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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Change in nonconscious incentive salience (as measured by the Affect Misattribution Procedure).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Oxytocin
Oxytocin intranasal spray, 6 intranasal sufflations which deliver a total of 24 international units of oxytocin
干预措施: Oxytocin (Drug)
Oxytocin
Oxytocin intranasal spray, 6 intranasal sufflations which deliver a total of 24 international units of oxytocin
干预措施: Lovingkindness Meditation (Behavioral)
Oxytocin
Oxytocin intranasal spray, 6 intranasal sufflations which deliver a total of 24 international units of oxytocin
干预措施: Mindfulness Meditation (Behavioral)
Placebo (for oxytocin)
Intranasal spray with all equivalent ingredients except oxytocin
干预措施: Placebo (for oxytocin) (Drug)
Placebo (for oxytocin)
Intranasal spray with all equivalent ingredients except oxytocin
干预措施: Lovingkindness Meditation (Behavioral)
Placebo (for oxytocin)
Intranasal spray with all equivalent ingredients except oxytocin
干预措施: Mindfulness Meditation (Behavioral)
Lovingkindness Meditation
Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod.
干预措施: Oxytocin (Drug)
Lovingkindness Meditation
Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod.
干预措施: Placebo (for oxytocin) (Drug)
Lovingkindness Meditation
Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod.
干预措施: Lovingkindness Meditation (Behavioral)
Mindfulness Meditation
Mindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod.
干预措施: Oxytocin (Drug)
Mindfulness Meditation
Mindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod.
干预措施: Placebo (for oxytocin) (Drug)
Mindfulness Meditation
Mindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod.
干预措施: Mindfulness Meditation (Behavioral)
结局指标
主要结局
Change in nonconscious incentive salience (as measured by the Affect Misattribution Procedure).
时间窗: 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.
Changes in meditation time
时间窗: 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.
Change in positive emotions (as measured by the Modified Daily Emotions Scale)
时间窗: 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.
次要结局
- Cardiac Vagal Tone(Baseline)
研究者
Barbara L. Fredrickson, PhD
Kenan Distinguished Professor
University of North Carolina, Chapel Hill