Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial

Abstract

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.

Figure 1

Low VIsion Depression Prevention TriAL (VITAL) cohort participation. BA = behavior activation; LVR = low vision rehabilitation visits; ST = supportive therapy.

Figure 2

Mediational analysis delineating mechanism by which Behavior Activation (BA) + low vision rehabilitation visits (LVR) prevent depression. BADS = Behavioral Activation for Depression Scale Social Impairment subscale; MOS = Medical Outcomes Study-6; PHQ-9 = Patient Health Ques tionnaire-9.