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Study of Wellness Behaviors as a Function of Oxytocin vs Placebo

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ClinicalTrials.gov Identifier: NCT01929161
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : July 18, 2016
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Barbara L. Fredrickson, PhD, University of North Carolina, Chapel Hill

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Sustained Positive Emotions Sustained Positive Behavior Change Drug: Oxytocin Drug: Placebo (for oxytocin) Behavioral: Lovingkindness Meditation Behavioral: Mindfulness Meditation Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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.
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
Oxytocin intranasal spray, 6 intranasal sufflations which deliver a total of 24 international units of oxytocin
Drug: Oxytocin
24 International Units
Other Name: Syntocinon

Behavioral: Lovingkindness Meditation
Behavioral: Mindfulness Meditation
Placebo Comparator: Placebo (for oxytocin)
Intranasal spray with all equivalent ingredients except oxytocin
Drug: Placebo (for oxytocin)
intranasal spray manufactured to mimic oxytocin nasal spray

Behavioral: Lovingkindness Meditation
Behavioral: Mindfulness Meditation
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 Name: Syntocinon

Drug: Placebo (for oxytocin)
intranasal spray manufactured to mimic oxytocin nasal spray

Behavioral: Lovingkindness Meditation
Placebo Comparator: Mindfulness Meditation
Mindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod.
Drug: Oxytocin
24 International Units
Other Name: Syntocinon

Drug: Placebo (for oxytocin)
intranasal spray manufactured to mimic oxytocin nasal spray

Behavioral: Mindfulness Meditation



Primary Outcome Measures :
  1. 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.

  2. 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.

  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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929161


Locations
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United States, North Carolina
UNC PEP Lab
Chapel Hill, North Carolina, United States, 27519
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Barbara L Fredrickson, Ph.D. University of North Carolina, Chapel Hill
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Responsible Party: Barbara L. Fredrickson, PhD, Kenan Distinguished Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01929161    
Other Study ID Numbers: 12-2371 IRB
R01NR012899-03S2 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Keywords provided by Barbara L. Fredrickson, PhD, University of North Carolina, Chapel Hill:
positive emotions
meditation
oxytocin
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs