Panic Disorder Clinical Trial
Official title:
Improving Quality of Primary Care for Anxiety Disorders
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.
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 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 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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