<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/NCT03304392</url>
  </required_header>
  <id_info>
    <org_study_id>375860</org_study_id>
    <nct_id>NCT03304392</nct_id>
  </id_info>
  <brief_title>Therapist-guided Internet-delivered Cognitive Behavioural Therapy</brief_title>
  <official_title>Advancing Mental Health Care by Improving the Delivery of Therapist-guided, Internet-delivered Cognitive Behavioural Therapy in Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Regina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Regina</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>
      Depression and anxiety are prevalent and disabling conditions that often go untreated.&#xD;
      Internet-delivered Cognitive Behaviour Therapy (ICBT) is a relatively new approach to&#xD;
      treatment that is a convenient way for patients to access care. ICBT is typically highly&#xD;
      standardized and involves patients reviewing weekly lessons over the Internet. Patients also&#xD;
      receive brief weekly support from a therapist via secure emails or phone calls. Past research&#xD;
      shows that ~75% of patients complete ICBT and report large symptom improvements. Although&#xD;
      these results are very promising, research also suggests that ICBT could potentially be&#xD;
      improved by being more personalized in terms of amount of therapist contact, especially for&#xD;
      clients with more severe symptoms. The current trial will involve therapists who work in a&#xD;
      clinic that specializes in ICBT. Over one year, 440 patients with depression and/or anxiety&#xD;
      will be randomized to either receive standardized (5 lessons completed in 8 weeks; once week&#xD;
      therapist contact) or personalized ICBT (5 lessons completed in 8 weeks; personalized&#xD;
      therapist contact depending on needs of patient). Psychosocial outcomes of patients in the&#xD;
      two treatment arms will be compared post-treatment and at 3-month, 6-month, and 1-year&#xD;
      follow-up from enrollment. Data on intervention usage, satisfaction measures, and costs will&#xD;
      also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Actual">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in depression</measure>
    <time_frame>baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up</time_frame>
    <description>Measured by Patient Health Questionnaire - 9 Item (PHQ-9)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in anxiety</measure>
    <time_frame>baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up</time_frame>
    <description>Measured by Generalize Anxiety Disorder - 7 Item (GAD7)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in psychological distress</measure>
    <time_frame>baseline, 8 weeks, 3 months, 6 months, and 1 year follow up</time_frame>
    <description>Measured by Kessler 10-Item Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disability</measure>
    <time_frame>baseline, 8 weeks, 3 months, 6 months, and 1 year follow up</time_frame>
    <description>Measure by Sheehan Disability Scale-3 Item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in panic symptoms</measure>
    <time_frame>baseline, 8 weeks, 3 months, 6 months, and 1 year follow up</time_frame>
    <description>Measured by Panic Disorder Severity Scale-Self Report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in social anxiety symptoms</measure>
    <time_frame>baseline, 8 weeks, 3 months, 6 months, and 1 year follow up</time_frame>
    <description>Measured by Social Interaction Anxiety Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in social phobia symptoms</measure>
    <time_frame>baseline, 8 weeks, 3 months, 6 months, and 1 year follow up</time_frame>
    <description>Measured by Social Phobia Scale-Short form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in post-traumatic symptoms</measure>
    <time_frame>Administered to only those participants meeting criteria for post-traumatic stress based on the modified brief Life Events Checklist for DSM 5 (LEC-5) at each time point: baseline, 3 months, 6 months, and 1 year follow up</time_frame>
    <description>Measured by PTSD Checklist 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life symptoms</measure>
    <time_frame>baseline, 8 weeks, 3 months, 6 months, and 1 year follow up</time_frame>
    <description>Measured by EQ-5D-5L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in treatment costs</measure>
    <time_frame>Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up</time_frame>
    <description>Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic alliance</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured by Working Alliance Inventory-Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment credibility</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>Measured by Credibility Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured by Internet-CBT Treatment Satisfaction Measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured by: number of lessons completed, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client, total words emailed to therapist, total words emailed from therapist to patient</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">449</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Personalized ICBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard ICBT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalized ICBT</intervention_name>
    <description>An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.</description>
    <arm_group_label>Personalized ICBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard ICBT</intervention_name>
    <description>An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.</description>
    <arm_group_label>Standard ICBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  residing in Saskatchewan, Canada&#xD;
&#xD;
          -  endorsing symptoms of anxiety or depression&#xD;
&#xD;
          -  able to access a computer and internet service&#xD;
&#xD;
          -  willing to provide a physician as emergency contact&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  high suicide risk&#xD;
&#xD;
          -  suicide attempt or hospitalization in the last year&#xD;
&#xD;
          -  primary problems with psychosis, alcohol or drug problems, mania&#xD;
&#xD;
          -  currently receiving active psychological treatment for anxiety or depression&#xD;
&#xD;
          -  not present in province during treatment; concerns about online therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather D Hadjistavropoulos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Regina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Online Therapy Unit, University of Regina</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4S 0A2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anxiety</keyword>
  <keyword>depression</keyword>
  <keyword>internet-delivered cognitive behaviour therapy</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>patient-centered</keyword>
  <keyword>knowledge implementation</keyword>
  <keyword>mental health system</keyword>
  <keyword>therapist-assistance</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/NCT03304392
org study id: 375860
nct id: NCT03304392
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Depression and anxiety are prevalent and disabling conditions that often go untreated.
