Preventing Depression in Patients With Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00042211
Recruitment Status : Completed
First Posted : July 26, 2002
Last Update Posted : January 8, 2014
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Thomas Jefferson University

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).

Condition or disease Intervention/treatment Phase
Depression Macular Degeneration Behavioral: Problem Solving Treatment Behavioral: Control Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Depression in Macular Degeneration
Study Start Date : February 2001
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Problem Solving Treatment
Behavioral: Problem Solving Treatment
Brief Cognitive Behavioral Therapy

Active Comparator: 2
Behavioral: Control
No treatment control

Primary Outcome Measures :
  1. Depression [ Time Frame: 6 Months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00042211

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
National Institute of Mental Health (NIMH)
Principal Investigator: barry rovner, md Thomas Jefferson University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Thomas Jefferson University Identifier: NCT00042211     History of Changes
Other Study ID Numbers: R01MH061331 ( U.S. NIH Grant/Contract )
R01MH061331 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2002    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: February 2008

Keywords provided by Thomas Jefferson University:
Depressive Disorder

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