View Clinical Trial (Medical Research Study)
Low Vision Depression Prevention Trial for Age Related Macular Degeneration
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19107 |
| Conditions: |
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Age-related Macular Degeneration - Depression |
| Purpose: |
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This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL
(VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent
depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative
intervention, a low vision occupational therapist collaborates with a low vision optometrist
to develop and implement a care plan based on a subject's vision status, rehabilitation
potential, and personal rehabilitation goals. An independent rater masked to treatment
assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and
targeted vision function and vision-related quality of life (secondary outcomes) at baseline
and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months
to evaluate long-term effects.
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| Study Summary: |
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Age-related macular degeneration (AMD) is the leading cause of blindness in older persons in
the U.S. and affects more than 10 million people. One third of patients with AMD become
clinically depressed when they lose the ability to pursue valued activities. Because their
depression is disabling and unlikely to be treated, preventing depression in AMD is a public
health imperative as the population ages.
We will recruit 200 subjects who have bilateral AMD and subthreshold depressive symptoms.
Their bilateral vision loss and subthreshold depressive symptoms increase their risk to
develop more severe depressive disorders and functional decline. We will randomize eligible
subjects to collaborative Low Vision Rehabilitation (LVR) (optometrist and home-based OT) or
enhanced LVR (optometrist and home-based Supportive Therapy). In this study, usual care LVR
is enhanced with Supportive Therapy (ST), which is a standardized placebo psychological
treatment that controls for attention.
Many older persons with AMD understandably become depressed when their vision loss prevents
them from pursuing valued goals. This necessitates a disease management strategy that
combines treatment for vision loss and depression. Because depression in AMD is rarely
treated, preventing depression is more sensible than waiting to treat it after diagnosis or
failing to treat it at all. As the population ages and more people are affected with AMD,
finding ways to prevent depression and improve daily functioning has great public health
importance. For these reasons, the VITAL Trial has high clinical significance to patients
with AMD, and wider public health significance as our society confronts the challenge of
caring for the growing population of older adults with chronic disabilities.
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| Criteria: |
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Inclusion Criteria:
- Age at least 65 years old
- Bilateral AMD
- Subthreshold depressive symptoms
- At least 1 vision goal that is important yet difficult to carry out
Exclusion Criteria:
- Uncontrolled glaucoma, diabetic retinopathy, corneal dystrophy, or cataracts for
which surgery within 6 months is likely will be exclusionary conditions
- Current diagnosis of depression
- Cognitive impairment
- Life-threatening illness or any other health conditions that interferes with study
activities.
- Patients who have received low vision rehabilitation or home-based OT in the
preceding 12 months will be excluded.
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| NCT ID: |
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NCT00769015 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Philadelphia, Pennsylvania 19107
United States
Robin J Casten, PhD
Phone: 215-503-1250
Email: Robin.Casten@Jefferson.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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