We propose a randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), to test the efficacy of a low vision rehabilitative (LVR) intervention to prevent depressive disorders in age-related macular degeneration (AMD). We have previously established that 30% of patients with AMD become depressed when they can no longer pursue valued goals. We propose an innovative intervention in which a low vision occupational therapist (OT) collaborates with a low vision optometrist to help patients to continue valued goals and thereby prevent depressive disorders. The OT will meet with subjects in their homes 6 times over 12 weeks, and use a problem-solving approach to facilitate device use training, home modifications, and compensatory strategies. Additionally, the OT will review subject progress with the optometrist 2 X during the intervention. We plan to recruit 200 subjects with subthreshold depressive symptoms and recent neovascular AMD (NVAMD) in one eye, who already have AMD in the fellow eye. Their recent bilateral vision loss and low level depressive symptoms increase their risk to develop more severe depressive disorders. We will randomize subjects to collaborative LVR (i.e., optometrist and OT) or enhanced LVR (i.e., optometrist and Supportive Therapy (ST)). In this study, usual LVR is """"""""enhanced"""""""" with ST, which is a standardized placebo treatment that controls for attention. The primary aim of the VITAL Trial is to test the efficacy of the collaborative intervention to reduce the incidence of depressive disorders (primary outcome) at 4 months. The secondary aims are to: a) test the efficacy of the collaborative intervention to improve targeted vision function and vision-related quality of life (secondary outcomes) at 4 months;b) test the collaborative intervention's long-term effect to prevent depressive disorders at 12 months;and c) test the collaborative intervention's long-term effect on targeted vision function and vision-related quality of life at 12 months. We also propose exploratory aims to understand the mechanisms of the intervention's effect and to estimate its cost and cost-effectiveness. AMD is the leading cause of blindness in older persons in the U.S., affects 10 million people, and is a growing public health problem as the population ages. In this context, the VITAL Trial has high clinical significance to patients with AMD, and wider public health significance as we confront the challenge of caring for older adults with chronic disabilities.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01EY018819-03
Application #
7940925
Study Section
Special Emphasis Panel (ZEY1-VSN (03))
Program Officer
Oversby, Steven
Project Start
2008-08-05
Project End
2012-07-31
Budget Start
2010-08-01
Budget End
2011-07-31
Support Year
3
Fiscal Year
2010
Total Cost
$936,326
Indirect Cost
Name
Thomas Jefferson University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
053284659
City
Philadelphia
State
PA
Country
United States
Zip Code
19107
Deemer, Ashley D; Massof, Robert W; Rovner, Barry W et al. (2017) Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci 58:1514-1520
Rovner, Barry W; Casten, Robin J; Hegel, Mark T et al. (2014) Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial. Ophthalmology 121:2204-11
Casten, Robin J; Rovner, Barry W (2013) Update on depression and age-related macular degeneration. Curr Opin Ophthalmol 24:239-43