Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-05 @ 5:55 PM
Study NCT ID:
NCT03771235
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2018-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Mindfulness-based Tic Reduction (Phase Two)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005879', 'term': 'Tourette Syndrome'}, {'id': 'D013981', 'term': 'Tic Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097813', 'term': 'Coping Skills'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-25', 'size': 159744, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-25T15:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score', 'timeFrame': 'Screening, Week 0, Week 9, Week 13, Week 35', 'description': 'Clinician-rated measure of tic severity'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impressions Scale', 'timeFrame': 'Weeks 0, 9, 13, 35'}, {'measure': 'Adult Tic Questionnaire', 'timeFrame': 'Weeks 0, 9, 13, 35'}, {'measure': 'Yale-Brown Obsessive Compulsive Scale', 'timeFrame': 'Weeks 0, 9, 13, 35'}, {'measure': 'Attention-Deficit Hyperactivity Rating Scale', 'timeFrame': 'Weeks 0, 9, 13, 35'}, {'measure': 'Depression Anxiety Stress Scale', 'timeFrame': 'Weeks 0, 9, 13, 35'}, {'measure': 'Premonitory Urge to Tic Scale', 'timeFrame': 'Weeks 0, 9, 13, 35'}, {'measure': 'Tic Rating Form', 'timeFrame': 'Weeks 1-8'}, {'measure': 'Problem Rating Form', 'timeFrame': 'Weeks 1-8'}, {'measure': 'Patient Health Questionnaire-9', 'timeFrame': 'Weeks 0, 9, 13, 35'}, {'measure': 'Work and Social Adjustment Survey', 'timeFrame': 'Weeks 0, 9, 13, 35'}, {'measure': 'Five Facet Mindfulness Questionnaire', 'timeFrame': 'Weeks 0, 4, 8, 9, 13, 35'}, {'measure': 'Credibility and Expectancy Questionnaire', 'timeFrame': 'Week 3'}, {'measure': 'Patient Satisfaction Questionnaire', 'timeFrame': 'Week 9'}, {'measure': 'Self Compassion Scale', 'timeFrame': 'Weeks 0, 9, 13, 35'}, {'measure': 'Affective Reactivity Index', 'timeFrame': 'Weeks 0, 9, 13, 35'}, {'measure': 'Brief Irritability Test', 'timeFrame': 'Weeks 0, 9, 13, 35'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tourette Syndrome', 'Tic Disorder', 'Online', 'Adults', 'Mindfulness', 'Therapy'], 'conditions': ['Tourette Syndrome', 'Persistent Tic Disorder']}, 'descriptionModule': {'briefSummary': 'Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially disabling neurobiological conditions. Although a range of pharmacological and psychosocial treatments exists, a significant number of individuals either do not respond to the current treatments or find them unacceptable. Thus, it is essential that researchers continue to develop and test novel treatment approaches.\n\nIn this randomized controlled trial the investigators will compare two different online group-based interventions for tics: a mindfulness-based program (Mindfulness-based Intervention for Tics (MBIT), and a psychoeducational and supportive therapy program (Tic Information and Coping Strategies (TICS)). The purpose of this study is to determine which intervention is more helpful for adults with a tic disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. be 18 years of age or older,\n2. possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,\n3. be fluent in English\n4. reside in the United States,\n5. either not be taking any tic suppressant medication or other psychotropic medication or be at a stable dose for 8 weeks prior to the baseline assessment and throughout the study\n\nExclusion Criteria:\n\n1. be receiving concurrent psychotherapy for the duration of the study\n2. have prior extensive experience with mindfulness and/or meditation and\n3. have another medical or psychological condition that would prevent the individual from fully engaging in the study or require a higher level of care (e.g., suicidality).'}, 'identificationModule': {'nctId': 'NCT03771235', 'briefTitle': 'Online Mindfulness-based Tic Reduction (Phase Two)', 'organization': {'class': 'OTHER', 'fullName': 'Bowdoin College'}, 'officialTitle': 'Online Mindfulness-based Tic Reduction: Development and Testing (Phase Two)', 'orgStudyIdInfo': {'id': '2018-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-based Intervention for Tics', 'description': '8-week group-based mindfulness-based program', 'interventionNames': ['Behavioral: Mindfulness-based Intervention for Tics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tic Information and Coping Strategies', 'description': '8-week group-based educational and supportive therapy program', 'interventionNames': ['Behavioral: Tic Information and Coping Strategies']}], 'interventions': [{'name': 'Mindfulness-based Intervention for Tics', 'type': 'BEHAVIORAL', 'description': 'Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practices.', 'armGroupLabels': ['Mindfulness-based Intervention for Tics']}, {'name': 'Tic Information and Coping Strategies', 'type': 'BEHAVIORAL', 'description': 'Psychological Intervention that focuses on learning more about tics, practicing a range of strategies for coping with tics (e.g., relaxation, effective communication), and discussing challenges commonly experienced by individuals with tics.', 'armGroupLabels': ['Tic Information and Coping Strategies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04011', 'city': 'Brunswick', 'state': 'Maine', 'country': 'United States', 'facility': 'Bowdoin College', 'geoPoint': {'lat': 43.91452, 'lon': -69.96533}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Hannah Reese, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bowdoin College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hannah Reese', 'investigatorAffiliation': 'Bowdoin College'}}}}