Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT04652869
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2020-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mindfulness + tDCS to Reduce Urgency Incontinence in Women
Sponsor:
Organization:
Raw JSON
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'term': 'Transcranial Direct Current Stimulation'}, {'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'conkca@upmc.edu', 'phone': '4125869840', 'title': 'Dr. Cynthia Conklin', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year 6 months (entire recruitment period)', 'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness Training', 'description': "Mindfulness training\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Mindfulness + tDCS', 'description': "Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': "Mindfulness training\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}, {'id': 'OG001', 'title': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex'}, {'id': 'OG002', 'title': 'Mindfulness + tDCS', 'description': "Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '90.4', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-weeks post intervention', 'description': 'Feasibility is measured as the number of participants who completed the study divided by the total number of participants who started the intervention.', 'unitOfMeasure': 'percentage of participants who completed', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants that started the intervention (i.e. attended the first intervention visit) was 61. Thus, 61 participants started the intervention, and 59 participant completed all visits and intervention procedures'}, {'type': 'PRIMARY', 'title': 'Acceptability of Study Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': "Mindfulness training\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}, {'id': 'OG001', 'title': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex'}, {'id': 'OG002', 'title': 'Mindfulness + tDCS', 'description': "Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}], 'classes': [{'categories': [{'measurements': [{'value': '85.6', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '83.4', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '80.4', 'spread': '12.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks post intervention', 'description': 'Acceptability of study procedures was measured by 8-items assessing burden, difficulty, likeability of the study procedures on a 0-100 scale on the Post-Study Survey. A higher score indicates greater acceptability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on number of mail-in acceptability questionnaires returned. Questionnaires were not returned for 2 participants in the transcranial direct current stimulation(tDCS) group and 2 participants in the Mindfulness group.'}, {'type': 'PRIMARY', 'title': 'Compliance With Study Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': "Mindfulness training\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}, {'id': 'OG001', 'title': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex'}, {'id': 'OG002', 'title': 'Mindfulness + tDCS', 'description': "Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}], 'classes': [{'title': 'Diary Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88.3', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '84.1', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '90.5', 'spread': '10.0', 'groupId': 'OG002'}]}]}, {'title': 'Mindfulness Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94.4', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '93.0', 'spread': '10.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks post intervention', 'description': 'Compliance with study procedures measured by 2-items with a 0-100 scale on the Post-Study Survey. A higher score indicates greater compliance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Transcranial Direct Current Stimulation group did not answer mindfulness compliance question. Analysis is based on number of mail-in acceptability questionnaires returned. Questionnaires were not returned for 2 participants in the transcranial direct current stimulation(tDCS) group and 2 participants in the Mindfulness group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': "Mindfulness training\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}, {'id': 'OG001', 'title': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex'}, {'id': 'OG002', 'title': 'Mindfulness + tDCS', 'description': "Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}], 'classes': [{'categories': [{'measurements': [{'value': '-25', 'spread': '20', 'groupId': 'OG000'}, {'value': '-35', 'spread': '13', 'groupId': 'OG001'}, {'value': '-19', 'spread': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-intervention) to 1 week after completion of intervention activities', 'description': 'Urinary urgency in response to personal photographic cues was self-reported by participants on 4 post-picture trial questions. Ratings were done using a 0-100 scale. The 4 items were averaged to calculate an urgency cue rating and safe cue rating for each picture trial. An overall Cue reactivity urgency rating was calculated for each participant by averaging their total urgency cue trial ratings. The same was done for safe cues.