University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT00158327
This study will determine the impact of a telephone-based care management program for primary care patients with panic disorder or generalized anxiety disorder.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 3
Pittsburgh, Pennsylvania, 15213, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: Measured at Month 12
Time frame: Measured at Month 12
Time frame: Measured at Month 12
Time frame: Measured at Month 12
Time frame: Measured at Month 12
Time frame: Measured at Month 12
Time frame: Measured at Month 12
University of Pittsburgh
Other
The RELAX Trial: Reducing Limitations From Anxiety in Primary Care
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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.
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