Disordered Eating BehaviorsNCT06012045
Enhanced Cue Exposure Therapy for Negative Emotional Eating
A study testing Enhanced Cue Exposure Therapy and Behavioral Lifestyle Intervention in people with Disordered Eating Behaviors and Binge Eating, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The current study aims to evaluate the efficacy of Enhanced Cue Exposure Therapy (E-CET) in reducing negative emotional eating (NEE), compared to an active control intervention, behavioral lifestyle intervention (BLI), in a parallel-group, participant-blinded, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disordered Eating Behaviors, Binge Eating
- What is being tested?
- Enhanced Cue Exposure Therapy and Behavioral Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Dec 2023to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or over
- a score >3.25 on the emotional eating subscale of the Dutch Eating Behavioural Questionnaire lasting for three months or longer
- confirmed to have, on average, two or more NEE episodes per week using ecological momentary assessments (EMAs)
Who cannot join
- active suicidal intent or plan
- psychiatric illnesses except mood disorders, anxiety disorders, and eating disorders because mood and anxiety disorders and symptoms are common in those with NEE
- currently receiving psychotherapy, or adjusting to changing psychiatric medication
- substance abuse
- any conditions or circumstances that prevent the participant from receiving all treatment sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Wai Sze Chan, PhD
About this study
Official title: A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating
The current study aims to evaluate the efficacy of Enhanced Cue Exposure Therapy (E-CET) in reducing negative emotional eating (NEE), compared to an active control intervention, behavioral lifestyle intervention (BLI), in a parallel-group, participant-blinded, randomized controlled trial. The secondary aim is to evaluate whether changes in conditioned stimulus-unconditioned stimulus (CS-US) expectancies mediate the changes in NEE.
Read the detailed description
Participants will be randomly assigned to either the experimental treatment or control BLI group. Participants in the experimental group will receive 6 weeks of E-CET treatment and those in the control group will receive 6 weeks of behavioral counselling integrating behavioral strategies for making changes related to diet and exercise. Outcomes will be assessed at baseline, posttreatment, and 3- and 12-month follow-ups.
Research question 1:
Is E-CET an efficacious intervention for reducing NEE?
Hypothesis 1:
E-CET will lead to greater reductions in NEE at posttreatment and follow-up compared to BLI.
Research question 2:
Does E-CET work via the violation of the CS-US expectancies?
Hypothesis 2:
Changes in the believability of CS-US expectancies will mediate the treatment effects of E-CET on NEE.
- Conditions
- Disordered Eating Behaviors, Binge Eating
- Being tested
- Enhanced Cue Exposure Therapy, Behavioral Lifestyle Intervention
- Keywords
- emotional eating, eating disorders, obesity, exposure and response prevention, behavioral therapy, randomized controlled trial, violation of expectancy, inhibitory learning, habituation, mechanism of change
- Medical subject headings
- Disordered Eating Behavior, Bulimia, Emotional Eating, Feeding and Eating Disorders, Obesity, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Cue Exposure TherapyBehavioural
The E-CET will consist of six weekly sessions and will be delivered by a clinical psychology trainee in person. Session #1 will be used to introduce to the participant the rationale and procedures of E-CET to establish therapeutic alliance, agreement on treatment goals and tasks, and to collect information on idiosyncratic CS-US expectancies to be targeted in exposures. Sessions #2 to #5 will be in vivo exposures. The interventionist will prompt the participant to evaluate the CS-US expectancy to facilitate the violation of the CS-US expectancy maintaining NEE. Between-session homework exposures will be planned and conducted by the participant in their naturalistic environment. They will also be reviewed at the beginning of the following session to consolidate learning. The final session will consist of consolidation of treatment gains and relapse prevention.
Behavioral Lifestyle InterventionBehavioural
The BLI will consist of six weekly sessions of behavioral counselling integrating behavioral strategies for participants to make dietary changes. These behavioral strategies will include education about healthy and balanced diets, goal-setting, problem-solving, and relaxation. A manualized protocol developed by the PI's team for previous studies in the local community will be used.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Cue Exposure Therapy | Experimental | This is the experimental arm. Participants will receive the 6-session enhanced cue exposure therapy. Receives: Behavioral: Enhanced Cue Exposure Therapy |
| Behavioral Lifestyle Intervention | Active comparator | This is the active control arm. Participants will receive the 6-session behavioral lifestyle intervention. Receives: Behavioral: Behavioral Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
The subscale consists of 13 items assessing the tendency to eat in response to negative emotions, on a 5-point Likert scale from 1 (never) to 5 (very often). The cutoff point of >3.25 is used to indicate negative emotional eating tendencies. Higher scores indicate greater tendency and severity.
