Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-06 @ 10:37 PM
Study NCT ID:
NCT01144104
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2010-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 925}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2010-05-14', 'studyFirstSubmitQcDate': '2010-06-10', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Process of Care', 'timeFrame': 'Within 24 hours of intervention delivery (physician post-visit assessment)', 'description': 'Minimally acceptable initial care, meaning 1) antidepressant prescription, 2) referral to a mental health specialist, or 3) follow up within 14 days if PHQ \\>= 15 or within 30 days otherwise'}, {'measure': 'Patient Outcomes', 'timeFrame': 'Stigma: Within 24 hours of intervention delivery (patient post-visit assessment); depression symptoms: 12 weeks', 'description': '1\\) Stigma as measured by a scale adapted from Kanter JW, Rusch LC, Brondino MJ. Depression self-stigma: a new measure and preliminary findings. J Nervous Mental Dis 1008; 196(9):663-70, and 2) depression symptoms measured via PHQ-8 scores.'}, {'measure': 'Toxicity', 'timeFrame': 'Within 24 hours of intervention delivery (patient and physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)', 'description': '1\\) Stigma as measured by a scale adapted from Kanter (see above) and 2) antidepressant prescribing by physician'}], 'secondaryOutcomes': [{'measure': 'Direct or indirect patient requests for depression treatment', 'timeFrame': 'Within 24 hours of intervention delivery (physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)', 'description': 'Patient request for medicine for depression or referral to a mental health professional'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '24193079', 'type': 'DERIVED', 'citation': 'Kravitz RL, Franks P, Feldman MD, Tancredi DJ, Slee CA, Epstein RM, Duberstein PR, Bell RA, Jackson-Triche M, Paterniti DA, Cipri C, Iosif AM, Olson S, Kelly-Reif S, Hudnut A, Dvorak S, Turner C, Jerant A. Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial. JAMA. 2013 Nov 6;310(17):1818-28. doi: 10.1001/jama.2013.280038.'}, {'pmid': '23594572', 'type': 'DERIVED', 'citation': 'Tancredi DJ, Slee CK, Jerant A, Franks P, Nettiksimmons J, Cipri C, Gottfeld D, Huerta J, Feldman MD, Jackson-Triche M, Kelly-Reif S, Hudnut A, Olson S, Shelton J, Kravitz RL. Targeted versus tailored multimedia patient engagement to enhance depression recognition and treatment in primary care: randomized controlled trial protocol for the AMEP2 study. BMC Health Serv Res. 2013 Apr 17;13:141. doi: 10.1186/1472-6963-13-141.'}]}, 'descriptionModule': {'briefSummary': 'This trial consists of two linked substudies.\n\nSubstudy 1: Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study\n\nSubstudy 2: Activating Messages for Enhancing Primary Care Practice (AMEP2): Toxicity Study\n\nThe purpose of the Effectiveness Study is to assess the comparative effectiveness of three multimedia educational interventions (a targeted educational video, a tailored interactive multimedia computer program, and an "attention control") for increasing the likelihood that primary care patients with significant depressive symptoms will seek appropriate care (n = 510). The primary study outcomes are provision of minimally acceptable initial care, reductions in depression-related stigma, and improvement in depression symptoms. (See Process of Care and Patient Outcomes in Primary Outcome Measure section.)\n\nThe purpose of the Toxicity Study is to assess the potential benefits (reduced stigma) and harms (inappropriate prescribing) associated with three multimedia depression educational interventions when administered to patients with few or no depressive symptoms (n = 308). The primary outcomes relating to this outcome are reducing depression-related stigma and reducing unnecessary prescribing. (See Toxicity in Primary Outcome Measure section.)\n\nBoth studies will look at the secondary outcome measure of patient requests for depression treatment.', 'detailedDescription': "This project is an investigator-initiated study involving two sequential phases and is funded by the National Institute of Mental Health. Phase I included the use of marketing research (i.e. focus groups, adaptive conjoint analysis, and other survey methods) to produce two clinic-based interventions: a public service announcement (PSA) and interactive multimedia computer program (IMCP). The two clinic-based interventions are intended to include messages that will activate patients to talk with their physicians about specific health concerns (depression) and/or any depressive symptoms they've been experiencing. In Phase II (as described in this registration protocol), those interventions will undergo assessment in a randomized controlled effectiveness trial (RCT) in primary care settings in Sacramento and San Francisco."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 25-70\n* Visual acuity and manual dexterity to operate a laptop computer\n\nExclusion Criteria:\n\n* Currently being treated for depression with anti-depressant medications'}, 'identificationModule': {'nctId': 'NCT01144104', 'acronym': 'AMEP2', 'briefTitle': 'Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Targeted and Tailored Messages to Enhance Depression Care', 'orgStudyIdInfo': {'id': '200917591'}, 'secondaryIdInfos': [{'id': '1R01MH079387-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH079387-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Public Service Announcements', 'description': 'Demographically targeted public service announcement', 'interventionNames': ['Behavioral: Public Service Announcement']}, {'type': 'EXPERIMENTAL', 'label': 'Interactive Multi-Media Computer Program', 'description': 'Personally tailored information about seeking care for depression based on respondent characteristics', 'interventionNames': ['Behavioral: Interactive Multi-Media Computer Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention Control Video', 'description': 'Two-minute video focusing on common sleep disorders.', 'interventionNames': ['Behavioral: Sleep Hygiene Video']}], 'interventions': [{'name': 'Public Service Announcement', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Public Service Announcements']}, {'name': 'Interactive Multi-Media Computer Program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Interactive Multi-Media Computer Program']}, {'name': 'Sleep Hygiene Video', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Attention Control Video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95758', 'city': 'Elk Grove', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health - Elk Grove Family Medicine', 'geoPoint': {'lat': 38.4088, 'lon': -121.37162}}, {'zip': '95655', 'city': 'Mather', 'state': 'California', 'country': 'United States', 'facility': 'VA Northern California Healthcare System', 'geoPoint': {'lat': 37.88215, 'lon': -119.85573}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente - Point West', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Richard L Kravitz, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'Mitchell L Feldman, MD, MPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}