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Telephone-Based Care Management Program for Individuals With Anxiety Disorders

This study is ongoing, but not recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Telephone-Based Care Management Program for Individuals With Anxiety Disorders
Official Title  The RELAX Trial: Reducing Limitations From Anxiety in Primary Care
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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary Outcome Measure  Health-related quality of life (SF-36 MCS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Anxiety Disorders
Panic Disorder
Intervention  Behavioral: Telephone-based collaborative care
Behavioral: Usual care
MEDLINE PMIDs 12676419
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  360
Start Date  March 2004
Completion Date December 2007
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
Gender Both
Ages 18 Years to 64 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00158327
Organization ID R01 MH59395
Secondary IDs †† RELAX, DSIR 82-SEPC
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Bruce L. Rollman, MD     University of Pittsburgh    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date August 2008
First Received Date  September 7, 2005
Last Updated Date August 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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