<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/NCT02978742</url>
  </required_header>
  <id_info>
    <org_study_id>59093009</org_study_id>
    <nct_id>NCT02978742</nct_id>
  </id_info>
  <brief_title>Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder</brief_title>
  <official_title>Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bulimia nervosa and binge eating disorder pose a public health concern due to their high&#xD;
      co-occurrence with other psychiatric disorders and poor physical health outcomes. It is&#xD;
      therefore concerning that less than half of these patients seek treatment for their&#xD;
      condition. People may be reluctant to seek treatment due to not wanting to disclose symptoms&#xD;
      to family members. Even for those who do wish to seek help, treatment is often inaccessible&#xD;
      due to the geographic centralization of eating disorder specialists and a low ratio of&#xD;
      specialists to patients. Therefore, the aim of this study is to test a potential solution to&#xD;
      these problems and make eating disorder care more private and accessible.&#xD;
&#xD;
      One possible way to improve the accessibility of treatment is through smartphone applications&#xD;
      (or &quot;apps&quot;). We are testing an app called Recovery Record, which is primarily a tool used to&#xD;
      self-monitor eating habits, where patients record their meals and related thoughts, feelings,&#xD;
      emotions, and behaviours (e.g., binge eating/purging). The app also offers additional&#xD;
      features such as discrete reminders to log meals, positive reinforcement, social support,&#xD;
      coping strategy suggestions, and linking users with clinicians for real-time feedback and&#xD;
      suggestions. The application is scientifically supported and has been tested with positive&#xD;
      results.&#xD;
&#xD;
      Recently, app developers have created a computer-automated 8-week treatment program that uses&#xD;
      the patient's data to provide a tailored and individualized treatment program. This program&#xD;
      aims to mimic the process of therapy by checking in with users, reminding them of their&#xD;
      reasons for wanting to recover, and working towards goals. We will be testing this automated&#xD;
      app treatment program, comparing it both with and without input from a trained coach&#xD;
      providing individualized feedback to users.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of bulimia nervosa (BN) is approximately 1.0-1.5% among women. With&#xD;
      consistently higher prevalence rates, binge eating disorder (BED) affects up to 3.5% of women&#xD;
      and 1.5% of men. These eating disorders represent a public health concern due to the high&#xD;
      comorbidity of BN and BED with other psychiatric disorders and the association with poor&#xD;
      physical health outcomes.&#xD;
&#xD;
      Given this public health impact, it is concerning that less than half of BN and BED patients&#xD;
      seek treatment for their eating disorder. This is especially concerning since a greater&#xD;
      duration of untreated illness is associated with a poorer prognosis. Individuals' reluctance&#xD;
      to seek treatment is likely due to factors such as an avoidance of disclosing symptoms to&#xD;
      family members or clinicians. For example, one study reported that 27% of adolescents with BN&#xD;
      declined participation because they did not want their families involved. Even for those who&#xD;
      do wish to engage, treatment is often inaccessible due to the geographic centralization of&#xD;
      eating disorder specialists and a low ratio of specialists to patients.&#xD;
&#xD;
      Given the ubiquity of smartphone devices among adults and adolescents, one possible way to&#xD;
      improve treatment accessibility and privacy is to offer it through a smartphone app. In&#xD;
      recent development, an evidence-based smartphone app called Recovery Record (RR) has been&#xD;
      conceived for use by people suffering from eating disorders as an adjunct to clinical&#xD;
      treatment. This tool allows patients to self-monitor eating behaviours, connect with their&#xD;
      clinician directly through the app, and provides other therapeutic features (e.g. cues coping&#xD;
      skill use). Preliminary findings suggest that the app is feasible, with 67% of users&#xD;
      continuing to log meals at 30 days. As well, RR is currently the most downloaded, most rated,&#xD;
      and highest rated app of its kind, which suggests it is highly acceptable among users.&#xD;
&#xD;
      In support of these findings, one study demonstrated that 26% of app users in a clinically&#xD;
      severe range at baseline demonstrated clinically significant reductions in eating disorder&#xD;
      symptoms at least 28 days later, which is consistent with other forms of self-help for BN.&#xD;
      Moreover, 89% of users reported that using Recovery Record helped their condition from&#xD;
      getting worse and a majority reported improvements to the frequency of disordered behaviours,&#xD;
      reported urges, and mood.&#xD;
&#xD;
      App developers have outfitted the app with an adaptive 8-week program that automatically uses&#xD;
      patient data to tailor treatment for individual users (i.e. an automated pure self-help&#xD;
      course of treatment). Although pure self-help is efficacious for BN and BED, self-help&#xD;
