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| Tracking Information | |||||
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| First Received Date ICMJE | January 29, 2005 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | July 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Anxiety symptoms | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00102427 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improving Quality of Primary Care for Patients With Anxiety and/or Panic Disorders | ||||
| Official Title ICMJE | Improving Quality of Primary Care for Anxiety Disorders | ||||
| Brief Summary | The purpose of this study is to determine if primary care patients with panic and/or generalized anxiety disorder can benefit from a telephone-based collaborative care intervention. |
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| Detailed Description | Panic and generalized anxiety disorders are serious conditions that often are inadequately recognized and treated, responsible for significant morbidity, and associated with excessive health services' utilization. More effective treatment interventions that involve both primary care physicians (PCPs) and patients are necessary to manage these conditions. Patients presenting for primary care services will be screened for panic and generalized anxiety disorders using the Primary Care Evaluation of Mental Disorder (PRIME-MD); patients and their PCPs will be informed of patients' diagnosis. Participants will then be randomly assigned to receive either a telephone-based collaborative care intervention or their PCPs' usual care. The telephone care intervention will involve a protocol that is based on the American Psychiatric Association's and other published guidelines for treating panic disorder (PD) and generalized anxiety disorder (GAD). The care manager will assess each patient's treatment preferences for either anxiolytic pharmacotherapy, a self-management workbook, referral to a community mental health speicalist, or some combination of these. The care manager will conduct periodic telephone follow-up interviews with intervention participants to inquire about anxiety symptoms, treatment adherence, review lesson plans, and any side effects they have experienced, as applicable. The care manager maintains correspondence with the PCPs of the telephone intervention participants via an electronic medical record system to rapidly relay information regarding patients' treatment and obtain the PCPs approval for initiating or adjusting pharmacotherapy according to the patient's response to treatment and protocol. A blinded research assistant who is unaware of participants' randomization group will conduct telephone interviews with all participants to assess the effectiveness of the intervention relative to the usual care control condition. These interviews will be conducted at baseline and at 2-, 4-, 8-, and 12-months follow-up. Measures assessed include anxiety symptoms, functional status, health services utilization, and overall quality of life. |
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| Study Phase | Phase II, Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Telephone-based collaborative care management | ||||
| 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 | ||||
| Enrollment ICMJE | |||||
| Completion Date | May 2003 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| 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 | NCT00102427 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01 MH09421 | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 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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