Preventing Depression in Patients With Macular Degeneration

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00042211
First received: July 24, 2002
Last updated: January 7, 2014
Last verified: February 2008

July 24, 2002
January 7, 2014
February 2001
January 2006   (final data collection date for primary outcome measure)
Depression [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00042211 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Preventing Depression in Patients With Macular Degeneration
Preventing Depression in Macular Degeneration

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Depression
  • Macular Degeneration
  • Behavioral: Problem Solving Treatment
    Brief Cognitive Behavioral Therapy
  • Behavioral: Control
    No treatment control
  • Experimental: 1
    Problem Solving Treatment
    Intervention: Behavioral: Problem Solving Treatment
  • Active Comparator: 2
    Control
    Intervention: Behavioral: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
January 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00042211
R01 MH61331, R01MH061331, DATR A4-GPS
Yes
Thomas Jefferson University
Thomas Jefferson University
National Institute of Mental Health (NIMH)
Principal Investigator: barry rovner, md Thomas Jefferson University
Thomas Jefferson University
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP