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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH059395 | U.S. NIH Grant/Contract | View source | |
| RELAX | |||
| DSIR 82-SEPC |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
This study will determine the impact of a telephone-based care management program for primary care patients with panic disorder or generalized anxiety disorder.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive telephone-based collaborative care |
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| 2 | Active Comparator | Participants will receive usual care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life (SF-36 MCS) | Measured at Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Generalized anxiety symptoms | Measured at Month 12 | |
| Panic disorder severity scale (PDSS) | Measured at Month 12 | |
| PHQ-9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce L. Rollman, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12676419 | Background | 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. doi: 10.1016/s0163-8343(03)00004-5. | |
| 21977355 | Derived | Behringer T, Rollman BL, Herbeck-Belnap B, Houck PR, Mazumdar S, Schwarz EB. Impact of physician counseling and perception of teratogenic risks: a survey of 96 nonpregnant women with anxiety. Prim Care Companion CNS Disord. 2011;13(2):PCC.10m01028. doi: 10.4088/PCC.10m01028. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| 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. |
|
| Measured at Month 12 |
| Alcohol use | Measured at Month 12 |
| Health services utilization | Measured at Month 12 |
| Health care costs | Measured at Month 12 |
| 18373143 | Derived | Rollman BL, Fischer GS, Zhu F, Belnap BH. Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment. J Gen Intern Med. 2008 Apr;23(4):447-50. doi: 10.1007/s11606-007-0449-0. |