Clinical trial NCT00769015: Low Vision Depression Prevention Trial for Age Related Macular Degeneration
Official title: Low Vision Depression Prevention Trial for Age Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Age-related Macular Degeneration
Depression
Keywords: age-related macular degeneration
depression
vision loss
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
name: Johns Hopkins University
First posted: 2008-10-08
Enrollment: 188
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative intervention, a low vision occupational therapist collaborates with a low vision optometrist to develop and implement a care plan based on a subject's vision status, rehabilitation potential, and personal rehabilitation goals. An independent rater masked to treatment assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and targeted vision function and vision-related quality of life (secondary outcomes) at baseline and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months to evaluate long-term effects.

Detailed description: Age-related macular degeneration (AMD) is the leading cause of blindness in older persons in the U.S. and affects more than 10 million people. One third of patients with AMD become clinically depressed when they lose the ability to pursue valued activities. Because their depression is disabling and unlikely to be treated, preventing depression in AMD is a public health imperative as the population ages.

We will recruit 200 subjects who have bilateral AMD and subthreshold depressive symptoms. Their bilateral vision loss and subthreshold depressive symptoms increase their risk to develop more severe depressive disorders and functional decline. We will randomize eligible subjects to collaborative Low Vision Rehabilitation (LVR) (optometrist and home-based OT) or enhanced LVR (optometrist and home-based Supportive Therapy). In this study, usual care LVR is enhanced with Supportive Therapy (ST), which is a standardized placebo psychological treatment that controls for attention.

Many older persons with AMD understandably become depressed when their vision loss prevents them from pursuing valued goals. This necessitates a disease management strategy that combines treatment for vision loss and depression. Because depression in AMD is rarely treated, preventing depression is more sensible than waiting to treat it after diagnosis or failing to treat it at all. As the population ages and more people are affected with AMD, finding ways to prevent depression and improve daily functioning has great public health importance. For these reasons, the VITAL Trial has high clinical significance to patients with AMD, and wider public health significance as our society confronts the challenge of caring for the growing population of older adults with chronic disabilities.

Eligibility criteria: Inclusion Criteria:

* Age at least 65 years old
* Bilateral AMD
* Subthreshold depressive symptoms
* At least 1 vision goal that is important yet difficult to carry out

Exclusion Criteria:

* Uncontrolled glaucoma, diabetic retinopathy, corneal dystrophy, or cataracts for which surgery within 6 months is likely will be exclusionary conditions
* Current diagnosis of depression
* Cognitive impairment
* Life-threatening illness or any other health conditions that interferes with study activities.
* Patients who have received low vision rehabilitation or home-based OT in the preceding 12 months will be excluded.

Primary outcomes:
measure: Depression
timeFrame: 4 months
Secondary outcomes:
measure: Vision Function: Distance Activities
timeFrame: 4 months
measure: Quality of Life: Dependency
timeFrame: 4 months
measure: Vision Function: Near Activities
timeFrame: 4 months
measure: Quality of Life: Mental Health
timeFrame: 4 months
measure: Quality of Life: Role Functioning
timeFrame: 4 months
measure: Quality of Life: Social Function
timeFrame: 4 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
citation: Rovner BW, Casten RJ, Hegel MT, Massof RW, Leiby BE, Ho AC, Tasman WS. Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial. Ophthalmology. 2014 Nov;121(11):2204-11. doi: 10.1016/j.ophtha.2014.05.002. Epub 2014 Jul 9.
citation: Deemer AD, Massof RW, Rovner BW, Casten RJ, Piersol CV. Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2017 Mar 1;58(3):1514-1520. doi: 10.1167/iovs.16-20001.