Bulimia NervosaNCT07768319
The Effectiveness of Online Group Dialectical Behavioral Therapy on Bulimia Nervosa
A study testing Online Group Dialectical Behavioral Therapy and Face-to-face Group Dialectical Behavioral Therapy in people with Bulimia Nervosa, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- Online Group Dialectical Behavioral Therapy and Face-to-face Group Dialectical 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 Dec 2020to 30 Nov 2023
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Online Group Dialectical Behavioral Therapy on Bulimia Nervosa: An Randomized-Controlled-Trial Study
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
- Being tested
- Online Group Dialectical Behavioral Therapy, Face-to-face Group Dialectical Behavioral Therapy
- Medical subject headings
- Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Group Dialectical Behavioral TherapyBehavioural
Also called Online G-DBT
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.
Face-to-face Group Dialectical Behavioral TherapyBehavioural
Also called Face-to-face G-DBT
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.
| Study group | Role | What they receive |
|---|---|---|
| online G-DBT | Experimental | Participants receive the G-DBT via videoconference weekly. Receives: 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. Receives: Behavioral: Face-to-face Group Dialectical Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 12 (end of the treatment), week 16 and week 24
Secondary outcomes (6)
Change of disordered eating from baseline
Measured by the total scores of EDE-Q and scores of its four subscales.
Measured: Baseline, week 12 (end of the treatment), week 16 and week 24
Changes of eating disorder related cognitive and behavioral characteristics
Measured by EDI(Eating Disorder Inventory), which consists of 8 subscales, 91 items.
Measured: Baseline, week 12 (end of the treatment), week 16 and week 24
Change of impulse control ability
Measured by Barratt Impulsiveness Scale Version 11 (BIS-11), which consists of 3 dimension, 26 items. Higher scores represent stronger impulse.
Measured: Baseline, week 12 (end of the treatment), week 16 and week 24
Change of depression level
Measured by Beck Depression Inventory (BDI-II), of which higher scores show deeper depression.
Measured: Baseline, week 12 (end of the treatment), week 16 and week 24
Change of anxiety level
Measured by Beck Anxiety Inventory (BAI). Higher scores show deeper anxiety.
Measured: Baseline, week 12 (end of the treatment), week 16 and week 24
Change of emotion regulation ability
Measured by Difficulties in Emotion Regulation Scale (DERS-16), which includes 16 items that falls into 5 factors.
Measured: Baseline, week 12 (end of the treatment), week 16 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Dec 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Responsible party
- Principal investigator, Jue CHEN, Shanghai Mental Health Center
- Investigators
- Jue Chen, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768319
- Sponsor's protocol ID
- 20Y11906500
- Other IDs
- 20Y11906500
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2022
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Online Group Dialectical Behavioral Therapy on Bulimia Nervosa: An Randomized-Controlled-Trial Study
- ClinicalTrials.gov ID
- NCT07768319
- Acronym / sponsor ID
- 20Y11906500
- Conditions
- Bulimia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 17 Aug 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online G-DBT | Experimental | Behavioral: Online Group Dialectical Behavioral TherapyParticipants receive the G-DBT via videoconference weekly. |
| face-to-face G-DBT | Active comparator | Behavioral: Face-to-face Group Dialectical Behavioral TherapyParticipants attend the traditional G-DBT weekly in Shanghai Mental Health Center. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Online Group Dialectical Behavioral TherapyAlso: Online G-DBTOnline 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. | Behavioural | online G-DBT |
| Face-to-face Group Dialectical Behavioral TherapyAlso: Face-to-face G-DBTThe 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. | Behavioural | face-to-face G-DBT |
Primary outcome
Changes of binge eating and purging episodes from baseline
Time frame: Baseline, week 12 (end of the treatment), week 16 and week 24
Measured by Eating Disorder Examination Questionnaire (EDE-Q, item 13 and 15). Core pathological behaviors of BN patients.
6 secondary outcomes
Change of disordered eating from baseline
Time frame: Baseline, week 12 (end of the treatment), week 16 and week 24
Changes of eating disorder related cognitive and behavioral characteristics
Time frame: Baseline, week 12 (end of the treatment), week 16 and week 24
Change of impulse control ability
Time frame: Baseline, week 12 (end of the treatment), week 16 and week 24
Change of depression level
Time frame: Baseline, week 12 (end of the treatment), week 16 and week 24
Change of anxiety level
Time frame: Baseline, week 12 (end of the treatment), week 16 and week 24
Change of emotion regulation ability
Time frame: Baseline, week 12 (end of the treatment), week 16 and week 24
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 25 Aug 2026.
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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?
A study testing Online Group Dialectical Behavioral Therapy and Face-to-face Group Dialectical Behavioral Therapy in people with Bulimia Nervosa, run by Shanghai Mental Health Center at 1 site in China.
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 25 Aug 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?
Changes of binge eating and purging episodes from baseline (time frame: Baseline, week 12 (end of the treatment), week 16 and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.