Meditation and Decision Making Study III

Meditation Clinical Trial

— MDMS3  

Official title:

Nonconscious Affective and Physiological Mediators of Behavioral Decision Making Study 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313779
• Other study ID #: 12-2428
• Secondary ID: R01AT007884-01
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: July 14, 2016
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: July 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Meditation

Intervention

Behavioral:
• Lovingkindness Meditation (LKM)
Compassionate behavior training (REVISE)
• Mindfulness Meditation

Locations

Country	Name	City	State
United States	UNC PEP Lab	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Barbara L. Fredrickson, PhD	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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):1045-62. doi: 10.1037/a0013262. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No

External Links

•   Study Webpage