Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158327
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2005-09-07
Brief Title:
Telephone-Based Care Management Program for Individuals With Anxiety Disorders
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
The RELAX Trial Reducing Limitations From Anxiety in Primary Care
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 82-SEPC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH059395 |
| R01MH059395 | NIH | None | None |
| RELAX | None | None | None |