Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedNovember 15, 2016
November 1, 2016
1.3 years
October 2, 2014
November 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in depressive symptoms
Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.
Baseline and 8 weeks
Secondary Outcomes (3)
Change in severity of anxiety symptoms
Baseline and 8 weeks
Change in self-efficacy
Baseline and 8 weeks
Change in life space
Baseline and 8 weeks
Study Arms (2)
Self-Care Tools
EXPERIMENTALThe 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.
Delayed Self-Care Tools
NO INTERVENTIONThis group will receive the self-care tools at the conclusion of the study.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maisonneuve-Rosemont Hospitallead
- Fonds de la Recherche en Santé du Québeccollaborator
- Fondation Antoine Turmelcollaborator
Study Sites (1)
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T2M4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen E. Freeman, PhD
Maisonneuve-Rosemont Hospital and University of Montreal
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 10, 2014
Study Start
October 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
November 15, 2016
Record last verified: 2016-11