Viewing Study NCT00102427



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Last Modification Date: 2024-10-26 @ 9:11 AM
Study NCT ID: NCT00102427
Status: COMPLETED
Last Update Posted: 2014-01-22
First Post: 2005-01-29

Brief Title: Improving Quality of Primary Care for Patients With Anxiety andor Panic Disorders
Sponsor: University of Pittsburgh
Organization: University of Pittsburgh

Study Overview

Official Title: Improving Quality of Primary Care for Anxiety Disorders
Status: COMPLETED
Status Verified Date: 2014-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine if primary care patients with panic andor generalized anxiety disorder can benefit from a telephone-based collaborative care intervention
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 Associations and other published guidelines for treating panic disorder PD and generalized anxiety disorder GAD The care manager will assess each patients treatment preferences for either anxiolytic pharmacotherapy a self-management workbook referral to a community mental health specialist 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 patients 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01MH059395 NIH None httpsreporternihgovquickSearchR01MH059395