DepressionNCT02261194
Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy
A study testing Self-Care Tools in people with Depression and Age-related Macular Degeneration, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression, Age-related Macular Degeneration
- What is being tested?
- Self-Care Tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression, Age-related Macular Degeneration
- Being tested
- Self-Care Tools
- Keywords
- depression, age-related macular degeneration, self-care, self-help
- Medical subject headings
- Depression, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Care ToolsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Self-Care Tools | Experimental | 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. Receives: Behavioral: Self-Care Tools |
| Delayed Self-Care Tools | No intervention | This group will receive the self-care tools at the conclusion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms
Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.
Measured: Baseline and 8 weeks
Secondary outcomes (3)
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).
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Fondation Antoine Turmel
- Responsible party
- Principal investigator, Ellen Freeman, Maisonneuve-Rosemont Hospital
- Investigators
- Ellen E. Freeman, PhD, Principal investigator, Maisonneuve-Rosemont Hospital and University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261194
- Sponsor's protocol ID
- Réseau Vision Freeman
- Status last verified
- Nov 2016
- First submitted
- 2 Oct 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT02261194
- Acronym / sponsor ID
- Réseau Vision Freeman
- Conditions
- Depression, Age-related Macular Degeneration
- Keywords
- depression, age-related macular degeneration, self-care, self-help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Fondation Antoine Turmel
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Care Tools | Experimental | Behavioral: Self-Care ToolsThe 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 intervention | –This group will receive the self-care tools at the conclusion of the study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Care Tools | Behavioural | Self-Care Tools |
Primary outcome
Change in depressive symptoms
Time frame: Baseline and 8 weeks
Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.
3 secondary outcomes
Change in severity of anxiety symptoms
Time frame: Baseline and 8 weeks
Change in self-efficacy
Time frame: Baseline and 8 weeks
Change in life space
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen E. Freeman, PhD principal investigator
Maisonneuve-Rosemont Hospital and University of Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Care Tools in people with Depression and Age-related Macular Degeneration, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.