Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy

November 14, 2016 updated by: Ellen Freeman, Maisonneuve-Rosemont Hospital
The purpose of this trial is to determine the short-term effect of a self-care intervention on depression in patients with age-related macular degeneration or diabetic retinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T2M4
        • Maisonneuve-Rosemont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of wet or dry AMD or diabetic retinopathy
  • age 50 years and older
  • at least mild depressive symptoms (a score of 5 or more on the PHQ-9)
  • no legal blindness (visual acuity better than 20/200 in better eye).

Exclusion Criteria:

  • the current use of cognitive behavioural therapy
  • suicidal intent
  • ocular surgery during the study period (intravitreal anti-VEGF injections will be allowed, e.g. Lucentis)
  • cognitive impairment
  • inability to speak and understand French or English
  • profound hearing impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Care Tools
The tool binder includes 3 core tools and 4 supplemental tools. The tools that will be provided include a variety of self-care approaches to manage depression including audio-visual, internet, and paper-based tools that might appeal to individuals with different learning styles. The 3 core tools consist of the Antidepressant Skills Workbook, a Mood Monitoring Tool, and a DVD on depression.
Behavioral: Self-Care Tools
No Intervention: Delayed Self-Care Tools
This group will receive the self-care tools at the conclusion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms
Time Frame: Baseline and 8 weeks
Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in severity of anxiety symptoms
Time Frame: Baseline and 8 weeks
The GAD-7 can be used to establish probable diagnoses of generalized anxiety disorder as well as grade its severity (mild, moderate and severe).
Baseline and 8 weeks
Change in self-efficacy
Time Frame: Baseline and 8 weeks
Self-efficacy will be measured with a 4-item scale, adapted from a validated diabetes self-care self-efficacy scale. Scores range from 0-12.
Baseline and 8 weeks
Change in life space
Time Frame: Baseline and 8 weeks
The Life Space Assessment asks about the spatial extent in which the participant has traveled over the last month. Scores range from 0-100.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Collaborators

Fonds de la Recherche en Santé du Québec
Fondation Antoine Turmel

Investigators

  • Principal Investigator: Ellen E. Freeman, PhD, Maisonneuve-Rosemont Hospital and University of Montreal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Réseau Vision Freeman

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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