Enhanced Cue Exposure Therapy for Negative Emotional Eating

NCT06012045 | Recruiting DMC

• 1 other identifier: EA220560
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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. The secondary aim is to evaluate whether changes in conditioned stimulus-unconditioned stimulus (CS-US) expectancies mediate the changes in NEE.

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; habituation; mechanism of change

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Changes in NEE

  14 months (up to 12-month follow-up)

• Changes in caloric consumption

  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)

  14 months (up to 12-month follow-up)

• Changes in eating disorder symptoms measured by the Eating Disorder Examination Questionnaire-Short (EDE-QS)

  14 months (up to 12-month follow-up)

• Changes in body weight

  14 months (up to 12-month follow-up)

Study Arms (2)

Enhanced Cue Exposure Therapy

EXPERIMENTAL

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

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.

Behavioral: Behavioral Lifestyle Intervention

Interventions

Enhanced Cue Exposure Therapy BEHAVIORAL

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.

Enhanced Cue Exposure Therapy

Behavioral Lifestyle Intervention BEHAVIORAL

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.

Behavioral Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Disordered Eating Behavior; Bulimia; Emotional Eating; Feeding and Eating Disorders; Obesity; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Chemically-Induced Disorders

Study Officials

• Wai Sze Chan, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wai Sze Chan, PhD

CONTACT

+85239172295; chanwais@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: December 21, 2023
• Primary Completion: August 30, 2025
• Study Completion: March 2, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: De-identified data will become available indefinitely
• Access Criteria: Requests to share data will be evaluated by the principal investigator

Locations

HK (1)