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Telephone-Based Care Management Program for Individuals With Anxiety Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00158327
First Posted: September 12, 2005
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Bruce Rollman, University of Pittsburgh
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The RELAX Trial: Reducing Limitations From Anxiety in Primary Care

Resource links provided by NLM:


Further study details as provided by Bruce Rollman, University of Pittsburgh:

Primary Outcome Measures:
  • Health-related quality of life (SF-36 MCS) [ Time Frame: Measured at Month 12 ]

Secondary Outcome Measures:
  • Generalized anxiety symptoms [ Time Frame: Measured at Month 12 ]
  • Panic disorder severity scale (PDSS) [ Time Frame: Measured at Month 12 ]
  • PHQ-9 [ Time Frame: Measured at Month 12 ]
  • Alcohol use [ Time Frame: Measured at Month 12 ]
  • Health services utilization [ Time Frame: Measured at Month 12 ]
  • Health care costs [ Time Frame: Measured at Month 12 ]

Estimated Enrollment: 360
Study Start Date: March 2004
Study Completion Date: February 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Active Comparator: 2
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158327


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Bruce L. Rollman, MD University of Pittsburgh
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruce Rollman, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00158327     History of Changes
Other Study ID Numbers: R01MH059395 ( U.S. NIH Grant/Contract )
RELAX
DSIR 82-SEPC
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Bruce Rollman, University of Pittsburgh:
Primary Health Care

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Panic Disorder
Pathologic Processes
Mental Disorders