Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-29 @ 3:30 PM
Study NCT ID:
NCT01057368
Status:
COMPLETED
Last Update Posted:
2014-06-05
First Post:
2010-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2010-01-22', 'studyFirstSubmitQcDate': '2010-01-22', 'lastUpdatePostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI BOLD', 'timeFrame': 'Pre, Post, Follow-up (WL & LTP)'}, {'measure': 'EEG', 'timeFrame': 'Pre, post, & follow-up (WL & LTP)'}, {'measure': 'Salivary Cortisol', 'timeFrame': 'Pre, post, & follow-up (WL & LTP)'}, {'measure': 'Behavioral', 'timeFrame': 'Pre, post, & follow-up (WL & LTP)'}, {'measure': 'Self-report', 'timeFrame': 'Pre, post, & follow-up (WL & LTP)'}], 'secondaryOutcomes': [{'measure': 'Self-report', 'timeFrame': 'Pre, post, & follow-up (WL & LTP)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Health', 'Mental Health']}, 'referencesModule': {'references': [{'pmid': '35899379', 'type': 'DERIVED', 'citation': 'Wielgosz J, Kral TRA, Perlman DM, Mumford JA, Wager TD, Lutz A, Davidson RJ. Neural Signatures of Pain Modulation in Short-Term and Long-Term Mindfulness Training: A Randomized Active-Control Trial. Am J Psychiatry. 2022 Oct;179(10):758-767. doi: 10.1176/appi.ajp.21020145. Epub 2022 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'This study is focused on the brain mechanisms and peripheral biological correlates of two different forms of meditation--mindfulness-based and compassion/loving-kindness. Project 1 is focused on the impact of compassion/loving-kindness meditation on emotional reactivity and emotion regulation. Project 2 is focused on the neural and behavioral correlates of mindfulness meditation and attention and pain regulation. In addition, Project 2 will examine the relations between changes in oscillatory rhythms during meditation and attention and pain processing. Project 3 will examine the impact of meditation on spontaneous brain activity during sleep. This project will also examine the impact of intensive meditation on regional changes in slow wave activity during subsequent sleep. Each of these projects will be conducted on the same participants so that interrelations among the various measures collected in the different projects can be examined. We believe that this study will dramatically advance the understanding of the mechanisms by which meditation produces changes in behavioral and biological processes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MRI safe\n\nExclusion Criteria:\n\n* Not available for scheduled visits or applicable interventions\n* Current medical conditions that may affect outcome measures, including chronic inflammatory diseases, asthma, serious mental health diagnoses, chronic pain conditions, a personal history of seizures\n* Regularly taking medications that may affect outcome measures, including pain medications, corticosteroids, immuno-suppressants, prescription sleep medications, psychotropic medications\n* Alcohol or non-prescription drug problems\n* Night-shift worker\n* Diagnosed sleep disorder or habits, such as late bedtime, that would prevent enough sleep in the laboratory\n* Previous training related to one of the two active interventions for meditation naive participants\n* Unwillingness or inability to engage in intervention activities as determined by participant or their primary care physician\n* Currently pregnant or planning on becoming pregnant in the next year\n* Currently nursing\n* Current IUD'}, 'identificationModule': {'nctId': 'NCT01057368', 'briefTitle': 'The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation', 'orgStudyIdInfo': {'id': 'WBP01-AT004952'}, 'secondaryIdInfos': [{'id': 'P01AT004952', 'link': 'https://reporter.nih.gov/quickSearch/P01AT004952', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness Based Stress Reduction', 'interventionNames': ['Behavioral: Mindfulness Based Stress Reduction (MBSR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Enhancement Program', 'interventionNames': ['Behavioral: Health Enhancement Program (HEP)']}, {'type': 'NO_INTERVENTION', 'label': 'Wait List Controls'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long Term Meditators', 'interventionNames': ['Behavioral: Day of intensive meditation practice']}], 'interventions': [{'name': 'Day of intensive meditation practice', 'type': 'BEHAVIORAL', 'description': 'Long-term meditators practice for \\~6 hours of meditation at each time point', 'armGroupLabels': ['Long Term Meditators']}, {'name': 'Mindfulness Based Stress Reduction (MBSR)', 'type': 'BEHAVIORAL', 'otherNames': ['MBSR'], 'description': '8-week class designed to enhance well-being through training in mindfulness meditation', 'armGroupLabels': ['Mindfulness Based Stress Reduction']}, {'name': 'Health Enhancement Program (HEP)', 'type': 'BEHAVIORAL', 'otherNames': ['HEP'], 'description': '8-week class designed to enhance well-being through training in physical activity, functional movement, music therapy, and nutrition', 'armGroupLabels': ['Health Enhancement Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Wisconsin Sleep Laboratory', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW-Health Sports Medicine & Integrative Medicine Program', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW-Madison, Laboratory for Affective Neuroscience', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Richard J Davidson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW-Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}