- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02261194
Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy
November 14, 2016 updated by: Ellen Freeman, Maisonneuve-Rosemont Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Quebec
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Montreal, Quebec, Canada, H1T2M4
- Maisonneuve-Rosemont Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
|
No Intervention: Delayed Self-Care Tools
This group will receive the self-care tools at the conclusion of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depressive symptoms
Time Frame: Baseline and 8 weeks
|
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
Time Frame: 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).
|
Baseline and 8 weeks
|
Change in self-efficacy
Time Frame: 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.
|
Baseline and 8 weeks
|
Change in life space
Time Frame: 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.
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ellen E. Freeman, PhD, Maisonneuve-Rosemont Hospital and University of Montreal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
October 2, 2014
First Submitted That Met QC Criteria
October 6, 2014
First Posted (Estimate)
October 10, 2014
Study Record Updates
Last Update Posted (Estimate)
November 15, 2016
Last Update Submitted That Met QC Criteria
November 14, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Mood Disorders
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Retinal Diseases
- Depression
- Depressive Disorder
- Macular Degeneration
- Diabetic Retinopathy
Other Study ID Numbers
- Réseau Vision Freeman
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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