xml: <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/NCT06012045</url>
    </required_header>
    <id_info>
      <org_study_id>EA220560</org_study_id>
      <nct_id>NCT06012045</nct_id>
    </id_info>
    <brief_title>A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating</brief_title>
    <official_title>A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of Hong Kong</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>
        The current study aims to evaluate the efficacy and feasibility of enhanced cue exposure&#xD;
        therapy (E-CET) in reducing negative emotional eating, in comparison to an active control&#xD;
        behavioral lifestyle intervention (BLI) in a double-blind, parallel, randomized controlled&#xD;
        trial. The secondary aim is to evaluate whether changes in the four types of CS-US expectancy&#xD;
        mediate the changes in NEE.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be randomly assigned to either the experimental treatment or control BLI&#xD;
        group. Those in the experimental group will receive 6 weeks of E-CET treatment and followed&#xD;
        up for 8 weeks post-treatment. Those in the control group will receive 6 weeks of behavioral&#xD;
        counselling integrating behavioral strategies for making changes related to diet and&#xD;
        exercise, followed up for 8 weeks post-treatment.&#xD;
  &#xD;
        Research question 1:&#xD;
  &#xD;
        Is E-CET an efficacious intervention for reducing NEE?&#xD;
  &#xD;
        Hypothesis 1:&#xD;
  &#xD;
        E-CET will lead to greater reductions in NEE at post-treatment and follow-up compared to BLI.&#xD;
  &#xD;
        Reseach question 2:&#xD;
  &#xD;
        Does E-CET work via the violation of the four types of expectancy?&#xD;
  &#xD;
        Hypothesis 2:&#xD;
  &#xD;
        Changes in the believability of the four types of expectancy will mediate the treatment&#xD;
        effects of E-CET on NEE.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2026</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>Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)</measure>
      <time_frame>14 weeks</time_frame>
      <description>Negative emotional eating measured by the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ) consisting of 13 items assessing the tendency to eat in response to feelings of depression, irritability, anger, anxiety, fear, boredom, disappointment, and stress on a 5-point Likert scale from 1 to 5. The cutoff point of &gt;3.25 is used to indicate negative emotional eating tendencies. Higher scores indicate greater tendency and severity</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in weight</measure>
      <time_frame>14 weeks</time_frame>
      <description>Measured in the laboratory using a digital measuring scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in mood</measure>
      <time_frame>14 weeks</time_frame>
      <description>Measured using the Depression, Anxiety and Stress Scale-21 (DASS-21) consisting of 21 items rated on 0 (not at all) to 3 (very much) Likert scales assessing symptoms of anxiety, depression, and stress symptoms. Higher scores indicate greater severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in quality of life</measure>
      <time_frame>14 weeks</time_frame>
      <description>Measured using the Satisfaction with Life Scale (SWLS) with five items measuring subjective life satisfaction on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher score indicate greater satisfaction with life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in treatment acceptability and satisfaction</measure>
      <time_frame>14 weeks</time_frame>
      <description>Measured by twelve items created to assess participant's perception of the acceptability and utility of E-CET for reducing NEE using a 7 point Likert scale from 0 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater perceived acceptability and utility of E-CET.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Disordered Eating Behaviors</condition>
    <condition>Binge Eating</condition>
    <arm_group>
      <arm_group_label>Enhanced Cue Exposure Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This is the experimental arm. Participants will receive the 6-session enhanced cue exposure therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Behavioral Lifestyle Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This is the active control arm. Participants will receive the 6-session behavioral lifestyle intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Enhanced Cue Exposure Therapy</intervention_name>
