<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/NCT03043833</url>
  </required_header>
  <id_info>
    <org_study_id>File 1516-077</org_study_id>
    <nct_id>NCT03043833</nct_id>
  </id_info>
  <brief_title>Internet-Delivered Cognitive Behavior Therapy for Anxiety and Depression Amongst French Canadians</brief_title>
  <official_title>Improving Access to Treatment for Anxiety and Depression Among French Canadians Using an Internet-Delivered Cognitive Behavior Therapy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universite de Moncton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Macquarie University, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universite de Moncton</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 study represents Phase II of a research program involving an international collaboration&#xD;
      with Macquarie University (Sydney, Australia) to implement an Internet-based cognitive&#xD;
      behavior therapy for the treatment of anxiety and depression in French-speaking Canadians&#xD;
      from the Atlantic Provinces.&#xD;
&#xD;
      The primary objective is to establish the clinical efficacy of a French-Canadian self-guided&#xD;
      format version of the Wellbeing Course by conducting a randomized-control trial where an&#xD;
      experimental group will be compared to a waitlist control group. A secondary objective is to&#xD;
      demonstrate the course's acceptability through participants' satisfaction with the course.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</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>Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Pretest, posttest (week 8), 3-month follow-up</time_frame>
    <description>Symptoms of depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>Pretest, posttest (week 8), 3-month follow-up</time_frame>
    <description>Symptoms of anxiety</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>Pretest, posttest (week 8), 3-month follow-up</time_frame>
    <description>Life satisfaction as assessed by the SWLS (Diener et al.,1995)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health as assessed by the Short-Form Health Survey</measure>
    <time_frame>Pretest (week 1), posttest (week 8), 3-month follow-up</time_frame>
    <description>Physical and mental health as assessed by the Short-Form Health Survey (SF-12; Ware et al., 1998)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in personality as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale</measure>
    <time_frame>Pretest (week 1), posttest (week 8), 3-month follow-up</time_frame>
    <description>Pathological personality traits as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale (SAPAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in anxiety as assessed by the Penn State Worry Questionnaire (PSWQ)</measure>
    <time_frame>Pretest (week 1), posttest (week 8), 3-month follow-up</time_frame>
    <description>Symptoms of worry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in social anxiety as assessed by the Social Phobia Inventory (SPIN)</measure>
    <time_frame>Pretest (week 1), posttest (week 8), 3-month follow-up</time_frame>
    <description>Symptoms of social anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in panic and agoraphobia as assessed by the Panic and Agoraphobia Scale (PAS)</measure>
    <time_frame>Pretest (week 1), posttest (week 8), 3-month follow-up</time_frame>
    <description>frequency and intensity of panic symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Major Depression</condition>
  <condition>Anxiety Disorders</condition>
  <arm_group>
    <arm_group_label>Wellbeing Course</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive the French-Canadian version of the Wellbeing Course consisting of five lessons based on cognitive behavior therapy delivered through the Internet over eight weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist-control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Waitlist Control Group will receive the French-Canadian version of the Wellbeing Course once the treatment group will have completed treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Wellbeing Course</intervention_name>
    <description>The Wellbeing Course (Titov et al., 2011) includes five online lessons:&#xD;
Lesson 1 presents information on the prevalence of anxiety disorders and depression as well as on how they may interfere with life goals. This lesson also discusses how cognitive, behavioral and physical symptoms can contribute to poor emotional health.&#xD;
Lesson 2 presents different strategies to generate realistic cognitions.&#xD;
Lesson 3 describes strategies for physical de-arousal and for re-engaging in reinforcing activities.&#xD;
Lesson 4 describes avoidance and safety behaviors in relation with anxiety and depression along with graded exposure.&#xD;
Lesson 5 is about problem solving, relapse prevention and staying well.&#xD;
For each lesson, a &quot;Do It Yourself&quot; guide is included as well vignettes and additional material.</description>
    <arm_group_label>Wellbeing Course</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residing in New-Brunswick, Nova-Scotia, Prince Edward Island, or Newfound land &amp;&#xD;
             Labrador&#xD;
&#xD;
          -  Having identified French as the first official language spoken and having good reading&#xD;
             comprehension in French.&#xD;
&#xD;
          -  Reliable Internet access&#xD;
&#xD;
          -  Clinically significant levels of depression or anxiety reflected by significant scores&#xD;
             on the following measures: PHQ-9 &gt; 9, GAD-7 &gt;7, Penn Stage Worry Questionnaire ≥ 45,&#xD;
             Social Phobia Inventory ≥ 19, Panic and Agoraphobia Scale ≥ 19, or by answering yes to&#xD;
