Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-01-04 @ 10:46 PM
Study NCT ID:
NCT01929161
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2013-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Wellness Behaviors as a Function of Oxytocin vs Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2013-08-01', 'studyFirstSubmitQcDate': '2013-08-21', 'lastUpdatePostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in positive emotions (as measured by the Modified Daily Emotions Scale)', 'timeFrame': 'Baseline and Weeks 1, 2, and 3', 'description': "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."}, {'measure': 'Change in nonconscious incentive salience (as measured by the Affect Misattribution Procedure).', 'timeFrame': 'Baseline and Weeks 1, 2, and 3', 'description': '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.'}, {'measure': 'Changes in meditation time', 'timeFrame': 'Weeks 1, 2, and 3', 'description': 'Self-reported meditation time recorded daily and weekly. In addition, meditation track play times will be recorded from the iPod.'}], 'secondaryOutcomes': [{'measure': 'Cardiac Vagal Tone', 'timeFrame': 'Baseline', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['positive emotions', 'meditation', 'oxytocin'], 'conditions': ['Sustained Positive Emotions', 'Sustained Positive Behavior Change']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between the ages of 35 and 64 years old.\n* Fluent in written and spoken English\n* Willingness or interest in learning to meditate\n* Computer literate with access to internet (weekly)\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Individuals on antihypertensive medication\n* Individuals who have or have had a regular meditation practice\n* Individuals who can read Chinese logographs'}, 'identificationModule': {'nctId': 'NCT01929161', 'briefTitle': 'Study of Wellness Behaviors as a Function of Oxytocin vs Placebo', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '12-2371 IRB'}, 'secondaryIdInfos': [{'id': 'R01NR012899-03S2', 'link': 'https://reporter.nih.gov/quickSearch/R01NR012899-03S2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin', 'description': 'Oxytocin intranasal spray, 6 intranasal sufflations which deliver a total of 24 international units of oxytocin', 'interventionNames': ['Drug: Oxytocin', 'Behavioral: Lovingkindness Meditation', 'Behavioral: Mindfulness Meditation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (for oxytocin)', 'description': 'Intranasal spray with all equivalent ingredients except oxytocin', 'interventionNames': ['Drug: Placebo (for oxytocin)', 'Behavioral: Lovingkindness Meditation', 'Behavioral: Mindfulness Meditation']}, {'type': 'EXPERIMENTAL', 'label': 'Lovingkindness Meditation', 'description': 'Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod.', 'interventionNames': ['Drug: Oxytocin', 'Drug: Placebo (for oxytocin)', 'Behavioral: Lovingkindness Meditation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Mindfulness Meditation', 'description': 'Mindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod.', 'interventionNames': ['Drug: Oxytocin', 'Drug: Placebo (for oxytocin)', 'Behavioral: Mindfulness Meditation']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Syntocinon'], 'description': '24 International Units', 'armGroupLabels': ['Lovingkindness Meditation', 'Mindfulness Meditation', 'Oxytocin']}, {'name': 'Placebo (for oxytocin)', 'type': 'DRUG', 'description': 'intranasal spray manufactured to mimic oxytocin nasal spray', 'armGroupLabels': ['Lovingkindness Meditation', 'Mindfulness Meditation', 'Placebo (for oxytocin)']}, {'name': 'Lovingkindness Meditation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Lovingkindness Meditation', 'Oxytocin', 'Placebo (for oxytocin)']}, {'name': 'Mindfulness Meditation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Mindfulness Meditation', 'Oxytocin', 'Placebo (for oxytocin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27519', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC PEP Lab', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Barbara L Fredrickson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kenan Distinguished Professor', 'investigatorFullName': 'Barbara L. Fredrickson, PhD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}