<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/NCT02252822</url>
  </required_header>
  <id_info>
    <org_study_id>59093006</org_study_id>
    <nct_id>NCT02252822</nct_id>
  </id_info>
  <brief_title>Improving Treatment Engagement for Adolescents With Bulimia Nervosa</brief_title>
  <official_title>Does Offering Adolescents Anonymous Access to Online CBT Self-Help for Bulimia Nervosa Improve Engagement in Treatment-Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although 4.7% of adolescents suffer from symptoms of bulimia nervosa (BN), only 1/5 seek&#xD;
      treatment. Hesitation to seek treatment is likely related to ego-syntonicity and fear of&#xD;
      disclosing symptoms to parents and clinicians. Furthermore, the physical symptoms of BN often&#xD;
      go unnoticed by parents and clinicians.&#xD;
&#xD;
      In order to eliminate the barriers that prevent adolescents from seeking treatment, this&#xD;
      study will offer anonymous access to online self-help cognitive behavioral therapy (CBT) for&#xD;
      BN. Online CBT (traditional, non-anonymous delivery) has been found to be effective and&#xD;
      acceptable treatment for adolescents with BN. Furthermore, in adults, this method has been&#xD;
      found to be as effective as specialized treatments, and more cost efficient.&#xD;
&#xD;
      To remain anonymous and accessible, the self-help approach in this study will be provided in&#xD;
      a non-guided, or pure format (only online sessions). Studies support that a pure self-help&#xD;
      methodology is as effective as a guided version.&#xD;
&#xD;
      Although anonymity may improve accessibility, this study design could also pose challenges in&#xD;
      areas such as recruitment, treatment completion and obtaining adequate informed consent.&#xD;
      Therefore, before embarking on a larger randomized control trail, we would like to propose a&#xD;
      small, non-controlled feasibility study to assess potential issues in these areas.&#xD;
&#xD;
      Primary hypotheses:&#xD;
&#xD;
      Recruitment: Based on communication with public health nurses in the high schools we plan to&#xD;
      recruit from, we hypothesize that it is feasible to recruit 1-5 adolescents over a 4-month&#xD;
      period from each of the 5 schools, and 1-5 from social media outlets such as Instagram,&#xD;
      Twitter, Facebook for a total of 5 participants over a 4-month period.&#xD;
&#xD;
      Treatment completion: Based on pervious studies of self-help for adolescent bulimia, we&#xD;
      hypothesize that approximately 15% of participants will not complete any sessions, and many&#xD;
      will only complete about half of the sessions.&#xD;
&#xD;
      Informed consent: Based on information from large randomized control studies in the UK, we&#xD;
      hypothesize that adolescents will be capable of providing online consent, and that we will be&#xD;
      able to adequately obtain consent without verbally communicating with participants.&#xD;
&#xD;
      Secondary hypothesis:&#xD;
&#xD;
      We hypothesize a non-guided (pure) version of online CBT-BN offered in an anonymous manner&#xD;
      will decrease BN symptoms after treatment completion, and at 3-month follow-up compared to&#xD;
      baseline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment</measure>
    <time_frame>4 months</time_frame>
    <description>The rate of recruitment per month will be compared to standard research recruitment rates, and extrapolation of these data will be a means of assessing feasibility for recruitment for a larger RCT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment completion</measure>
    <time_frame>2 months</time_frame>
    <description>The medium number of completed online sessions will be compared to previous studies on self-help online CBT for BN in order to ensure at least comparable completion rates are achieved using our novel treatment design. Participants will be provided with a feedback form following treatment completion in order to assess treatment satisfaction and adherence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Informed consent</measure>
    <time_frame>Baseline</time_frame>
    <description>The informed consent process will be evaluated based on the participants ability to effectively answer online questions aimed at determining an understanding of the consent process. Participants would need to answer all questions correctly in order to be deemed capable of consenting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating Disorder Examination-Questionnaire Version (EDE-Q)</measure>
    <time_frame>Baseline, 8weeks (post-intervention), 3-month follow-up</time_frame>
    <description>This measure will asses effectiveness of online self-help CBT-BN in improving BN symptoms. The EDE-Q measures 4 areas of eating disorder pathology (eating concern, weight concern, dietary restraint and shape concern).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Eating Disorders</condition>
  <arm_group>
    <arm_group_label>The Overcoming Bulimia Online Programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This treatment incorporates a combination of cognitive-behavioral, motivational and education strategies. The program will be presented in 8 collaborative, multi-media, web based CBT sessions for BN.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Overcoming Bulimia Online Programme</intervention_name>
    <arm_group_label>The Overcoming Bulimia Online Programme</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents with symptoms of BN (full threshold or subthreshold) defined by&#xD;
             self-reported symptoms of binging and compensatory behaviours (self-induced vomiting,&#xD;
             laxative abuse, diet pills, and diuretics). Excessive exercise and fasting will not be&#xD;
             included due to the potential for subjectively in a self-report format.&#xD;
&#xD;
          -  Ages of 16-18.&#xD;
&#xD;
          -  Consent from the adolescent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adolescent is actively engaged in psychological treatment for bulimia nervosa.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Keshen, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Capital Health, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Capital Health District Health Authority</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H2E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Aaron Keshen</investigator_full_name>
    <investigator_title>Psychiatrist</investigator_title>
  </responsible_party>
  <keyword>Eating Disorders</keyword>
  <keyword>Self Help</keyword>
  <keyword>Anonymous CBT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
    <mesh_term>Bulimia Nervosa</mesh_term>
  </condition_browse>
  <!-- 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/NCT02252822
org study id: 59093006
nct id: NCT02252822
lead sponsor: 
has dmc: No
Although 4.7% of adolescents suffer from symptoms of bulimia nervosa (BN), only 1/5 seek
      treatment. Hesitation to seek treatment is likely related to ego-syntonicity and fear of
      disclosing symptoms to parents and clinicians. Furthermore, the physical symptoms of BN often
      go unnoticed by parents and clinicians.

