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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00042211 |
Purpose
This study will evaluate the effectiveness of a Problem Solving Treatment in preventing depression in elderly patients with age-related macular degeneration (AMD).
| Condition | Intervention | Phase |
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Depression Macular Degeneration |
Behavioral: Problem Solving Treatment Behavioral: Control |
Phase III |
| Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
| MedlinePlus related topics: | Depression Macular Degeneration |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Preventing Depression in Macular Degeneration |
| Enrollment: | 206 |
| Study Start Date: | February 2001 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Problem Solving Treatment
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Behavioral: Problem Solving Treatment
Brief Cognitive Behavioral Therapy
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2: Active Comparator
Control
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Behavioral: Control
No treatment control
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AMD is the most common cause of blindness in older adults. The disease limits the ability to read, see familiar faces, and walk independently. Almost 2 million persons (about 5 percent of the U.S. population over age 65) are now affected, and this number will triple by the year 2020. This study will target patients with neovascular AMD (NV-AMD), a form of AMD which can lead to sudden vision loss, substantial disability, and depression. Because depression is itself disabling and not likely to be recognized nor treated by ophthalmologists, preventing depression in people with NV-AMD is important.
Patients are randomly assigned to either PST or a usual care control condition. The primary outcome measure is a DSM-IV diagnosis of depression. Patients are evaluated at baseline, Month 2 (immediately post-intervention), Month 6 (for the primary efficacy analysis), and Month 12 (to evaluate sustained effects). The study will also assess the impact of PST on levels of disability and vision-related quality of life.
Eligibility
| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Contacts and Locations More Information
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Rovner BW, Casten RJ. Activity loss and depression in age-related macular degeneration. Am J Geriatr Psychiatry. 2002 May-Jun;10(3):305-10.
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Rovner BW, Casten RJ. Neuroticism predicts depression and disability in age-related macular degeneration. J Am Geriatr Soc. 2001 Aug;49(8):1097-100.
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Rovner BW, Ganguli M. Depression and disability associated with impaired vision: the MoVies Project. J Am Geriatr Soc. 1998 May;46(5):617-9.
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Rovner BW, Casten RJ, Tasman WS. Effect of depression on vision function in age-related macular degeneration. Arch Ophthalmol. 2002 Aug; 120(8): 1041-4.
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Tasman, W., & Rovner, B. W. (in press). Age related macular degeneration: reating the whole person. Archives in Ophthalmology
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Casten, R. J., Rovner, B. W., & Tasmas, W. (in press). Age related macular degeneration and depression: a review of recent research. Current Opinions in Ophthalmololgy.
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Casten, R. J., & Rovner, B. W. The role of psychological characteristics in the use and perceived importance of low vision aids. Submitted to the Journal of Vision Impairment and Blindness
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Rovner, B. W., & Casten, R. J. Stability of Visual Acuity Measurement in Depression. Submitted to the Archives of Ophthalmology.
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| Responsible Party: | Thomas Jefferson University ( Barry Rovner, MD ) |
| Study ID Numbers: | R01 MH61331, DATR A4-GPS |
| First Received: | July 24, 2002 |
| Last Updated: | February 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00042211 |
| Health Authority: | United States: Federal Government |
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