<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/NCT03230669</url>
  </required_header>
  <id_info>
    <org_study_id>6006626</org_study_id>
    <nct_id>NCT03230669</nct_id>
  </id_info>
  <brief_title>Computer-assisted Delivery of Cognitive Behavioral Therapy for Mental Health and Addictions in Canada</brief_title>
  <official_title>Computer-assisted Delivery of Cognitive Behavioral Therapy for Mental Health and Addictions in Canada</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Prince Edward Island</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Prince Edward Island</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Computer-based Training for Cognitive Behavioural Therapy (CBT4CBT) is a new on-line&#xD;
      addiction treatment developed by Dr Kathleen Carroll at the Yale School of Medicine in New&#xD;
      Haven, Connecticut. CBT4CBT consists of seven one-hour long online sessions that teach key&#xD;
      concepts, including dealing with cravings, problem solving, and decision making skills, to&#xD;
      help users reduce substance abuse. CBT4CBT has been rigorously tested throughout various&#xD;
      communities in the United States with great success and is currently being rolled out&#xD;
      throughout the States. The therapeutic approach of CBT4CBT is unique as its efficacy,&#xD;
      durability and cost-savings have been proven in several rigorous clinical trials and will be&#xD;
      magnified by the fact that the program can be delivered in Canada, allowing for increased and&#xD;
      continual improvements in population health. CBT4CBT has been accepted by both patients and&#xD;
      addiction treatment personnel alike and has won numerous clinical innovation awards.&#xD;
&#xD;
      A collaboration has now been formed between Dr Carroll and Drs Michelle Patterson and Juergen&#xD;
      Krause of the UPEI Centre for Health and Community Research (CHCR) that will bring CBT4CBT to&#xD;
      Canada. While CBT4CBT has previously been tested in urban areas, there are many advantages to&#xD;
      offering computer-based training to more rural populations (such as PEI). These more remote&#xD;
      areas frequently suffer from a lack of services, as well as a lack of continuity with the&#xD;
      services currently offered. CBT4CBT may very well provide that needed continuity to&#xD;
      Addictions treatment and has also been shown to improve retention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CBT4CBT will be the first computer-based, cognitive behavioural therapy program for&#xD;
      Addictions treatment to be offered in Canada. CBT4CBT has been rigorously tested in urban&#xD;
      populations in the United States but this collaboration will be the first pilot trial in&#xD;
      First Nation and other rural communities in Canada. Prince Edward Island has a&#xD;
      self-proclaimed need for innovative new substance abuse treatments and CBT4CBT may provide&#xD;
      the continuity and retention to traditional therapy programs that current available treatment&#xD;
      options often lack. This study will allow CBT4CBT to be tested in several Prince Edward&#xD;
      Island communities to gage its efficacy and effectiveness. The results and feedback received&#xD;
      from the pilot study will allow the program to be adapted for Canadian populations in order&#xD;
      to optimize its positive outcomes within Canada.&#xD;
&#xD;
      CBT4CBT has been tested in urban populations in the United States in three rigorous&#xD;
      randomized clinical trials with great success. The nature of CBT4CBT suggests it would also&#xD;
      be beneficial in rural and remote populations which are common across Canada. Computer based&#xD;
      treatments are cost-effective and although their nature necessitates human participants they&#xD;
      have minimal risk associated with them. As the first computer based training for Addictions&#xD;
      in Canada this research project could have broad implications for treatment in Addictions&#xD;
      across our country.&#xD;
&#xD;
      Analysis techniques will be based on those used in previous CBT4CBT trials conducted by our&#xD;
      collaborator, Dr Carroll.&#xD;
&#xD;
      The primary substance abuse outcomes (self-reported abstinence) will be assessed throughout&#xD;
      the study and through a six month follow-up. Additional outcomes will include use of other&#xD;
      services (medical, legal), patient and provider satisfaction, as well as the costs of&#xD;
      implementing the program. Each week, the counsellors will deliver a questionnaire (provided&#xD;
      by the CHCR) which covers this range of topics to their patient participating in the trial.&#xD;
      The data will be analyzed with a focus on feasibility (retention in both conditions, levels&#xD;
      of substance abuse, health problems, and cost by condition).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment and data collection issues&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 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>primary substance use</measure>
    <time_frame>6 months</time_frame>
    <description>Substance use of individuals of their primary drug (or drug of choice)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary substance use</measure>
    <time_frame>6 months</time_frame>
    <description>Substance use of individuals including all drugs which are not their drug of choice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare, social and justice interaction</measure>
    <time_frame>6 months</time_frame>
    <description>Use of healthcare, social and justice services by the individuals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CBT4CBT feedback</measure>
    <time_frame>8 weeks</time_frame>
    <description>Detailed feedback from experimental group individuals on the cbt4cbt program</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Substance Abuse</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>this arm receives treatment as usual and no intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBT4CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm receives treatment as usual and in addition are given access to an online therapy, cbt4cbt. If placed in this group, individuals are asked to use the online therapy for a minimum of 30 minutes each week for the trial duration of 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cbt4cbt</intervention_name>
    <description>This arm receives treatment as usual and in addition are given access to an online therapy, cbt4cbt. If placed in this group, individuals are asked to use the online therapy for a minimum of 30 minutes each week for the trial duration of 8 weeks.</description>
    <arm_group_label>CBT4CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In order to create as representative a sample as possible, the inclusion criteria will&#xD;
             be fairly broad, including any consenting individual who reports substance abuse in&#xD;
             the past thirty days.&#xD;
&#xD;
          -  Individuals who are struggling with substance abuse (the definition of 'abuse' is&#xD;
             determined by their counselor).&#xD;
&#xD;
          -  Individuals who are 18 years of age or older&#xD;
&#xD;
          -  Individuals who have used their substance of choice within the past 28 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are currently suicidal, homicidal, or require immediate&#xD;
             hospitalization will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juergen Krause, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Prince Edward Island</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Prince Edward Island</name>
      <address>
        <city>Charlottetown</city>
        <state>Prince Edward Island</state>
        <zip>C1A 4P3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>May 4, 2021</last_update_submitted>
  <last_update_submitted_qc>May 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Prince Edward Island</investigator_affiliation>
    <investigator_full_name>Mary Ann MacSwain</investigator_full_name>
    <investigator_title>Project Coordinator</investigator_title>
  </responsible_party>
  <keyword>substance abuse</keyword>
  <keyword>addiction</keyword>
  <keyword>etherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03230669/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 8, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03230669/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03230669
org study id: 6006626
nct id: NCT03230669
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Computer-based Training for Cognitive Behavioural Therapy (CBT4CBT) is a new on-line
      addiction treatment developed by Dr Kathleen Carroll at the Yale School of Medicine in New
      Haven, Connecticut. CBT4CBT consists of seven one-hour long online sessions that teach key
      concepts, including dealing with cravings, problem solving, and decision making skills, to
      help users reduce substance abuse. CBT4CBT has been rigorously tested throughout various
      communities in the United States with great success and is currently being rolled out
      throughout the States. The therapeutic approach of CBT4CBT is unique as its efficacy,
      durability and cost-savings have been proven in several rigorous clinical trials and will be
      magnified by the fact that the program can be delivered in Canada, allowing for increased and
      continual improvements in population health. CBT4CBT has been accepted by both patients and
      addiction treatment personnel alike and has won numerous clinical innovation awards.

