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Improving Quality of Primary Care for Patients With Anxiety and/or Panic Disorders

Primary Purpose

Panic Disorder, Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telephone-based collaborative care management
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Anxiety, Panic, Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center

Outcomes

Primary Outcome Measures

Anxiety symptoms

Secondary Outcome Measures

Full Information

First Posted
January 29, 2005
Last Updated
January 21, 2014
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00102427
Brief Title
Improving Quality of Primary Care for Patients With Anxiety and/or Panic Disorders
Official Title
Improving Quality of Primary Care for Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Anxiety Disorder
Keywords
Anxiety, Panic, Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Telephone-based collaborative care management
Primary Outcome Measure Information:
Title
Anxiety symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce L. Rollman, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12676419
Citation
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. doi: 10.1016/s0163-8343(03)00004-5.
Results Reference
background
PubMed Identifier
16330721
Citation
Rollman BL, Belnap BH, Mazumdar S, Houck PR, Zhu F, Gardner W, Reynolds CF 3rd, Schulberg HC, Shear MK. A randomized trial to improve the quality of treatment for panic and generalized anxiety disorders in primary care. Arch Gen Psychiatry. 2005 Dec;62(12):1332-41. doi: 10.1001/archpsyc.62.12.1332.
Results Reference
result
PubMed Identifier
18373143
Citation
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. doi: 10.1007/s11606-007-0449-0.
Results Reference
derived

Learn more about this trial

Improving Quality of Primary Care for Patients With Anxiety and/or Panic Disorders

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