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

NCT ID: NCT02261194

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-02-29

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.

Detailed Description

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Conditions

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Depression Age-related Macular Degeneration

Keywords

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depression age-related macular degeneration self-care self-help

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Self-Care Tools

Intervention Type BEHAVIORAL

Delayed Self-Care Tools

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self-Care Tools

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role collaborator

Fondation Antoine Turmel

UNKNOWN

Sponsor Role collaborator

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ellen Freeman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen E. Freeman, PhD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital and University of Montreal

Locations

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Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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Réseau Vision Freeman

Identifier Type: -

Identifier Source: org_study_id