search
Back to results

A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating

Primary Purpose

Disordered Eating Behaviors, Binge Eating

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Cue Exposure Therapy
Behavioral Lifestyle Intervention
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disordered Eating Behaviors focused on measuring emotional eating, eating disorders, obesity, exposure and response prevention, behavioral therapy, randomized controlled trial, violation of expectancy, inhibitory learning, habituation, mechanism of change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18 or over A score >3.25 on the emotional eating subscale of the Dutch Eating Behavioural Questionnaire Confirmed to have on average at least 2 negative emotional eating episodes per week using daily tracking of previous 2 weeks Not currently receiving psychotherapy or psychiatric help Exclusion Criteria: Has an active suicidal plan or suicide intention Has psychiatric illnesses except mood disorders as mood disorders or mood disorder symptoms may be common in those with NEE Substance abuse Any conditions or circumstances that prevent the participant from receiving all treatment session

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Enhanced Cue Exposure Therapy

    Behavioral Lifestyle Intervention

    Arm Description

    This is the experimental arm. Participants will receive the 6-session enhanced cue exposure therapy.

    This is the active control arm. Participants will receive the 6-session behavioral lifestyle intervention.

    Outcomes

    Primary Outcome Measures

    Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
    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

    Secondary Outcome Measures

    Changes in weight
    Measured in the laboratory using a digital measuring scale.
    Changes in mood
    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.
    Changes in quality of life
    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.
    Changes in treatment acceptability and satisfaction
    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.

    Full Information

    First Posted
    August 21, 2023
    Last Updated
    August 21, 2023
    Sponsor
    The University of Hong Kong
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06012045
    Brief Title
    A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating
    Official Title
    A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2026 (Anticipated)
    Study Completion Date
    November 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disordered Eating Behaviors, Binge Eating
    Keywords
    emotional eating, eating disorders, obesity, exposure and response prevention, behavioral therapy, randomized controlled trial, violation of expectancy, inhibitory learning, habituation, mechanism of change

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Enhanced Cue Exposure Therapy
    Arm Type
    Experimental
    Arm Description
    This is the experimental arm. Participants will receive the 6-session enhanced cue exposure therapy.
    Arm Title
    Behavioral Lifestyle Intervention
    Arm Type
    Active Comparator
    Arm Description
    This is the active control arm. Participants will receive the 6-session behavioral lifestyle intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced Cue Exposure Therapy
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavioral Lifestyle Intervention
    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.
    Primary Outcome Measure Information:
    Title
    Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
    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
    Time Frame
    14 weeks
    Secondary Outcome Measure Information:
    Title
    Changes in weight
    Description
    Measured in the laboratory using a digital measuring scale.
    Time Frame
    14 weeks
    Title
    Changes in mood
    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.
    Time Frame
    14 weeks
    Title
    Changes in quality of life
    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.
    Time Frame
    14 weeks
    Title
    Changes in treatment acceptability and satisfaction
    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.
    Time Frame
    14 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18 or over A score >3.25 on the emotional eating subscale of the Dutch Eating Behavioural Questionnaire Confirmed to have on average at least 2 negative emotional eating episodes per week using daily tracking of previous 2 weeks Not currently receiving psychotherapy or psychiatric help Exclusion Criteria: Has an active suicidal plan or suicide intention Has psychiatric illnesses except mood disorders as mood disorders or mood disorder symptoms may be common in those with NEE Substance abuse Any conditions or circumstances that prevent the participant from receiving all treatment session
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wai Sze Chan, PhD
    Phone
    +85239172295
    Email
    chanwais@hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wai Sze Chan, PhD
    Organizational Affiliation
    The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified individual patient data may be shared upon request for research purposes.
    IPD Sharing Time Frame
    De-identified data will become available indefinitely
    IPD Sharing Access Criteria
    Requests to share data will be evaluated by the principal investigator

    Learn more about this trial

    A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating

    We'll reach out to this number within 24 hrs