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Recruiting NCT06012045

Enhanced Cue Exposure Therapy for Negative Emotional Eating

No phase Interventional Disordered Eating Behaviors Binge Eating

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced Cue Exposure Therapy, Behavioral Lifestyle Intervention.
Who it may be relevant to
Registry conditions: Disordered Eating Behaviors, Binge Eating. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Enhanced Cue Exposure Therapy
    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 t
  • Behavioral Behavioral Lifestyle Intervention
    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.

Primary outcome measures

  • 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)]
  • Number of EMA-measured NEE episodes [Time frame: 14 months (up to 12-month follow-up)]
Secondary outcome measures (7)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The University of Hong Kong — Hong Kong

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. PMID 40393615

Identifiers

NCT: NCT06012045 · EA220560

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