Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-12 @ 12:19 PM
Study NCT ID:
NCT02605902
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2015-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020323', 'term': 'Tics'}, {'id': 'D005879', 'term': 'Tourette Syndrome'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D013981', 'term': 'Tic Disorders'}, {'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': 'D012064', 'term': 'Relaxation Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2015-11-12', 'studyFirstSubmitQcDate': '2015-11-13', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'YGTSS-TTS', 'timeFrame': '1 week after end of treatment'}], 'secondaryOutcomes': [{'measure': 'YGTSS-TTS', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': 'Clinical Global Impression-Improvement Score (CGI-I)', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': 'Clinical Global Impression - Severity Score (CGI-S)', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': 'Modified Rush Video-Based Tic Rating Scale (MRVS)', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': 'Adult Tic Questionnaire (ATQ) (self-report rating)', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': 'Tourette Syndrome-Quality of Life Scale (GTS-QoL)', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': 'Premonitory Urge for Tics Scale (PUTS)', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': "Conners' Adult ADHD Rating Scale (CAARS)", 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': 'Yale-Brown Obsessive Compulsive Scale (Y-BOCS)', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}, {'measure': 'Working Alliance Inventory-Short Revised (WAI-SR)', 'timeFrame': '1 week, 3 months and 6 months after end of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic tic disorders', 'Tourette syndrome'], 'conditions': ['Tics', 'Tourette Syndrome']}, 'descriptionModule': {'briefSummary': 'Gilles da la Tourette syndrome (TS)\\* is a common chronic neuropsychiatric disorder characterized by motor and vocal tics. In most adult patients, quality of life is significantly impaired. TS, therefore, is a cost-intensive disease (in Germany: mean total costs=€3404/year). Despite significant adverse effects, dopamine receptor antagonists were recommended as first choice treatment for many years. Although efficacy could be demonstrated only recently, today, behavioral therapy with face-to-face Comprehensive Behavioral Intervention for Tics (CBIT) (including psychoeducation, habit reversal training, function-based assessment and intervention, and relaxation training) is recommended as first line treatment for tics. In Germany, however, dissemination of CBIT is restricted due to a considerable lack of well-trained therapists. The aim of this study is to overcome this deficiency by creating a new and sophisticated internet-delivered CBIT (iCBIT) program. In addition, internet-delivered CBIT will shorten waiting time, will reach additional groups of patients and will be - once developed and established - highly cost-effective (about € 100 vs. € 1450 for face-to-face CBIT). Investigators want to perform a multicenter, randomized, controlled, observer-blind trial including 160 adult patients in order to demonstrate that 8 sessions (10 weeks) of iCBIT are superior to internet-delivered psychoeducation/relaxation in adult patients with TS. Both immediate (1 week after end of treatment) and long-term effects (after 3 and 6 months) will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic tic disorder or Tourette syndrome according to DSM-5\n* Age ≥18 years; Yale Global Tic Severity Scale (YGTSS) total tic score (TTS) \\> 14 or \\> 10 (for patients only with motor or vocal tics)\n* Clinical Global Impression-Severity Score (CGI-S) \\> 4\n* Medication for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study\n* Fluent German in speaking and writing\n* Ability to give informed consent and signed informed consent\n\nExclusion Criteria:\n\n* History of schizophrenia or pervasive developmental disorder\n* Comorbid obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), depression, anxiety disorder when unstable and/or in need of an initial adjustment for a therapy\n* History of behavioral treatment for tics\n* Current illicit substance abuse or addiction (clinically diagnosed)\n* Secondary tic disorder or other significant neurological and psychiatric disease\n* No internet access or ability to use the internet\n* Participation in a study with medicinal products or devices is not allowed within 6 weeks before inclusion or concurrent to this study'}, 'identificationModule': {'nctId': 'NCT02605902', 'acronym': 'ONLINE-TICS', 'briefTitle': 'Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Randomized Observer Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders', 'orgStudyIdInfo': {'id': 'online-tics iCBIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'iCBIT', 'description': 'internet-delivered Comprehensive Behavioral Intervention for Tics (iCBIT) consisting of psychoeducation, habit reversal training (HRT), function-based assessment and intervention, and relaxation training', 'interventionNames': ['Behavioral: (i)Comprehensive Behavioral Intervention for Tics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control intervention/reference test', 'description': 'internet-delivered psychoeducation and relaxation training.', 'interventionNames': ['Behavioral: internet-delivered psychoeducation and relaxation training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'face-to-face CBIT-treatment', 'description': 'face-to-face CBIT-treatment', 'interventionNames': ['Behavioral: (i)Comprehensive Behavioral Intervention for Tics']}], 'interventions': [{'name': '(i)Comprehensive Behavioral Intervention for Tics', 'type': 'BEHAVIORAL', 'otherNames': ['(i)CBIT'], 'armGroupLabels': ['face-to-face CBIT-treatment', 'iCBIT']}, {'name': 'internet-delivered psychoeducation and relaxation training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control intervention/reference test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80336', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Psychiatric Clinic of the Ludwig-Maximilians-University', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '30559', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Psychotherapist practice', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'University of Dresden, Dep. of Child and Adolescent Psychiatry', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'University Medical Center Schleswig-Holstein, UK-SH Campus Lübeck, Department of Neurology', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Kirsten Mueller-Vahl, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical school Hannover, Clinic for Psychosomatics and Psychotherapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Kirsten Mueller-Vahl', 'investigatorAffiliation': 'Hannover Medical School'}}}}