Preventing Depression in Patients With Macular Degeneration

Sponsor
Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT00042211
Collaborator
National Institute of Mental Health (NIMH) (NIH)
206
1
2
59
3.5

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
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 :
Feb 1, 2001
Actual Primary Completion Date :
Jan 1, 2006
Actual Study Completion Date :
Jan 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Problem Solving Treatment

Behavioral: Problem Solving Treatment
Brief Cognitive Behavioral Therapy

Active Comparator: 2

Control

Behavioral: Control
No treatment control

Outcome Measures

Primary Outcome Measures

  1. Depression [6 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: barry rovner, md, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00042211
Other Study ID Numbers:
  • R01MH061331
  • R01MH061331
  • DATR A4-GPS
First Posted:
Jul 26, 2002
Last Update Posted:
Jan 8, 2014
Last Verified:
Feb 1, 2008
Keywords provided by Thomas Jefferson University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 8, 2014