Feeding and Eating DisordersNCT05873127

Web-based Guided Self-help CBT-E vs Online G-CBT-E for Binge Eating Behavior

A study testing web-based guided self-help Enhanced Cognitive Behavioral therapy and online Enhanced Cognitive Behavioral therapy in people with Feeding and Eating Disorders, run by Shanghai Mental Health Center at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Feeding and Eating Disorders
What is being tested?: web-based guided self-help Enhanced Cognitive Behavioral therapy and online Enhanced Cognitive Behavioral therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 1 Jan 2023to 10 Apr 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: 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.

Conditions: Feeding and Eating Disorders
Being tested: web-based guided self-help Enhanced Cognitive Behavioral therapy, online Enhanced Cognitive Behavioral therapy
Medical subject headings: Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

web-based guided self-help Enhanced Cognitive Behavioral therapyBehavioural
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.
online Enhanced Cognitive Behavioral therapyBehavioural
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.

Study groups in NCT05873127
Study group	Role	What they receive
web-based guided self-help CBT-E	Experimental	After randomization, 8-10 patients were assigned to self-help CBT-E group each time. Receives: Behavioral: web-based guided self-help Enhanced Cognitive Behavioral therapy
online group CBT-E	Experimental	After randomization, 8-10 patients were assigned to online CBT-E group each time. Receives: Behavioral: online Enhanced Cognitive Behavioral therapy
waiting group	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Change in Eating Disorder Examination Questionnaire (EDE-Q) at Post-Treatment and During Follow-Up
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.
Measured: Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)

Secondary outcomes (3)

Barratt Impulsivity Scale-Version 11 (BIS-11)
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.
Measured: 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)
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.
Measured: Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
Beck Anxiety Inventory (BAI)
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.
Measured: Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202310 Apr 2026

First posted24 May 2023
Study start1 Jan 2023
Primary completion30 Jan 2026
Study completion10 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Feeding and Eating DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05873127
Sponsor's protocol ID: 202140092
Status last verified: Apr 2026
First submitted: 23 Apr 2023
Last updated: 28 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The study protocol and baseline characteristics of participants.

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.
PubMed 31046920
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.
PubMed 35610603
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.
PubMed 31840285
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.
PubMed 33350574

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Feeding and Eating Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study of Web-based Guided Self-help CBT-E Versus Online Group CBT-E for Binge Eating Behavior
ClinicalTrials.gov ID: NCT05873127
Acronym / sponsor ID: 202140092
Conditions: Feeding and Eating Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Shanghai Mental Health CenterUniversity, hospital or other
Study start: 1 Jan 2023 (actual)
Primary completion: 30 Jan 2026 (actual)
Study completion: 10 Apr 2026 (actual)
First posted: 24 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
web-based guided self-help CBT-E	Experimental	Behavioral: web-based guided self-help Enhanced Cognitive Behavioral therapyAfter randomization, 8-10 patients were assigned to self-help CBT-E group each time.
online group CBT-E	Experimental	Behavioral: online Enhanced Cognitive Behavioral therapyAfter randomization, 8-10 patients were assigned to online CBT-E group each time.
waiting group	No intervention	–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.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
web-based guided self-help Enhanced Cognitive Behavioral therapyThe 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.	Behavioural	web-based guided self-help CBT-E
online Enhanced Cognitive Behavioral therapyA 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.	Behavioural	online group CBT-E

Primary outcome

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.

3 secondary outcomes

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)
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)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Background: PubMed 31046920Agras 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.
Background: PubMed 35610603Hay 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.
Background: PubMed 31840285Atwood 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.
Background: PubMed 33350574da 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.
Individual participant dataSharing planned: Yes. The study protocol and baseline characteristics of participants.

Related trials for Feeding and Eating Disorders

Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Recruiting
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II
Avoidant/Restrictive Food Intake Disorder (ARFID)
Not yet recruiting
Expand Your Horizon-Spanish
Body Image, Body Image Dissatisfaction
Recruiting
Specialist Supportive Clinical Management (SSCM) for Children and Adolescents With Anorexia Nervosa and Atypical Anorexia Nervosa
Anorexia Nervosa, Atypical Anorexia Nervosa
Not yet recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jue Chen, PHD principal investigator

Shanghai Mental Health Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05873127, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.