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| 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. |
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| 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. |
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| 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 ] |
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| Condition † | Anxiety Disorders Panic Disorder |
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| Intervention † | Behavioral: Telephone-based collaborative care Behavioral: Usual care |
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| 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:
Exclusion Criteria:
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| 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 † |
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| 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 | ||||