Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00271856
Status:
COMPLETED
Last Update Posted:
2012-04-17
First Post:
2005-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV
Sponsor:
Organization:
Raw JSON
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The BDI consists of 21 items that are rated on a 4-point scale according to how severely they are experienced. Scores range from 0-63, with higher scores reflecting greater depression.', 'unitOfMeasure': 'scores on the scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analyses.'}, {'type': 'PRIMARY', 'title': 'Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mindfulness-Based Stress Reduction (MBSR)', 'description': 'Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.'}, {'id': 'OG001', 'title': '1-HIV Education/Self-management', 'description': 'HIV education/self-management workshop: 8 weekly classes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'groupId': 'OG000', 'lowerLimit': '-2.14', 'upperLimit': '0.99'}, {'value': '-2.03', 'groupId': 'OG001', 'lowerLimit': '-3.35', 'upperLimit': '-0.71'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months', 'description': 'Perception of stress was measured with the 10-item version of the Perceived Stress Scale. This widely used measure of perceived stress was designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate how often they felt or thought a certain way over the past month on a 4-point scale (0 = Never, 4 = Very Often). Scores range from 0-40, with higher scores reflecting greater perceived stress.', 'unitOfMeasure': 'scores on the scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analyses.'}, {'type': 'PRIMARY', 'title': 'Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mindfulness-Based Stress Reduction (MBSR)', 'description': 'Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.'}, {'id': 'OG001', 'title': '1-HIV Education/Self-management', 'description': 'HIV education/self-management workshop: 8 weekly classes.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000', 'lowerLimit': '-0.74', 'upperLimit': '3.13'}, {'value': '1.64', 'groupId': 'OG001', 'lowerLimit': '-0.22', 'upperLimit': '3.50'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months', 'description': 'Emotion was assessed with the Positive and Negative Affect Schedule (PANAS). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Positive Affect (PA) score is derived from summing the scores on the 10 positive emotions. Scores on the PA subscale range from 0-40, with higher scores reflecting more positive affect over the past week.', 'unitOfMeasure': 'scores on the scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analyses'}, {'type': 'PRIMARY', 'title': 'Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mindfulness-Based Stress Reduction (MBSR)', 'description': 'Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.'}, {'id': 'OG001', 'title': '1-HIV Education/Self-management', 'description': 'HIV education/self-management workshop: 8 weekly classes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.17', 'groupId': 'OG000', 'lowerLimit': '-4.25', 'upperLimit': '-0.085'}, {'value': '-2.63', 'groupId': 'OG001', 'lowerLimit': '-4.27', 'upperLimit': '-0.99'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months', 'description': 'Emotion was assessed with the Positive and Negative Affect Schedule (PANAS\\\\). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Negative Affect (NA) score is derived from summing the scores on the 10 negative emotions. Scores on the NA subscale range from 0-40, with higher scores reflecting more negative affect over the past week.', 'unitOfMeasure': 'scores on the scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analyses.'}, {'type': 'PRIMARY', 'title': 'Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mindfulness-Based Stress Reduction (MBSR)', 'description': 'Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.'}, {'id': 'OG001', 'title': '1-HIV Education/Self-management', 'description': 'HIV education/self-management workshop: 8 weekly classes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-2.44', 'upperLimit': '0.44'}, {'value': '-1.46', 'groupId': 'OG001', 'lowerLimit': '-2.71', 'upperLimit': '-0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months', 'description': 'We used the Patient Health Questionnaire (PHQ-9) as a measure of depressive symptom severity. The PHQ-9 is the depression module of the self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument. Participants rate the frequency of 9 depression symptoms over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores reflecting greater severity of depressive symptoms.', 'unitOfMeasure': 'scores on the scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0 Mindfulness-Based Stress Reduction (MBSR)', 'description': 'Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.'}, {'id': 'FG001', 'title': '1-HIV Education/Self-management', 'description': 'HIV education/self-management workshop: 8 weekly classes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Participants were recruited between July 2005 to August 2008 through newspaper advertisements, electronic bulletin boards, community postings and fliers in clinics.', 'preAssignmentDetails': 'Enrolled participants were screened to determine if inclusion criteria were met. This process included structured phone interviews, medical history review, and laboratory results.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '0 Mindfulness-Based Stress Reduction (MBSR)', 'description': 'Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.'}, {'id': 'BG001', 'title': '1-HIV Education/Self-management', 'description': 'HIV education/self-management workshop: 8 weekly classes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '9.36', 'groupId': 'BG000'}, {'value': '40.5', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '40.8', 'spread': '9.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-11', 'studyFirstSubmitDate': '2005-12-30', 'resultsFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2005-12-30', 'lastUpdatePostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-02', 'studyFirstPostDateStruct': {'date': '2006-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CD4 T-cell Count', 'timeFrame': 'baseline to 12 months'}, {'measure': 'Change in Depression as Measured by Beck Depression Inventory (BDI)', 'timeFrame': 'baseline to 12 months', 'description': 'The BDI is a widely used outcome measure for studies of depression. The BDI consists of 21 items that are rated on a 4-point scale according to how severely they are experienced. Scores range from 0-63, with higher scores reflecting greater depression.'