\n\nCue reactivity was calculated as the difference between the overall rating averages for urgency cues and safe cues.\n\nCue reactivity post-intervention was subtracted from that calculated for baseline. A lower score indicates greater reduction in cue-reactivity', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to computer error at the time of data collection, data were not collected for three participants for this analysis (one per group).'}, {'type': 'PRIMARY', 'title': 'Reaction Time to Urinary Stroop Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': "Mindfulness training\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}, {'id': 'OG001', 'title': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex'}, {'id': 'OG002', 'title': 'Mindfulness + tDCS', 'description': "Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}], 'classes': [{'categories': [{'measurements': [{'value': '-36.95', 'spread': '102.25', 'groupId': 'OG000'}, {'value': '-16.89', 'spread': '87.30', 'groupId': 'OG001'}, {'value': '-81.63', 'spread': '78.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-intervention) to 1 week after completion of intervention activities', 'description': 'Change in reaction time to words associated with urgency from baseline to post-intervention. A lower score indicates greater reduction in reaction time.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to computer error at the time of data collection, data were not collected for three participants for this analysis (one per group).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': "Mindfulness training\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}, {'id': 'OG001', 'title': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex'}, {'id': 'OG002', 'title': 'Mindfulness + tDCS', 'description': "Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.65', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '-2.10', 'spread': '0.79', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-intervention) to 1 week after completion of intervention activities', 'description': 'Change from baseline in severity of bladder problem measured by the ICIQ-FLUTS (International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms) a 12-item questionnaire (each item rated 0-4) evaluating urinary tract symptoms and impact on quality of life. A higher total score indicates greater symptoms and greater impact on quality of life. Score range (0-48) ICIQ-FLUTS was completed at baseline (pre-intervention) and one week after completion of all intervention activities. Pre-intervention score was subtracted from post-intervention score. A more negative score indicates greater symptom reduction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training', 'description': "Mindfulness training\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}, {'id': 'OG001', 'title': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex'}, {'id': 'OG002', 'title': 'Mindfulness + tDCS', 'description': "Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '-0.95', 'spread': '0.23', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-intervention) to 1 week after completion of intervention activities', 'description': 'Change in the number of Urge Urinary Incontinence (UUI) episodes was calculated from the mean number of incontinence episodes per day reported on a 3-day bladder diary pre-treatment and mean the number of UUI episodes per day on a 7-day bladder diary measured the week immediately after intervention concluded (post treatment). Post-intervention mean was subtracted from baseline mean. A more negative score indicates greater reduction in UUI episodes.', 'unitOfMeasure': 'Number of incontinence episodes/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness Training', 'description': "Mindfulness training\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}, {'id': 'FG001', 'title': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex'}, {'id': 'FG002', 'title': 'Mindfulness + tDCS', 'description': "Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Recruitment occurred by telephone screening respondents to research registries (Pitt+Me and the Pepper Research Registry of Older Adults), online advertising, other advertisements (flyers in senior centers and public places i.e. libraries, coffee shops, senior centers, hospital noticeboards), and referrals from the Benedum Geriatric center, local urogynecologists and urologists, faculty geriatricians, and local women's health and continence centers.", 'preAssignmentDetails': 'Participant exclusion prior to randomization occurred if the participant did not have enough urgency places, failed a urine screen, did not react to urgency cues at pre-test cue-reactivity, or chose not to continue participation after session 1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness Training', 'description': "Mindfulness training\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}, {'id': 'BG001', 'title': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex'}, {'id': 'BG002', 'title': 'Mindfulness + tDCS', 'description': "Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nTranscranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex\n\nMindfulness: Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment."