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Clinical Trials/NCT00545220
NCT00545220CompletedNot Applicable

Problem Solving Training and Low Vision Rehabilitation

University of Alabama at Birmingham1 site in 1 country430 target enrollmentStarted: October 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
430
Locations
1
Primary Endpoint
Center for Epidemiological Studies Depression Scale (CES-D)

Study Overview

Brief Summary

Vision loss can result in feelings of frustration, helplessness, anxiety, depression, and anger, which compromise a person's activities of everyday living. While emotional distress may resolve in some persons without intervention, unmanaged and persistent distress places the person at risk for continued decrements in health status and the potential development of more severe conditions (i.e., depression, poor health outcomes). Persons with low vision will be recruited and randomly assigned to either an innovative, problem-solving training (PST) intervention group designed specifically for persons with low vision or a sham intervention/control group. Primary and secondary outcomes will be assessed at baseline prior to intervention and at 3 month follow-up, 7 month follow-up, 12 month follow-up, and 24 month follow-up by a research interviewer masked to participants' randomization. This project will: (1) demonstrate how specified physical and emotional outcomes of persons with low vision change across time, (2) evaluate the effectiveness of a PST intervention that will be delivered to persons with low vision; and (3) identify persons with low vision who are at risk for adverse emotional and health outcomes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •+19 yrs of age
  • •Underwent a low vision rehabilitation initial eye exam
  • •No more than 2 errors on cognitive on cognitive screening measure (SPBS)
  • •Must have access to telephone
  • •No significant hearing problems
  • •No significant communication problems
  • •Speaks fluent English

Exclusion Criteria

  • Not provided

Arms & Interventions

1

Experimental

PST

Intervention: problem-solving training (Behavioral)

2

Sham Comparator

Attention Control

Intervention: sham intervention (Behavioral)

Outcomes

Primary Outcomes

Center for Epidemiological Studies Depression Scale (CES-D)

Time Frame: baseline, 3months, 6 months, 12 months, 24 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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