Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06012045
Other study ID # EA220560
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date November 30, 2026

Study information

Verified date August 2023
Source The University of Hong Kong
Contact Wai Sze Chan, PhD
Phone +85239172295
Email chanwais@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date November 30, 2026
Est. primary completion date November 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the score on the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ) 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 14 weeks
Secondary Changes in weight Measured in the laboratory using a digital measuring scale. 14 weeks
Secondary Changes in mood 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. 14 weeks
Secondary Changes in quality of life 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. 14 weeks
Secondary Changes in treatment acceptability and satisfaction 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. 14 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04038190 - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course Phase 2
Terminated NCT04278755 - Binge Eating & Birth Control Phase 2
Not yet recruiting NCT06454123 - Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity N/A
Completed NCT00537810 - Treatment of Binge Eating in Obese Patients in Primary Care Phase 4
Recruiting NCT05509257 - Naltrexone Neuroimaging in Teens With Eating Disorders Early Phase 1
Completed NCT03687658 - Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating N/A
Not yet recruiting NCT06326099 - Brief Binge Eating and Drinking Online Intervention N/A
Recruiting NCT05937243 - Identifying Effective Technological-based Augmentations to Enhance Outcomes From Self-help Cognitive Behavior Therapy for Binge Eating N/A
Completed NCT00607789 - Study of Duloxetine vs Placebo in Treatment of Binge Eating Disorder With Depression Phase 4
Completed NCT04117542 - Working Memory in Overweight Children With and Without Loss of Control Eating
Recruiting NCT04211818 - Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach (GLUCOPULSE) N/A
Completed NCT03429114 - Emotion Regulation in Binge Eating and Purging Among Adolescents
Completed NCT05041660 - Using Virtual Reality and Sensor Technology to Enhance Outcomes From Treatment for Binge Eating N/A
Completed NCT03007459 - The Health of Competitive Fitness Athletes
Completed NCT02180984 - The Effects of Repetitive Transcranial Magnetic Stimulation in Obese People With BED N/A
Completed NCT00829283 - Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care N/A
Completed NCT00307619 - An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder. Phase 3
Active, not recruiting NCT04127214 - The ITA Model of Integrated Treatment of Eating Disorders
Not yet recruiting NCT06129461 - A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings in Pregnancy N/A
Recruiting NCT05177705 - The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement Early Phase 1