Low Vision Depression Prevention Trial for Age Related Macular Degeneration
NCT ID: NCT00769015
Last Updated: 2014-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
188 participants
INTERVENTIONAL
2009-06-30
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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BA-LVR
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR
Low vision clinic-based optometry plus 6 in-home occupational therapy visits
ST-LVR
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR
Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
Interventions
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BA-LVR
Low vision clinic-based optometry plus 6 in-home occupational therapy visits
ST-LVR
Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
Eligibility Criteria
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Inclusion Criteria
* Bilateral AMD
* Subthreshold depressive symptoms
* At least 1 vision goal that is important yet difficult to carry out
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Johns Hopkins University
OTHER
Thomas Jefferson University
OTHER
Responsible Party
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Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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References
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Rovner BW, Casten RJ, Hegel MT, Massof RW, Leiby BE, Ho AC, Tasman WS. Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial. Ophthalmology. 2014 Nov;121(11):2204-11. doi: 10.1016/j.ophtha.2014.05.002. Epub 2014 Jul 9.
Deemer AD, Massof RW, Rovner BW, Casten RJ, Piersol CV. Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2017 Mar 1;58(3):1514-1520. doi: 10.1167/iovs.16-20001.
Other Identifiers
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