Enhanced Cue Exposure Therapy for Negative Emotional Eating

NCT ID: NCT06012045

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-21

Study Completion Date

2026-03-02

Brief Summary

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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

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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

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Disordered Eating Behaviors Binge Eating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enhanced Cue Exposure Therapy

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

Group Type EXPERIMENTAL

Enhanced Cue Exposure Therapy

Intervention Type 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.

Behavioral Lifestyle Intervention

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

Group Type ACTIVE_COMPARATOR

Behavioral Lifestyle Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Chan Wai Sze

Principal Investigator, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wai Sze Chan, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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The University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Wai Sze Chan, PhD

Role: CONTACT

+85239172295

Facility Contacts

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Wai Sze Chan, PhD

Role: primary

Other Identifiers

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EA220560

Identifier Type: -

Identifier Source: org_study_id

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