Measured: 14 months (up to 12-month follow-up)
Number of EMA-measured NEE episodes
Participants will respond to fixed-interval prompts asking whether they have engaged in NEE in the assessment period. The sum of all the reported episodes during the seven days will be computed to indicate the frequency of NEE per week.
Measured: 14 months (up to 12-month follow-up)
Secondary outcomes (7)
Changes in NEE
It will be indexed by the association between negative emotionality and caloric consumption measured in three days a week. Negative emotionality will be measured using the four fixed interval prompts per day. Participants will be asked to select the negative emotions applied to them at the moment and rate the intensity of the selected negative emotions on a visual analog scale from 0 (not at all) to 100 (very intense). Caloric consumption will be measured by the 24-hour dietary recall interview conducted for three days a week. Stronger associations will indicate greater NEE.
Measured: 14 months (up to 12-month follow-up)
Changes in caloric consumption
It will be measured by the 24-hour dietary recall interview conducted for three days a week. Nutrition information on food intake (calories, protein, carbohydrates, fat, dietary fibre, sugar, and sodium) will be processed by trained research assistants.
Measured: 14 months (up to 12-month follow-up)
Changes in external eating measured by the external eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
The subscale consists of 10 items assessing the tendency to eat in response to external cues on a 5-point Likert scale from 1 (never) to 5 (very often). Higher scores indicate greater frequencies of disordered eating.
Measured: 14 months (up to 12-month follow-up)
Changes in eating disorder symptoms measured by the Eating Disorder Examination Questionnaire-Short (EDE-QS)
It consists of 12 items assessing the symptoms of eating disorders for the preceding seven days rated on a 4-point Likert scale from 0 (0 days) to 3 (6-7 days). Higher global scores indicate greater eating disorder symptoms.
Measured: 14 months (up to 12-month follow-up)
Changes in body weight
It will be measured in the laboratory using a digital weighing scale.
Measured: 14 months (up to 12-month follow-up)
Changes in mood measured using the Depression, Anxiety and Stress Scale-21 (DASS-21)
The scale consists of 21 items rated on 0 (not at all) to 3 (very much) Likert scales assessing symptoms of anxiety, depression, and stress.
Measured: 14 months (up to 12-month follow-up)
Changes in quality of life measured using the Satisfaction with Life Scale (SWLS)
It is a 5-item scale measuring subjective life satisfaction on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher total scores indicate greater life satisfaction.
Measured: 14 months (up to 12-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start21 Dec 2023
- Primary completion30 Aug 2025 (estimated)
- Study completion2 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disordered Eating BehaviorsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chan Wai Sze, The University of Hong Kong
- Investigators
- Wai Sze Chan, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012045
- Sponsor's protocol ID
- EA220560
- Status last verified
- Apr 2025
- First submitted
- 21 Aug 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data may be shared upon request for research purposes.
Publications
Chan WS, Cheng WY. Study protocol for a parallel-group, randomized controlled trial of enhanced cue exposure therapy for negative emotional eating. Contemp Clin Trials. 2025 Jul;154:107955. doi: 10.1016/j.cct.2025.107955. Epub 2025 May 18.
PubMed 40393615
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Enhanced Cue Exposure Therapy for Negative Emotional Eating
- ClinicalTrials.gov ID
- NCT06012045
- Acronym / sponsor ID
- EA220560
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 2 Mar 2026 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims to evaluate the efficacy of Enhanced Cue Exposure Therapy (E-CET) in reducing negative emotional eating (NEE), compared to an active control intervention, behavioral lifestyle intervention (BLI), in a parallel-group, participant-blinded, randomized controlled trial. The secondary aim is to evaluate whether changes in conditioned stimulus-unconditioned stimulus (CS-US) expectancies mediate the changes in NEE.
Detailed description
Participants will be randomly assigned to either the experimental treatment or control BLI group. Participants in the experimental group will receive 6 weeks of E-CET treatment and those in the control group will receive 6 weeks of behavioral counselling integrating behavioral strategies for making changes related to diet and exercise. Outcomes will be assessed at baseline, posttreatment, and 3- and 12-month follow-ups.
Research question 1:
Is E-CET an efficacious intervention for reducing NEE?
Hypothesis 1:
E-CET will lead to greater reductions in NEE at posttreatment and follow-up compared to BLI.
