Study of Wellness Behaviors as a Function of Oxytocin vs Placebo

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Sustained Positive Behavior Change, Sustained Positive Emotions

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo (for oxytocin)
* Behavioral: Lovingkindness Meditation
* Behavioral: Mindfulness Meditation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Previous research by other labs has also found that OT administration increases vagal reactivity. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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positive emotions, meditation, oxytocin