Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-04 @ 11:10 PM
Study NCT ID:
NCT02098018
Status:
COMPLETED
Last Update Posted:
2016-08-02
First Post:
2014-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Stress Reduction Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2014-03-18', 'studyFirstSubmitQcDate': '2014-03-24', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Perceived Stress', 'timeFrame': 'baseline to 24 weeks', 'description': 'Participants will complete a short questionnaire about how stressed they feel. There will be 4 time points: baseline, week 8, week 12, week 24.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stress']}, 'referencesModule': {'references': [{'pmid': '34868736', 'type': 'DERIVED', 'citation': 'Braun TD, Riley KE, Kunicki ZJ, Finkelstein-Fox L, Conboy LA, Park CL, Schifano E, Abrantes AM, Lazar SW. Internalized weight stigma and intuitive eating among stressed adults during a mindful yoga intervention: associations with changes in mindfulness and self-compassion. Health Psychol Behav Med. 2021 Nov 19;9(1):933-950. doi: 10.1080/21642850.2021.1992282. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'There are many ways to reduce stress. This study will compare 2 different programs for reducing stress. In addition to looking at how well the programs reduce stress, we will also ask questions about how these programs may be working.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25-50 years of age\n* Able to engage in moderate physical activity\n* Interested in being treated for stress\n\nExclusion Criteria:\n\n* Use of psychotropic medications within 6 months prior to study.\n* History of extreme physical or psychological trauma.\n* Medical conditions that would interfere with study procedures or confound results, such as diabetes, pregnancy, or paralysis.\n* Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, or eating disorder.'}, 'identificationModule': {'nctId': 'NCT02098018', 'briefTitle': 'Comparison of Stress Reduction Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'orgStudyIdInfo': {'id': 'R34AT007197', 'link': 'https://reporter.nih.gov/quickSearch/R34AT007197', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Program 1', 'description': 'Program 1', 'interventionNames': ['Behavioral: Program 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Program 2', 'description': 'Program 2', 'interventionNames': ['Behavioral: Program 2']}], 'interventions': [{'name': 'Program 2', 'type': 'BEHAVIORAL', 'description': 'A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.', 'armGroupLabels': ['Program 2']}, {'name': 'Program 1', 'type': 'BEHAVIORAL', 'description': 'A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.', 'armGroupLabels': ['Program 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Storrs', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut- Storrs', 'geoPoint': {'lat': 41.80843, 'lon': -72.24952}}, {'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusettts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sara Lazar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Connecticut', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Research Scientist', 'investigatorFullName': 'Sara W Lazar', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}