The Effectiveness of Online Group Dialectical Behavioral Therapy on Bulimia Nervosa

NCT07768319 | Completed

• 1 other identifier: 20Y11906500
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Bulimia Nervosa (BN) is a kind of chronic refractory mental disorder with high prevalence and relapse rate, which would cause serious damage to physical and mental health. Dialectical Behavioral Therapy (DBT) is an internationally effective and evidence-based therapy for BN patients. Previous studies have found that DBT group therapy can significantly improve the core symptoms of BN patients. Our research group has conducted DBT group therapy for BN, and found that after 12 weeks of treatment, the frequencies of binge eating and purging behavior of BN patients were significantly reduced. However, with the high cost of ground-based group therapy and low coverage, it is difficult to promote the G-DBT(Group Dialectical Behavioral Therapy) for BN, considering the shortage of mental health resource in China. Besides, videoconferencing-based psychotherapy has gradually emerged in recent years. However, there is still a lack of clinical studies on the videoconferencing-based G-DBT for BN at home and abroad to confirm its efficacy and feasibility. Therefore, this study intends to use a randomized controlled study by randomly allocating BN patients into videoconferencing-based G-DBT group and traditional G-DBT group for 12 weeks. By comparing the changes of core symptoms and psychological characteristics of BN patients before and after treatment, this study aims to illustrate the efficacy and feasibility of videoconferencing-based G-DBT is no less than traditional G-DBT.

Conditions

Bulimia Nervosa

Outcome Measures

Primary Outcomes (1)

• Changes of binge eating and purging episodes from baseline

  Measured by Eating Disorder Examination Questionnaire (EDE-Q, item 13 and 15). Core pathological behaviors of BN patients.

  Baseline, week 12 (end of the treatment), week 16 and week 24

Secondary Outcomes (6)

• Change of disordered eating from baseline

  Baseline, week 12 (end of the treatment), week 16 and week 24

• Changes of eating disorder related cognitive and behavioral characteristics

  Baseline, week 12 (end of the treatment), week 16 and week 24

• Change of impulse control ability

  Baseline, week 12 (end of the treatment), week 16 and week 24

• Change of depression level

  Baseline, week 12 (end of the treatment), week 16 and week 24

• Change of anxiety level

  Baseline, week 12 (end of the treatment), week 16 and week 24

Study Arms (2)

online G-DBT

EXPERIMENTAL

Participants receive the G-DBT via videoconference weekly.

Behavioral: Online Group Dialectical Behavioral Therapy

face-to-face G-DBT

ACTIVE COMPARATOR

Participants attend the traditional G-DBT weekly in Shanghai Mental Health Center.

Behavioral: Face-to-face Group Dialectical Behavioral Therapy

Interventions

Online Group Dialectical Behavioral Therapy BEHAVIORAL

Online G-DBT is an adapted version of G-DBT delivered via video-conference. The specific design of G-DBT is the same as traditional face-to-face G-DBT. It also consists of 12 sessions, which is conducted weekly and lasts for 120 minutes. There are two therapists in charge of the therapy.

Also known as: Online G-DBT

online G-DBT

Face-to-face Group Dialectical Behavioral Therapy BEHAVIORAL

The G-DBT consists of 12 sessions, each lasting 120 minutes, and is held once a week. Two DBT therapists lead the patients to learn mindfulness skills, emotion regulation skills, pain tolerance skills, and interpersonal effectiveness skills. The aim is to help the patients reduce binge eating and harmful behaviors by regulating their emotions. Each sessions is conducted in a face-to-face way, in the psychological therapy room of the outpatient clinic in Shanghai Mental Health Center.

Also known as: Face-to-face G-DBT

face-to-face G-DBT

Eligibility Criteria

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

You may qualify if:

• Female, 18-35 years old, right-handed;
• Education level is junior high school or above;
• Meet the Diagnostic criteria of Bulimia Nervosa in DSM-5 (The diagnostic and statistical manual of mental disorders，DSM), body mass index (BMI)≥18.5 kg/m2;
• Did not receive systematic nutritional therapy, psychiatric drug therapy or any form of psychological therapy within 1 month before enrollment;
• Able to understand the study and agree to participate.

You may not qualify if:

• Those who meet other DSM-5 diagnoses besides BN, such as substance abuse/dependence, depression, bipolar disorder, anxiety disorder, obsessive-compulsive disorder, etc. And those with high risk of suicide, strong disruptive impulse or antisocial behavior.
• Patients with serious primary or secondary physical disease, cognitive impairment, so that they can not complete the required assessment.
• Have received systematic nutritional therapy, individual and group psychotherapy previously.
• Have taken neuroblockers, antidepressants, lithium salts, stimulants, antiepileptic drugs and other psychotropic drugs within the past 1 month.
• For other reasons that researchers consider it inappropriate to participate in this clinical trial.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Shanghai Municipal Science and Technology Commission: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

Location

MeSH Terms

Conditions

Bulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Jue Chen, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department Director

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 17, 2026
• Study Start: December 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2023
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

CN (1)