Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02023957
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2013-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot With Interactive Computer-assisted Screening for Mental Health in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-01', 'studyFirstSubmitDate': '2013-12-12', 'studyFirstSubmitQcDate': '2013-12-24', 'lastUpdatePostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Symptom reduction', 'timeFrame': '6 month', 'description': 'Measurement of this outcome depends on availability of funds for follow-up phone interviews'}], 'primaryOutcomes': [{'measure': 'Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence', 'timeFrame': 'Day 1', 'description': 'Chart review for the index visit'}, {'measure': 'Patient discussion on mental health', 'timeFrame': 'Day 1', 'description': 'Exit Survey of patients after the index visit'}], 'secondaryOutcomes': [{'measure': 'Patient intention to see a mental health counselor', 'timeFrame': 'Day 1', 'description': 'Exit Survey of patients after the index visit'}, {'measure': 'Patient satisfaction with health services', 'timeFrame': 'Day 1', 'description': 'Exit Survey of patients after the index visit'}, {'measure': 'Patient enablement to cope with these conditions', 'timeFrame': 'Day 1', 'description': 'Exit Survey of patients after the index visit'}, {'measure': 'Patient adherence to follow-up advice and referrals to mental health support', 'timeFrame': '3 month', 'description': 'Chart review'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Interactive Health-risk assessment', 'Primary Care', 'Randomized', 'Open Label', 'Efficacy Study'], 'conditions': ['Mental Health Disorders']}, 'referencesModule': {'references': [{'pmid': '28401134', 'type': 'DERIVED', 'citation': 'Ahmad F, Lou W, Shakya Y, Ginsburg L, Ng PT, Rashid M, Dinca-Panaitescu S, Ledwos C, McKenzie K. Preconsult interactive computer-assisted client assessment survey for common mental disorders in a community health centre: a randomized controlled trial. CMAJ Open. 2017 Mar 1;5(1):E190-E197. doi: 10.9778/cmajo.20160118. eCollection 2017 Jan-Mar.'}, {'pmid': '27663508', 'type': 'DERIVED', 'citation': 'Ferrari M, Ahmad F, Shakya Y, Ledwos C, McKenzie K. Computer-assisted client assessment survey for mental health: patient and health provider perspectives. BMC Health Serv Res. 2016 Sep 23;16(1):516. doi: 10.1186/s12913-016-1756-0.'}]}, 'descriptionModule': {'briefSummary': "The current protocol pertains to the evaluation of the interactive computer-assisted screening (iCAS) tool through a pilot randomized control trial. The purpose of this evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection of common mental health conditions (i.e. major depression/generalized anxiety/post-traumatic stress disorder/alcohol dependence), and patients' discussion on mental health.", 'detailedDescription': 'The iCAS tool is a health-risk assessment survey that is completed by adult patients using touch-screen iPad device in their waiting time before seeing their clinician (family physician or nurse practitioner). The computer program generates tailored risk-report for the clinician and a simple recommendation sheet for the patient, with community resources and health information, at the point of care. The iCAS tool currently includes validated screening scales for depression, generalized anxiety, posttraumatic stress disorder and alcohol abuse. There are some questions on the social determinants of mental health as well. The current versions of the tool are in English and Spanish; a Chinese language version will also be developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Speak/read Spanish\n* Speak/read English\n* Visiting the consenting clinician\n\nExclusion Criteria:\n\n* Patient accompanied by a family member for interpretation\n* New patients coming for first visit\n* Patients feeling unwell (self-report)\n* Inability of the research staff to offer study details in privacy'}, 'identificationModule': {'nctId': 'NCT02023957', 'acronym': 'iCAS', 'briefTitle': 'A Pilot With Interactive Computer-assisted Screening for Mental Health in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'York University'}, 'officialTitle': 'Interactive Computer-assisted Screening for Mental Health in Primary Care', 'orgStudyIdInfo': {'id': 'e2013 - 291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interactive computer-assisted screening', 'description': 'Eligible patients completed the interactive computer-assisted screening (iCAS) tool in English or Spanish before seeing the consenting clinician. Participating patients then received the iCAS generated tailored recommendation sheet. Participating clinicians received the iCAS generated risk report.', 'interventionNames': ['Behavioral: Interactive computer-assisted screening (iCAS)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Eligible patients randomized to the control group completed their standard visit to the participating clinician. There was no pre-visit health risk screening. There were no tailored reports for the patients or clinicians.'}], 'interventions': [{'name': 'Interactive computer-assisted screening (iCAS)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Interactive computer-assisted screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M3J 1P3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'York University', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Farah Ahmad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'York University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'York University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'North York General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Farah Ahmad', 'investigatorAffiliation': 'York University'}}}}