Child Behavior Disorders |
Bullying |
Clinical Trial: Telephone-Based Care Management Program for Individuals with Anxiety Disorders
This study is currently recruiting patients.
Verified by National Institute of Mental Health (NIMH) September 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Anxiety Disorders Panic Disorder | Behavior: Telephone-based collaborative care Behavior: Mental health treatment | Phase III |
MedlinePlus related topics: Anxiety; Panic Disorder
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: The RELAX Trial: Reducing Limitations from Anxiety in Primary Care
Secondary Outcomes: Generalized anxiety symptoms; panic disorder symptoms; depressive symptoms; alcohol use; health services utilization; health care costs
Expected Total Enrollment: 360
Study start: March 2004; Expected completion: February 2008
Last follow-up: December 2007; Data entry closure: December 2007
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 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
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
Location and Contact Information
Pennsylvania
University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Bea Herbeck Belnap, Dr. Biol. Hum. 412-692-2659 belnapbh@upmc.edu
Bruce L Rollman, MD, MPH, Principal Investigator
M. Katherine Shear, MD, Principal Investigator
Bea Herbeck Belnap, Dr. Biol Hum, Sub-Investigator
Jack R Cornelius, MD, Sub-Investigator
Joseph Conigliaro, MD, Sub-Investigator
Sati Mazumdar, PhD, Sub-Investigator
Eric Lenze, MD, Sub-Investigator
Mark S. Roberts, MD, Sub-Investigator
Herbert C. Schulberg, PhD, Sub-Investigator
Edward P. Post, MD, Sub-Investigator
Bruce L. Rollman, MD, Principal Investigator, 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.
Last Updated: September 10, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00158327
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13

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