Telephone-Based Care Management Program for Individuals With Anxiety Disorders - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00158327

Purpose

This study will determine the impact of a telephone-based care management program for primary care patients with panic disorder or generalized anxiety disorder.

Condition	Intervention	Phase
Anxiety Disorders Panic Disorder	Behavioral: Telephone-based collaborative care Behavioral: Usual care	Phase III

MedlinePlus related topics: Anxiety Panic Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	The RELAX Trial: Reducing Limitations From Anxiety in Primary Care

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

Primary Outcome Measures:

Health-related quality of life (SF-36 MCS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Generalized anxiety symptoms [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Panic disorder severity scale (PDSS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
PHQ-9 [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Alcohol use [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Health services utilization [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Health care costs [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	March 2004
Estimated Study Completion Date:	December 2007
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive telephone-based collaborative care	Behavioral: Telephone-based collaborative care 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.
2: Active Comparator Participants will receive usual care	Behavioral: Usual care 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.

Arms

Assigned Interventions

1: Experimental

Participants will receive telephone-based collaborative care

Behavioral: Telephone-based collaborative care

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.

2: Active Comparator

Participants will receive usual care

Behavioral: Usual care

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.

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158327

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Bruce L. Rollman, MD

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.

Publications indexed to this study:

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.

Responsible Party:	University of Pittsburgh ( Bruce L. Rollman, MD, MPH; Associate Professor of Medicine )
Study ID Numbers:	R01 MH59395, RELAX, DSIR 82-SEPC
Study First Received:	September 7, 2005
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00158327
Health Authority:	United States: Federal Government

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

Primary Health Care

Study placed in the following topic categories:

Panic Disorder
Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009