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

Mindfulness Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02433431
• Other study ID #: IRBSTUDY2015_00000122
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2015
• Last updated: January 26, 2016
• Start date: February 2015

Study information

• Verified date: January 2016
• Source: Carnegie Mellon University
• Contact: Emily K Lindsay, MS
• Phone: 412-268-8113
• Email: elindsay[@]andrew.cmu.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mindfulness
• Psychological Stress
• Stress, Psychological

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Carnegie Mellon University	Pittsburgh	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
Carnegie Mellon University	01 Expert Systems, LLC, Mind and Life Institute, Hadley, Massachusetts, Penn State University, University of Pittsburgh, Virginia Commonwealth University, Yoga Science Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	Perceived stress measured by the PSS		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Mindfulness facets measured by the FFMQ-sf		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Mindfulness measured by the PHLMS		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Attentional control measured by the ACS		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Nonattachment measured by Nonattachment Scale		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Subjective health measured by the SF-12		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Sleep quality measured by the PSQI-sf		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Loneliness measured by the UCLA Loneliness Scale		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Interpersonal support measured by the ISEL-12		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Social network measured by the SNI		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Depression measured by the CES-D-10		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Mind-wandering measured by the RRQ		change from baseline to post-intervention, which is an average of 3.5 weeks	No
Other	Treatment expectancies measured by Credibility/Expectancy Questionnaire		post-intervention, which is an average of 3.5 weeks	No
Other	Alerting, orienting, and executive control measured by the ANT task		post-intervention, which is an average of 3.5 weeks	No
Other	Subjective responses to the training program intervention		composite of ratings made after each of 14 intervention lessons, an average of 2 weeks following baseline	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Subjective stress in response to social evaluative threat (TSST)		assessed at post-intervention, which is an average of 3.5 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Evening salivary cortisol		change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks	No
Secondary	Sustained attention measured by the Dichotic Listening Task		change from baseline to post-intervention, which is an average of 3.5 weeks	No