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

NCT05873127 | Completed

• 1 other identifier: 202140092
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)

• Beck Anxiety Inventory (BAI)

  Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)

Study Arms (3)

web-based guided self-help CBT-E

EXPERIMENTAL

After randomization, 8-10 patients were assigned to self-help CBT-E group each time.

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.

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.

Interventions

web-based guided self-help Enhanced Cognitive Behavioral therapy BEHAVIORAL

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.

web-based guided self-help CBT-E

online Enhanced Cognitive Behavioral therapy BEHAVIORAL

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.

online group CBT-E

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (4)

• 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.

  PMID: 31046920 BACKGROUND

• 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.

  PMID: 35610603 BACKGROUND

• 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.

  PMID: 31840285 BACKGROUND

• 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.

  PMID: 33350574 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jue Chen, PHD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 24, 2023
• Study Start: January 1, 2023
• Primary Completion: January 30, 2026
• Study Completion: April 10, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Researchers will share data when the study is completed in December 2024.
• Access Criteria: CBT-E; bulimia nervosa; binge eating; online CBT-E

Locations

CN (1)