Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT03456505
Status:
COMPLETED
Last Update Posted:
2018-10-01
First Post:
2018-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dissecting De-automatization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-28', 'studyFirstSubmitDate': '2018-01-12', 'studyFirstSubmitQcDate': '2018-02-28', 'lastUpdatePostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conditioned Eyeblink Frequency', 'timeFrame': '9 minutes', 'description': 'Between group differences in the frequency of conditioned eyeblinks over the six reinforcement blocks.'}], 'secondaryOutcomes': [{'measure': 'Positive Emotion Regulation Task', 'timeFrame': '5 minutes', 'description': 'Between group differences in affective change occasioned by savoring positive images will be measured by comparing increases in self-reported positive affect (5-point Likert scale) from pre- to post- positive image, viewing block.'}, {'measure': 'Negative Emotion Regulation Task', 'timeFrame': '5 minutes', 'description': 'Between group differences in affective change occasioned by positively reappraising negative images will be measured by comparing increases in self-reported negative affect (5-point Likert scale) from pre- to post- negative image, viewing block.'}, {'measure': 'Self-Transcendence (NADA-State)', 'timeFrame': '2 minutes', 'description': "Between group differences in the degree to which mindfulness training alters participants' sense of self as measured by the nondaul awareness dimension assessment's (NADA) state form."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mindfulness']}, 'descriptionModule': {'briefSummary': 'The proposed study will assess the effects of mindfulness meditation training on an eye blink conditioning (EBC) task in a sample of novice meditators. This methodology will allow investigation of whether mindfulness interrupts classical conditioning through the process of de-automatization. Implicit learning rates, as reflective of unconscious habit formation and measured by the frequency of conditioned responses during the EBC, will be a main outcome of interest. The proposed study will also assess the effects of mindfulness meditation training on an emotion regulation (ER) task, with a specific focus on reappraisal of negative images and savoring of positive images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-60,\n2. willingness to participate in study interventions and assessments.\n\nExclusion Criteria:\n\n1. Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention, or a history of meditation practice,\n2. Learning disability, significant memory problems or significant attentional disruptions as determined by self-report,\n3. History of head injury resulting in loss of consciousness.'}, 'identificationModule': {'nctId': 'NCT03456505', 'briefTitle': 'Dissecting De-automatization', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Dissecting De-automatization: The Effect of Mindfulness Training on Unconscious Habit Formation', 'orgStudyIdInfo': {'id': 'IRB_00088540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness', 'description': 'Participants randomly assigned to the mindfulness meditation condition will meet for five, 15-minute sessions, in which they will receive training in basic mindfulness skills (Wallace, 2006).', 'interventionNames': ['Behavioral: Mindfulness Meditation Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Listening', 'description': "Participants randomly assigned to the active listening condition will meet for five, 15-minute sessions, in which they will listen to Gilbert White's The Natural History of Selborne.", 'interventionNames': ['Behavioral: Active Listening']}], 'interventions': [{'name': 'Mindfulness Meditation Training', 'type': 'BEHAVIORAL', 'description': 'A researcher will guide participants through 5 mindfulness meditations, each lasting 11 minutes in length.', 'armGroupLabels': ['Mindfulness']}, {'name': 'Active Listening', 'type': 'BEHAVIORAL', 'description': 'A researcher will read participants 5 selections from The Natural History of Selborne, each lasting 11 minutes in length.', 'armGroupLabels': ['Active Listening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adam Hanley', 'investigatorAffiliation': 'University of Utah'}}}}