Low Vision Depression Prevention Trial for Age Related Macular Degeneration

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DESCRIPTION (provided by applicant): 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.