      Internet-delivered Cognitive Behaviour Therapy (ICBT) is a relatively new approach to
      treatment that is a convenient way for patients to access care. ICBT is typically highly
      standardized and involves patients reviewing weekly lessons over the Internet. Patients also
      receive brief weekly support from a therapist via secure emails or phone calls. Past research
      shows that ~75% of patients complete ICBT and report large symptom improvements. Although
      these results are very promising, research also suggests that ICBT could potentially be
      improved by being more personalized in terms of amount of therapist contact, especially for
      clients with more severe symptoms. The current trial will involve therapists who work in a
      clinic that specializes in ICBT. Over one year, 440 patients with depression and/or anxiety
      will be randomized to either receive standardized (5 lessons completed in 8 weeks; once week
      therapist contact) or personalized ICBT (5 lessons completed in 8 weeks; personalized
      therapist contact depending on needs of patient). Psychosocial outcomes of patients in the
      two treatment arms will be compared post-treatment and at 3-month, 6-month, and 1-year
      follow-up from enrollment. Data on intervention usage, satisfaction measures, and costs will
      also be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in depression
time frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
description: Measured by Patient Health Questionnaire - 9 Item (PHQ-9)
measure: Change in anxiety
time frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
description: Measured by Generalize Anxiety Disorder - 7 Item (GAD7)
measure: Change in psychological distress
time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
description: Measured by Kessler 10-Item Scale
measure: Change in disability
time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
description: Measure by Sheehan Disability Scale-3 Item
measure: Change in panic symptoms
time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
description: Measured by Panic Disorder Severity Scale-Self Report
measure: Change in social anxiety symptoms
time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
description: Measured by Social Interaction Anxiety Scale
measure: Change in social phobia symptoms
time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
description: Measured by Social Phobia Scale-Short form
measure: Change in post-traumatic symptoms
time frame: Administered to only those participants meeting criteria for post-traumatic stress based on the modified brief Life Events Checklist for DSM 5 (LEC-5) at each time point: baseline, 3 months, 6 months, and 1 year follow up
description: Measured by PTSD Checklist 5
measure: Change in quality of life symptoms
time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
description: Measured by EQ-5D-5L
measure: Change in treatment costs
time frame: Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up
description: Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
measure: Therapeutic alliance
time frame: 8 weeks
description: Measured by Working Alliance Inventory-Short Form
measure: Treatment credibility
time frame: baseline and 8 weeks
description: Measured by Credibility Questionnaire
measure: Treatment satisfaction
time frame: 8 weeks
description: Measured by Internet-CBT Treatment Satisfaction Measure
measure: Engagement
time frame: 8 weeks
description: Measured by: number of lessons completed, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client, total words emailed to therapist, total words emailed from therapist to patient
arm group label: Personalized ICBT
arm group type: Experimental
description: An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.
arm group label: Standard ICBT
arm group type: Active Comparator
description: An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.
intervention type: Behavioral
intervention name: Personalized ICBT
description: An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.
arm group label: Personalized ICBT
intervention type: Behavioral
intervention name: Standard ICBT
description: An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.
arm group label: Standard ICBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heather D Hadjistavropoulos, PhD
role: Principal Investigator
affiliation: University of Regina
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No