Telephone-Based Care Management Program for Individuals With Anxiety Disorders

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bruce Rollman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00158327
First received: September 7, 2005
Last updated: January 21, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Pittsburgh:

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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Pittsburgh
Investigators
Principal Investigator: Bruce L. Rollman, MD University of Pittsburgh
  More Information

Publications:
Additional 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: R01 MH59395, R01MH059395, RELAX, DSIR 82-SEPC
Study First Received: September 7, 2005
Last Updated: January 21, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Primary Health Care

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

ClinicalTrials.gov processed this record on September 16, 2014