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

Shanghai Mental Health Center

Status: Not yet enrolling

Conditions: Feeding and Eating Disorders

Treatments: Behavioral: online Enhanced Cognitive Behavioral therapy; Behavioral: web-based guided self-help Enhanced Cognitive Behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05873127

202140092

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

web-based guided self-help CBT-E

Experimental group

Description:

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

Treatment:

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

online group CBT-E

Experimental group

Description:

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

Treatment:

Behavioral: online Enhanced Cognitive Behavioral therapy

waiting group

No Intervention group

Description:

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.