Sustained Positive EmotionsPhase 1NCT01929161
Study of Wellness Behaviors as a Function of Oxytocin vs Placebo
A Phase 1 study testing Oxytocin, Lovingkindness Meditation and Mindfulness Meditation in people with Sustained Positive Emotions and Sustained Positive Behavior Change, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Sustained Positive Emotions, Sustained Positive Behavior Change
- What is being tested?
- Oxytocin, Lovingkindness Meditation and Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Oxytocin, Placebo (for oxytocin), Lovingkindness Meditation, Mindfulness Meditation
- Keywords
- positive emotions, meditation, oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
24 International Units
Placebo (for oxytocin)Drug
intranasal spray manufactured to mimic oxytocin nasal spray
Lovingkindness MeditationBehavioural
Mindfulness MeditationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Oxytocin intranasal spray, 6 intranasal sufflations which deliver a total of 24 international units of oxytocin Receives: Drug: Oxytocin; Behavioral: Lovingkindness Meditation; Behavioral: Mindfulness Meditation |
| Placebo (for oxytocin) | Placebo comparator | Intranasal spray with all equivalent ingredients except oxytocin Receives: 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. Receives: 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. Receives: Drug: Oxytocin; Drug: Placebo (for oxytocin); Behavioral: Mindfulness Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Weeks 1, 2, and 3
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sustained Positive EmotionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Barbara L. Fredrickson, PhD, University of North Carolina, Chapel Hill
- Investigators
- Barbara L Fredrickson, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929161
- Sponsor's protocol ID
- 12-2371 IRB
- Other IDs
- R01NR012899-03S2
- Status last verified
- Jul 2016
- First submitted
- 1 Aug 2013
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01929161
- Acronym / sponsor ID
- 12-2371 IRB
- Keywords
- positive emotions, meditation, oxytocin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin, Behavioral: Lovingkindness Meditation, Behavioral: Mindfulness MeditationOxytocin intranasal spray, 6 intranasal sufflations which deliver a total of 24 international units of oxytocin |
| Placebo (for oxytocin) | Placebo comparator | Drug: Placebo (for oxytocin), Behavioral: Lovingkindness Meditation, Behavioral: Mindfulness MeditationIntranasal spray with all equivalent ingredients except oxytocin |
| Lovingkindness Meditation | Experimental | Drug: Oxytocin, Drug: Placebo (for oxytocin), Behavioral: Lovingkindness MeditationLovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod. |
| Mindfulness Meditation | Placebo comparator | Drug: Oxytocin, Drug: Placebo (for oxytocin), Behavioral: Mindfulness MeditationMindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: Syntocinon24 International Units | Drug | Lovingkindness Meditation, Mindfulness Meditation, Oxytocin |
| Placebo (for oxytocin)intranasal spray manufactured to mimic oxytocin nasal spray | Drug | Lovingkindness Meditation, Mindfulness Meditation, Placebo (for oxytocin) |
| Lovingkindness Meditation | Behavioural | Lovingkindness Meditation, Oxytocin, Placebo (for oxytocin) |
| Mindfulness Meditation | Behavioural | Mindfulness Meditation, Oxytocin, Placebo (for oxytocin) |
Primary outcome
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.
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.
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.
1 secondary outcome
Cardiac Vagal Tone
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara L Fredrickson, Ph.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin, Lovingkindness Meditation and Mindfulness Meditation in people with Sustained Positive Emotions and Sustained Positive Behavior Change, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in positive emotions (as measured by the Modified Daily Emotions Scale) (time frame: Baseline and Weeks 1, 2, and 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.