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

Not Applicable

Completed

• Conditions: Age-related Macular Degeneration; Depression
• Interventions: Behavioral: Self-Care Tools

• Registration Number: NCT02261194
• Lead Sponsor: Maisonneuve-Rosemont Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-10
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Care Tools	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.

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms	Baseline and 8 weeks	Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.

Secondary Outcome Measures

Name	Time	Method
Change in severity of anxiety symptoms	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).
Change in self-efficacy	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.
Change in life space	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.

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada