Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT02630758
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
2015-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-Based Yoga Intervention for Women With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': '3 months', 'description': 'Change from Baseline Body Mass Index at 3 months'}, {'measure': '7-Day Physical Activity Recall', 'timeFrame': '3 months', 'description': 'Change from Baseline Physical Activity at 3 months'}], 'primaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': '3 months', 'description': 'Change from Baseline Depression at 3 months'}], 'secondaryOutcomes': [{'measure': 'Ruminative Responses Scale', 'timeFrame': '3 months', 'description': 'Change from Baseline Rumination at 3 months'}, {'measure': 'Five Facet Mindfulness Questionnaire', 'timeFrame': '3 months', 'description': 'Change from Baseline Mindfulness at 3 months'}, {'measure': 'Perceived Stress Scale', 'timeFrame': '3 months', 'description': 'Change from Perceived Stress at 3 months'}, {'measure': 'Pittsburgh Sleep Scale', 'timeFrame': '3 months', 'description': 'Change from Baseline Sleep at 3 months'}, {'measure': 'Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form', 'timeFrame': '3 months', 'description': 'Change from Baseline Quality of LIfe Enjoyment and Satisfaction at 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'yoga', 'mindfulness'], 'conditions': ['Depression', 'Depressive Symptoms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women.', 'detailedDescription': "This study was a prospective, randomized controlled intervention pilot study conducted in a metropolitan city in the upper Midwest of the United States. Forty women who met the criteria for depression based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (SCID-I; First, Spitzer, Gibbon, \\& Williams, 1997)were randomized to an experimental mindfulness-based yoga condition (n=20) or a walking control condition (n=20). Both programs were home-based motivational sessions delivered over the telephone and lasted 12 weeks. Assessments were conducted at baseline, three months (i.e., post-intervention), one-month follow-up (i.e., one month after the intervention ended). Participants were instructed to continue their usual depression care. The primary dependent variable was depressive symptoms based on the Beck Depression Inventory (BDI). The secondary dependent variable was rumination scores on the Ruminative Responses Scale (RRS). This protocol was approved by the University of Minnesota's Institutional Review Board (IRB). Participants completed informed consent forms sent through the mail; consent to participate in physical activity was also obtained from the participant's healthcare provider. Recruitment for this trial occurred from February, 2013 to January, 2014 and follow-up assessments were completed by May, 2014."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* a personal history of depression (i.e., ever being told by a healthcare provider that they had depression or given an antidepressant for depression)\n* able to read and write in the English language\n* able to commit to two sessions (yoga or walking) per week for 12 weeks\n* demonstrate a willingness to be randomly assigned to either of the study arms\n* be yoga naïve, defined as not taking more than four yoga classes in the past two years and not more than one class in the past month.\n\nExclusion Criteria:\n\n* individuals with a history of bipolar disorder or schizophrenia and/or who had been hospitalized for a psychiatric disorder within six months prior to the eligibility screening\n* individuals not providing signed informed consent\n* individuals reporting any other health problems that would interfere with regular yoga practice or walking sessions\n* individuals who engaged in more than 90 minutes of moderate intensity physical activity per week during the month prior to the eligibility screening.'}, 'identificationModule': {'nctId': 'NCT02630758', 'briefTitle': 'Mindfulness-Based Yoga Intervention for Women With Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Mindfulness-Based Yoga Intervention for Women With Depression', 'orgStudyIdInfo': {'id': '1203P11124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-based Yoga', 'description': 'Participants in the 12-week mindfulness-based yoga condition were guided by a gentle yoga DVD that included postures (asanas), pranayama (breathing exercises), and relaxation (meditation). Participants were asked to complete 60-75 minutes of the DVD twice per week and were encouraged to do more if they were interested.\n\nFollowing the initial baseline assessment and randomization telephone interview, participants in the yoga group completed weekly 15-minute telephone sessions for the first month and bi-weekly telephone sessions for the second and third for a total of eight sessions over the 12 weeks. The mindfulness telephone sessions were modified from the Mindfulness-Based Stress Reduction.', 'interventionNames': ['Behavioral: Mindfulness-based Yoga']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Walking Control Group', 'description': 'The 12-week walking control condition included twice-weekly home practice with a 65-minute walking DVD (Sansone, 2008) and eight telephone sessions with the telephone counselor.\n\nParticipants were asked to complete 60 minutes of the DVD (or other walking) twice weekly and encouraged to do more if they were interested.\n\nParticipants received telephone sessions on the same schedule as the yoga condition. The education sessions covered a variety of health and wellness related topics.', 'interventionNames': ['Behavioral: Walking Control Condition']}], 'interventions': [{'name': 'Mindfulness-based Yoga', 'type': 'BEHAVIORAL', 'description': 'See study arm description.', 'armGroupLabels': ['Mindfulness-based Yoga']}, {'name': 'Walking Control Condition', 'type': 'BEHAVIORAL', 'description': 'See study arm description.', 'armGroupLabels': ['Walking Control Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Beth A Lewis, PHD, L.P.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}