<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/NCT03261050</url>
  </required_header>
  <id_info>
    <org_study_id>MH111782</org_study_id>
    <secondary_id>1R61MH111782</secondary_id>
    <nct_id>NCT03261050</nct_id>
  </id_info>
  <brief_title>Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders</brief_title>
  <official_title>Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</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>
      Most people with an eating disorder (ED) do not receive good treatment. The investigators&#xD;
      have developed a new brief group treatment that is supposed to work by reducing how much&#xD;
      women with an ED value the impossible thinness standard promoted by the media and how much&#xD;
      they value/crave binge foods. The investigators want to test whether the treatment actually&#xD;
      changes those two mechanisms using brain scan data, which is more objective than completing&#xD;
      questionnaires and even interviews.&#xD;
&#xD;
      In the first phase of the study (R61), the investigators will compare women in the treatment&#xD;
      versus those on a wait-list. If the investigators can show that the treatment &quot;works&quot; (does&#xD;
      what the investigators think it does) compared to no active treatment (women will be allowed&#xD;
      to seek and receive outside help but investigators will not provide it until after the&#xD;
      wait-list), investigators will conduct the second phase of study (R33),where they will&#xD;
      randomly assign women with an ED to either the new treatment or to a group treatment that&#xD;
      represents what many college mental health clinics provide to their clients with ED.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Only 3-20% of individuals with eating disorders (EDs) receive treatment, and those who do&#xD;
      rarely receive evidence-based treatments because they are very intensive and costly, few&#xD;
      clinicians deliver them, and they differ for the various EDs. These factors have hindered&#xD;
      broad implementation of evidence-based treatments, implying that a brief frontline outpatient&#xD;
      treatment for a range of EDs that could be easily, cheaply, and widely implemented would&#xD;
      address a major public health problem. There is also limited experimental evidence regarding&#xD;
      factors that maintain EDs and mechanisms of action for ED treatments. The investigators&#xD;
      propose to conduct a project that translates basic persuasion research into clinical&#xD;
      hypotheses and a novel treatment.&#xD;
&#xD;
      The investigators hypothesize that EDs are maintained by (1) excessive valuation of the thin&#xD;
      beauty ideal, which prompts caloric restriction and other unhealthy weight control behaviors&#xD;
      (vomiting, laxative use, excessive exercise) that increase binge eating risk, and (2)&#xD;
      excessive valuation of high-calorie foods, which maintains binge eating. The investigators&#xD;
      propose to evaluate a treatment that addresses these hypothesized maintenance processes. Two&#xD;
      pilot trials evaluated a novel 8-session group dissonance-based treatment (Counter&#xD;
      Attitudinal Therapy; CAT) wherein women with any ED appropriate for outpatient care completed&#xD;
      activities in which they collectively discuss costs of pursuing the thin ideal and the ED&#xD;
      behaviors in which they personally engage (unhealthy weight control behaviors and binge&#xD;
      eating), which putatively creates dissonance about engaging in those particular behaviors&#xD;
      that reduce valuation of the thin ideal and high-calorie binge foods.&#xD;
&#xD;
      During the COVID-19 shelter-at-home orders taking place at both research sites, the&#xD;
      investigators will not measure in-person only outcomes including fMRI, ECG, computerized&#xD;
      implicit associated tests, and height and weight measurements for all participants that have&#xD;
      assessments during this order. The investigators will continue to conduct treatment groups&#xD;
      that will be administered on a virtual platform.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2024</primary_completion_date>
  <phase>Phase 3</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 occurrences of binge eating episodes using Eating Disorder Diagnostic Interview</measure>
    <time_frame>Week 8; R33 also reviews at 6-month follow-up</time_frame>
    <description>Interviewer assesses frequency in binge eating episodes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic Interview</measure>
    <time_frame>Week 8; R33 also reviews at 6-month follow-up</time_frame>
    <description>Interviewer assesses frequency of compensatory weight control behaviors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment Questionnaire</measure>
    <time_frame>Week 8; R33 also reviews at 6-month follow-up</time_frame>
    <description>Interviewer assesses change in psychosocial impairment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in reward region of the brain using fMRI</measure>
    <time_frame>Week 1 and Week 8</time_frame>
    <description>Assess if CAT produces larger pre-post reductions in reward region in response to thin models and binge food (Not collected during COVID-19 shelter-at-home order)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)</measure>
    <time_frame>Weeks 2, 4 and 6</time_frame>
    <description>Assess if there are any changes in suicide ideation/attempts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in negative affect using the Positive Affect and Negative Affect Scale-Revised</measure>
    <time_frame>Weeks 2, 4, and 6</time_frame>
    <description>Assess if there are any changes in negative affect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body dissatisfaction using the Body Dissatisfaction Scale</measure>
    <time_frame>Weeks 2, 4 and 6</time_frame>
    <description>Assess if there are any changes in body dissatisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food addiction using the Yale Food Addiction Scale version 2.0</measure>
    <time_frame>Weeks 2, 4, and 6</time_frame>