      A collaboration has now been formed between Dr Carroll and Drs Michelle Patterson and Juergen
      Krause of the UPEI Centre for Health and Community Research (CHCR) that will bring CBT4CBT to
      Canada. While CBT4CBT has previously been tested in urban areas, there are many advantages to
      offering computer-based training to more rural populations (such as PEI). These more remote
      areas frequently suffer from a lack of services, as well as a lack of continuity with the
      services currently offered. CBT4CBT may very well provide that needed continuity to
      Addictions treatment and has also been shown to improve retention.
CBT4CBT will be the first computer-based, cognitive behavioural therapy program for
      Addictions treatment to be offered in Canada. CBT4CBT has been rigorously tested in urban
      populations in the United States but this collaboration will be the first pilot trial in
      First Nation and other rural communities in Canada. Prince Edward Island has a
      self-proclaimed need for innovative new substance abuse treatments and CBT4CBT may provide
      the continuity and retention to traditional therapy programs that current available treatment
      options often lack. This study will allow CBT4CBT to be tested in several Prince Edward
      Island communities to gage its efficacy and effectiveness. The results and feedback received
      from the pilot study will allow the program to be adapted for Canadian populations in order
      to optimize its positive outcomes within Canada.

      CBT4CBT has been tested in urban populations in the United States in three rigorous
      randomized clinical trials with great success. The nature of CBT4CBT suggests it would also
      be beneficial in rural and remote populations which are common across Canada. Computer based
      treatments are cost-effective and although their nature necessitates human participants they
      have minimal risk associated with them. As the first computer based training for Addictions
      in Canada this research project could have broad implications for treatment in Addictions
      across our country.

      Analysis techniques will be based on those used in previous CBT4CBT trials conducted by our
      collaborator, Dr Carroll.

      The primary substance abuse outcomes (self-reported abstinence) will be assessed throughout
      the study and through a six month follow-up. Additional outcomes will include use of other
      services (medical, legal), patient and provider satisfaction, as well as the costs of
      implementing the program. Each week, the counsellors will deliver a questionnaire (provided
      by the CHCR) which covers this range of topics to their patient participating in the trial.
      The data will be analyzed with a focus on feasibility (retention in both conditions, levels
      of substance abuse, health problems, and cost by condition).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: primary substance use
time frame: 6 months
description: Substance use of individuals of their primary drug (or drug of choice)
measure: Secondary substance use
time frame: 6 months
description: Substance use of individuals including all drugs which are not their drug of choice
measure: Healthcare, social and justice interaction
time frame: 6 months
description: Use of healthcare, social and justice services by the individuals
measure: CBT4CBT feedback
time frame: 8 weeks
description: Detailed feedback from experimental group individuals on the cbt4cbt program
arm group label: Control
arm group type: No Intervention
description: this arm receives treatment as usual and no intervention.
arm group label: CBT4CBT
arm group type: Experimental
description: This arm receives treatment as usual and in addition are given access to an online therapy, cbt4cbt. If placed in this group, individuals are asked to use the online therapy for a minimum of 30 minutes each week for the trial duration of 8 weeks.
intervention type: Other
intervention name: cbt4cbt
description: This arm receives treatment as usual and in addition are given access to an online therapy, cbt4cbt. If placed in this group, individuals are asked to use the online therapy for a minimum of 30 minutes each week for the trial duration of 8 weeks.
arm group label: CBT4CBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Juergen Krause, phd
role: Principal Investigator
affiliation: University of Prince Edward Island
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Prince Edward Island
investigator full name: Mary Ann MacSwain
investigator title: Project Coordinator
mesh term: Substance-Related Disorders
mesh term: Behavior, Addictive
sharing ipd: No
provided document: 
provided document: 