NCT02313779

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

December 8, 2014

Last Update Submit

July 14, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Cardiac Vagal Tone

    Baseline

Study Arms (4)

Neutral

PLACEBO COMPARATOR

Reading passage about brain function which is masked as a news article.

Behavioral: Lovingkindness Meditation (LKM)Behavioral: Mindfulness Meditation

Lovingkindness Meditation (LKM)

EXPERIMENTAL

Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod.

Behavioral: Lovingkindness Meditation (LKM)

Mindfulness Meditation

PLACEBO COMPARATOR

Mindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod.

Behavioral: Mindfulness Meditation

Positivity

EXPERIMENTAL

Reading passage about prioritizing positive emotions which is masked as a news article.

Behavioral: Lovingkindness Meditation (LKM)Behavioral: Mindfulness Meditation

Interventions

Compassionate behavior training (REVISE)

Lovingkindness Meditation (LKM)NeutralPositivity
Mindfulness MeditationNeutralPositivity

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC PEP Lab

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (4)

  • 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.

    PMID: 18954193BACKGROUND
  • 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.

    PMID: 19267330BACKGROUND
  • 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.

    PMID: 23275681BACKGROUND
  • 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.

    PMID: 16248714BACKGROUND

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Barbara L Fredrickson, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nonconscious Affective and Physiological Mediators of Behavioral Decision Making Study 3

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 10, 2014

Study Start

December 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 15, 2016

Record last verified: 2016-07

Locations