Viewing Study NCT03126305


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Study NCT ID: NCT03126305
Status: COMPLETED
Last Update Posted: 2020-11-18
First Post: 2017-04-19
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Initial Development and Dissemination of OC-Go
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Usability Scale (SUS)', 'timeFrame': '6 weeks', 'description': '10-item self-report measure assessing the usability of the OC-Go application'}, {'measure': 'Usability Evaluation for e-Learning Applications (UELA),', 'timeFrame': '6 weeks', 'description': '54-item self-report measure assessing the usability of the OC-Go application'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exposure', 'response prevention', 'web-based application'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'The clinical component of Phase I application development examines the clinical utility, feasibility, and functionality of the OC-Go application via an 8-month pilot trial consisting of 50 standard CBT sessions augmented with OC-Go in OCD-diagnosed children who are receiving treatment through the pediatric OCD treatment programs in the UCLA Division of Child and Adolescent Psychiatry', 'detailedDescription': 'This project seeks to refine and assess OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application designed to increase patient adherence to evidence-based treatment (EBT) for Obsessive Compulsive Disorder (OCD), a common and impairing condition, and provider ability to effectively implement EBTs. OC-Go allows clinicians to create and push tailored assignments to patients on their mobile devices with an optimized user interface that includes patient accountability and support features. Accordingly, patients can be guided to do assignments by themselves between sessions with increased fidelity over the course of treatment. Once therapy assignments are created and shared to a crowd-sourced and curated public library, any clinician can assign any task to any patient for homework or in-session use with one touch. Use of OC-Go is expected to increase patient engagement, compliance, treatment efficiency, dissemination of EBTs, and therapist confidence and expertise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children receiving exposure based CBT through the UCLA Child OCD, Anxiety and Tic Disorders Clinic or Pediatric OCD Intensive Outpatient Program and their parents', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children receiving exposure based CBT through the UCLA Child OCD, Anxiety and Tic Disorders Clinic or Pediatric OCD Intensive Outpatient Program and their parents\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03126305', 'acronym': 'OC-GoPhaseI', 'briefTitle': 'Initial Development and Dissemination of OC-Go', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool', 'orgStudyIdInfo': {'id': 'R42MH111277-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R42MH111277-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OC-Go', 'description': 'Approximately 10-20 9-17 year-olds receiving exposure based cognitive behavior therapy for OCD through the UCLA Division of Child and Adolescent Psychiatry OCD treatment programs', 'interventionNames': ['Other: OC-Go']}], 'interventions': [{'name': 'OC-Go', 'type': 'OTHER', 'description': 'OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application that allows clinicians to create and push tailored treatment assignments to patients on their mobile devices', 'armGroupLabels': ['OC-Go']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024-1759', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Univ. of California / Los Angeles / Semel Inst.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'John Piacentini, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Peter Tuerk, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virtually Better, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Virtually Better, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry and Biobehavioral Sciences', 'investigatorFullName': 'John Piacentini', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}