      augmented by coaching (from a health care profession) has been associated with even better&#xD;
      outcomes (with a moderate effect size). Given the support for this smartphone app and this&#xD;
      potential avenue for providing private and accessible care to Nova Scotians, the aim of this&#xD;
      study is to assess the efficacy of this adaptive smartphone app program, both coached and&#xD;
      uncoached, for BN and BED patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study not funded.&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Change in Eating Disorder Symptom Severity</measure>
    <time_frame>Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up</time_frame>
    <description>Self-reported symptom severity will be assessed with the Eating Disorder Examination Questionnaire (EDE-Q).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Binge Eating and Purging Frequency</measure>
    <time_frame>Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up</time_frame>
    <description>Binge/purge frequency for the month prior will be gathered from self-reported EDE-Q responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Impairment</measure>
    <time_frame>Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up</time_frame>
    <description>The Clinical Impairment Assessment (CIA) will be used to identify changes in psychosocial impairment related to the participant's eating disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Satisfaction</measure>
    <time_frame>Measured at end of treatment (up to 8 weeks)</time_frame>
    <description>Likert-scale and open-ended questions specific to the intervention will be used to assess participant satisfaction with treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Adherence</measure>
    <time_frame>Measured from start of treatment to the end of treatment (up to 8 weeks)</time_frame>
    <description>Treatment completion will be defined as completing more than 75% of the 8-week treatment program and treatment dropout will be defined as completing any less than 75% of the program.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Diagnosis of Bulimia Nervosa or Binge Eating Disorder</measure>
    <time_frame>Pre-Screening</time_frame>
    <description>A DSM-V diagnosis of bulimia nervosa or binge eating disorder will be determined with the Eating Disorder Diagnostic Scale (EDDS).</description>
  </other_outcome>
  <other_outcome>
    <measure>Suicidality</measure>
    <time_frame>Pre-Screening</time_frame>
    <description>Risk of suicide will be determined with the Columbia - Suicide Severity Rating Scale, Self-Report Screening Version (C-SSRS).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Eating Disorder</condition>
  <condition>Bulimia Nervosa</condition>
  <condition>Binge Eating Disorder</condition>
  <arm_group>
    <arm_group_label>Coached Recovery Record App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete the 8-week adaptive Recovery Record app program and will be linked with a healthcare professional who will provide standardized coaching, in the way of feedback and support to participants for the duration of the program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Uncoached Recovery Record App</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will complete the 8-week adaptive Recovery Record app program on their own (i.e., without a coach providing feedback and support).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adaptive Recovery Record App</intervention_name>
    <description>Participants will use the Recovery Record smartphone app, which is a meal monitoring tool, that incorporates discrete reminders, motivational tools, social support, summative feedback, and coping skill suggestions. Participants will also receive tailored, algorithm-generated content in a structured manner that mimics the progression of psychotherapy (e.g., checking in with users, reminding them of their reasons for wanting to recover, and working towards goals) over the course of 8 weeks.</description>
    <arm_group_label>Coached Recovery Record App</arm_group_label>
    <arm_group_label>Uncoached Recovery Record App</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standardized Coaching</intervention_name>
    <description>Coaches (dietitians or mental health clinicians) will review patients' logs daily and participants will receive one communication of standardized feedback each day through the app based on their food records. A standardized feedback manual to be used by coaches has been developed by co-investigators (two PhD psychologists and one psychiatrist), and all feedback will be monitored for consistency and quality by co-investigators.</description>
    <arm_group_label>Coached Recovery Record App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM-V diagnosis of bulimia nervosa or binge eating disorder&#xD;
&#xD;
          -  Ages 16-65 years&#xD;
&#xD;
          -  Has an Apple or Android smartphone with a data plan or daily access to Wi-Fi&#xD;
&#xD;
          -  Is able to download smartphone applications from the Apple App Store or Google Play&#xD;
             Store to their smartphone&#xD;
&#xD;
          -  Lives in Canada&#xD;
&#xD;
          -  Provides consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Actively engaged in psychological treatment, specifically for bulimia nervosa or binge&#xD;
             eating disorder&#xD;