}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '12.8', 'groupId': 'BG002'}, {'value': '60.7', 'spread': '10.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-13', 'size': 266645, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-02T16:16', 'hasProtocol': True}, {'date': '2022-09-13', 'size': 179594, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-02T15:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2020-11-25', 'resultsFirstSubmitDate': '2024-02-02', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-03', 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study', 'timeFrame': '4-weeks post intervention', 'description': 'Feasibility is measured as the number of participants who completed the study divided by the total number of participants who started the intervention.'}, {'measure': 'Acceptability of Study Procedures', 'timeFrame': '4-weeks post intervention', 'description': 'Acceptability of study procedures was measured by 8-items assessing burden, difficulty, likeability of the study procedures on a 0-100 scale on the Post-Study Survey. A higher score indicates greater acceptability.'}, {'measure': 'Compliance With Study Procedures', 'timeFrame': '4-weeks post intervention', 'description': 'Compliance with study procedures measured by 2-items with a 0-100 scale on the Post-Study Survey. A higher score indicates greater compliance.'}, {'measure': 'Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues.', 'timeFrame': 'Baseline (pre-intervention) to 1 week after completion of intervention activities', 'description': 'Urinary urgency in response to personal photographic cues was self-reported by participants on 4 post-picture trial questions. Ratings were done using a 0-100 scale. The 4 items were averaged to calculate an urgency cue rating and safe cue rating for each picture trial. An overall Cue reactivity urgency rating was calculated for each participant by averaging their total urgency cue trial ratings. The same was done for safe cues.\n\nCue reactivity was calculated as the difference between the overall rating averages for urgency cues and safe cues.\n\nCue reactivity post-intervention was subtracted from that calculated for baseline. A lower score indicates greater reduction in cue-reactivity'}, {'measure': 'Reaction Time to Urinary Stroop Task', 'timeFrame': 'Baseline (pre-intervention) to 1 week after completion of intervention activities', 'description': 'Change in reaction time to words associated with urgency from baseline to post-intervention. A lower score indicates greater reduction in reaction time.'}, {'measure': 'Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)', 'timeFrame': 'Baseline (pre-intervention) to 1 week after completion of intervention activities', 'description': 'Change from baseline in severity of bladder problem measured by the ICIQ-FLUTS (International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms) a 12-item questionnaire (each item rated 0-4) evaluating urinary tract symptoms and impact on quality of life. A higher total score indicates greater symptoms and greater impact on quality of life. Score range (0-48) ICIQ-FLUTS was completed at baseline (pre-intervention) and one week after completion of all intervention activities. Pre-intervention score was subtracted from post-intervention score. A more negative score indicates greater symptom reduction.'}, {'measure': 'Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention', 'timeFrame': 'Baseline (pre-intervention) to 1 week after completion of intervention activities', 'description': 'Change in the number of Urge Urinary Incontinence (UUI) episodes was calculated from the mean number of incontinence episodes per day reported on a 3-day bladder diary pre-treatment and mean the number of UUI episodes per day on a 7-day bladder diary measured the week immediately after intervention concluded (post treatment). Post-intervention mean was subtracted from baseline mean. A more negative score indicates greater reduction in UUI episodes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcranial Direct Current Stimulation (tDCS)', 'Mindfulness', 'Situational Urge Urinary Incontinence'], 'conditions': ['Urinary Incontinence, Urge']}, 'descriptionModule': {'briefSummary': 'Urge urinary incontinence (UUI) is a common problem in older women, which vastly reduces quality of life. UUI sufferers frequently report situational triggers (e.g. approaching the front door) leading to urinary urgency and/or leakage, which can be caused by psychological conditioning. This project will test the feasibility, acceptability, and efficacy of brief mindfulness (MI) and non-invasive brain stimulation (transcranial direct current stimulation; tDCS) to reduce reactivity to personal urgency cues and attenuate symptoms of UUI. This is a novel step towards providing personalized efficacious non-pharmacologic treatment for UUI.', 'detailedDescription': 'Urinary urgency incontinence (UUI) is a highly prevalent, morbid and costly (up to $83 billion/year) disorder among older women, with up to 36% of those over 65 afflicted. One commonly experienced phenomenon among those with UUI is conditioned bladder responses to external triggers, often labeled "situational incontinence." Situational incontinence is described by sufferers as urinary urgency and leakage