Research question 2:
Does E-CET work via the violation of the CS-US expectancies?
Hypothesis 2:
Changes in the believability of CS-US expectancies will mediate the treatment effects of E-CET on NEE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Cue Exposure Therapy | Experimental | Behavioral: Enhanced Cue Exposure TherapyThis is the experimental arm. Participants will receive the 6-session enhanced cue exposure therapy. |
| Behavioral Lifestyle Intervention | Active comparator | Behavioral: Behavioral Lifestyle InterventionThis is the active control arm. Participants will receive the 6-session behavioral lifestyle intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 or over
- a score >3.25 on the emotional eating subscale of the Dutch Eating Behavioural Questionnaire lasting for three months or longer
- confirmed to have, on average, two or more NEE episodes per week using ecological momentary assessments (EMAs)
Key exclusion criteria (5 listed)
- active suicidal intent or plan
- psychiatric illnesses except mood disorders, anxiety disorders, and eating disorders because mood and anxiety disorders and symptoms are common in those with NEE
- currently receiving psychotherapy, or adjusting to changing psychiatric medication
- substance abuse
- any conditions or circumstances that prevent the participant from receiving all treatment sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Cue Exposure TherapyThe E-CET will consist of six weekly sessions and will be delivered by a clinical psychology trainee in person. Session #1 will be used to introduce to the participant the rationale and procedures of E-CET to establish therapeutic alliance, agreement on treatment goals and tasks, and to collect information on idiosyncratic CS-US expectancies to be targeted in exposures. Sessions #2 to #5 will be in vivo exposures. The interventionist will prompt the participant to evaluate the CS-US expectancy to facilitate the violation of the CS-US expectancy maintaining NEE. Between-session homework exposures will be planned and conducted by the participant in their naturalistic environment. They will also be reviewed at the beginning of the following session to consolidate learning. The final session will consist of consolidation of treatment gains and relapse prevention. | Behavioural | Enhanced Cue Exposure Therapy |
| Behavioral Lifestyle InterventionThe BLI will consist of six weekly sessions of behavioral counselling integrating behavioral strategies for participants to make dietary changes. These behavioral strategies will include education about healthy and balanced diets, goal-setting, problem-solving, and relaxation. A manualized protocol developed by the PI's team for previous studies in the local community will be used. | Behavioural | Behavioral Lifestyle Intervention |
Primary outcome
Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
Time frame: 14 months (up to 12-month follow-up)
The subscale consists of 13 items assessing the tendency to eat in response to negative emotions, on a 5-point Likert scale from 1 (never) to 5 (very often). The cutoff point of >3.25 is used to indicate negative emotional eating tendencies. Higher scores indicate greater tendency and severity.
Number of EMA-measured NEE episodes
Time frame: 14 months (up to 12-month follow-up)
Participants will respond to fixed-interval prompts asking whether they have engaged in NEE in the assessment period. The sum of all the reported episodes during the seven days will be computed to indicate the frequency of NEE per week.
7 secondary outcomes
Changes in NEE
Time frame: 14 months (up to 12-month follow-up)
Changes in caloric consumption
Time frame: 14 months (up to 12-month follow-up)
Changes in external eating measured by the external eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ)
Time frame: 14 months (up to 12-month follow-up)
Changes in eating disorder symptoms measured by the Eating Disorder Examination Questionnaire-Short (EDE-QS)
Time frame: 14 months (up to 12-month follow-up)
Changes in body weight
Time frame: 14 months (up to 12-month follow-up)
Changes in mood measured using the Depression, Anxiety and Stress Scale-21 (DASS-21)
Time frame: 14 months (up to 12-month follow-up)
Changes in quality of life measured using the Satisfaction with Life Scale (SWLS)
Time frame: 14 months (up to 12-month follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 40393615Chan WS, Cheng WY. Study protocol for a parallel-group, randomized controlled trial of enhanced cue exposure therapy for negative emotional eating. Contemp Clin Trials. 2025 Jul;154:107955. doi: 10.1016/j.cct.2025.107955. Epub 2025 May 18.
- Individual participant dataSharing planned: Yes. De-identified individual patient data may be shared upon request for research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wai Sze Chan, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Cue Exposure Therapy and Behavioral Lifestyle Intervention in people with Disordered Eating Behaviors and Binge Eating, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wai Sze Chan, PhD (+85239172295, chanwais@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ) (time frame: 14 months (up to 12-month follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06012045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.