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Preventing Depression in Patients With Macular Degeneration

Primary Purpose

Depression, Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Problem Solving Treatment
Control
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Depressive Disorder, Blindness, Aged

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Problem Solving Treatment

Control

Outcomes

Primary Outcome Measures

Depression

Secondary Outcome Measures

Full Information

First Posted
July 24, 2002
Last Updated
January 7, 2014
Sponsor
Thomas Jefferson University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00042211
Brief Title
Preventing Depression in Patients With Macular Degeneration
Official Title
Preventing Depression in Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Macular Degeneration
Keywords
Depressive Disorder, Blindness, Aged

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Problem Solving Treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Treatment
Intervention Description
Brief Cognitive Behavioral Therapy
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
No treatment control
Primary Outcome Measure Information:
Title
Depression
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
barry rovner, md
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11994218
Citation
Rovner BW, Casten RJ. Activity loss and depression in age-related macular degeneration. Am J Geriatr Psychiatry. 2002 May-Jun;10(3):305-10.
Results Reference
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PubMed Identifier
11555073
Citation
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.
Results Reference
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PubMed Identifier
9588377
Citation
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.
Results Reference
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Citation
Rovner, B.W., Casten, R.J., & Tasman, W.S. (in press). Depression impairs visionfunction in age-related macular degeneration.Archives of Ophthalmology.
Results Reference
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PubMed Identifier
12149057
Citation
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.
Results Reference
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PubMed Identifier
15078685
Citation
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.
Results Reference
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PubMed Identifier
15118503
Citation
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.
Results Reference
background
Citation
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
Results Reference
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PubMed Identifier
15728758
Citation
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.
Results Reference
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PubMed Identifier
17679633
Citation
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.
Results Reference
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Preventing Depression in Patients With Macular Degeneration

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