      <description>The E-CET will consist of six weekly sessions and will be delivered by a clinical psychology trainee in person. The first session will be used to introduce the rationale and procedures of E-CET to the participant to establish therapeutic alliance, agreement on treatment goals and tasks, and to collect information on idiosyncratic CS-US expectancies to be targeted in exposures. In this session, questions will be asked specifically to assess idiosyncratic CS-US expectancies related to the four categories: positive reinforcement, craving/drive reduction, mood regulation, and disinhibition. An exhaustive list of all idiosyncratic NEE-triggering cues and CSUS expectancies will be generated from this session. These cues and CS-US expectancies will be targeted in the following exposure sessions and in homework exposures with the goal to cover as many of them as possible during the 6-week treatment.</description>
      <arm_group_label>Enhanced Cue Exposure Therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioral Lifestyle Intervention</intervention_name>
      <description>It consists of six weekly sessions of behavioral counseling integrating behavioral strategies for making changes related to diet and exercise. These behavioral strategies will include education about healthy and balanced diets, and ways to attain the minimum level of physical activity for wellbeing (150 minutes moderate-to-vigorous exercise per week), goalsetting, problem-solving, coping, and relaxation. A manualized protocol developed by the PI's team for previous studies in the local community will be used.</description>
      <arm_group_label>Behavioral Lifestyle Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18 or over&#xD;
  &#xD;
            -  A score &gt;3.25 on the emotional eating subscale of the Dutch Eating Behavioural&#xD;
               Questionnaire&#xD;
  &#xD;
            -  Confirmed to have on average at least 2 negative emotional eating episodes per week&#xD;
               using daily tracking of previous 2 weeks&#xD;
  &#xD;
            -  Not currently receiving psychotherapy or psychiatric help&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has an active suicidal plan or suicide intention&#xD;
  &#xD;
            -  Has psychiatric illnesses except mood disorders as mood disorders or mood disorder&#xD;
               symptoms may be common in those with NEE&#xD;
  &#xD;
            -  Substance abuse&#xD;
  &#xD;
            -  Any conditions or circumstances that prevent the participant from receiving all&#xD;
               treatment session&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wai Sze Chan, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wai Sze Chan, PhD</last_name>
      <phone>+85239172295</phone>
      <email>chanwais@hku.hk</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Dr. Chan Wai Sze</investigator_full_name>
      <investigator_title>Dr Chan Wai Sze</investigator_title>
    </responsible_party>
    <keyword>emotional eating</keyword>
    <keyword>eating disorders</keyword>
    <keyword>obesity</keyword>
    <keyword>exposure and response prevention</keyword>
    <keyword>behavioral therapy</keyword>
    <keyword>randomized controlled trial</keyword>
    <keyword>violation of expectancy</keyword>
    <keyword>inhibitory learning</keyword>
    <keyword>habituation</keyword>
    <keyword>mechanism of change</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bulimia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified individual patient data may be shared upon request for research purposes.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>De-identified data will become available indefinitely</ipd_time_frame>
      <ipd_access_criteria>Requests to share data will be evaluated by the principal investigator</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012045
  org study id: EA220560
  nct id: NCT06012045
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The current study aims to evaluate the efficacy and feasibility of enhanced cue exposure
        therapy (E-CET) in reducing negative emotional eating, in comparison to an active control
        behavioral lifestyle intervention (BLI) in a double-blind, parallel, randomized controlled
        trial. The secondary aim is to evaluate whether changes in the four types of CS-US expectancy
        mediate the changes in NEE.
  Participants will be randomly assigned to either the experimental treatment or control BLI
        group. Those in the experimental group will receive 6 weeks of E-CET treatment and followed
        up for 8 weeks post-treatment. Those in the control group will receive 6 weeks of behavioral
        counselling integrating behavioral strategies for making changes related to diet and
        exercise, followed up for 8 weeks post-treatment.
  
