Telephone-Based Care Management Program for Individuals With Anxiety Disorders

Anxiety Disorders Clinical Trial

Official title:

The RELAX Trial: Reducing Limitations From Anxiety in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158327
• Other study ID #: R01MH059395
• Secondary ID: R01MH059395RELAX
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: January 21, 2014
• Start date: March 2004
• Est. completion date: February 2011

Study information

• Verified date: January 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: February 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Panic Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life (SF-36 MCS)		Measured at Month 12	No
Secondary	Generalized anxiety symptoms		Measured at Month 12	No
Secondary	Panic disorder severity scale (PDSS)		Measured at Month 12	No
Secondary	PHQ-9		Measured at Month 12	No
Secondary	Alcohol use		Measured at Month 12	No
Secondary	Health services utilization		Measured at Month 12	No
Secondary	Health care costs		Measured at Month 12	No