<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/NCT03762460</url>
  </required_header>
  <id_info>
    <org_study_id>H17-02786</org_study_id>
    <secondary_id>V17-02786</secondary_id>
    <nct_id>NCT03762460</nct_id>
  </id_info>
  <brief_title>A Pilot Study of eHealth Tools in a Tertiary-care Setting</brief_title>
  <official_title>Pilot Randomized Clinical Trial of eHealth Tools</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vancouver Coastal Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Healthy Minds Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This feasibility study investigates the use of eHealth tools within routine medical treatment&#xD;
      for patients with depression in an outpatient psychiatric setting. The study investigates&#xD;
      whether patients find a mobile-optimized online eHealth tool to be acceptable and feasible,&#xD;
      and whether clinical and functional outcomes improve with use of the online eHealth tool,&#xD;
      compared to informational online resources for mental health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Major Depressive Disorder (MDD) is increasingly recognized as the most common psychiatric&#xD;
      disorder and as one of the most common medical diagnoses worldwide.&#xD;
&#xD;
      Measurement-based care (MBC) is an evidence-based approach for providing effective clinical&#xD;
      care to patients with MDD. MBC utilizes validated rating scales to assess symptom severity,&#xD;
      functional impairments, treatment adherence, and side-effect burden to personalize clinical&#xD;
      decision-making based on measured outcomes and clinical algorithms. However, despite evidence&#xD;
      demonstrating improved outcomes, MBC is still not routinely used by physicians. Barriers to&#xD;
      the use of MBC include lack of knowledge of which scales to use, how to incorporate&#xD;
      measurements into clinical charting systems, and the extra time needed for repeated&#xD;
      assessments.&#xD;
&#xD;
      Our research team developed a web-based application (app) optimized for mobile devices to&#xD;
      address the treatment gap in MBC for people with depression, especially those who are working&#xD;
      while depressed. This user-friendly eHealth tool encourages patients to actively participate&#xD;
      in MBC by using their smartphones, tablets, or computers to screen, monitor, and manage&#xD;
      depressive symptoms and functional outcomes. Results can be easily displayed and printed to&#xD;
      share with clinicians, thereby affording health professionals a simple and cost-effective&#xD;
      means to integrate MBC into standard practices and to optimize treatment for MDD at the point&#xD;
      of care, without needing additional materials, equipment, or staffing.&#xD;
&#xD;
      This research study investigates the feasibility of using a mobile-optimized online eHealth&#xD;
      tool to support MBC in routine clinical care for MDD within an outpatient psychiatric&#xD;
      setting.&#xD;
&#xD;
      To determine both the clinical and practical utility of eMBC, this study will enroll&#xD;
      &quot;real-world&quot; patients with few exclusion criteria and undergoing naturalistic treatments so&#xD;
      that findings will be generalizable to other clinical settings and practices.&#xD;
&#xD;
      Note: As of April, 2020 (before recruitment started), because of the pandemic the study&#xD;
      protocol was changed to be fully virtual, with a change in the primary outcome to a patient&#xD;
      feasibility outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">November 9, 2022</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility-of-use outcome: Percentage of patients who use the eHealth tool (MoodFx) 3 or more times over the 6-month period</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of patients who use the eHealth tool (MoodFx), defined as 3 or more uses over the 6-month follow up period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change scores on the Quick Inventory of Depressive Symptomatology (QIDS-SR) from baseline to follow up at 8 weeks and 6 months.</measure>
    <time_frame>8 weeks and 6 months</time_frame>
    <description>The Quick Inventory of Depressive Symptomatology (QIDS-SR) is a self-report scale to assess symptoms of depression and consists of 16 items, 9 of which contribute to a summed total score (i.e., only the highest score of items 1-4, 6-9, and 15-16 are counted towards the total score). Higher scores indicate more severe symptoms, with individual item scores ranging from 0-3 and total scores ranging from 0-27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores on the Patient Health Questionnaire (PHQ-9) from baseline to follow up at 8 weeks and 6 months.</measure>
    <time_frame>8 weeks and 6 months</time_frame>
    <description>The Patient Health Questionnaire (PHQ-9) is a brief, self-rated scale assessing symptoms of depression. The scale consists of 9 items rated on a scale from 0-3, with higher scores indicating more severe symptoms. Item scores are summed to yield a total score, range 0-27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores on the Generalized Anxiety Disorder scale (GAD-7) from baseline to follow up at 8 weeks and 6 months.</measure>
    <time_frame>8 weeks and 6 months</time_frame>
    <description>The Generalized Anxiety Disorder scale (GAD-7) is a brief, self-rated scale assessing symptoms of generalized anxiety. The scale consists of 7 items rated on a scale from 0-3, with higher scores indicating more severe symptoms. Item scores are summed to yield a total score, range 0-21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores on the Sheehan Disability Scale (SDS) from baseline to follow up at 8 weeks and 6 months.</measure>