when confronted with specific contextual triggers or cues, such as approaching the front/garage door \'latch-key incontinence\', and exposure to running water such as doing dishes. Generally ascribed to \'bladder spasms\' (detrusor overactivity), studies have revealed that anywhere between 42% and 80% of women with UUI experience situationally provoked urgency, with approximately 26% of those experiencing situationally triggered leakage. The researchers recent work has focused on developing methods to recreate exposure to individuals\' situational urgency cues, testing the impact of "urgency" and "safe" cues on self-report urgency and actual leakage, and finally assessing the role of bladder control mechanisms in the brain in response to these personal situational cues. The researchers found that women with situational UUI experienced increased urgency and leakage when exposed to personal "urgency" versus "safe" photographic cues from their daily lives. Further, brain areas related to attentional and visuospatial processing were activated during exposure to urge, but not safe, cues. Past studies of urgency simulated by bladder filling, show that prefrontal cortex, a seat of executive control, is activated to aid in controlling bladder activation. However, the study found that the prefrontal cortex (PFC) was not recruited during exposure to visual cues among women with situational urgency. Thus, the researchers propose that interventions capable of enhancing PFC activation during exposure to urgency situations should enable women to gain executive control over cues and result in less cue-provoked urgency and leakage, as well as overall UUI symptomatology. Using these now well-tested methods to personalize stimuli with photographs of urgency-provoking situational cues, the goal is to test the feasibility, acceptability, and compliance of these promising methods to attenuate urgency-related reactivity and reduce UUI symptoms. These novel methods include: (1) Brief mindfulness (MI) focused on body scan and acceptance language, (2) Transcranial direct current stimulation (tDCS) applied to the dorsolateral PFC, and (3) a combination of MI + tDCS. Sixty women with situational UUI will be randomized into a 7-session study, with a mail-in follow up 1-week post-training. All participants will undergo 4 urgency-cue exposure training sessions during which they will engage in one of the three interventions, based on group. Changes in urgency will be assessed via pre-post training differences in: Cue-reactivity to personal urge and safe cues, reaction time to a urinary Stroop task, self-report severity of bladder problems, and UUI episodes and urgency ratings on a daily bladder diary. Attenuating reactivity to situational urgency cues will increase our ability to complement and enhance the efficacy of UUI therapy and reduce symptom burden for its many sufferers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female; 40+ years old\n* Self-report situational urgency in at least 4 of 15 common scenarios\n* At least 2 leaks/week\n* Urge Urinary Incontinence symptomatology bother score ≥4\n\nExclusion Criteria:\n\n* Cognitive impairment (inability to complete tasks) as measured by Montreal Cognitive Assessment (MoCA) score \\< 26\n* Urinary retention (PVR\\>200ml)\n* Interstitial cystitis\n* Spinal cord injury\n* Pelvic irradiation or other cause of pelvic nerve damage\n* Active urinary tract infection (UTI)'}, 'identificationModule': {'nctId': 'NCT04652869', 'briefTitle': 'Mindfulness + tDCS to Reduce Urgency Incontinence in Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Mindfulness + tDCS to Reduce Urgency Incontinence in Women', 'orgStudyIdInfo': {'id': 'STUDY19110132'}, 'secondaryIdInfos': [{'id': '1R21AG064361', 'link': 'https://reporter.nih.gov/quickSearch/1R21AG064361', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness Training', 'description': 'Mindfulness training', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'EXPERIMENTAL', 'label': 'Transcranial Direct Current Stimulation (tDCS)', 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex', 'interventionNames': ['Device: Transcranial direct current stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness + tDCS', 'description': 'Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex', 'interventionNames': ['Device: Transcranial direct current stimulation', 'Behavioral: Mindfulness']}], 'interventions': [{'name': 'Transcranial direct current stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex', 'armGroupLabels': ['Mindfulness + tDCS', 'Transcranial Direct Current Stimulation (tDCS)']}, {'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'description': "Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment.", 'armGroupLabels': ['Mindfulness + tDCS', 'Mindfulness Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Cynthia Conklin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Becky Clarkson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Following publication, no end date', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.', 'accessCriteria': 'Any purpose'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cynthia Conklin', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Cynthia Conklin', 'investigatorAffiliation': 'University of Pittsburgh'}}}}