Preventing Depression in Patients With Macular Degeneration

NCT ID: NCT00042211

Last Updated: 2014-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2006-01-31

Brief Summary

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This study will evaluate the effectiveness of a Problem Solving Treatment in preventing depression in elderly patients with age-related macular degeneration (AMD).

Detailed Description

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AMD is the most common cause of blindness in older adults. The disease limits the ability to read, see familiar faces, and walk independently. Almost 2 million persons (about 5 percent of the U.S. population over age 65) are now affected, and this number will triple by the year 2020. This study will target patients with neovascular AMD (NV-AMD), a form of AMD which can lead to sudden vision loss, substantial disability, and depression. Because depression is itself disabling and not likely to be recognized nor treated by ophthalmologists, preventing depression in people with NV-AMD is important.

Patients are randomly assigned to either PST or a usual care control condition. The primary outcome measure is a DSM-IV diagnosis of depression. Patients are evaluated at baseline, Month 2 (immediately post-intervention), Month 6 (for the primary efficacy analysis), and Month 12 (to evaluate sustained effects). The study will also assess the impact of PST on levels of disability and vision-related quality of life.

Conditions

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Depression Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Problem Solving Treatment

Group Type EXPERIMENTAL

Problem Solving Treatment

Intervention Type BEHAVIORAL

Brief Cognitive Behavioral Therapy

2

Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

No treatment control

Interventions

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Problem Solving Treatment

Brief Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Control

No treatment control

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Bilateral macular degeneration
* Visual acuity of 20/40 or worse in better eye
* Residence within 40 miles of Wills Eye Hospital in Philadelphia, PA
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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barry rovner, md

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Rovner BW, Casten RJ. Activity loss and depression in age-related macular degeneration. Am J Geriatr Psychiatry. 2002 May-Jun;10(3):305-10.

Reference Type BACKGROUND
PMID: 11994218 (View on PubMed)

Rovner BW, Casten RJ. Neuroticism predicts depression and disability in age-related macular degeneration. J Am Geriatr Soc. 2001 Aug;49(8):1097-100. doi: 10.1046/j.1532-5415.2001.49215.x.

Reference Type BACKGROUND
PMID: 11555073 (View on PubMed)

Rovner BW, Ganguli M. Depression and disability associated with impaired vision: the MoVies Project. J Am Geriatr Soc. 1998 May;46(5):617-9. doi: 10.1111/j.1532-5415.1998.tb01080.x.

Reference Type BACKGROUND
PMID: 9588377 (View on PubMed)

Rovner BW, Casten RJ, Tasman WS. Effect of depression on vision function in age-related macular degeneration. Arch Ophthalmol. 2002 Aug;120(8):1041-4. doi: 10.1001/archopht.120.8.1041.

Reference Type BACKGROUND
PMID: 12149057 (View on PubMed)

Tasman W, Rovner B. Age-related macular degeneration: treating the whole patient. Arch Ophthalmol. 2004 Apr;122(4):648-9. doi: 10.1001/archopht.122.4.648. No abstract available.

Reference Type BACKGROUND
PMID: 15078685 (View on PubMed)

Casten RJ, Rovner BW, Tasman W. Age-related macular degeneration and depression: a review of recent research. Curr Opin Ophthalmol. 2004 Jun;15(3):181-3. doi: 10.1097/01.icu.0000120710.35941.3f.

Reference Type BACKGROUND
PMID: 15118503 (View on PubMed)

Casten, R. J., & Rovner, B. W. The role of psychological characteristics in the use and perceived importance of low vision aids. Submitted to the Journal of Vision Impairment and Blindness

Reference Type BACKGROUND

Rovner BW, Casten R. Stability of visual acuity measurement in depression. Am J Geriatr Psychiatry. 2005 Mar;13(3):255-8. doi: 10.1176/appi.ajgp.13.3.255.

Reference Type BACKGROUND
PMID: 15728758 (View on PubMed)

Rovner BW, Casten RJ, Hegel MT, Leiby BE, Tasman WS. Preventing depression in age-related macular degeneration. Arch Gen Psychiatry. 2007 Aug;64(8):886-92. doi: 10.1001/archpsyc.64.8.886.

Reference Type DERIVED
PMID: 17679633 (View on PubMed)

Other Identifiers

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R01MH061331

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DATR A4-GPS

Identifier Type: -

Identifier Source: secondary_id

R01MH061331

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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