Enhanced Cue Exposure Therapy for Negative Emotional Eating

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.

Study Overview

• Status: Recruiting
• Conditions: Disordered Eating Behaviors; Binge Eating
• Intervention / Treatment: Behavioral: Enhanced Cue Exposure Therapy; Behavioral: Behavioral Lifestyle Intervention

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 Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wai Sze Chan, PhD; Phone Number: +85239172295; Email: chanwais@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The University of Hong Kong
    • Contact: Wai Sze Chan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Cue Exposure Therapy; This is the experimental arm. Participants will receive the 6-session enhanced cue exposure therapy.	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 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.
Active Comparator: Behavioral Lifestyle Intervention; This is the active control arm. Participants will receive the 6-session behavioral lifestyle intervention.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	14 months (up to 12-month follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	14 months (up to 12-month follow-up)
Changes in body weight	It will be measured in the laboratory using a digital weighing scale.	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.	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.	14 months (up to 12-month follow-up)

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Wai Sze Chan, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2023
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): March 2, 2026

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; obesity; habituation; exposure and response prevention; eating disorders; behavioral therapy; emotional eating; mechanism of change; inhibitory learning; violation of expectancy
• Additional Relevant MeSH Terms: Hyperphagia; Signs and Symptoms, Digestive; Bulimia
• Other Study ID Numbers: EA220560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No