Trials / Completed
CompletedNCT00042211
Preventing Depression in Patients With Macular Degeneration
Preventing Depression in Macular Degeneration
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 206 (actual)
- Sponsor
- Thomas Jefferson University · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the effectiveness of a Problem Solving Treatment in preventing depression in elderly patients with age-related macular degeneration (AMD).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Problem Solving Treatment | Brief Cognitive Behavioral Therapy |
| BEHAVIORAL | Control | No treatment control |
Timeline
- Start date
- 2001-02-01
- Primary completion
- 2006-01-01
- Completion
- 2006-01-01
- First posted
- 2002-07-26
- Last updated
- 2014-01-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00042211. Inclusion in this directory is not an endorsement.