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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02261194

Enrollment

Registered

2014-10-10

Start date

2014-10-31

Completion date

2016-02-29

Last updated

2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration, Depression

Keywords

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

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.

Interventions

BEHAVIORALSelf-Care Tools

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026