Elsevier

Ophthalmology

Volume 121, Issue 11, November 2014, Pages 2204-2211
Ophthalmology

Original article
Low Vision Depression Prevention Trial in Age-Related Macular Degeneration: A Randomized Clinical Trial

https://doi.org/10.1016/j.ophtha.2014.05.002Get rights and content

Purpose

To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD).

Design

Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months.

Participants

Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188).

Interventions

Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention.

Main Outcome Measures

The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire–25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes).

Results

At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27–1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27–0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life.

Conclusions

An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid depression will increase. Promoting interactions between ophthalmology, optometry, rehabilitation, psychiatry, and behavioral psychology may prevent depression in this population.

Section snippets

Eligibility and Trial Design

Institutional review board/ethics committee approval was obtained to conduct VITAL (clinicaltrials.gov NCT00769015). All subjects provided informed consent; study procedures were compliant with the Health Insurance Portability and Accountability Act and adhered to the tenets of the Declaration of Helsinki. Subjects were recruited from a large private retina practice associated with the Wills Eye Hospital, Philadelphia, Pennsylvania, who met the following inclusion criteria: (1) age >65 years,

Results

Figure 1 depicts the study flow chart. From July 2009 to February 2013, we reviewed the records of 2324 potentially eligible patients. Of them, 1158 (49.8%) declined participation, 706 (30.4%) were ineligible, and 272 (11.8%) could not be reached. There were no differences between enrolled subjects and eligible patients who declined participation with regard to age, sex, or visual acuity (data not shown). Baseline assessments were conducted on 222 subjects. Of them, 23 subjects declined further

Discussion

We found that an integrated mental health and low vision intervention halved the incidence of depressive disorders (i.e., 12.6% vs 23.4%) relative to standard outpatient LVR in a high-risk population of patients with AMD. Previous studies indicate that the incidence of depression in the absence of any rehabilitative treatment in patients with AMD ranges from 20% to 28%.28, 29 The preventive efficacy of BA+LVR was strong, with an NNT of 9 to prevent 1 case of depression. For subjects with worse

Acknowledgments

A Data and Safety Monitoring Committee ensured subject safety and supervised recruitment, data collection and analyses, and preparation of this manuscript. The committee members were Sheryl F. Kelsey, PhD, Chair (University of Pittsburgh, Pittsburgh, PA); Dianne M. Bartels, RN, MA, PhD (University of Minnesota, Minneapolis, MN); Donald C. Fletcher, MD (California Pacific Medical Center/Smith-Kettlewell Eye Research Institute, San Francisco, CA); Michele Melia, ScM (Jaeb Center for Health

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  • Cited by (0)

    Financial Disclosure(s): This work was supported by NEI grant U01 EY018819.

    The authors have no proprietary or commercial interest in any materials discussed in this article.

    Members of the Data and Safety Monitoring Committee and the Wills Eye Study Group are: The Wills Eye AMD Study Group: William E. Benson, MD, Gary C. Brown, MD, Jay L. Federman, MD, Mitchell S. Fineman, MD, David H. Fischer, MD, Sunir J. Garg, MD, Allen C. Ho, MD, Jason Hsu, MD, Richard S. Kaiser, MD, Alfred C. Lucier, MD, Joseph I. Maguire, MD, J. Arch McNamara, MD, Carl H. Park, MD, Carl D. Regillo, MD, Lov K. Sarin, MD, Arunan Sivalingam, MD, Marc J. Spirn, MD, and James F. Vander, MD.

    Deceased.

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