Meditation and Decision Making Study III (MDMS3)

Nonconscious Affective and Physiological Mediators of Behavioral Decision Making Study 3

The overarching goal of the proposed research is to investigate the role of emotions in facilitating successful lifestyle change, defined as healthy behavioral decisions repeated daily, or near daily.

Participants are asked to make two lab visits during the course of four weeks to complete electronic questionnaires, be monitored for psychophysiological activity (e.g. heart rate, blood pressure, respiration), and listen to a guided meditation audio track. Additionally, between the two visits participants will be asked to complete weekly surveys that ask about daily meditation practice (outside of the lab) and general emotions.

Study Overview

• Status: Completed
• Conditions: Meditation
• Intervention / Treatment: Behavioral: Lovingkindness Meditation (LKM); Behavioral: Mindfulness Meditation

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC PEP Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Fluent in written and spoken English, with a high school reading level
• Willingness or interest in learning to meditate
• Computer literate with internet access

Exclusion Criteria:

• Individuals who are able to read Chinese logographs
• Individuals who have or have had a regular meditation practice, defined as having attended a 6-week or longer meditation class, practicing meditation at least 3 days a week for up to 6-weeks.
• Individuals with allergies to adhesive materials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Neutral; Reading passage about brain function which is masked as a news article.	Behavioral: Lovingkindness Meditation (LKM); Compassionate behavior training (REVISE); Behavioral: Mindfulness Meditation
Experimental: Lovingkindness Meditation (LKM); Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod.	Behavioral: Lovingkindness Meditation (LKM); Compassionate behavior training (REVISE)
Placebo Comparator: Mindfulness Meditation; Mindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod.	Behavioral: Mindfulness Meditation
Experimental: Positivity; Reading passage about prioritizing positive emotions which is masked as a news article.	Behavioral: Lovingkindness Meditation (LKM); Compassionate behavior training (REVISE); Behavioral: Mindfulness Meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in positive emotions (as measured by the Modified Daily Emotions Scale)	Modified Daily Emotions Scale (mDES) - This measure of explicit positive affect has been successfully used by the PI in multiple studies to detect changes in positive emotion. Previous work by the PI found that Cronbach's alpha coefficient for the mDES positive emotion composite variable was 0.93 in sample of mid-life community adults similar to those anticipated for this study.	Baseline and Weeks 1, 2, and 3
Change in nonconscious incentive salience (as measured by the Affect Misattribution Procedure)	Affect Misattribution Procedure (AMP) - This measure of nonconscious incentive salience has acceptable internal consistency for an indirect measure of affect (.69 - .90) and has been found to predict judgments and behavioral outcomes above and beyond self-report measures.	Baseline and Weeks 1, 2, and 3
Changes in meditation time	Self-reported meditation time recorded daily and weekly. In addition, meditation track play times will be recorded from the iPod.	Weeks 1, 2, and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Vagal Tone	This measure of parasympathetic control over the heart has been positively associated with both emotional and social functioning. Previous work by the PI's team has found that baseline vagal tone predicts increased positive response to lovingkindness meditation (LKM), and that LKM in turn increases vagal tone.	Baseline

Collaborators and Investigators

• Sponsor: Barbara L. Fredrickson, PhD
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Barbara L Fredrickson, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Fredrickson BL, Cohn MA, Coffey KA, Pek J, Finkel SM. Open hearts build lives: positive emotions, induced through loving-kindness meditation, build consequential personal resources. J Pers Soc Psychol. 2008 Nov;95(5):1045-1062. doi: 10.1037/a0013262.
• Carmody J, Baer RA, L B Lykins E, Olendzki N. An empirical study of the mechanisms of mindfulness in a mindfulness-based stress reduction program. J Clin Psychol. 2009 Jun;65(6):613-26. doi: 10.1002/jclp.20579.
• Johnson KJ, Waugh CE, Fredrickson BL. Smile to see the forest: Facially expressed positive emotions broaden cognition. Cogn Emot. 2010 Feb 19;24(2):299-321. doi: 10.1080/02699930903384667.
• Payne BK, Cheng CM, Govorun O, Stewart BD. An inkblot for attitudes: affect misattribution as implicit measurement. J Pers Soc Psychol. 2005 Sep;89(3):277-93. doi: 10.1037/0022-3514.89.3.277.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (Estimate): December 10, 2014

Study Record Updates

• Last Update Posted (Estimate): July 15, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 12-2428; R01AT007884-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No