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

Primary Purpose

Depression, Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self-Care Tools
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, age-related macular degeneration, self-care, self-help

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maisonneuve-Rosemont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-Care Tools

Delayed Self-Care Tools

Arm Description

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.

This group will receive the self-care tools at the conclusion of the study.

Outcomes

Primary Outcome Measures

Change in depressive symptoms
Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.

Secondary Outcome Measures

Change in severity of anxiety symptoms
The GAD-7 can be used to establish probable diagnoses of generalized anxiety disorder as well as grade its severity (mild, moderate and severe).
Change in self-efficacy
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.
Change in life space
The Life Space Assessment asks about the spatial extent in which the participant has traveled over the last month. Scores range from 0-100.

Full Information

First Posted
October 2, 2014
Last Updated
November 14, 2016
Sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Fonds de la Recherche en Santé du Québec, Fondation Antoine Turmel
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1. Study Identification

Unique Protocol Identification Number
NCT02261194
Brief Title
Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy
Official Title
Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Fonds de la Recherche en Santé du Québec, Fondation Antoine Turmel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Age-related Macular Degeneration
Keywords
depression, age-related macular degeneration, self-care, self-help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Care Tools
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Self-Care Tools
Arm Type
No Intervention
Arm Description
This group will receive the self-care tools at the conclusion of the study.
Intervention Type
Behavioral
Intervention Name(s)
Self-Care Tools
Primary Outcome Measure Information:
Title
Change in depressive symptoms
Description
Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in severity of anxiety symptoms
Description
The GAD-7 can be used to establish probable diagnoses of generalized anxiety disorder as well as grade its severity (mild, moderate and severe).
Time Frame
Baseline and 8 weeks
Title
Change in self-efficacy
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in life space
Description
The Life Space Assessment asks about the spatial extent in which the participant has traveled over the last month. Scores range from 0-100.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen E. Freeman, PhD
Organizational Affiliation
Maisonneuve-Rosemont Hospital and University of Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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