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Preventing Depression in Patients With Macular Degeneration

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00042211
First received: July 24, 2002
Last updated: February 12, 2008
Last verified: February 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Depression
Macular Degeneration
 Behavioral: Problem Solving Treatment
Behavioral: Control
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Depression in Macular Degeneration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Depression [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: February 2001
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Problem Solving Treatment
 Behavioral: Problem Solving Treatment
Brief Cognitive Behavioral Therapy
Active Comparator: 2
Control
 Behavioral: Control
No treatment control

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042211

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
  More Information

Publications:
Tasman, W., & Rovner, B. W. (in press). Age related macular degeneration: reating the whole person. Archives in Ophthalmology
Casten, R. J., Rovner, B. W., & Tasmas, W. (in press). Age related macular degeneration and depression: a review of recent research. Current Opinions in Ophthalmololgy.
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
Rovner, B. W., & Casten, R. J. Stability of Visual Acuity Measurement in Depression. Submitted to the Archives of Ophthalmology.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Barry Rovner, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00042211     History of Changes
Other Study ID Numbers: R01 MH61331, DATR A4-GPS
Study First Received: July 24, 2002
Last Updated: February 12, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Depressive Disorder
Blindness
Aged

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

ClinicalTrials.gov processed this record on May 19, 2013