Low Vision Depression Prevention Trial for Age Related Macular Degeneration

NCT00769015 | Completed Phase 3 Results DMC

• 1 other identifier: 1U01EY018819
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Macular Degeneration; Depression

Keywords

age-related macular degeneration; depression; vision loss

Outcome Measures

Primary Outcomes (1)

• Depression

  The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. \< 20/100), baseline better eye scotoma size, baseline depression scores \[Patient Health Questionnaire (PHQ-9)\], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.

  4 months

Secondary Outcomes (6)

• Vision Function: Distance Activities

  4 months

• Quality of Life: Dependency

  4 months

• Vision Function: Near Activities

  4 months

• Quality of Life: Mental Health

  4 months

• Quality of Life: Role Functioning

  4 months

Study Arms (2)

BA-LVR

EXPERIMENTAL

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

ST-LVR

PLACEBO COMPARATOR

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

Interventions

BA-LVR BEHAVIORAL

Low vision clinic-based optometry plus 6 in-home occupational therapy visits

BA-LVR

ST-LVR BEHAVIORAL

Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

ST-LVR

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Dartmouth-Hitchcock Medical Center: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• 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.

  PMID: 25016366 RESULT

• 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.

  PMID: 28273318 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Depression; Vision Disorders

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Behavioral Symptoms; Behavior; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robin Casten
• Organization: Thomas Jefferson University

Robin.Casten@jefferson.edu

215-503-1250

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: June 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 20, 2014
• Results First Posted: November 20, 2014

Record last verified: 2014-11

Locations

US (1)