- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05873127
Web-based Guided Self-help CBT-E vs Online G-CBT-E for Binge Eating Behavior
April 22, 2026 updated by: Shanghai Mental Health Center
A Randomized Controlled Study of Web-based Guided Self-help CBT-E Versus Online Group CBT-E for Binge Eating Behavior
Eating disorders with binge eating as the core feature include bulimia nervosa (BN) and binge eating disorder (BED).
In recent years, the prevalence rate has increased rapidly, mostly among women, accompanied by emotional problems, physiological complications and increased risks of obesity and depression, which bring great pain to patients.
Enhanced Cognitive Behavioral therapy (CBT-E) for eating disorders is an evidence-based and effective first-line psychotherapy for BN and BED.
CBT-E is implemented in various forms.
In addition to face-to-face therapy, online group CBT-E and guided self-help CBT-E can significantly reduce binge eating in BN and BED patients.
However, there are no relevant clinical studies in China.
Since 2008, the applicant has carried out CBT treatment and research on eating disorders, translated and published the self-help book "Overcoming Overeating", and accumulated rich clinical research experience.
This study intends to establish a set of CBT-E self-help therapy courses suitable for Chinese binge eating patients, and conduct a randomized controlled study of web-based guided self-help CBT-E and online group CBT-E to compare the effectiveness of the treatment modalities in the treatment of binge eating and the feasibility of online guided self-help CBT-E and online group CBT-E in the treatment of binge eating.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200030
- Shanghai Mental Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Han nationality, aged 18-35 years old;
- Students with junior high school education or above;
- Meet the diagnostic criteria of BN or BED in DSM-5, body mass index (BMI)≥18.5 kg/m2;
- no systematic nutritional treatment, psychiatric drug treatment or any form of psychological treatment was received within 1 month before enrollment;
- Each patient must understand the nature of this study and sign informed consent.
Exclusion Criteria:
- Persons meeting other DSM-5 diagnoses other than BN and BED, such as substance abuse/dependence, depression, bipolar disorder, anxiety disorder, obsessive-compulsive disorder, etc., persons at high risk of suicide, persons with strong destructive impulses or antisocial behaviors;
- The patient has severe primary or secondary physical disease or cognitive impairment, which makes the patient unable to complete the required symptom assessment and psychological tests;
- Have received systematic nutritional therapy, individual and group psychotherapy;
- Those who have taken neuroblockers, antidepressants, lithium salts, stimulants, antiepileptics and other psychotropic drugs within the past 1 month;
- Participation in this clinical trial was deemed inappropriate by the investigator for other reasons.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: web-based guided self-help CBT-E
After randomization, 8-10 patients were assigned to self-help CBT-E group each time.
|
The subjects would learn and practice CBT-E course through the online learning platform for 12 times, and were required to complete the course once a week.
|
|
Experimental: online group CBT-E
After randomization, 8-10 patients were assigned to online CBT-E group each time.
|
A closed structured group would be established by online video conference for group CBT-E therapy.
Each group would receive 12 group sessions, once a week for 120 minutes each time.
Each group would be led by two CBT therapists, all of whom are nationally registered psychotherapists with systematic professional training.
|
|
No Intervention: waiting group
After randomization, 8-10 patients were assigned to the waiting list each time, and they would be allocated to web-based guided self-help CBT-E or online group CBT-E randomly after a 12-week waiting period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Eating Disorder Examination Questionnaire (EDE-Q) at Post-Treatment and During Follow-Up
Time Frame: Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
|
Questions 13 to 15 of the Eating Disorder Survey Scale (EDE-Q) were used to assess the proportion of patients with no binge eating behavior in the last 28 days.
|
Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barratt Impulsivity Scale-Version 11 (BIS-11)
Time Frame: Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
|
To evaluate the changes in impulse suppression ability of patients before and after treatment, the Barratt Impulsivity Scale-11 (BIS-11) comprises 30 questions.
Each question is on a 4-point scale from 1 to 4. Scores range from 30 to 120, with higher scores indicating higher levels of impulsivity.
|
Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
|
|
Beck Depression Inventory-Version 2 (BDI-2)
Time Frame: Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
|
To assess the changes of depressive mood before and after treatment, the Beck Depression Inventory-Version 2 (BDI-2) comprises 21 questions.
Each question is on a 4-point scale from 0 to 3. Scores range from 0 to 63, with higher scores indicating higher levels of depression.
|
Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
|
|
Beck Anxiety Inventory (BAI)
Time Frame: Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
|
To assess the changes of anxiety mood before and after treatment, the Beck Anxiety Inventory (BAI) comprises 21 questions.
Each question is on a 4-point scale from 0 to 3. Scores range from 0 to 63, with higher scores indicating higher levels of anxiety.
|
Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jue Chen, PHD, Shanghai Mental Health Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Agras WS. Cognitive Behavior Therapy for the Eating Disorders. Psychiatr Clin North Am. 2019 Jun;42(2):169-179. doi: 10.1016/j.psc.2019.01.001. Epub 2019 Apr 2.
- Hay P, Palavras MA, da Luz FQ, Dos Anjos Garnes S, Sainsbury A, Touyz S, Appolinario JC, Claudino AM. Physical and mental health outcomes of an integrated cognitive behavioural and weight management therapy for people with an eating disorder characterized by binge eating and a high body mass index: a randomized controlled trial. BMC Psychiatry. 2022 May 24;22(1):355. doi: 10.1186/s12888-022-04005-y.
- Atwood ME, Friedman A. A systematic review of enhanced cognitive behavioral therapy (CBT-E) for eating disorders. Int J Eat Disord. 2020 Mar;53(3):311-330. doi: 10.1002/eat.23206. Epub 2019 Dec 16.
- da Luz FQ, Hay P, Wisniewski L, Cordas T, Sainsbury A. The treatment of binge eating disorder with cognitive behavior therapy and other therapies: An overview and clinical considerations. Obes Rev. 2020 Dec 17. doi: 10.1111/obr.13180. Online ahead of print.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
January 30, 2026
Study Completion (Actual)
April 10, 2026
Study Registration Dates
First Submitted
April 23, 2023
First Submitted That Met QC Criteria
May 15, 2023
First Posted (Actual)
May 24, 2023
Study Record Updates
Last Update Posted (Actual)
April 28, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202140092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The study protocol and baseline characteristics of participants.
IPD Sharing Time Frame
Researchers will share data when the study is completed in December 2024.
IPD Sharing Access Criteria
CBT-E; bulimia nervosa; binge eating; online CBT-E
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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