Improving Quality of Primary Care for Patients With Anxiety and/or Panic Disorders - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00102427

Purpose

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.

Condition	Intervention	Phase
Panic Disorder Anxiety Disorder	Behavioral: Telephone-based collaborative care management	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Improving Quality of Primary Care for Anxiety Disorders

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Panic Disorder

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Anxiety symptoms

Study Start Date:	July 2000
Estimated Study Completion Date:	May 2003

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Panic disorder or generalized anxiety disorder
A Structured Interview Guide to the Hamilton Rating Scale for Anxiety (SIGH-A) score of at least 14 for participants with generalized anxiety disorder OR Panic Disorder Severity Scale (PDSS) score of at least 7 for participants with panic disorder
Primary care physician has agreed to participate in the study
Speaks English and able to participate in phone assessments and information/self-management program
Gives consent to allow research staff to notify the participant's primary care physician of diagnosis

Exclusion Criteria:

Thoughts of suicide
Current psychotic disorder
Current bipolar disorder
Alcohol or other substance disorder within the past 2 months prior to study entry
Organic anxiety syndromes, including those due to medical illness or drugs
Unstable medical conditions
Plans to leave current physician during the year after study start
Life expectancy less than 1 year
Previously enrolled in a similar panic or generalized anxiety disorder study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102427

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Bruce L. Rollman, MD, MPH

University of Pittsburgh

More Information

Publications:

Rollman BL, Herbeck Belnap B, Reynolds CF, Schulberg HC, Shear MK. A contemporary protocol to assist primary care physicians in the treatment of panic and generalized anxiety disorders. Gen Hosp Psychiatry. 2003 Mar-Apr;25(2):74-82.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rollman BL, Fischer GS, Zhu F, Belnap BH. Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment. J Gen Intern Med. 2008 Apr;23(4):447-50.

ClinicalTrials.gov Identifier:	NCT00102427 History of Changes
Other Study ID Numbers:	R01 MH09421
Study First Received:	January 29, 2005
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Anxiety
Panic
Generalized Anxiety Disorder

Additional relevant MeSH terms:

Anxiety Disorders
Panic Disorder
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012