        Research question 1:
  
        Is E-CET an efficacious intervention for reducing NEE?
  
        Hypothesis 1:
  
        E-CET will lead to greater reductions in NEE at post-treatment and follow-up compared to BLI.
  
        Reseach question 2:
  
        Does E-CET work via the violation of the four types of expectancy?
  
        Hypothesis 2:
  
        Changes in the believability of the four types of expectancy will mediate the treatment
        effects of E-CET on NEE.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
  time frame: 14 weeks
  description: Negative emotional eating measured by the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ) consisting of 13 items assessing the tendency to eat in response to feelings of depression, irritability, anger, anxiety, fear, boredom, disappointment, and stress on a 5-point Likert scale from 1 to 5. The cutoff point of >3.25 is used to indicate negative emotional eating tendencies. Higher scores indicate greater tendency and severity
  measure: Changes in weight
  time frame: 14 weeks
  description: Measured in the laboratory using a digital measuring scale.
  measure: Changes in mood
  time frame: 14 weeks
  description: Measured using the Depression, Anxiety and Stress Scale-21 (DASS-21) consisting of 21 items rated on 0 (not at all) to 3 (very much) Likert scales assessing symptoms of anxiety, depression, and stress symptoms. Higher scores indicate greater severity.
  measure: Changes in quality of life
  time frame: 14 weeks
  description: Measured using the Satisfaction with Life Scale (SWLS) with five items measuring subjective life satisfaction on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher score indicate greater satisfaction with life.
  measure: Changes in treatment acceptability and satisfaction
  time frame: 14 weeks
  description: Measured by twelve items created to assess participant's perception of the acceptability and utility of E-CET for reducing NEE using a 7 point Likert scale from 0 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater perceived acceptability and utility of E-CET.
  arm group label: Enhanced Cue Exposure Therapy
  arm group type: Experimental
  description: This is the experimental arm. Participants will receive the 6-session enhanced cue exposure therapy.
  arm group label: Behavioral Lifestyle Intervention
  arm group type: Active Comparator
  description: This is the active control arm. Participants will receive the 6-session behavioral lifestyle intervention.
  intervention type: Behavioral
  intervention name: Enhanced Cue Exposure Therapy
  description: The E-CET will consist of six weekly sessions and will be delivered by a clinical psychology trainee in person. The first session will be used to introduce the rationale and procedures of E-CET to the participant to establish therapeutic alliance, agreement on treatment goals and tasks, and to collect information on idiosyncratic CS-US expectancies to be targeted in exposures. In this session, questions will be asked specifically to assess idiosyncratic CS-US expectancies related to the four categories: positive reinforcement, craving/drive reduction, mood regulation, and disinhibition. An exhaustive list of all idiosyncratic NEE-triggering cues and CSUS expectancies will be generated from this session. These cues and CS-US expectancies will be targeted in the following exposure sessions and in homework exposures with the goal to cover as many of them as possible during the 6-week treatment.
  arm group label: Enhanced Cue Exposure Therapy
  intervention type: Behavioral
  intervention name: Behavioral Lifestyle Intervention
  description: It consists of six weekly sessions of behavioral counseling integrating behavioral strategies for making changes related to diet and exercise. These behavioral strategies will include education about healthy and balanced diets, and ways to attain the minimum level of physical activity for wellbeing (150 minutes moderate-to-vigorous exercise per week), goalsetting, problem-solving, coping, and relaxation. A manualized protocol developed by the PI's team for previous studies in the local community will be used.
  arm group label: Behavioral Lifestyle Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wai Sze Chan, PhD
  role: Principal Investigator
  affiliation: The University of Hong Kong
  last name: Wai Sze Chan, PhD
  phone: +85239172295
  email: chanwais@hku.hk
  responsible party type: Principal Investigator
  investigator affiliation: The University of Hong Kong
  investigator full name: Dr. Chan Wai Sze
  investigator title: Dr Chan Wai Sze
  mesh term: Bulimia
  sharing ipd: Yes
  ipd description: De-identified individual patient data may be shared upon request for research purposes.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code
  ipd time frame: De-identified data will become available indefinitely
  ipd access criteria: Requests to share data will be evaluated by the principal investigator