<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/NCT03259347</url>
  </required_header>
  <id_info>
    <org_study_id>IndPrevPilot</org_study_id>
    <secondary_id>1R01MH086582-01A1</secondary_id>
    <nct_id>NCT03259347</nct_id>
  </id_info>
  <brief_title>Eating Disorders Programs: An Indicated Trial</brief_title>
  <official_title>Eating Disorders Programs: An Indicated Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Research Institute</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>Oregon Research Institute</source>
  <oversight_info>
    <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 assess the effectiveness of two body acceptance programs for&#xD;
      women. Participants may experience reduction of eating pathology and prevention of future&#xD;
      obesity and eating disorders; may derive a sense of altruism and contribution to furthering&#xD;
      understanding of a public health problem.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2012</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 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>Change from Baseline Eating Disorder Diagnostic responses using the Eating Disorder Examination questionnaire at 8 weeks and 6 months</measure>
    <time_frame>Measured at baseline, week 8, and Month 6</time_frame>
    <description>Evaluate change (if any) by using the Eating Disorder Examination questionnaire at the 8 week and 6 month mark.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessments using Ideal-Body Stereotype Scale-Revised</measure>
    <time_frame>Measured at baseline, week 8, and Month 6</time_frame>
    <description>Evaluate the participants' perception of the ideal-body stereotype</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessments using Satisfaction and Dissatisfaction with Body Parts Scale</measure>
    <time_frame>Measured at baseline, week 8, and Month 6</time_frame>
    <description>Evaluate participants' level of satisfaction and dissatisfaction with specific parts of their bodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessments using Dutch Restrained Eating Scale</measure>
    <time_frame>Measured at baseline, week 8, and Month 6</time_frame>
    <description>Evaluate participants ability to exercise restraint in regards to food</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessments using Positive Affect and Negative Affect Scale-Revised</measure>
    <time_frame>Measured at baseline, week 8, and Month 6</time_frame>
    <description>Measure participants' affect and monitor any changes that may occur.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessments using Beliefs About Appearance Scale</measure>
    <time_frame>Measured at baseline, week 8, and Month 6</time_frame>
    <description>Evaluate participants' perceptions and beliefs on physical appearance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">534</enrollment>
  <condition>Body Image</condition>
  <condition>Eating Disorders</condition>
  <arm_group>
    <arm_group_label>Counter-attitudinal therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Counter-attitudinal therapy (CAT) is dissonance-based group intervention. CAT consists of behavioral, written, and verbal exercises in which participants discuss the costs of pursuing the thin ideal and behaviors that are used to pursue the thin ideal. The intervention is 8 sessions long (1-hr each) and is administered by a trained facilitator who uses an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational-support group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The educational support group intervention that is representative of typical treatment groups offered at universities and community settings. For the current study, the educational support group was designed to match the dissonance group on treatment modality (group-based), duration (8 1-hr sessions), and use of an intervention script administered by a trained facilitator. In the intervention sessions, participants will be provided with a basic education about eating disorders, support for themselves and fellow group members, and learn mindfulness techniques.Participants will be asked to complete weekly homework assignments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group-based Therapy</intervention_name>
    <description>Young women with body dissatisfaction will be randomized to one of two conditions: 1) an educational-support group condition; or 2) a counter-attitudinal therapy condition. We will test if a brief dissonance-based eating disorder prevention program produces intervention effects when delivered to participants with sub-threshold and threshold eating disorders.</description>
    <arm_group_label>Counter-attitudinal therapy</arm_group_label>
    <arm_group_label>Educational-support group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant indicates sub-threshold or threshold eating disorder.&#xD;
&#xD;
          -  Participant is available to participate in the intervention sessions.&#xD;
&#xD;
          -  Participants must be MRI eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant does not indicate sub-threshold or threshold eating disorder.&#xD;
&#xD;
          -  Participant is unable to attend intervention sessions.&#xD;
&#xD;
          -  Participant cannot participate if MRI ineligible.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>
    <facility>
      <name>Drexel University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>March 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Feeding and Eating Disorders</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/NCT03259347
org study id: IndPrevPilot
secondary id: 1R01MH086582-01A1
nct id: NCT03259347
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the effectiveness of two body acceptance programs for
      women. Participants may experience reduction of eating pathology and prevention of future
      obesity and eating disorders; may derive a sense of altruism and contribution to furthering
      understanding of a public health problem.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Eating Disorder Diagnostic responses using the Eating Disorder Examination questionnaire at 8 weeks and 6 months
time frame: Measured at baseline, week 8, and Month 6
description: Evaluate change (if any) by using the Eating Disorder Examination questionnaire at the 8 week and 6 month mark.
measure: Assessments using Ideal-Body Stereotype Scale-Revised
time frame: Measured at baseline, week 8, and Month 6
description: Evaluate the participants' perception of the ideal-body stereotype
measure: Assessments using Satisfaction and Dissatisfaction with Body Parts Scale
time frame: Measured at baseline, week 8, and Month 6
description: Evaluate participants' level of satisfaction and dissatisfaction with specific parts of their bodies
measure: Assessments using Dutch Restrained Eating Scale
time frame: Measured at baseline, week 8, and Month 6
description: Evaluate participants ability to exercise restraint in regards to food
measure: Assessments using Positive Affect and Negative Affect Scale-Revised
time frame: Measured at baseline, week 8, and Month 6
description: Measure participants' affect and monitor any changes that may occur.
measure: Assessments using Beliefs About Appearance Scale
time frame: Measured at baseline, week 8, and Month 6
description: Evaluate participants' perceptions and beliefs on physical appearance.
arm group label: Counter-attitudinal therapy
arm group type: Experimental
description: Counter-attitudinal therapy (CAT) is dissonance-based group intervention. CAT consists of behavioral, written, and verbal exercises in which participants discuss the costs of pursuing the thin ideal and behaviors that are used to pursue the thin ideal. The intervention is 8 sessions long (1-hr each) and is administered by a trained facilitator who uses an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
arm group label: Educational-support group
arm group type: Active Comparator
description: The educational support group intervention that is representative of typical treatment groups offered at universities and community settings. For the current study, the educational support group was designed to match the dissonance group on treatment modality (group-based), duration (8 1-hr sessions), and use of an intervention script administered by a trained facilitator. In the intervention sessions, participants will be provided with a basic education about eating disorders, support for themselves and fellow group members, and learn mindfulness techniques.Participants will be asked to complete weekly homework assignments.
intervention type: Behavioral
intervention name: Group-based Therapy
description: Young women with body dissatisfaction will be randomized to one of two conditions: 1) an educational-support group condition; or 2) a counter-attitudinal therapy condition. We will test if a brief dissonance-based eating disorder prevention program produces intervention effects when delivered to participants with sub-threshold and threshold eating disorders.
arm group label: Counter-attitudinal therapy
arm group label: Educational-support group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Feeding and Eating Disorders