<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/NCT02970734</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00066393</org_study_id>
    <nct_id>NCT02970734</nct_id>
  </id_info>
  <brief_title>Evaluating an Internet-based Program for Anxious Adolescents</brief_title>
  <official_title>Evaluating an Internet-based Program for Anxious Adolescents: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed&#xD;
      as a disorder and serious enough to require treatment affects up to 10% of all adolescents by&#xD;
      the age of 16. The median age of onset is 11 years, making these disorders some of the&#xD;
      earliest to develop. Anxiety disorders can have serious negative effects on a young person's&#xD;
      personal relationships, school performance, and family life. These disorders may not be&#xD;
      discovered by adolescents, parents and health care providers. Even if anxiety disorders are&#xD;
      discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if&#xD;
      their anxiety is not treated properly. The investigators will carry out research to test&#xD;
      Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can&#xD;
      use this treatment from home via the computer. Breathe will include information materials and&#xD;
      personalized homework assignments to help anxious adolescents learn ways to manage anxiety.&#xD;
      More information can be found and www.TheBreatheStudy.com&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled trial (RCT) with two groups, an Internet-delivered&#xD;
      cognitive behavioural therapy (CBT) experimental group (Breathe) and a resource webpage&#xD;
      (control group; considered treatment as usual for youth waiting for services). The&#xD;
      investigators will evaluate several methodological processes and outcomes through the&#xD;
      following objectives:&#xD;
&#xD;
        1. To determine the effectiveness of a self-guided Internet-based CBT program with limited&#xD;
           telephone and email support in reducing anxiety symptoms among adolescents with&#xD;
           mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based&#xD;
           webpage.&#xD;
&#xD;
        2. To explore mediators and moderators of the Internet-based CBT program.&#xD;
&#xD;
        3. To determine the effectiveness of a self-guided Internet-based CBT program in improving&#xD;
           quality of life as compared to a usual self-help intervention.&#xD;
&#xD;
        4. To determine adherence to a self-guided Internet-based CBT program.&#xD;
&#xD;
        5. To determine the cost-effectiveness of the Internet-based CBT program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">November 22, 2018</completion_date>
  <primary_completion_date type="Actual">August 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score</measure>
    <time_frame>baseline to 6 weeks post-baseline (post-intervention)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in adolescent anxiety using the total MASC 2 score</measure>
    <time_frame>6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life using the Youth Quality of Life Instrument - Short Form (YQOL-SF)</measure>
    <time_frame>baseline to 6 weeks post-baseline (post-intervention), 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User experience</measure>
    <time_frame>6 weeks post-baseline (post-intervention)</time_frame>
    <description>Developed by the investigators, this electronically administered, self-report instrument will assess participant satisfaction (e.g., ease of use, layout, convenience) perceived credibility and impact (e.g., helpfulness, knowledge gains, confidence in the program/website), and adherence and usage (e.g., barriers and facilitators to treatment) with an Internet-based program/webpage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention adherence</measure>
    <time_frame>6 weeks post-baseline (post-intervention)</time_frame>
    <description>Intervention adherence will be measured by documenting the number of sessions and homework tasks completed. The investigators will also record the number of tailored sessions completed by each participant (intervention condition) and site visits (control condition). These data will be collected through the intervention's software system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health care utilization</measure>
    <time_frame>baseline, 18 weeks post-baseline</time_frame>
    <description>Developed by the investigators, this self-report instrument will assess whether participants have accessed health care resources (i.e., met with a psychologist/psychiatrist/family doctor/hospital etc.) and if so, how many times.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>Through study conduct, an average of 1 year.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Retention rate</measure>
    <time_frame>Through study conduct, an average of 1 year.</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">563</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Breathe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 sessions of Internet-based cognitive behavioural therapy (CBT) with limited telephone and e-mail support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resource webpage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Webpage that provides general resources on anxiety</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breathe</intervention_name>
    <description>Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.</description>
    <arm_group_label>Breathe</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resource Webpage</intervention_name>
    <description>Static webpage listing anxiety resources.</description>
    <arm_group_label>Resource webpage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Score of ≥25 on the Screen for Child Anxiety Related Disorders (SCARED)&#xD;
&#xD;
          -  Ability to read and write English&#xD;
&#xD;
          -  Regular access to a telephone and a computer system with high speed Internet service&#xD;
&#xD;
          -  Ability to use the computer to interact with web material&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive screen on the Ask Suicide-Screening Questionnaire (ASQ)&#xD;
&#xD;
          -  Positive screen on the Schizophrenia Test and Early Psychosis Indicator (STEPI;&#xD;
             modified version)&#xD;
&#xD;
          -  Score of ≥3 on the Alcohol Use Disorders Identification Test Consumption subscale&#xD;
             (AUDIT-C)&#xD;
&#xD;
          -  Residence outside of Canada&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda Newton</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Breathe Team</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5N 3G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>April 30, 2019</last_update_submitted>
  <last_update_submitted_qc>April 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02970734
org study id: Pro00066393
nct id: NCT02970734
lead sponsor: 
has dmc: No
Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed
      as a disorder and serious enough to require treatment affects up to 10% of all adolescents by
      the age of 16. The median age of onset is 11 years, making these disorders some of the
      earliest to develop. Anxiety disorders can have serious negative effects on a young person's
      personal relationships, school performance, and family life. These disorders may not be
      discovered by adolescents, parents and health care providers. Even if anxiety disorders are
      discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if
      their anxiety is not treated properly. The investigators will carry out research to test
      Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can
      use this treatment from home via the computer. Breathe will include information materials and
      personalized homework assignments to help anxious adolescents learn ways to manage anxiety.
      More information can be found and www.TheBreatheStudy.com
This study is a randomized controlled trial (RCT) with two groups, an Internet-delivered
      cognitive behavioural therapy (CBT) experimental group (Breathe) and a resource webpage
      (control group; considered treatment as usual for youth waiting for services). The
      investigators will evaluate several methodological processes and outcomes through the
      following objectives:

