NCT00042211

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P50-P75 for phase_3 depression

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_3 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

January 8, 2014

Status Verified

February 1, 2008

Enrollment Period

4.9 years

First QC Date

July 24, 2002

Last Update Submit

January 7, 2014

Conditions

DepressionMacular Degeneration

Keywords

Depressive DisorderBlindnessAged

Outcome Measures

Primary Outcomes (1)

  • Depression

    6 Months

Study Arms (2)

1

EXPERIMENTAL

Problem Solving Treatment

Behavioral: Problem Solving Treatment

2

ACTIVE COMPARATOR

Control

Behavioral: Control

Interventions

Problem Solving TreatmentBEHAVIORAL

Brief Cognitive Behavioral Therapy

1
ControlBEHAVIORAL

No treatment control

2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Bilateral macular degeneration
  • Visual acuity of 20/40 or worse in better eye
  • Residence within 40 miles of Wills Eye Hospital in Philadelphia, PA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (9)

  • Rovner BW, Casten RJ. Activity loss and depression in age-related macular degeneration. Am J Geriatr Psychiatry. 2002 May-Jun;10(3):305-10.

    PMID: 11994218BACKGROUND

  • Rovner BW, Casten RJ. Neuroticism predicts depression and disability in age-related macular degeneration. J Am Geriatr Soc. 2001 Aug;49(8):1097-100. doi: 10.1046/j.1532-5415.2001.49215.x.

    PMID: 11555073BACKGROUND

  • Rovner BW, Ganguli M. Depression and disability associated with impaired vision: the MoVies Project. J Am Geriatr Soc. 1998 May;46(5):617-9. doi: 10.1111/j.1532-5415.1998.tb01080.x.

    PMID: 9588377BACKGROUND

  • Rovner BW, Casten RJ, Tasman WS. Effect of depression on vision function in age-related macular degeneration. Arch Ophthalmol. 2002 Aug;120(8):1041-4. doi: 10.1001/archopht.120.8.1041.

    PMID: 12149057BACKGROUND

  • Tasman W, Rovner B. Age-related macular degeneration: treating the whole patient. Arch Ophthalmol. 2004 Apr;122(4):648-9. doi: 10.1001/archopht.122.4.648. No abstract available.

    PMID: 15078685BACKGROUND

  • Casten RJ, Rovner BW, Tasman W. Age-related macular degeneration and depression: a review of recent research. Curr Opin Ophthalmol. 2004 Jun;15(3):181-3. doi: 10.1097/01.icu.0000120710.35941.3f.

    PMID: 15118503BACKGROUND

  • 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

    BACKGROUND

  • Rovner BW, Casten R. Stability of visual acuity measurement in depression. Am J Geriatr Psychiatry. 2005 Mar;13(3):255-8. doi: 10.1176/appi.ajgp.13.3.255.

    PMID: 15728758BACKGROUND

  • Rovner BW, Casten RJ, Hegel MT, Leiby BE, Tasman WS. Preventing depression in age-related macular degeneration. Arch Gen Psychiatry. 2007 Aug;64(8):886-92. doi: 10.1001/archpsyc.64.8.886.

    PMID: 17679633DERIVED

MeSH Terms

Conditions

DepressionMacular DegenerationDepressive DisorderBlindness

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorRetinal DegenerationRetinal DiseasesEye DiseasesMood DisordersMental DisordersVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • barry rovner, md

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2002

First Posted

July 26, 2002

Study Start

February 1, 2001

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

January 8, 2014

Record last verified: 2008-02

Locations

US(1)