    <description>Assess if there are any changes in food addiction (Only collected during R61 phase)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in valuation of thin ideal using the Thin Ideal Valuation Scale</measure>
    <time_frame>Weeks 2, 4, 6, and 8; R33 also reviews at 6-month follow-up</time_frame>
    <description>Assess if there are any changes in valuation of the thin beauty ideal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dietary restraint using the 10-item Dutch Restrained Eating Scale</measure>
    <time_frame>Week 8; R33 also reviews at 6-month follow-up</time_frame>
    <description>Assess if there are any changes in dietary restraint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in implicit associations of binge foods, thin models, and eating disorder behavior words</measure>
    <time_frame>Week 8; R33 also reviews at 6-month follow-up</time_frame>
    <description>Three implicit association tasks will assess response to binge foods, thin models, and eating disorder behavior words at pre- and post-test (Not collected during COVID-19 shelter-at-home order)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Eating Disorder</condition>
  <arm_group>
    <arm_group_label>Body Project Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An 8-session group-delivered eating disorder treatment that seeks to reduce valuation of the thin ideal and eating disordered behaviors used to pursue this ideal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interpersonal Psychotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An 8-session group-delivered eating disorder treatment that seeks to improve interpersonal functioning because this is theorized to maintain eating pathology.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counter Attitudinal Therapy</intervention_name>
    <description>8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities.</description>
    <arm_group_label>Body Project Treatment</arm_group_label>
    <arm_group_label>Interpersonal Psychotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interpersonal Therapy</intervention_name>
    <description>8 weekly 60 minute sessions of interpersonal-based treatment wherein women with an eating disorder complete verbal, written, and behavioral activities.</description>
    <arm_group_label>Interpersonal Psychotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM-5 eating disorder&#xD;
&#xD;
          -  Must have a primary care doctor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speakers&#xD;
&#xD;
          -  BMI &lt;75% ideal body weight&#xD;
&#xD;
          -  Current acute suicidal ideation (defined as thoughts of a specific method or plan)&#xD;
&#xD;
          -  Comorbid psychiatric disorder that would disrupt groups (e.g., bipolar disorder,&#xD;
             substance misuse)&#xD;
&#xD;
          -  Serious medical problems (e.g., diabetes)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>34 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Stice, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Research Institute</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>September 9, 2023</last_update_submitted>
  <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Eric Stice</investigator_full_name>
    <investigator_title>Professor of Psychiatry and Behavioral Sciences</investigator_title>
  </responsible_party>
  <keyword>Eating disorder</keyword>
  <keyword>Counter attitudinal therapy</keyword>
  <keyword>fMRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Feeding and Eating Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study data will be shared via the National Database for Clinical Trials Related to Mental Illness (NDCT), which is part of the NIMH Data Archive (NDA). All data, with the exception of video recordings of the participants in treatment, will be provided.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Descriptive/raw data will be submitted while the study is ongoing (every 6 months). Analyzed data will be submitted either when results are published or after the completion of the award period, whichever comes first.</ipd_time_frame>
  </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/NCT03261050
org study id: MH111782
secondary id: 1R61MH111782
nct id: NCT03261050
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Most people with an eating disorder (ED) do not receive good treatment. The investigators
      have developed a new brief group treatment that is supposed to work by reducing how much
      women with an ED value the impossible thinness standard promoted by the media and how much
      they value/crave binge foods. The investigators want to test whether the treatment actually
      changes those two mechanisms using brain scan data, which is more objective than completing
      questionnaires and even interviews.

      In the first phase of the study (R61), the investigators will compare women in the treatment
      versus those on a wait-list. If the investigators can show that the treatment "works" (does
      what the investigators think it does) compared to no active treatment (women will be allowed
      to seek and receive outside help but investigators will not provide it until after the
      wait-list), investigators will conduct the second phase of study (R33),where they will
      randomly assign women with an ED to either the new treatment or to a group treatment that
      represents what many college mental health clinics provide to their clients with ED.
Only 3-20% of individuals with eating disorders (EDs) receive treatment, and those who do
      rarely receive evidence-based treatments because they are very intensive and costly, few
      clinicians deliver them, and they differ for the various EDs. These factors have hindered
      broad implementation of evidence-based treatments, implying that a brief frontline outpatient
      treatment for a range of EDs that could be easily, cheaply, and widely implemented would
      address a major public health problem. There is also limited experimental evidence regarding
      factors that maintain EDs and mechanisms of action for ED treatments. The investigators
      propose to conduct a project that translates basic persuasion research into clinical
      hypotheses and a novel treatment.

