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

Sponsor

The University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06012045

Collaborator

(none)

130

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The current study aims to evaluate the efficacy and feasibility of enhanced cue exposure therapy (E-CET) in reducing negative emotional eating, in comparison to an active control behavioral lifestyle intervention (BLI) in a double-blind, parallel, randomized controlled trial. The secondary aim is to evaluate whether changes in the four types of CS-US expectancy mediate the changes in NEE.

Condition or Disease	Intervention/Treatment	Phase
Disordered Eating Behaviors Binge Eating	Behavioral: Enhanced Cue Exposure Therapy Behavioral: Behavioral Lifestyle Intervention	N/A

Detailed Description

Participants will be randomly assigned to either the experimental treatment or control BLI group. Those in the experimental group will receive 6 weeks of E-CET treatment and followed up for 8 weeks post-treatment. Those in the control group will receive 6 weeks of behavioral counselling integrating behavioral strategies for making changes related to diet and exercise, followed up for 8 weeks post-treatment.

Research question 1:

Is E-CET an efficacious intervention for reducing NEE?

Hypothesis 1:

E-CET will lead to greater reductions in NEE at post-treatment and follow-up compared to BLI.

Reseach question 2:

Does E-CET work via the violation of the four types of expectancy?

Hypothesis 2:

Changes in the believability of the four types of expectancy will mediate the treatment effects of E-CET on NEE.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2026

Anticipated Study Completion Date :

Nov 30, 2026

Arms and Interventions

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. The first session will be used to introduce the rationale and procedures of E-CET to the participant to establish therapeutic alliance, agreement on treatment goals and tasks, and to collect information on idiosyncratic CS-US expectancies to be targeted in exposures. In this session, questions will be asked specifically to assess idiosyncratic CS-US expectancies related to the four categories: positive reinforcement, craving/drive reduction, mood regulation, and disinhibition. An exhaustive list of all idiosyncratic NEE-triggering cues and CSUS expectancies will be generated from this session. These cues and CS-US expectancies will be targeted in the following exposure sessions and in homework exposures with the goal to cover as many of them as possible during the 6-week treatment.
Active Comparator: Behavioral Lifestyle Intervention This is the active control arm. Participants will receive the 6-session behavioral lifestyle intervention.	Behavioral: Behavioral Lifestyle Intervention It consists of six weekly sessions of behavioral counseling integrating behavioral strategies for making changes related to diet and exercise. These behavioral strategies will include education about healthy and balanced diets, and ways to attain the minimum level of physical activity for wellbeing (150 minutes moderate-to-vigorous exercise per week), goalsetting, problem-solving, coping, and relaxation. A manualized protocol developed by the PI's team for previous studies in the local community will be used.

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. The first session will be used to introduce the rationale and procedures of E-CET to the participant to establish therapeutic alliance, agreement on treatment goals and tasks, and to collect information on idiosyncratic CS-US expectancies to be targeted in exposures. In this session, questions will be asked specifically to assess idiosyncratic CS-US expectancies related to the four categories: positive reinforcement, craving/drive reduction, mood regulation, and disinhibition. An exhaustive list of all idiosyncratic NEE-triggering cues and CSUS expectancies will be generated from this session. These cues and CS-US expectancies will be targeted in the following exposure sessions and in homework exposures with the goal to cover as many of them as possible during the 6-week treatment.

Active Comparator: Behavioral Lifestyle Intervention

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

Behavioral: Behavioral Lifestyle Intervention

It consists of six weekly sessions of behavioral counseling integrating behavioral strategies for making changes related to diet and exercise. These behavioral strategies will include education about healthy and balanced diets, and ways to attain the minimum level of physical activity for wellbeing (150 minutes moderate-to-vigorous exercise per week), goalsetting, problem-solving, coping, and relaxation. A manualized protocol developed by the PI's team for previous studies in the local community will be used.

Outcome Measures

Primary Outcome Measures

Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ) [14 weeks]
Negative emotional eating measured by the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ) consisting of 13 items assessing the tendency to eat in response to feelings of depression, irritability, anger, anxiety, fear, boredom, disappointment, and stress on a 5-point Likert scale from 1 to 5. The cutoff point of >3.25 is used to indicate negative emotional eating tendencies. Higher scores indicate greater tendency and severity

Secondary Outcome Measures

Changes in weight [14 weeks]
Measured in the laboratory using a digital measuring scale.
Changes in mood [14 weeks]
Measured using the Depression, Anxiety and Stress Scale-21 (DASS-21) consisting of 21 items rated on 0 (not at all) to 3 (very much) Likert scales assessing symptoms of anxiety, depression, and stress symptoms. Higher scores indicate greater severity.
Changes in quality of life [14 weeks]
Measured using the Satisfaction with Life Scale (SWLS) with five items measuring subjective life satisfaction on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher score indicate greater satisfaction with life.
Changes in treatment acceptability and satisfaction [14 weeks]
Measured by twelve items created to assess participant's perception of the acceptability and utility of E-CET for reducing NEE using a 7 point Likert scale from 0 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater perceived acceptability and utility of E-CET.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 18 or over
A score >3.25 on the emotional eating subscale of the Dutch Eating Behavioural Questionnaire
Confirmed to have on average at least 2 negative emotional eating episodes per week using daily tracking of previous 2 weeks
Not currently receiving psychotherapy or psychiatric help

Exclusion Criteria:

Has an active suicidal plan or suicide intention
Has psychiatric illnesses except mood disorders as mood disorders or mood disorder symptoms may be common in those with NEE
Substance abuse
Any conditions or circumstances that prevent the participant from receiving all treatment session