&#xD;
          -  Lacks English fluency&#xD;
&#xD;
          -  High risk for suicide, as determined by the Columbia Suicide Severity Rating Scale&#xD;
             (Self-Report Screening Version)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Keshen, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nova Scotia Health Authority</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>
  <link>
    <url>http://www.recoveryrecord.com</url>
    <description>Recovery Record Smartphone Application Website</description>
  </link>
  <reference>
    <citation>Tregarthen JP, Lock J, Darcy AM. Development of a smartphone application for eating disorder self-monitoring. Int J Eat Disord. 2015 Nov;48(7):972-82. doi: 10.1002/eat.22386. Epub 2015 Jul 27.</citation>
    <PMID>26213130</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2018</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>Bulimia Nervosa</keyword>
  <keyword>Binge Eating Disorder</keyword>
  <keyword>App</keyword>
  <keyword>Smartphone</keyword>
  <keyword>Self-Help</keyword>
  <keyword>Coaching</keyword>
  <keyword>Recovery Record</keyword>
  <keyword>Mobile Phone</keyword>
  <keyword>Cognitive Behavioral Therapy</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>Binge-Eating Disorder</mesh_term>
    <mesh_term>Bulimia Nervosa</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/NCT02978742
org study id: 59093009
nct id: NCT02978742
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bulimia nervosa and binge eating disorder pose a public health concern due to their high
      co-occurrence with other psychiatric disorders and poor physical health outcomes. It is
      therefore concerning that less than half of these patients seek treatment for their
      condition. People may be reluctant to seek treatment due to not wanting to disclose symptoms
      to family members. Even for those who do wish to seek help, treatment is often inaccessible
      due to the geographic centralization of eating disorder specialists and a low ratio of
      specialists to patients. Therefore, the aim of this study is to test a potential solution to
      these problems and make eating disorder care more private and accessible.

      One possible way to improve the accessibility of treatment is through smartphone applications
      (or "apps"). We are testing an app called Recovery Record, which is primarily a tool used to
      self-monitor eating habits, where patients record their meals and related thoughts, feelings,
      emotions, and behaviours (e.g., binge eating/purging). The app also offers additional
      features such as discrete reminders to log meals, positive reinforcement, social support,
      coping strategy suggestions, and linking users with clinicians for real-time feedback and
      suggestions. The application is scientifically supported and has been tested with positive
      results.

      Recently, app developers have created a computer-automated 8-week treatment program that uses
      the patient's data to provide a tailored and individualized treatment program. This program
      aims to mimic the process of therapy by checking in with users, reminding them of their
      reasons for wanting to recover, and working towards goals. We will be testing this automated
      app treatment program, comparing it both with and without input from a trained coach
      providing individualized feedback to users.
The prevalence of bulimia nervosa (BN) is approximately 1.0-1.5% among women. With
      consistently higher prevalence rates, binge eating disorder (BED) affects up to 3.5% of women
      and 1.5% of men. These eating disorders represent a public health concern due to the high
      comorbidity of BN and BED with other psychiatric disorders and the association with poor
      physical health outcomes.

      Given this public health impact, it is concerning that less than half of BN and BED patients
      seek treatment for their eating disorder. This is especially concerning since a greater
      duration of untreated illness is associated with a poorer prognosis. Individuals' reluctance
      to seek treatment is likely due to factors such as an avoidance of disclosing symptoms to
      family members or clinicians. For example, one study reported that 27% of adolescents with BN
      declined participation because they did not want their families involved. Even for those who
      do wish to engage, treatment is often inaccessible due to the geographic centralization of
      eating disorder specialists and a low ratio of specialists to patients.

      Given the ubiquity of smartphone devices among adults and adolescents, one possible way to
      improve treatment accessibility and privacy is to offer it through a smartphone app. In
      recent development, an evidence-based smartphone app called Recovery Record (RR) has been
      conceived for use by people suffering from eating disorders as an adjunct to clinical
      treatment. This tool allows patients to self-monitor eating behaviours, connect with their
      clinician directly through the app, and provides other therapeutic features (e.g. cues coping
      skill use). Preliminary findings suggest that the app is feasible, with 67% of users
      continuing to log meals at 30 days. As well, RR is currently the most downloaded, most rated,
      and highest rated app of its kind, which suggests it is highly acceptable among users.

