Study of Wellness Behaviors as a Function of Oxytocin vs Placebo

July 14, 2016 updated by: Barbara L. Fredrickson, PhD, University of North Carolina, Chapel Hill

Affective and Genomic Mediators of Sustained Behavior Change: A Randomized, Dual-blind, Placebo-controlled Experimental Design That Will Examine Wellness Behavior as a Function of Oxytocin vs. Placebo.

The specific aim of this study is to test whether oxytocin (OT) boosts the positive emotion yield of a new wellness behavior (Lovingkindness meditation or Mindfulness meditation) and thereby increases nonconscious motives that shape daily behavioral decisions to repeat it, which in turn foster positive emotions that further augment nonconscious motives in an upward spiral dynamic.

The proposed research targets three hypotheses: (1) Oxytocin manipulation magnifies (i.e., moderates) the positive emotion yield of Lovingkindness meditation; (2) The positive emotion yield of meditation, which varies by experimental condition, increases the nonconscious incentive salience of Wellness Behavior-related cues; and (3) Behavioral decisions predict positive emotions, sparking the relationships among OT manipulation, positive emotion yield, and nonconscious incentive salience of Wellness Behavior-related cues.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27519
        • UNC PEP Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between the ages of 35 and 64 years old.
  • Fluent in written and spoken English
  • Willingness or interest in learning to meditate
  • Computer literate with access to internet (weekly)

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Individuals on antihypertensive medication
  • Individuals who have or have had a regular meditation practice
  • Individuals who can read Chinese logographs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Mindfulness Meditation
Mindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod.
Behavioral: Mindfulness Meditation
Drug: Oxytocin
24 International Units
Other Names:
  • Syntocinon
Drug: Placebo (for oxytocin)
intranasal spray manufactured to mimic oxytocin nasal spray
Experimental: Oxytocin
Oxytocin intranasal spray, 6 intranasal sufflations which deliver a total of 24 international units of oxytocin
Behavioral: Mindfulness Meditation
Drug: Oxytocin
24 International Units
Other Names:
  • Syntocinon
Behavioral: Lovingkindness Meditation
Placebo Comparator: Placebo (for oxytocin)
Intranasal spray with all equivalent ingredients except oxytocin
Behavioral: Mindfulness Meditation
Behavioral: Lovingkindness Meditation
Drug: Placebo (for oxytocin)
intranasal spray manufactured to mimic oxytocin nasal spray
Experimental: Lovingkindness Meditation
Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod.
Drug: Oxytocin
24 International Units
Other Names:
  • Syntocinon
Behavioral: Lovingkindness Meditation
Drug: Placebo (for oxytocin)
intranasal spray manufactured to mimic oxytocin nasal spray

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)
Time Frame: Baseline and Weeks 1, 2, and 3
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
Changes in meditation time
Time Frame: Weeks 1, 2, and 3
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
Change in nonconscious incentive salience (as measured by the Affect Misattribution Procedure).
Time Frame: Baseline and Weeks 1, 2, and 3
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Vagal Tone
Time Frame: Baseline
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. Previous research by other labs has also found that OT administration increases vagal reactivity.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Barbara L Fredrickson, Ph.D., University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 1, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-2371 IRB
  • R01NR012899-03S2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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