Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT04241120
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2020-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility Study for Treating Trichotillomania With Wearable Device and App System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sameer@habitaware.com', 'phone': '2489904720', 'title': 'Sameer Kumar', 'organization': 'HabitAware'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': '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.\n\nDevice and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '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.\n\nReminder bracelet control condition: 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.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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.\n\nDevice and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.'}, {'id': 'OG001', 'title': '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.\n\nReminder bracelet control condition: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Four weeks', 'description': 'Measured via post-treatment surveys.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was only for the experimental group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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.\n\nDevice and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.'}, {'id': 'OG001', 'title': '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.\n\nReminder bracelet control condition: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Four weeks', 'description': 'Measured by post treatment survey results', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was only for the experimental group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Can Implement HRT Procedures With 80% Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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.\n\nDevice and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.'}, {'id': 'OG001', 'title': '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.\n\nReminder bracelet control condition: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Four weeks', 'description': 'Measured by trained clinician observing the participant perform the procedures', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was only for the experimental group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 30% Improvement in Clinical Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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.\n\nDevice and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.'}, {'id': 'OG001', 'title': '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.\n\nReminder bracelet control condition: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Four weeks', 'description': 'Measured via pre- and post-treatment MGH-HPS (Massachusetts General Hospital Hair Pulling Scale) and/or NIMH-TSS (National Institute of Mental Health - Trichotillomania Symptom Severity) scores for those in the HabitAware conditions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '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.\n\nDevice and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.'}, {'id': 'FG001', 'title': '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.\n\nReminder bracelet control condition: 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '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.\n\nDevice and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.'}, {'id': 'BG001', 'title': '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.\n\nReminder bracelet control condition: 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '15.5', 'groupId': 'BG000'}, {'value': '31.2', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '36.7', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-18', 'size': 129245, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-02T12:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2020-01-21', 'resultsFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2020-01-23', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-28', 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week.', 'timeFrame': 'Four weeks', 'description': 'Measured via post-treatment surveys.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.', 'timeFrame': 'Four weeks', 'description': 'Measured by post treatment survey results'}, {'measure': 'Number of Participants That Can Implement HRT Procedures With 80% Accuracy', 'timeFrame': 'Four weeks', 'description': 'Measured by trained clinician observing the participant perform the procedures'}, {'measure': 'Number of Participants With 30% Improvement in Clinical Symptoms', 'timeFrame': 'Four weeks', 'description': 'Measured via pre- and post-treatment MGH-HPS (Massachusetts General Hospital Hair Pulling Scale) and/or NIMH-TSS (National Institute of Mental Health - Trichotillomania Symptom Severity) scores for those in the HabitAware conditions.'}]}, 'oversightModule': {'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 was created. In this study, we will test the feasibility 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\n1. 18 years of age or older\n2. Speak fluent English\n3. Current diagnosis of TTM\n4. Score above the normative mean on the automatic pulling subscale of the MIST-A\n5. Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks)\n\nExclusion Criteria:\n\n1. Currently receiving psychotherapy\n2. Other psychiatric condition requiring more immediate care\n3. Have previously used any behavior awareness devices (e.g. Keen)'}, 'identificationModule': {'nctId': 'NCT04241120', 'briefTitle': 'Feasibility Study for Treating Trichotillomania With Wearable Device and App System', 'organization': {'class': 'INDUSTRY', 'fullName': 'HabitAware Inc.'}, 'officialTitle': 'Feasibility Study for Treating Trichotillomania With Wearable Device and App System Using Habit Reversal Training', 'orgStudyIdInfo': {'id': '31257150'}, 'secondaryIdInfos': [{'id': 'R43MH114773', 'link': 'https://reporter.nih.gov/quickSearch/R43MH114773', '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']}, {'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.', 'interventionNames': ['Behavioral: Reminder bracelet control condition']}], 'interventions': [{'name': 'Device and app system designed for participant to self-administer Habit Reversal Training', 'type': 'BEHAVIORAL', 'description': 'Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.', 'armGroupLabels': ['Experimental group - HabitAware condition']}, {'name': 'Reminder bracelet 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.', 'armGroupLabels': ['Control group - reminder bracelet condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55426', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HabitAware, Inc.', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HabitAware Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Marquette University', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}