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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261194
• Other study ID #: Réseau Vision Freeman
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: November 14, 2016
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: November 2016
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Depression
• Depressive Disorder
• Diabetic Retinopathy
• Macular Degeneration

Intervention

Behavioral:
• Self-Care Tools

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital	Fondation Antoine Turmel, Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depressive symptoms	Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.	Baseline and 8 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No