| ID | Type | Description | Link |
|---|---|---|---|
| R01MH053932 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| National Institutes of Health (NIH) | NIH |
| The University of Texas Health Science Center, Houston | OTHER |
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The purpose of this study is to determine whether cognitive behavior therapy (CBT) is effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older in a primary care setting.
Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders among older adults. Anxiety in older adults is associated with decreased physical activity, poorer self-perceptions of health, decreased life satisfaction, and increased loneliness. Because many older adults with anxiety seek assistance in a medical setting, treatment has been primarily pharmacological. There is, however, limited evidence of the effectiveness of psychotropic medications. Given the potential difficulties in prescribing psychotropic medications in later life (e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternative or adjuncts.
The treatment phase of this study lasts 10 weeks, during which patients will be randomly assigned to either cognitive behavior therapy (CBT) or usual care. Follow-up will last 12 months after treatment completion, during which time patients will complete telephone assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cognitive Behavior Therapy |
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| 2 | Active Comparator | Usual Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavior Therapy | Behavioral | 8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period |
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| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Baseline and 3, 6, 9, 12 and 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional and health status | Baseline and 3, 6, 9, 12 and 15 months | |
| Quality of life inventory (QOLI) | Baseline and 3, 6, 9, 12 and 15 months | |
| Satisfaction with CBT and general health care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda A. Stanley, Ph.D. | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Center for Quality of Care and Utilization Studies | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16325733 | Background | Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders. Psychiatr Clin North Am. 2005 Dec;28(4):871-96, ix. doi: 10.1016/j.psc.2005.09.006. No abstract available. | |
| 16299425 | Background | Stanley MA, Kunik ME. Anxiety in primary care: a frontier for mental health services research. Med Care. 2005 Dec;43(12):1161-3. doi: 10.1097/01.mlr.0000190923.04095.80. No abstract available. |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Kelsey Research Foundation |
| OTHER |
| Kelsey-Seybold Clinic | OTHER |
| Michael E. DeBakey VA Medical Center | FED |
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| Telephone check-in | Behavioral | Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition |
|
| Baseline and 3, 6, 9, 12 and 15 months |
| Service utilization | Baseline and 3, 6, 9, 12 and 15 months |
| Depression | Baseline and 3, 6, 9, 12 and 15 months |
| Sleep quality | Baseline and 3, 6, 9, 12 and 15 months |
| Use of alcohol and other substances | Baseline and 3, 6, 9, 12 and 15 months |
| 12527544 | Background | Stanley MA, Hopko DR, Diefenbach GJ, Bourland SL, Rodriguez H, Wagener P. Cognitive-behavior therapy for late-life generalized anxiety disorder in primary care: preliminary findings. Am J Geriatr Psychiatry. 2003 Jan-Feb;11(1):92-6. |
| 25497362 | Derived | Shrestha S, Stanley MA, Wilson NL, Cully JA, Kunik ME, Novy DM, Rhoades HM, Amspoker AB. Predictors of change in quality of life in older adults with generalized anxiety disorder. Int Psychogeriatr. 2015 Jul;27(7):1207-15. doi: 10.1017/S1041610214002567. Epub 2014 Dec 12. |
| 19351943 | Derived | Stanley MA, Wilson NL, Novy DM, Rhoades HM, Wagener PD, Greisinger AJ, Cully JA, Kunik ME. Cognitive behavior therapy for generalized anxiety disorder among older adults in primary care: a randomized clinical trial. JAMA. 2009 Apr 8;301(14):1460-7. doi: 10.1001/jama.2009.458. |