Low Vision Depression Prevention Trial for Age Related Macular Degeneration (VITAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Thomas Jefferson University
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Johns Hopkins University
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00769015
First received: October 7, 2008
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Age-related Macular Degeneration
Depression
Behavioral: BA-LVR
Behavioral: ST-LVR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Low Vision Depression Prevention Trial for Age Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Depression [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vision Function [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BA-LVR
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
Behavioral: BA-LVR
Low vision clinic-based optometry plus 6 in-home occupational therapy visits
Placebo Comparator: ST-LVR
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
Behavioral: ST-LVR
Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769015

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Robin J Casten, PhD    215-503-1250    Robin.Casten@Jefferson.edu   
Contact: Barry Rovner, MD    215-503-1254    Barry.Rovner@Jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Dartmouth-Hitchcock Medical Center
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00769015     History of Changes
Other Study ID Numbers: 1U01EY018819
Study First Received: October 7, 2008
Last Updated: August 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Thomas Jefferson University:
age-related macular degeneration
depression
vision loss

Additional relevant MeSH terms:
Depression
Depressive Disorder
Macular Degeneration
Behavioral Symptoms
Eye Diseases
Mental Disorders
Mood Disorders
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014