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| Tracking Information | |||||
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| First Received Date ICMJE | March 14, 2001 | ||||
| Last Updated Date | August 6, 2009 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00012766 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Team Treatment of Depression in Primary Care | ||||
| Official Title ICMJE | Effectiveness of Team Treatment of Depression in Primary Care | ||||
| Brief Summary | 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. |
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| Detailed Description | Background: 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. Objectives: This effectiveness study adapted collaborative care to the VA primary care setting ("collaborative care") and compared it with consult-liaison care ("CL care"). Methods: Patients within a VA primary care clinic were randomly assigned by firm to the two interventions. In 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. Status: Complete. Final Report submitted June 30, 2001. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Integrated team care | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 360 | ||||
| Completion Date | March 2001 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Several 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. Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00012766 | ||||
| Responsible Party | Hedrick, Susan - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | IIR 95-097 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | January 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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