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Telephone-Based Care Management Program for Individuals With Anxiety Disorders

Primary Purpose

Anxiety Disorders, Panic Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Telephone-based collaborative care
Usual care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Primary Health Care

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of panic disorder or generalized anxiety disorder Score of 7 or higher on the Panic Disorder Severity Scale score OR a score of 14 or higher on the Structured Interview Guide for the Hamilton Anxiety Scale Life expectancy greater than 1 year Have a household telephone and can be contacted by phone for the duration of the study Able to read and write in English Exclusion Criteria: Presently receiving treatment for a psychiatric disorder from a mental health specialist At risk for suicide History of bipolar disorder Dependence on alcohol or other substances within 6 months prior to study entry Organic anxiety syndromes, including those secondary to medical illness or drugs Unstable medical conditions that would interfere with the study Plan to leave their primary care source during the study or for 1 year after study completion

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive telephone-based collaborative care

Participants will receive usual care

Outcomes

Primary Outcome Measures

Health-related quality of life (SF-36 MCS)

Secondary Outcome Measures

Generalized anxiety symptoms
Panic disorder severity scale (PDSS)
PHQ-9
Alcohol use
Health services utilization
Health care costs

Full Information

First Posted
September 7, 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
NCT00158327
Brief Title
Telephone-Based Care Management Program for Individuals With Anxiety Disorders
Official Title
The RELAX Trial: Reducing Limitations From Anxiety in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
This study will determine the impact of a telephone-based care management program for primary care patients with panic disorder or generalized anxiety disorder.
Detailed Description
Numerous studies have shown that telephone-based collaborative care programs may be an effective way to monitor the quality of life of individuals with mental health issues such as anxiety disorders. With regular monitoring through telephone conversations, health care providers can gain information from their patients in a convenient forum. This study will determine whether a telephone-based care management program can improve anxiety symptoms, alcohol abuse, employment patterns, use of health care services, and health-related quality of life for individuals with panic disorder or generalized anxiety disorder (GAD). Participants will be randomly assigned to receive either usual care or a telephone-based collaborative care program for 12 months. Usual care may include one or more of several different treatments such as pharmacotherapy and cognitive behavioral therapy; the treatments will be chosen by participants' physicians. Participants assigned to the telephone-based program will have a choice of what type of treatment they will receive; the choices will include pharmacotherapy, workbook training designed to help participants improve their coping skills, referral to a community mental health specialist, or some combination of these treatments. Participants receiving usual care will continue their treatment for 12 months. After 12 months, these participants will undergo interviews and complete self-report scales for assessment of their anxiety symptoms, health care use, alcohol use, and quality of life. Their participation in the trial will end after 12 months. Participants in the telephone intervention group will receive telephone calls 1 to 2 times every month for 12 months. During the calls, participants will be asked about their attitude toward and adherence to their treatment regimen. They will also be asked about recent episodes of anxiety they have experienced and what coping techniques they have used. Monthly follow-up calls will continue for an additional 12 months after the first year of the study; this will help determine the long-term effectiveness of the telephone-based intervention.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive telephone-based collaborative care
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive usual care
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based collaborative care
Intervention Description
Participants assigned to the telephone-based program will have a choice of what type of treatment they will receive. The choices will include pharmacotherapy, workbook training designed to help participants improve their coping skills, referral to a community mental health specialist, or some combination of these treatments. Participants will receive telephone calls one to two times every month for 12 months. During the calls, participants will be asked about their attitude toward and adherence to their treatment regimen. They will also be asked about recent episodes of anxiety they have experienced and what coping techniques they have used.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual care may include one or more of several different treatments such as pharmacotherapy and cognitive behavioral therapy; the treatments will be chosen by participants' physicians and will be delivered for 12 months.
Primary Outcome Measure Information:
Title
Health-related quality of life (SF-36 MCS)
Time Frame
Measured at Month 12
Secondary Outcome Measure Information:
Title
Generalized anxiety symptoms
Time Frame
Measured at Month 12
Title
Panic disorder severity scale (PDSS)
Time Frame
Measured at Month 12
Title
PHQ-9
Time Frame
Measured at Month 12
Title
Alcohol use
Time Frame
Measured at Month 12
Title
Health services utilization
Time Frame
Measured at Month 12
Title
Health care costs
Time Frame
Measured at Month 12

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: Diagnosis of panic disorder or generalized anxiety disorder Score of 7 or higher on the Panic Disorder Severity Scale score OR a score of 14 or higher on the Structured Interview Guide for the Hamilton Anxiety Scale Life expectancy greater than 1 year Have a household telephone and can be contacted by phone for the duration of the study Able to read and write in English Exclusion Criteria: Presently receiving treatment for a psychiatric disorder from a mental health specialist At risk for suicide History of bipolar disorder Dependence on alcohol or other substances within 6 months prior to study entry Organic anxiety syndromes, including those secondary to medical illness or drugs Unstable medical conditions that would interfere with the study Plan to leave their primary care source during the study or for 1 year after study completion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce L. Rollman, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
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
21977355
Citation
Behringer T, Rollman BL, Herbeck-Belnap B, Houck PR, Mazumdar S, Schwarz EB. Impact of physician counseling and perception of teratogenic risks: a survey of 96 nonpregnant women with anxiety. Prim Care Companion CNS Disord. 2011;13(2):PCC.10m01028. doi: 10.4088/PCC.10m01028.
Results Reference
derived
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

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Telephone-Based Care Management Program for Individuals With Anxiety Disorders

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