Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-26 @ 3:57 PM
Study NCT ID:
NCT00012766
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Team Treatment of Depression in Primary Care
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'completionDateStruct': {'date': '2001-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2001-03-14', 'studyFirstSubmitQcDate': '2001-03-15', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-03-16', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression', 'Primary Health Care']}, 'referencesModule': {'references': [{'pmid': '12534758', 'type': 'RESULT', 'citation': "Hedrick SC, Chaney EF, Felker B, Liu CF, Hasenberg N, Heagerty P, Buchanan J, Bagala R, Greenberg D, Paden G, Fihn SD, Katon W. Effectiveness of collaborative care depression treatment in Veterans' Affairs primary care. J Gen Intern Med. 2003 Jan;18(1):9-16. doi: 10.1046/j.1525-1497.2003.11109.x."}, {'pmid': '12719501', 'type': 'RESULT', 'citation': 'Liu CF, Hedrick SC, Chaney EF, Heagerty P, Felker B, Hasenberg N, Fihn S, Katon W. Cost-effectiveness of collaborative care for depression in a primary care veteran population. Psychiatr Serv. 2003 May;54(5):698-704. doi: 10.1176/appi.ps.54.5.698.'}, {'pmid': '10843272', 'type': 'RESULT', 'citation': 'Fischer EP, Marder SR, Smith GR, Owen RR, Rubenstein L, Hedrick SC, Curran GM. Quality Enhancement Research Initiative in Mental Health. Med Care. 2000 Jun;38(6 Suppl 1):I70-81. doi: 10.1097/00005650-200006001-00008.'}, {'pmid': '15154020', 'type': 'RESULT', 'citation': 'Felker BL, Hedrick SC, Chaney EF, Liu CF, Heagerty P, Caples H, Lin P, Katon W. Identifying Depressed Patients With a High Risk of Comorbid Anxiety in Primary Care. Prim Care Companion J Clin Psychiatry. 2003 Jun;5(3):104-110. doi: 10.4088/pcc.v05n0301.'}, {'pmid': '16173913', 'type': 'RESULT', 'citation': 'Lin P, Campbell DG, Chaney EF, Liu CF, Heagerty P, Felker BL, Hedrick SC. The influence of patient preference on depression treatment in primary care. Ann Behav Med. 2005 Oct;30(2):164-73. doi: 10.1207/s15324796abm3002_9.'}, {'pmid': '15213794', 'type': 'RESULT', 'citation': 'Kanter JW, Epler AJ, Chaney EF, Liu CF, Heagerty P, Lin P, Felker B, Hedrick SC. Comparison of 3 Depression Screening Methods and Provider Referral in a Veterans Affairs Primary Care Clinic. Prim Care Companion J Clin Psychiatry. 2003 Dec;5(6):245-250. doi: 10.4088/pcc.v05n0601.'}]}, 'descriptionModule': {'briefSummary': 'Most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.', 'detailedDescription': 'Background:\n\nMost depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.\n\nObjectives:\n\nThis effectiveness study adapted collaborative care to the VA primary care setting ("collaborative care") and compared it with consult-liaison care ("CL care").\n\nMethods:\n\nPatients within a VA primary care clinic were randomly assigned by firm to the two interventions.\n\nIn collaborative care, existing staff resources were reorganized to form a multidisciplinary mental health specialist team. The team developed a treatment plan based on an initial assessment and suggested the plan to the primary care provider. Primary care providers\' treatment efforts were then supported by brief Social Work telephone calls designed to support adherence and monitor symptomatology. Treatment results were systematically reviewed and suggestions for treatment modification were fed back to the primary providers. In CL care, the primary care providers were informed of the diagnosis and study clinicians facilitated referrals to Psychiatry residents in-clinic as requested. Mailed and in-clinic surveys and provider referral were used to recruit 168 collaborative care and 186 CL care patients who met criteria for major depression and/or dysthymia based on structured interview. Patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, or had primary alcohol abuse. Outcome data on the SCL-20 depression symptomatology measure, Veterans SF-36, and Sheehan Disability Scale were collected at baseline, 3 and 9 months. VA utilization and costs of care were analyzed.\n\nStatus:\n\nComplete. Final Report submitted June 30, 2001.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSeveral screening methods including mailed and in-clinic surveys and provider referral were used to recruit 168 team and 188 CL study patients who met criteria for major depression and/or dysthymia based on structured interview. Patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, had primary alcohol abuse, or were too impaired to participate in the screening interview. Outcome data on the SCL-20 depression symptomatology measure, SF-36V, and Sheehan functional impairment measure were collected at baseline, 3 and 9 months.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00012766', 'briefTitle': 'Effectiveness of Team Treatment of Depression in Primary Care', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Effectiveness of Team Treatment of Depression in Primary Care', 'orgStudyIdInfo': {'id': 'IIR 95-097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1', 'interventionNames': ['Behavioral: Integrated team care']}], 'interventions': [{'name': 'Integrated team care', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Susan C. Hedrick, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA'}, {'name': 'Edmund F. Chaney, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}