Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT00105833
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Outcomes 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2005-03-16', 'studyFirstSubmitQcDate': '2005-03-16', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Checklist SCL-20 score', 'timeFrame': 'SCL-20 score over 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '18071900', 'type': 'RESULT', 'citation': 'Snyder K, Dobscha SK, Ganzini L, Hoffman WF, Delorit MA. Clinical outcomes of integrated psychiatric and general medical care. Community Ment Health J. 2008 Jun;44(3):147-54. doi: 10.1007/s10597-007-9117-4. Epub 2007 Dec 11.'}, {'pmid': '17336659', 'type': 'RESULT', 'citation': 'Williams JW Jr, Gerrity M, Holsinger T, Dobscha S, Gaynes B, Dietrich A. Systematic review of multifaceted interventions to improve depression care. Gen Hosp Psychiatry. 2007 Mar-Apr;29(2):91-116. doi: 10.1016/j.genhosppsych.2006.12.003.'}, {'pmid': '17250493', 'type': 'RESULT', 'citation': 'Dobscha SK, Corson K, Pruitt S, Crutchfield M, Gerrity MS. Measuring depression and pain with home health monitors. Telemed J E Health. 2006 Dec;12(6):702-6. doi: 10.1089/tmj.2006.12.702.'}, {'pmid': '17015865', 'type': 'RESULT', 'citation': 'Dobscha SK, Corson K, Hickam DH, Perrin NA, Kraemer DF, Gerrity MS. Depression decision support in primary care: a cluster randomized trial. Ann Intern Med. 2006 Oct 3;145(7):477-87. doi: 10.7326/0003-4819-145-7-200610030-00005.'}, {'pmid': '17634781', 'type': 'RESULT', 'citation': 'Gerrity MS, Corson K, Dobscha SK. Screening for posttraumatic stress disorder in VA primary care patients with depression symptoms. J Gen Intern Med. 2007 Sep;22(9):1321-4. doi: 10.1007/s11606-007-0290-5. Epub 2007 Jul 17.'}, {'pmid': '18071094', 'type': 'RESULT', 'citation': 'Dobscha SK, Corson K, Gerrity MS. Depression treatment preferences of VA primary care patients. Psychosomatics. 2007 Nov-Dec;48(6):482-8. doi: 10.1176/appi.psy.48.6.482.'}, {'pmid': '17029000', 'type': 'RESULT', 'citation': 'Dobscha SK, Winterbottom LM, Snodgrass LS. Reducing drug costs at a Veterans Affairs hospital by increasing market-share of generic fluoxetine. Community Ment Health J. 2007 Feb;43(1):75-84. doi: 10.1007/s10597-006-9062-7. Epub 2006 Sep 22.'}, {'pmid': '15609737', 'type': 'RESULT', 'citation': 'Corson K, Gerrity MS, Dobscha SK. Screening for depression and suicidality in a VA primary care setting: 2 items are better than 1 item. Am J Manag Care. 2004 Nov;10(11 Pt 2):839-45.'}, {'pmid': '15785225', 'type': 'RESULT', 'citation': 'Dobscha SK, Corson K, Solodky J, Gerrity MS. Use of videoconferencing for depression research: enrollment, retention, and patient satisfaction. Telemed J E Health. 2005 Feb;11(1):84-9. doi: 10.1089/tmj.2005.11.84.'}, {'pmid': '12556600', 'type': 'RESULT', 'citation': 'Dobscha SK, Anderson TA, Hoffman WF, Winterbottom LM, Turner EH, Snodgrass LS, Hauser P. Strategies to decrease costs of prescribing selective serotonin reuptake inhibitors at a VA Medical Center. Psychiatr Serv. 2003 Feb;54(2):195-200. doi: 10.1176/appi.ps.54.2.195.'}, {'pmid': '12850654', 'type': 'RESULT', 'citation': 'Dobscha SK, Gerrity MS, Corson K, Bahr A, Cuilwik NM. Measuring adherence to depression treatment guidelines in a VA primary care clinic. Gen Hosp Psychiatry. 2003 Jul-Aug;25(4):230-7. doi: 10.1016/s0163-8343(03)00020-3.'}]}, 'descriptionModule': {'briefSummary': 'Depression is common in primary care settings, and associated with substantial physical and psychosocial impairment and increased healthcare utilization. Despite efforts to educate primary care providers, depression is often undetected or undertreated in primary care settings. The main objective of this study was to determine the impact of a low-intensity, care management intervention on depression treatment outcomes of patients in a VA primary care setting.', 'detailedDescription': 'OBJECTIVE(S): The primary objective of the study was to determine the impact of a low-intensity, care management intervention on depression treatment outcomes of patients in a VA primary care setting. Secondary objectives were to determine the extent to which primary care clinicians adhere to major depression treatment guidelines, the extent to which the intervention impacts healthcare utilization, and to examine the impact of provider and patient covariates (including pain and adherence) on depression treatment response PLAN: Randomized controlled trial. METHODS: All clinicians first