      In support of these findings, one study demonstrated that 26% of app users in a clinically
      severe range at baseline demonstrated clinically significant reductions in eating disorder
      symptoms at least 28 days later, which is consistent with other forms of self-help for BN.
      Moreover, 89% of users reported that using Recovery Record helped their condition from
      getting worse and a majority reported improvements to the frequency of disordered behaviours,
      reported urges, and mood.

      App developers have outfitted the app with an adaptive 8-week program that automatically uses
      patient data to tailor treatment for individual users (i.e. an automated pure self-help
      course of treatment). Although pure self-help is efficacious for BN and BED, self-help
      augmented by coaching (from a health care profession) has been associated with even better
      outcomes (with a moderate effect size). Given the support for this smartphone app and this
      potential avenue for providing private and accessible care to Nova Scotians, the aim of this
      study is to assess the efficacy of this adaptive smartphone app program, both coached and
      uncoached, for BN and BED patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Eating Disorder Symptom Severity
time frame: Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up
description: Self-reported symptom severity will be assessed with the Eating Disorder Examination Questionnaire (EDE-Q).
measure: Change in Binge Eating and Purging Frequency
time frame: Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up
description: Binge/purge frequency for the month prior will be gathered from self-reported EDE-Q responses.
measure: Change in Clinical Impairment
time frame: Measured at start of treatment, end of treatment (up to 8 weeks), and 3-month follow-up
description: The Clinical Impairment Assessment (CIA) will be used to identify changes in psychosocial impairment related to the participant's eating disorder.
measure: Treatment Satisfaction
time frame: Measured at end of treatment (up to 8 weeks)
description: Likert-scale and open-ended questions specific to the intervention will be used to assess participant satisfaction with treatment.
measure: Treatment Adherence
time frame: Measured from start of treatment to the end of treatment (up to 8 weeks)
description: Treatment completion will be defined as completing more than 75% of the 8-week treatment program and treatment dropout will be defined as completing any less than 75% of the program.
measure: Diagnosis of Bulimia Nervosa or Binge Eating Disorder
time frame: Pre-Screening
description: A DSM-V diagnosis of bulimia nervosa or binge eating disorder will be determined with the Eating Disorder Diagnostic Scale (EDDS).
measure: Suicidality
time frame: Pre-Screening
description: Risk of suicide will be determined with the Columbia - Suicide Severity Rating Scale, Self-Report Screening Version (C-SSRS).
arm group label: Coached Recovery Record App
arm group type: Experimental
description: Participants will complete the 8-week adaptive Recovery Record app program and will be linked with a healthcare professional who will provide standardized coaching, in the way of feedback and support to participants for the duration of the program.
arm group label: Uncoached Recovery Record App
arm group type: Active Comparator
description: Participants will complete the 8-week adaptive Recovery Record app program on their own (i.e., without a coach providing feedback and support).
intervention type: Behavioral
intervention name: Adaptive Recovery Record App
description: Participants will use the Recovery Record smartphone app, which is a meal monitoring tool, that incorporates discrete reminders, motivational tools, social support, summative feedback, and coping skill suggestions. Participants will also receive tailored, algorithm-generated content in a structured manner that mimics the progression of psychotherapy (e.g., checking in with users, reminding them of their reasons for wanting to recover, and working towards goals) over the course of 8 weeks.
arm group label: Coached Recovery Record App
arm group label: Uncoached Recovery Record App
intervention type: Behavioral
intervention name: Standardized Coaching
description: Coaches (dietitians or mental health clinicians) will review patients' logs daily and participants will receive one communication of standardized feedback each day through the app based on their food records. A standardized feedback manual to be used by coaches has been developed by co-investigators (two PhD psychologists and one psychiatrist), and all feedback will be monitored for consistency and quality by co-investigators.
arm group label: Coached Recovery Record App
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Aaron Keshen, MD, FRCPC
role: Principal Investigator
affiliation: Nova Scotia Health Authority
facility: 
country: Canada
url: http://www.recoveryrecord.com
description: Recovery Record Smartphone Application Website
citation: Tregarthen JP, Lock J, Darcy AM. Development of a smartphone application for eating disorder self-monitoring. Int J Eat Disord. 2015 Nov;48(7):972-82. doi: 10.1002/eat.22386. Epub 2015 Jul 27.
PMID: 26213130
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: Binge-Eating Disorder
mesh term: Bulimia Nervosa
sharing ipd: No