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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Age-related Macular Degeneration

Intervention / Treatment
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* Behavioral: Self-Care Tools


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Care Tools<br>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<br> <br> |
| No Intervention: Delayed Self-Care Tools<br>This group will receive the self-care tools at the conclusion of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, age-related macular degeneration, self-care, self-help