      The investigators hypothesize that EDs are maintained by (1) excessive valuation of the thin
      beauty ideal, which prompts caloric restriction and other unhealthy weight control behaviors
      (vomiting, laxative use, excessive exercise) that increase binge eating risk, and (2)
      excessive valuation of high-calorie foods, which maintains binge eating. The investigators
      propose to evaluate a treatment that addresses these hypothesized maintenance processes. Two
      pilot trials evaluated a novel 8-session group dissonance-based treatment (Counter
      Attitudinal Therapy; CAT) wherein women with any ED appropriate for outpatient care completed
      activities in which they collectively discuss costs of pursuing the thin ideal and the ED
      behaviors in which they personally engage (unhealthy weight control behaviors and binge
      eating), which putatively creates dissonance about engaging in those particular behaviors
      that reduce valuation of the thin ideal and high-calorie binge foods.

      During the COVID-19 shelter-at-home orders taking place at both research sites, the
      investigators will not measure in-person only outcomes including fMRI, ECG, computerized
      implicit associated tests, and height and weight measurements for all participants that have
      assessments during this order. The investigators will continue to conduct treatment groups
      that will be administered on a virtual platform.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in occurrences of binge eating episodes using Eating Disorder Diagnostic Interview
time frame: Week 8; R33 also reviews at 6-month follow-up
description: Interviewer assesses frequency in binge eating episodes
measure: Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic Interview
time frame: Week 8; R33 also reviews at 6-month follow-up
description: Interviewer assesses frequency of compensatory weight control behaviors
measure: Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment Questionnaire
time frame: Week 8; R33 also reviews at 6-month follow-up
description: Interviewer assesses change in psychosocial impairment
measure: Change in reward region of the brain using fMRI
time frame: Week 1 and Week 8
description: Assess if CAT produces larger pre-post reductions in reward region in response to thin models and binge food (Not collected during COVID-19 shelter-at-home order)
measure: Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)
time frame: Weeks 2, 4 and 6
description: Assess if there are any changes in suicide ideation/attempts
measure: Change in negative affect using the Positive Affect and Negative Affect Scale-Revised
time frame: Weeks 2, 4, and 6
description: Assess if there are any changes in negative affect
measure: Change in body dissatisfaction using the Body Dissatisfaction Scale
time frame: Weeks 2, 4 and 6
description: Assess if there are any changes in body dissatisfaction
measure: Change in food addiction using the Yale Food Addiction Scale version 2.0
time frame: Weeks 2, 4, and 6
description: Assess if there are any changes in food addiction (Only collected during R61 phase)
measure: Change in valuation of thin ideal using the Thin Ideal Valuation Scale
time frame: Weeks 2, 4, 6, and 8; R33 also reviews at 6-month follow-up
description: Assess if there are any changes in valuation of the thin beauty ideal
measure: Change in dietary restraint using the 10-item Dutch Restrained Eating Scale
time frame: Week 8; R33 also reviews at 6-month follow-up
description: Assess if there are any changes in dietary restraint
measure: Change in implicit associations of binge foods, thin models, and eating disorder behavior words
time frame: Week 8; R33 also reviews at 6-month follow-up
description: Three implicit association tasks will assess response to binge foods, thin models, and eating disorder behavior words at pre- and post-test (Not collected during COVID-19 shelter-at-home order)
arm group label: Body Project Treatment
arm group type: Experimental
description: An 8-session group-delivered eating disorder treatment that seeks to reduce valuation of the thin ideal and eating disordered behaviors used to pursue this ideal.
arm group label: Interpersonal Psychotherapy
arm group type: Active Comparator
description: An 8-session group-delivered eating disorder treatment that seeks to improve interpersonal functioning because this is theorized to maintain eating pathology.
intervention type: Behavioral
intervention name: Counter Attitudinal Therapy
description: 8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities.
arm group label: Body Project Treatment
arm group label: Interpersonal Psychotherapy
intervention type: Behavioral
intervention name: Interpersonal Therapy
description: 8 weekly 60 minute sessions of interpersonal-based treatment wherein women with an eating disorder complete verbal, written, and behavioral activities.
arm group label: Interpersonal Psychotherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 34 Years
healthy volunteers: No
last name: Eric Stice, PhD
role: Principal Investigator
affiliation: Oregon Research Institute
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Eric Stice
investigator title: Professor of Psychiatry and Behavioral Sciences
mesh term: Feeding and Eating Disorders
sharing ipd: Yes
ipd description: Study data will be shared via the National Database for Clinical Trials Related to Mental Illness (NDCT), which is part of the NIMH Data Archive (NDA). All data, with the exception of video recordings of the participants in treatment, will be provided.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: Descriptive/raw data will be submitted while the study is ongoing (every 6 months). Analyzed data will be submitted either when results are published or after the completion of the award period, whichever comes first.