             the question &quot;Is anxiety or low mood a problem for you&quot;&#xD;
&#xD;
          -  Not currently participating in cognitive-behavioral therapy&#xD;
&#xD;
          -  No changes in medication for 4 weeks prior to the study, nor any changes in medication&#xD;
             for the next 2 months&#xD;
&#xD;
          -  Willing to disclose personal information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of psychotic symptoms&#xD;
&#xD;
          -  Presence of severe depression as indicated by scores ≥ 23 on the PHQ-9, or a score &gt; 2&#xD;
             on item 9 of the PHQ-9&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>France Talbot, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Université de Moncton</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Université de Moncton - Adult Clinical Psychology Laboratory</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1A 3E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>April 30, 2018</last_update_submitted>
  <last_update_submitted_qc>April 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universite de Moncton</investigator_affiliation>
    <investigator_full_name>France Talbot</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>There is currently in place a memorandum of understanding with Macquarie University, our collaborators. This agreement allows for the sharing of data once personally identifiable information has been removed.</ipd_description>
  </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/NCT03043833
org study id: File 1516-077
nct id: NCT03043833
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study represents Phase II of a research program involving an international collaboration
      with Macquarie University (Sydney, Australia) to implement an Internet-based cognitive
      behavior therapy for the treatment of anxiety and depression in French-speaking Canadians
      from the Atlantic Provinces.

      The primary objective is to establish the clinical efficacy of a French-Canadian self-guided
      format version of the Wellbeing Course by conducting a randomized-control trial where an
      experimental group will be compared to a waitlist control group. A secondary objective is to
      demonstrate the course's acceptability through participants' satisfaction with the course.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
time frame: Pretest, posttest (week 8), 3-month follow-up
description: Symptoms of depression
measure: Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
time frame: Pretest, posttest (week 8), 3-month follow-up
description: Symptoms of anxiety
measure: Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS)
time frame: Pretest, posttest (week 8), 3-month follow-up
description: Life satisfaction as assessed by the SWLS (Diener et al.,1995)
measure: Changes in health as assessed by the Short-Form Health Survey
time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
description: Physical and mental health as assessed by the Short-Form Health Survey (SF-12; Ware et al., 1998)
measure: Changes in personality as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale
time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
description: Pathological personality traits as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale (SAPAS)
measure: Changes in anxiety as assessed by the Penn State Worry Questionnaire (PSWQ)
time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
description: Symptoms of worry
measure: Changes in social anxiety as assessed by the Social Phobia Inventory (SPIN)
time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
description: Symptoms of social anxiety symptoms
measure: Changes in panic and agoraphobia as assessed by the Panic and Agoraphobia Scale (PAS)
time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
description: frequency and intensity of panic symptoms
arm group label: Wellbeing Course
arm group type: Experimental
description: Will receive the French-Canadian version of the Wellbeing Course consisting of five lessons based on cognitive behavior therapy delivered through the Internet over eight weeks.
arm group label: Waitlist-control
arm group type: No Intervention
description: The Waitlist Control Group will receive the French-Canadian version of the Wellbeing Course once the treatment group will have completed treatment.
intervention type: Behavioral
intervention name: The Wellbeing Course
description: The Wellbeing Course (Titov et al., 2011) includes five online lessons:
Lesson 1 presents information on the prevalence of anxiety disorders and depression as well as on how they may interfere with life goals. This lesson also discusses how cognitive, behavioral and physical symptoms can contribute to poor emotional health.
Lesson 2 presents different strategies to generate realistic cognitions.
Lesson 3 describes strategies for physical de-arousal and for re-engaging in reinforcing activities.
Lesson 4 describes avoidance and safety behaviors in relation with anxiety and depression along with graded exposure.
Lesson 5 is about problem solving, relapse prevention and staying well.
For each lesson, a "Do It Yourself" guide is included as well vignettes and additional material.
arm group label: Wellbeing Course
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: France Talbot, Ph.D.
role: Study Director
affiliation: Université de Moncton
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Universite de Moncton
investigator full name: France Talbot
investigator title: Associate Professor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
sharing ipd: Undecided
ipd description: There is currently in place a memorandum of understanding with Macquarie University, our collaborators. This agreement allows for the sharing of data once personally identifiable information has been removed.