<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02261194</url>
  </required_header>
  <id_info>
    <org_study_id>Réseau Vision Freeman</org_study_id>
    <nct_id>NCT02261194</nct_id>
  </id_info>
  <brief_title>Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy</brief_title>
  <official_title>Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maisonneuve-Rosemont Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fonds de la Recherche en Santé du Québec</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondation Antoine Turmel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maisonneuve-Rosemont Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to determine the short-term effect of a self-care intervention&#xD;
      on depression in patients with age-related macular degeneration or diabetic retinopathy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in depressive symptoms</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in severity of anxiety symptoms</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>The GAD-7 can be used to establish probable diagnoses of generalized anxiety disorder as well as grade its severity (mild, moderate and severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in life space</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>The Life Space Assessment asks about the spatial extent in which the participant has traveled over the last month. Scores range from 0-100.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Depression</condition>
  <condition>Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Self-Care Tools</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Self-Care Tools</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive the self-care tools at the conclusion of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-Care Tools</intervention_name>
    <arm_group_label>Self-Care Tools</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of wet or dry AMD or diabetic retinopathy&#xD;
&#xD;
          -  age 50 years and older&#xD;
&#xD;
          -  at least mild depressive symptoms (a score of 5 or more on the PHQ-9)&#xD;
&#xD;
          -  no legal blindness (visual acuity better than 20/200 in better eye).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the current use of cognitive behavioural therapy&#xD;
&#xD;
          -  suicidal intent&#xD;
&#xD;
          -  ocular surgery during the study period (intravitreal anti-VEGF injections will be&#xD;
             allowed, e.g. Lucentis)&#xD;
&#xD;
          -  cognitive impairment&#xD;
&#xD;
          -  inability to speak and understand French or English&#xD;
&#xD;
          -  profound hearing impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen E. Freeman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maisonneuve-Rosemont Hospital and University of Montreal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maisonneuve-Rosemont Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>November 14, 2016</last_update_submitted>
  <last_update_submitted_qc>November 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maisonneuve-Rosemont Hospital</investigator_affiliation>
    <investigator_full_name>Ellen Freeman</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>depression</keyword>
  <keyword>age-related macular degeneration</keyword>
  <keyword>self-care</keyword>
  <keyword>self-help</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02261194
org study id: Réseau Vision Freeman
nct id: NCT02261194
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in depressive symptoms
time frame: Baseline and 8 weeks
description: Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.
measure: Change in severity of anxiety symptoms
time frame: Baseline and 8 weeks
description: The GAD-7 can be used to establish probable diagnoses of generalized anxiety disorder as well as grade its severity (mild, moderate and severe).
measure: Change in self-efficacy
time frame: Baseline and 8 weeks
description: 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.
measure: Change in life space
time frame: Baseline and 8 weeks
description: The Life Space Assessment asks about the spatial extent in which the participant has traveled over the last month. Scores range from 0-100.
arm group label: Self-Care Tools
arm group type: Experimental
description: 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.
arm group label: Delayed Self-Care Tools
arm group type: No Intervention
description: This group will receive the self-care tools at the conclusion of the study.
intervention type: Behavioral
intervention name: Self-Care Tools
arm group label: Self-Care Tools
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Ellen E. Freeman, PhD
role: Principal Investigator
affiliation: Maisonneuve-Rosemont Hospital and University of Montreal
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Maisonneuve-Rosemont Hospital
investigator full name: Ellen Freeman
investigator title: Associate Professor
mesh term: Macular Degeneration
mesh term: Diabetic Retinopathy
mesh term: Depression
mesh term: Depressive Disorder