeFrame: assessed at post-intervention, which is an average of 3.5 weeks, at 2-minute intervals during session
measure: Evening salivary cortisol
timeFrame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
measure: Sustained attention measured by the Dichotic Listening Task
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
Other outcomes:
measure: Daily life affect assessed via Ecological Momentary Assessment
timeFrame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
measure: Daily life social interactions assessed via Ecological Momentary Assessment
timeFrame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
measure: Perceived stress measured by the PSS
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Mindfulness facets measured by the FFMQ-sf
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Mindfulness measured by the PHLMS
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Attentional control measured by the ACS
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Nonattachment measured by Nonattachment Scale
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Subjective health measured by the SF-12
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Sleep quality measured by the PSQI-sf
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Loneliness measured by the UCLA Loneliness Scale
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Interpersonal support measured by the ISEL-12
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Social network measured by the SNI
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Depression measured by the CES-D-10
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Mind-wandering measured by the RRQ
timeFrame: change from baseline to post-intervention, which is an average of 3.5 weeks
measure: Treatment expectancies measured by Credibility/Expectancy Questionnaire
timeFrame: post-intervention, which is an average of 3.5 weeks
measure: Alerting, orienting, and executive control measured by the ANT task
timeFrame: post-intervention, which is an average of 3.5 weeks
measure: Subjective responses to the training program intervention
timeFrame: composite of ratings made after each of 14 intervention lessons, an average of 2 weeks following baseline
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Emily K Lindsay, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Carnegie Mellon University
name: J. David Creswell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.