<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/NCT03767907</url>
  </required_header>
  <id_info>
    <org_study_id>073/2018</org_study_id>
    <nct_id>NCT03767907</nct_id>
  </id_info>
  <brief_title>Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial</brief_title>
  <official_title>Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Addiction and Mental Health</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>
      The purpose of this study is to compare the efficacy and cost-effectiveness of a&#xD;
      Computer-based Training for Cognitive Behavioural Therapy (CBT4CBT) to treatment as usual in&#xD;
      outpatients seeking treatment for substance use disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifty-two adult outpatients seeking treatment for substance use disorder from the Centre for&#xD;
      Addiction and Mental Health Addictions Program will be randomized to receive either a&#xD;
      computer-based training for cognitive behavioural therapy or treatment as usual for eight&#xD;
      weeks. Participants will complete interviews, questionnaires, and other assessments (urine&#xD;
      toxicology and physiological assessments) at week 0, at week 8, and at 6 month follow-up).&#xD;
      Measures will assess alcohol and drug consumption, substance use disorder symptoms and&#xD;
      associated features, quality of life, and healthcare costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Timeline Follow-Back (TLFB)</measure>
    <time_frame>30 days</time_frame>
    <description>Frequency (days) of substance use over the past 30 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urine Toxicology Screen</measure>
    <time_frame>30 days</time_frame>
    <description>Determine substance use in past 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Addiction Severity Index (ASI)</measure>
    <time_frame>30 days</time_frame>
    <description>Substance Use Disorder symptom severity&#xD;
Subscale scores are calculated for 7 domains (medical, employment/support status, alcohol, drug, legal, family/social and psychological). Subscale scores are summed scores ranging from 0-1 with higher scores indicating greater problem severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO Quality of Life (WHOQOL-BREF)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Quality of Life&#xD;
Subscale scores are calculated for 4 domains (physical health, psychological, social relationships and environment) and for &quot;overall&quot; and &quot;general health&quot; quality of life. Subscale scores have a range of 0 to 100 with higher scores indicating greater quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Program and Client Costs-Substance Abuse Treatment (PACC-SAT)</measure>
    <time_frame>7 days</time_frame>
    <description>Healthcare Costs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Substance Dependence</condition>
  <arm_group>
    <arm_group_label>Online Cognitive Behavioural Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computer-based training for cognitive behavioural therapy (CBT4CBT) consists of seven modules, and includes a series of interactive videos presenting characters portrayed by professional actors struggling with real-life situations. These characters first experience a common risky situation or problem and then demonstrate the application of a targeted skill. The program further comprises games and interactive exercises to teach and model effective use of skills and strategies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as usual consists of weekly group and/or individual psychotherapy as determined by the clinical team. Psychotherapy will include structured relapse prevention, include cognitive and behavioural techniques, motivational enhancement, mindfulness, and specialized topics (e.g., vocational training, rainbow services) as appropriate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computer-based Training for Cognitive Behavioural Therapy</intervention_name>
    <description>Interactive content organized into seven modules, illustrating real-life scenarios associated with common risky situations, which illustrate the application of targeted skills and strategies</description>
    <arm_group_label>Online Cognitive Behavioural Therapy</arm_group_label>
    <other_name>CBT4CBT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment As Usual</intervention_name>
    <description>Treatment as usual will include standard psychosocial care determined to be appropriate or necessary, on an individual patient basis.</description>
    <arm_group_label>Treatment as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Fluency in English&#xD;
&#xD;
          3. Understanding and willingness to comply with study requirements&#xD;
&#xD;
          4. Meet diagnostic criteria for current substance use disorder&#xD;
&#xD;
          5. Have used substance in the past 30 days&#xD;
&#xD;
          6. Treatment-seeking for substance misuse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to read at sixth grade level&#xD;
&#xD;
          2. Untreated or unstable severe psychiatric or medical disorder&#xD;
&#xD;
          3. Acute suicidal or homicidal ideation&#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>Lena C. Quilty, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Campbell Family Mental Health Research Institute, CAMH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Campbell Family Mental Health Research Institute, CAMH</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 2S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.camh.ca/research</url>
    <description>Information about research at the Centre for Addiction and Mental Health</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Lena Quilty</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>cognitive behavioural therapy</keyword>
  <keyword>online treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</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/NCT03767907
org study id: 073/2018
nct id: NCT03767907
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the efficacy and cost-effectiveness of a
      Computer-based Training for Cognitive Behavioural Therapy (CBT4CBT) to treatment as usual in
      outpatients seeking treatment for substance use disorder.
Fifty-two adult outpatients seeking treatment for substance use disorder from the Centre for
      Addiction and Mental Health Addictions Program will be randomized to receive either a
      computer-based training for cognitive behavioural therapy or treatment as usual for eight
      weeks. Participants will complete interviews, questionnaires, and other assessments (urine
      toxicology and physiological assessments) at week 0, at week 8, and at 6 month follow-up).
      Measures will assess alcohol and drug consumption, substance use disorder symptoms and
      associated features, quality of life, and healthcare costs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Timeline Follow-Back (TLFB)
time frame: 30 days
description: Frequency (days) of substance use over the past 30 days
measure: Urine Toxicology Screen
time frame: 30 days
description: Determine substance use in past 30 days
measure: Addiction Severity Index (ASI)
time frame: 30 days
description: Substance Use Disorder symptom severity
Subscale scores are calculated for 7 domains (medical, employment/support status, alcohol, drug, legal, family/social and psychological). Subscale scores are summed scores ranging from 0-1 with higher scores indicating greater problem severity.
measure: WHO Quality of Life (WHOQOL-BREF)
time frame: 4 weeks
description: Quality of Life
Subscale scores are calculated for 4 domains (physical health, psychological, social relationships and environment) and for "overall" and "general health" quality of life. Subscale scores have a range of 0 to 100 with higher scores indicating greater quality of life.
measure: Program and Client Costs-Substance Abuse Treatment (PACC-SAT)
time frame: 7 days
description: Healthcare Costs
arm group label: Online Cognitive Behavioural Therapy
arm group type: Experimental
description: Computer-based training for cognitive behavioural therapy (CBT4CBT) consists of seven modules, and includes a series of interactive videos presenting characters portrayed by professional actors struggling with real-life situations. These characters first experience a common risky situation or problem and then demonstrate the application of a targeted skill. The program further comprises games and interactive exercises to teach and model effective use of skills and strategies.
arm group label: Treatment as Usual
arm group type: Active Comparator
description: Treatment as usual consists of weekly group and/or individual psychotherapy as determined by the clinical team. Psychotherapy will include structured relapse prevention, include cognitive and behavioural techniques, motivational enhancement, mindfulness, and specialized topics (e.g., vocational training, rainbow services) as appropriate.
intervention type: Behavioral
intervention name: Computer-based Training for Cognitive Behavioural Therapy
description: Interactive content organized into seven modules, illustrating real-life scenarios associated with common risky situations, which illustrate the application of targeted skills and strategies
arm group label: Online Cognitive Behavioural Therapy
other name: CBT4CBT
intervention type: Behavioral
intervention name: Treatment As Usual
description: Treatment as usual will include standard psychosocial care determined to be appropriate or necessary, on an individual patient basis.
arm group label: Treatment as Usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lena C. Quilty, PhD
role: Principal Investigator
affiliation: Campbell Family Mental Health Research Institute, CAMH
facility: 
country: Canada
url: http://www.camh.ca/research
description: Information about research at the Centre for Addiction and Mental Health
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Lena Quilty
investigator title: Senior Scientist
mesh term: Substance-Related Disorders
sharing ipd: No