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Completed

NCT Number: NCT02261194

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

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.

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Key information

Conditions

Depression Age-Related Macular Degeneration Behavior Behavioral Symptoms Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T2M4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-Care Tools

Behavioral

Primary outcomes

  1. Change in depressive symptoms

    Time frame: Baseline and 8 weeks

    Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Collaborators

  • Fondation Antoine Turmel
  • Fonds de la Recherche en Santé du Québec

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 10, 2014
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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