participated in the MacArthur Depression Education Program (DEP). After stratification by discipline and site, clinicians were randomized to receive the Depression Decision Support (DDS) intervention versus usual care (which included an on-site mental health team). Patients were nested within clinician intervention status. DDS intervention clinicians received serial reports of depression severity scores and other clinical data for their enrolled patients. The DDS care manager made one telephone contact with each intervention patient, and invited patients to attend a depression group education session. The DDS team monitored patient depression severity over time, and targeted additional time and effort towards patients not showing improvement. Additional DDS intervention included making further recommendations to primary care clinicians, and in some cases, a one-time consultation with the DDS psychiatrist.\n\nPotential subjects were identified from lists of patients due for appointments with primary care clinicians, and were contacted for telephone screening. Patients were enrolled if they had Patient Health Questionnaire (PHQ-9) scores \\>10 or a Hopkins Symptom Checklist (SCL-20) score of \\> 1.0 at a subsequent in-person interview. There were no restrictions by age or sex. Patients were excluded if they had psychotic symptoms, dementia, serious suicidal ideation, very severe depression (PHQ-9 \\>25), or had been treated by mental health clinicians within the previous six months. The intervention lasted 12 months. Depression symptom severity (SCL-20) and health related quality of life (SF-36V) at 6 and 12-months were primary outcomes. Primary analyses employed mixed-model repeated measure analyses of covariance, which include a random effect for clinician and fixed effects for time and intervention status.\n\nFINDINGS TO DATE: Five Portland VA clinic sites and 41 clinicians participated. 3,103 patients were screened, and 402 patients were enrolled. Three hundred seventy-five met final eligibility criteria. There were no adverse events. SCL-20 scores improved in both groups over 12 months (slope: -.382; 95% CI -.488, -.276), but there was no effect of the intervention on SCL-20 or Short Form-36V compared to usual care. There was greater initial improvement in PHQ-9 for intervention patients (p=.030); however, this effect diminished over time. At 12 months, intervention patients reported greater satisfaction (p=.002), and were more likely to have received antidepressants. To date, 10 manuscripts supported by the project have been published. One manuscript examining associations between stressful live events and depression outcomes has been submitted for publication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrimary care patients of eligible providers with depression (Patient Health Questionnaire \\[PHQ-9\\] depression scores of 10 to 25 or Hopkins Symptom Checklist-20 \\[SCL-20\\] scores \\>= 1.0)\n\nExclusion Criteria:\n\nPatients who had received treatment from mental health specialists within the previous 6 months; who had received a diagnosis of psychotic disorder, dementia, or bipolar disorder; or who were considered to be terminally ill'}, 'identificationModule': {'nctId': 'NCT00105833', 'acronym': 'DEP-PC', 'briefTitle': 'Improving Outcomes of Depression in Primary Care', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Improving Outcomes of Depression in Primary Care', 'orgStudyIdInfo': {'id': 'MHI 20-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Multifaceted collaborative intervention for depression based in primary care', 'interventionNames': ['Behavioral: Collaborative Care - Depression Decision Support (DDS)']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 2', 'description': 'Treatment as usual'}], 'interventions': [{'name': 'Collaborative Care - Depression Decision Support (DDS)', 'type': 'BEHAVIORAL', 'otherNames': ['Depression Decision Support (DDS)'], 'description': 'Multifaceted collaborative intervention for depression based in primary care', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Portland Health Care System, Portland, OR', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Steven K. Dobscha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Portland Health Care System, Portland, OR'}, {'name': 'Martha S. Gerrity, MD MPH PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Portland Health Care System, Portland, OR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}