    <time_frame>8 weeks and 6 months</time_frame>
    <description>The Sheehan Disability Scale (SDS) is a brief self-report scale assessing functional impairment in three inter-related domains: work/school, social and home/family life. The user rates the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 11 point visual analog scale (range 0-10). Higher scores indicate greater impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores on the Lam Employment Absence and Productivity Scale (LEAPS) from baseline to follow up at 8 weeks and 6 months.</measure>
    <time_frame>8 weeks and 6 months</time_frame>
    <description>The Lam Employment Absence and Productivity Scale (LEAPS) is a brief self-rated scale to assess patients' work functioning. The LEAPS consists of 10 items rated on a 5-point scale from 0-4, with higher scores indicating greater impairment. Item scores are summed to yield a total score, range 0-28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores on the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) from baseline to follow up at 8 weeks and 6 months.</measure>
    <time_frame>8 weeks and 6 months</time_frame>
    <description>The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire assessing life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores on the Euro-QOL-5Lscale (EQ-5D-5L) from baseline to follow up at 8 weeks and 6 months.</measure>
    <time_frame>8 weeks and 6 months</time_frame>
    <description>The Euro-QOL scale (EQ-5D) is a standardised self-report instrument for measuring generic health status. It consists of 5 items evaluating rated on a 5-level scale from no impairments to complete impairment. The 5 rating levels can be quantified as ranging from 0 to 4, with higher scores indicating higher impairment. Total score ranges from 0 to 20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with eHealth tool as measured by the System Usability Scale.</measure>
    <time_frame>6 months</time_frame>
    <description>The System Usability Scale is a 10-item survey that evaluates user satisfaction with online tools, applications, etc. Each item is rated on a 5-point scale (from 0-4), with higher scores indicating greater satisfaction. Item scores may be added together to yield scores ranging from 0-40, and then multiplied by 2.5 for scores ranging from 0-100. (Note these scores are not percentages or percentiles.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Online eHealth Tool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this group will use a personally-owned smartphone, tablet, or computer to access the online eHealth tool.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Informational website (control)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants randomized to this group will receive information about online resources for mental health</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online eHealth tool</intervention_name>
    <description>Mobile-optimized online eHealth tool to support MBC.</description>
    <arm_group_label>Online eHealth Tool</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Informational website</intervention_name>
    <description>Participants randomized to this group will receive information about online resources for mental health</description>
    <arm_group_label>Informational website (control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 19-65 and capable of informed consent;&#xD;
&#xD;
          2. diagnosis of major depressive episode (MDE) by the Diagnostic and Statistical Manual,&#xD;
             Fifth Edition (DSM-5) criteria as determined by the clinic psychiatrist;&#xD;
&#xD;
          3. at least moderate depression as defined by QIDS-SR score of 10 or higher on the Quick&#xD;
             Inventory for Depressive Symptomatology, Self-Rated (QIDS-SR);&#xD;
&#xD;
          4. access to an Internet-enabled computer or mobile device; and&#xD;
&#xD;
          5. able to read and understand English sufficiently to use the eMBC platform&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. active psychotic or substance use disorder; or&#xD;
&#xD;
          2. severe suicidality as judged by the psychiatrist.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond W Lam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UBC Mood Disorders Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T1Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>April 11, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Raymond Lam</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Measurement-Based Care</keyword>
  <keyword>e-Mental Health</keyword>
  <keyword>Functional Outcomes</keyword>
  <keyword>Occupational Functioning</keyword>
  <keyword>Cognition</keyword>
  <keyword>Mobile Technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03762460
org study id: H17-02786
secondary id: V17-02786
nct id: NCT03762460
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This feasibility study investigates the use of eHealth tools within routine medical treatment
      for patients with depression in an outpatient psychiatric setting. The study investigates
      whether patients find a mobile-optimized online eHealth tool to be acceptable and feasible,
      and whether clinical and functional outcomes improve with use of the online eHealth tool,
      compared to informational online resources for mental health.
Major Depressive Disorder (MDD) is increasingly recognized as the most common psychiatric
      disorder and as one of the most common medical diagnoses worldwide.

