Low Vision Depression Prevention Trial for Age Related Macular Degeneration

描述（由申请人提供）：我们提出了一项随机对照临床试验，低视力抑郁症预防试验（VITAL），以测试低视力康复（LVR）干预预防年龄相关性黄斑变性（AMD）抑郁症的疗效。我们之前已经确定，30%的AMD患者在无法再追求有价值的目标时会变得抑郁。我们提出了一种创新的干预措施，其中低视力职业治疗师（OT）与低视力验光师合作，帮助患者继续实现有价值的目标，从而预防抑郁症。OT将在12周内与受试者在家中会面6次，并使用解决问题的方法促进器械使用培训、家庭改造和补偿策略。此外，OT将在干预期间与验光师一起审查受试者的进展。我们计划招募200名受试者，其中一只眼睛患有阈下抑郁症状和近期新生血管性AMD（NVAMD），另一只眼睛已经患有AMD。他们最近的双侧视力丧失和低水平的抑郁症状增加了他们患上更严重抑郁症的风险。我们将受试者随机分配至协作LVR（即，验光师和OT）或增强的LVR（即，验光师和支持治疗（ST））。在这项研究中，通常的LVR是“增强”与ST，这是一个标准化的安慰剂治疗，控制注意力。VITAL试验的主要目的是测试协作干预在4个月时降低抑郁症发生率（主要结局）的疗效。次要目标是：a）在4个月时测试协作干预改善目标视觉功能和视觉相关生活质量（次要结果）的功效; B）在12个月时测试协作干预预防抑郁症的长期效果;以及c）在12个月时测试协作干预对目标视觉功能和视觉相关生活质量的长期效果。我们还提出了探索性的目的，以了解干预的效果的机制，并估计其成本和成本效益。AMD是美国老年人失明的主要原因，影响着1000万人，随着人口老龄化，这是一个日益严重的公共卫生问题。在这种情况下，VITAL试验对AMD患者具有很高的临床意义，并且在我们面临照顾患有慢性残疾的老年人的挑战时具有更广泛的公共卫生意义。

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.