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Preventing Depression in Patients With Macular Degeneration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00042211
First Posted: July 26, 2002
Last Update Posted: January 8, 2014
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Thomas Jefferson University
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Depression in Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Depression [ Time Frame: 6 Months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00042211


Locations
United States, Pennsylvania
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00042211     History of Changes
Other Study ID Numbers: R01MH061331 ( U.S. NIH Grant/Contract )
DATR A4-GPS
First Submitted: July 24, 2002
First Posted: July 26, 2002
Last Update Posted: January 8, 2014
Last Verified: February 2008

Keywords provided by Thomas Jefferson University:
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