      In order to eliminate the barriers that prevent adolescents from seeking treatment, this
      study will offer anonymous access to online self-help cognitive behavioral therapy (CBT) for
      BN. Online CBT (traditional, non-anonymous delivery) has been found to be effective and
      acceptable treatment for adolescents with BN. Furthermore, in adults, this method has been
      found to be as effective as specialized treatments, and more cost efficient.

      To remain anonymous and accessible, the self-help approach in this study will be provided in
      a non-guided, or pure format (only online sessions). Studies support that a pure self-help
      methodology is as effective as a guided version.

      Although anonymity may improve accessibility, this study design could also pose challenges in
      areas such as recruitment, treatment completion and obtaining adequate informed consent.
      Therefore, before embarking on a larger randomized control trail, we would like to propose a
      small, non-controlled feasibility study to assess potential issues in these areas.

      Primary hypotheses:

      Recruitment: Based on communication with public health nurses in the high schools we plan to
      recruit from, we hypothesize that it is feasible to recruit 1-5 adolescents over a 4-month
      period from each of the 5 schools, and 1-5 from social media outlets such as Instagram,
      Twitter, Facebook for a total of 5 participants over a 4-month period.

      Treatment completion: Based on pervious studies of self-help for adolescent bulimia, we
      hypothesize that approximately 15% of participants will not complete any sessions, and many
      will only complete about half of the sessions.

      Informed consent: Based on information from large randomized control studies in the UK, we
      hypothesize that adolescents will be capable of providing online consent, and that we will be
      able to adequately obtain consent without verbally communicating with participants.

      Secondary hypothesis:

      We hypothesize a non-guided (pure) version of online CBT-BN offered in an anonymous manner
      will decrease BN symptoms after treatment completion, and at 3-month follow-up compared to
      baseline.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recruitment
time frame: 4 months
description: The rate of recruitment per month will be compared to standard research recruitment rates, and extrapolation of these data will be a means of assessing feasibility for recruitment for a larger RCT.
measure: Treatment completion
time frame: 2 months
description: The medium number of completed online sessions will be compared to previous studies on self-help online CBT for BN in order to ensure at least comparable completion rates are achieved using our novel treatment design. Participants will be provided with a feedback form following treatment completion in order to assess treatment satisfaction and adherence.
measure: Informed consent
time frame: Baseline
description: The informed consent process will be evaluated based on the participants ability to effectively answer online questions aimed at determining an understanding of the consent process. Participants would need to answer all questions correctly in order to be deemed capable of consenting.
measure: Eating Disorder Examination-Questionnaire Version (EDE-Q)
time frame: Baseline, 8weeks (post-intervention), 3-month follow-up
description: This measure will asses effectiveness of online self-help CBT-BN in improving BN symptoms. The EDE-Q measures 4 areas of eating disorder pathology (eating concern, weight concern, dietary restraint and shape concern).
arm group label: The Overcoming Bulimia Online Programme
arm group type: Experimental
description: This treatment incorporates a combination of cognitive-behavioral, motivational and education strategies. The program will be presented in 8 collaborative, multi-media, web based CBT sessions for BN.
intervention type: Behavioral
intervention name: Overcoming Bulimia Online Programme
arm group label: The Overcoming Bulimia Online Programme
criteria: 
gender: All
minimum age: 16 Years
maximum age: 18 Years
healthy volunteers: No
last name: Aaron Keshen, MD, FRCPC
role: Principal Investigator
affiliation: Capital Health, Canada
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Aaron Keshen
investigator title: Psychiatrist
mesh term: Bulimia
mesh term: Feeding and Eating Disorders
mesh term: Bulimia Nervosa