      Measurement-based care (MBC) is an evidence-based approach for providing effective clinical
      care to patients with MDD. MBC utilizes validated rating scales to assess symptom severity,
      functional impairments, treatment adherence, and side-effect burden to personalize clinical
      decision-making based on measured outcomes and clinical algorithms. However, despite evidence
      demonstrating improved outcomes, MBC is still not routinely used by physicians. Barriers to
      the use of MBC include lack of knowledge of which scales to use, how to incorporate
      measurements into clinical charting systems, and the extra time needed for repeated
      assessments.

      Our research team developed a web-based application (app) optimized for mobile devices to
      address the treatment gap in MBC for people with depression, especially those who are working
      while depressed. This user-friendly eHealth tool encourages patients to actively participate
      in MBC by using their smartphones, tablets, or computers to screen, monitor, and manage
      depressive symptoms and functional outcomes. Results can be easily displayed and printed to
      share with clinicians, thereby affording health professionals a simple and cost-effective
      means to integrate MBC into standard practices and to optimize treatment for MDD at the point
      of care, without needing additional materials, equipment, or staffing.

      This research study investigates the feasibility of using a mobile-optimized online eHealth
      tool to support MBC in routine clinical care for MDD within an outpatient psychiatric
      setting.

      To determine both the clinical and practical utility of eMBC, this study will enroll
      "real-world" patients with few exclusion criteria and undergoing naturalistic treatments so
      that findings will be generalizable to other clinical settings and practices.

      Note: As of April, 2020 (before recruitment started), because of the pandemic the study
      protocol was changed to be fully virtual, with a change in the primary outcome to a patient
      feasibility outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Feasibility-of-use outcome: Percentage of patients who use the eHealth tool (MoodFx) 3 or more times over the 6-month period
time frame: 6 months
description: Percentage of patients who use the eHealth tool (MoodFx), defined as 3 or more uses over the 6-month follow up period
measure: Change scores on the Quick Inventory of Depressive Symptomatology (QIDS-SR) from baseline to follow up at 8 weeks and 6 months.
time frame: 8 weeks and 6 months
description: The Quick Inventory of Depressive Symptomatology (QIDS-SR) is a self-report scale to assess symptoms of depression and consists of 16 items, 9 of which contribute to a summed total score (i.e., only the highest score of items 1-4, 6-9, and 15-16 are counted towards the total score). Higher scores indicate more severe symptoms, with individual item scores ranging from 0-3 and total scores ranging from 0-27.
measure: Change scores on the Patient Health Questionnaire (PHQ-9) from baseline to follow up at 8 weeks and 6 months.
time frame: 8 weeks and 6 months
description: The Patient Health Questionnaire (PHQ-9) is a brief, self-rated scale assessing symptoms of depression. The scale consists of 9 items rated on a scale from 0-3, with higher scores indicating more severe symptoms. Item scores are summed to yield a total score, range 0-27.
measure: Change scores on the Generalized Anxiety Disorder scale (GAD-7) from baseline to follow up at 8 weeks and 6 months.
time frame: 8 weeks and 6 months
description: The Generalized Anxiety Disorder scale (GAD-7) is a brief, self-rated scale assessing symptoms of generalized anxiety. The scale consists of 7 items rated on a scale from 0-3, with higher scores indicating more severe symptoms. Item scores are summed to yield a total score, range 0-21.
measure: Change scores on the Sheehan Disability Scale (SDS) from baseline to follow up at 8 weeks and 6 months.
time frame: 8 weeks and 6 months
description: The Sheehan Disability Scale (SDS) is a brief self-report scale assessing functional impairment in three inter-related domains: work/school, social and home/family life. The user rates the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 11 point visual analog scale (range 0-10). Higher scores indicate greater impairment.
measure: Change scores on the Lam Employment Absence and Productivity Scale (LEAPS) from baseline to follow up at 8 weeks and 6 months.
time frame: 8 weeks and 6 months
description: The Lam Employment Absence and Productivity Scale (LEAPS) is a brief self-rated scale to assess patients' work functioning. The LEAPS consists of 10 items rated on a 5-point scale from 0-4, with higher scores indicating greater impairment. Item scores are summed to yield a total score, range 0-28.
measure: Change scores on the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) from baseline to follow up at 8 weeks and 6 months.
time frame: 8 weeks and 6 months
description: The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire assessing life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score.
measure: Change scores on the Euro-QOL-5Lscale (EQ-5D-5L) from baseline to follow up at 8 weeks and 6 months.
time frame: 8 weeks and 6 months
description: The Euro-QOL scale (EQ-5D) is a standardised self-report instrument for measuring generic health status. It consists of 5 items evaluating rated on a 5-level scale from no impairments to complete impairment. The 5 rating levels can be quantified as ranging from 0 to 4, with higher scores indicating higher impairment. Total score ranges from 0 to 20.
measure: Satisfaction with eHealth tool as measured by the System Usability Scale.
time frame: 6 months
description: The System Usability Scale is a 10-item survey that evaluates user satisfaction with online tools, applications, etc. Each item is rated on a 5-point scale (from 0-4), with higher scores indicating greater satisfaction. Item scores may be added together to yield scores ranging from 0-40, and then multiplied by 2.5 for scores ranging from 0-100. (Note these scores are not percentages or percentiles.
arm group label: Online eHealth Tool
arm group type: Experimental
description: Participants randomized to this group will use a personally-owned smartphone, tablet, or computer to access the online eHealth tool.
arm group label: Informational website (control)
arm group type: Placebo Comparator
description: Participants randomized to this group will receive information about online resources for mental health
intervention type: Other
intervention name: Online eHealth tool
description: Mobile-optimized online eHealth tool to support MBC.
arm group label: Online eHealth Tool
intervention type: Other
intervention name: Informational website
description: Participants randomized to this group will receive information about online resources for mental health
arm group label: Informational website (control)
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Raymond W Lam, MD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Raymond Lam
investigator title: Professor
mesh term: Depression
sharing ipd: No