        1. To determine the effectiveness of a self-guided Internet-based CBT program with limited
           telephone and email support in reducing anxiety symptoms among adolescents with
           mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based
           webpage.

        2. To explore mediators and moderators of the Internet-based CBT program.

        3. To determine the effectiveness of a self-guided Internet-based CBT program in improving
           quality of life as compared to a usual self-help intervention.

        4. To determine adherence to a self-guided Internet-based CBT program.

        5. To determine the cost-effectiveness of the Internet-based CBT program.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score
time frame: baseline to 6 weeks post-baseline (post-intervention)
measure: Change in adolescent anxiety using the total MASC 2 score
time frame: 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)
measure: Change in quality of life using the Youth Quality of Life Instrument - Short Form (YQOL-SF)
time frame: baseline to 6 weeks post-baseline (post-intervention), 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)
measure: User experience
time frame: 6 weeks post-baseline (post-intervention)
description: Developed by the investigators, this electronically administered, self-report instrument will assess participant satisfaction (e.g., ease of use, layout, convenience) perceived credibility and impact (e.g., helpfulness, knowledge gains, confidence in the program/website), and adherence and usage (e.g., barriers and facilitators to treatment) with an Internet-based program/webpage.
measure: Intervention adherence
time frame: 6 weeks post-baseline (post-intervention)
description: Intervention adherence will be measured by documenting the number of sessions and homework tasks completed. The investigators will also record the number of tailored sessions completed by each participant (intervention condition) and site visits (control condition). These data will be collected through the intervention's software system.
measure: health care utilization
time frame: baseline, 18 weeks post-baseline
description: Developed by the investigators, this self-report instrument will assess whether participants have accessed health care resources (i.e., met with a psychologist/psychiatrist/family doctor/hospital etc.) and if so, how many times.
measure: Recruitment rate
time frame: Through study conduct, an average of 1 year.
measure: Retention rate
time frame: Through study conduct, an average of 1 year.
arm group label: Breathe
arm group type: Experimental
description: 6 sessions of Internet-based cognitive behavioural therapy (CBT) with limited telephone and e-mail support
arm group label: Resource webpage
arm group type: Active Comparator
description: Webpage that provides general resources on anxiety
intervention type: Behavioral
intervention name: Breathe
description: Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.
arm group label: Breathe
intervention type: Behavioral
intervention name: Resource Webpage
description: Static webpage listing anxiety resources.
arm group label: Resource webpage
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amanda Newton
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No