Skip to main content
OpenTrials
Completed

NCT Number: NCT00158327

Telephone-Based Care Management Program for Individuals With Anxiety Disorders

This study will determine the impact of a telephone-based care management program for primary care patients with panic disorder or generalized anxiety disorder.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone-based collaborative care

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Health-related quality of life (SF-36 MCS)

    Time frame: Measured at Month 12

Secondary outcomes

  1. Generalized anxiety symptoms

    Time frame: Measured at Month 12

  2. Panic disorder severity scale (PDSS)

    Time frame: Measured at Month 12

  3. PHQ-9

    Time frame: Measured at Month 12

  4. Alcohol use

    Time frame: Measured at Month 12

  5. Health services utilization

    Time frame: Measured at Month 12

  6. Health care costs

    Time frame: Measured at Month 12

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

The RELAX Trial: Reducing Limitations From Anxiety in Primary Care

Important dates

Study start
2004
Primary completion
2010
Study completion
2011
First posted
Sep 12, 2005
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.