Study of Wellness Behaviors as a Function of Oxytocin vs Placebo

NCT01929161 | Completed Phase 1

• 2 other identifiers: 12-2371 IRBR01NR012899-03S2
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Sustained Positive Emotions; Sustained Positive Behavior Change

Keywords

positive emotions; meditation; oxytocin

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)

Oxytocin

EXPERIMENTAL

Oxytocin intranasal spray, 6 intranasal sufflations which deliver a total of 24 international units of oxytocin

Drug: Oxytocin; Behavioral: Lovingkindness Meditation; Behavioral: Mindfulness Meditation

Placebo (for oxytocin)

PLACEBO COMPARATOR

Intranasal spray with all equivalent ingredients except oxytocin

Drug: Placebo (for oxytocin); Behavioral: Lovingkindness Meditation; Behavioral: Mindfulness Meditation

Lovingkindness Meditation

EXPERIMENTAL

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

Drug: Oxytocin; Drug: Placebo (for oxytocin); Behavioral: Lovingkindness Meditation

Mindfulness Meditation

PLACEBO COMPARATOR

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

Drug: Oxytocin; Drug: Placebo (for oxytocin); Behavioral: Mindfulness Meditation

Interventions

Oxytocin DRUG

24 International Units

Also known as: Syntocinon

Lovingkindness Meditation; Mindfulness Meditation; Oxytocin

Placebo (for oxytocin) DRUG

intranasal spray manufactured to mimic oxytocin nasal spray

Lovingkindness Meditation; Mindfulness Meditation; Placebo (for oxytocin)

Lovingkindness Meditation BEHAVIORAL

Lovingkindness Meditation; Oxytocin; Placebo (for oxytocin)

Mindfulness Meditation BEHAVIORAL

Mindfulness Meditation; Oxytocin; Placebo (for oxytocin)

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

UNC PEP Lab

Chapel Hill, North Carolina, 27519, United States

Location

MeSH Terms

Interventions

Oxytocin; Mindfulness

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Barbara L Fredrickson, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kenan Distinguished Professor

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 27, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 18, 2016

Record last verified: 2016-07

Locations

US (1)