Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 3:23 PM
Study NCT ID:
NCT05118633
Status:
UNKNOWN
Last Update Posted:
2023-03-02
First Post:
2021-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technology Assisted Treatment for Trichotillomania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014256', 'term': 'Trichotillomania'}], 'ancestors': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in clinical symptoms amongst participants', 'timeFrame': 'Eight weeks', 'description': 'Demonstrated improvement in clinical symptoms on the MGH-HPS and/or NIMH-TSS for those in the HabitAware condition.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hair Pulling Disorder', 'Body-Focused Repetitive Behaviors', 'Trichotillomania'], 'conditions': ['Trichotillomania']}, 'descriptionModule': {'briefSummary': 'Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. Behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven effective. In an effort to enhance awareness, a wrist worn motion detection device and a companion mobile application was created. In this study, we will test the initial efficacy of the HabitAware device and accompanying app as a system for delivering self-administered habit reversal training (HRT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to participate;\n* Current diagnosis of TTM (as assessed via TDI);\n* Regular access to a smartphone with GPS capabilities (i.e., available for completing assessment probes throughout the day);\n\nExclusion Criteria:\n\n* Currently receiving psychotherapy\n* Other psychiatric condition requiring more immediate care\n* Have previously used any behavior awareness devices (e.g. Keen)'}, 'identificationModule': {'nctId': 'NCT05118633', 'briefTitle': 'Technology Assisted Treatment for Trichotillomania', 'organization': {'class': 'INDUSTRY', 'fullName': 'HabitAware Inc.'}, 'officialTitle': 'Technology Assisted Treatment for Trichotillomania', 'orgStudyIdInfo': {'id': 'R44MH114773', 'link': 'https://reporter.nih.gov/quickSearch/R44MH114773', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group - HabitAware condition', 'description': 'This group will receive the device which alerts the participant when performing hair pulling behavior and the app which provides psychoeducation and components of Habit Reversal Training.', 'interventionNames': ['Behavioral: Device and app system designed for participant to self-administer Habit Reversal Training and Stimulus Control']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group - reminder bracelet condition', 'description': 'This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull, as well as being asked to journal about their daily activities in an app.', 'interventionNames': ['Behavioral: Reminder bracelet and journaling app control condition']}], 'interventions': [{'name': 'Device and app system designed for participant to self-administer Habit Reversal Training and Stimulus Control', 'type': 'BEHAVIORAL', 'description': 'Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training and Stimulus Control. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania, as well as receive stimulus control reminders.', 'armGroupLabels': ['Experimental group - HabitAware condition']}, {'name': 'Reminder bracelet and journaling app control condition', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull. They will also be instructed to journal in an app on their phone several times per day.', 'armGroupLabels': ['Control group - reminder bracelet condition']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sameer Kumar, BS', 'role': 'CONTACT', 'email': 'sameer@habitaware.com', 'phone': '248-990-4720'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HabitAware Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kent State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}