Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-05 @ 6:04 PM
Study NCT ID:
NCT03069118
Status:
UNKNOWN
Last Update Posted:
2017-03-13
First Post:
2017-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
90-Day Online Substance Use Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-08', 'studyFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2017-02-27', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASSIST', 'timeFrame': '90-day', 'description': 'The Alcohol, Smoking and Substance Involvement Screening Test'}, {'measure': 'WHOQOL-BREF', 'timeFrame': '90-day', 'description': 'World Health Organization Quality of Life (BREF) Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Net Promoter Score', 'timeFrame': '90-day', 'description': 'User Satisfaction Survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'Online Treatment', 'Digital Intervention'], 'conditions': ['Addictive Behavior', 'Alcohol Use Disorder', 'Alcohol Abuse', 'Drug Abuse', 'Drug Use Disorders']}, 'descriptionModule': {'briefSummary': 'Individuals indicating risky substance use are randomly assigned either to a three-month online intervention on the Workit Health platform or a waitlist/treatment as usual. Those randomized to treatment will report reduced consumption of alcohol and other drugs and higher quality of life at study conclusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of this research are adults who self-identify as wanting to change their relationship to alcohol or drugs, who report currently using alcohol or drugs, or having recently stopped, who have access to an internet-enabled device, who are not currently suffering from untreated acute medical or psychiatric conditions, who anticipate being able to access the intervention over a six-month period, and who are able to freely consent to participate by themselves.\n\nExclusion Criteria:\n\n* Because the intervention is written for an adult audience, as well as the logistical challenges of having private access to an internet enabled device, this research is limited to participants over the age of 18.'}, 'identificationModule': {'nctId': 'NCT03069118', 'briefTitle': '90-Day Online Substance Use Program', 'organization': {'class': 'INDUSTRY', 'fullName': 'Workit Health'}, 'officialTitle': 'Effectiveness of a Remote Behavioral Intervention and Coaching Support for Risky Substance Users in a Randomized Control Trial', 'orgStudyIdInfo': {'id': '#2016/10/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Three-month intervention on the online Workit Health platform', 'interventionNames': ['Behavioral: Treatment - Workit Health Online Program']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'A list of online resources/waitlist', 'interventionNames': ['Behavioral: Control - Resource List']}], 'interventions': [{'name': 'Treatment - Workit Health Online Program', 'type': 'BEHAVIORAL', 'description': 'The Workit Health program is an adaptive "recovery in your pocket" harm reduction and sobriety solution that provides 24-hour access to adaptive lessons, mentorship, written and audio driven therapeutic exercises and tools, and peer-to-peer coaching. Users access our online site and enter an initial 90-day program that takes a holistic approach to recovery by addressing the physical, mental, emotional, and social aspects of addiction. As they advance, they move through successive levels that include lessons, activities, and assignments. Bonus materials, such as meditations and suggested reading, give users timely opportunities to dive deeper into a problem they are struggling with that day. Workit Health implements evidence-based strategies such as CBT, DBT, and MI.', 'armGroupLabels': ['Treatment']}, {'name': 'Control - Resource List', 'type': 'BEHAVIORAL', 'description': 'Tailored list of resources.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48103', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meghan Moynihan, PhD', 'role': 'CONTACT', 'email': 'meghan@workithealth.com'}, {'name': 'Lisa McLaughlin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Workit Health', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Meghan Moynihan, PhD', 'role': 'CONTACT', 'email': 'meghan@workithealth.com'}], 'overallOfficials': [{'name': 'Lisa McLaughlin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Workit Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Workit Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}