}, {'measure': 'Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)', 'timeFrame': 'baseline to 12 months', 'description': 'Perception of stress was measured with the 10-item version of the Perceived Stress Scale. This widely used measure of perceived stress was designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate how often they felt or thought a certain way over the past month on a 4-point scale (0 = Never, 4 = Very Often). Scores range from 0-40, with higher scores reflecting greater perceived stress.'}, {'measure': 'Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score', 'timeFrame': 'baseline to 12 months', 'description': 'Emotion was assessed with the Positive and Negative Affect Schedule (PANAS). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Positive Affect (PA) score is derived from summing the scores on the 10 positive emotions. Scores on the PA subscale range from 0-40, with higher scores reflecting more positive affect over the past week.'}, {'measure': 'Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score', 'timeFrame': 'baseline to 12 months', 'description': 'Emotion was assessed with the Positive and Negative Affect Schedule (PANAS\\\\). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Negative Affect (NA) score is derived from summing the scores on the 10 negative emotions. Scores on the NA subscale range from 0-40, with higher scores reflecting more negative affect over the past week.'}, {'measure': 'Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'baseline to 12 months', 'description': 'We used the Patient Health Questionnaire (PHQ-9) as a measure of depressive symptom severity. The PHQ-9 is the depression module of the self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument. Participants rate the frequency of 9 depression symptoms over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores reflecting greater severity of depressive symptoms.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (Short Form Health Survey; SF-36); Cortisol (Basal a.m. and Diurnal Change); T-cell Activation (i.e. CD38-cell Surface Marker) and NK Cell Number and Function; Autonomic Nervous System Activity ; Cell Aging', 'timeFrame': '3, 6, and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Meditation', 'Stress', 'Randomized Controlled Trial', 'Complementary Therapies', 'MBSR', 'Not on ART medications'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'To examine the effects of Mindfulness-Based Stress Reduction (MBSR) and education groups on HIV (Human Immunodeficiency Syndrome) infection. Key outcomes include CD4 and viral load, stress hormones, depression and quality of life.', 'detailedDescription': 'Stress and depression are associated with more rapid loss of CD4 cells in HIV infection. Interventions that slow the advance of HIV infection and delay the introduction of antiretroviral therapy (ART) could make an important contribution to HIV management in both the developed and developing world. We are conducting a 330 person randomized, controlled clinical trial of MBSR for persons with HIV-1 infection and CD4 T-lymphocyte counts \\> 250 cells/µm who are not on antiretroviral therapy. Participants are randomized in a 1:1 distribution to either the MBSR intervention or to an education group that will control for the attention and social interaction aspects of MBSR. Participants are evaluated at 0, 3, 6 and 12 months. Key outcome measures at 12 months include differences in CD4 T cell counts, HIV viral load, perceived stress, depression, and positive affect. We are also examining whether MBSR is associated with changes in neuroendocrine function (autonomic nervous system activity, cortisol secretion) and alterations in immune function that may serve as intermediate steps between the neuroendocrine effects of MBSR and CD4 T cell counts, such as changes in T cell activation. A subset of 90 participants will be studied in additional detail using a structured laboratory stress challenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV+\n* Viral Load\\>100\n* CD4 T-Cells\\>250\n* Not on Antiretroviral therapy (ART)\n* Ability to Speak English\n* Stable address/living situation\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Use of ART within the past 120 days\n* Any substance abuse,mental health or medical condition that the opinion of the Principal Investigator (PI) would make it difficult for the potential participant to participate in the intervention\n* Plans to start ART in the next 12 months\n* Previous MBSR training and/or current practice\n* Current use or use in past 6 months (mos.) of chemotherapy or immunomodulator drugs, including oral steroids or plans to start in the next 12 mos.\n* Initiation of new class of psychiatric medication in past 2 months.'}, 'identificationModule': {'nctId': 'NCT00271856', 'briefTitle': 'Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Mindfulness-Based Stress Reduction (MBSR), Stress Arousal and Immune Response in Early HIV', 'orgStudyIdInfo': {'id': 'P01AT002024', 'link': 'https://reporter.nih.gov/quickSearch/P01AT002024', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'P01AT002024', 'link': 'https://reporter.nih.gov/quickSearch/P01AT002024', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0', 'description': 'Mindfulness Based Stress Reduction (MBSR)', 'interventionNames': ['Behavioral: Mindfulness-Based Stress Reduction (MBSR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'HIV education/self-management workshop', 'interventionNames': ['Behavioral: HIV-education and self-management workshop']}], 'interventions': [{'name': 'Mindfulness-Based Stress Reduction (MBSR)', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness meditation'], 'description': '8 week MBSR course', 'armGroupLabels': ['0']}, {'name': 'HIV-education and self-management workshop', 'type': 'BEHAVIORAL', 'description': '8-week group covering a variety of educational topics about managing HIV infection.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143-1726', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Osher Center for Integrative Medicine', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Frederick M. Hecht, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Susan Folkman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}