Bulimia Nervosa
Conditions
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.
Interventions
BEHAVIORALOnline Group Dialectical Behavioral Therapy
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.
BEHAVIORALFace-to-face Group Dialectical Behavioral Therapy
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.
Sponsors
Shanghai Mental Health Center
Shanghai Municipal Science and Technology Commission
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of binge eating and purging episodes from baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of disordered eating from baseline | Baseline, week 12 (end of the treatment), week 16 and week 24 | Measured by the total scores of EDE-Q and scores of its four subscales. |
| Changes of eating disorder related cognitive and behavioral characteristics | Baseline, week 12 (end of the treatment), week 16 and week 24 | Measured by EDI(Eating Disorder Inventory), which consists of 8 subscales, 91 items. |
| Change of impulse control ability | Baseline, week 12 (end of the treatment), week 16 and week 24 | Measured by Barratt Impulsiveness Scale Version 11 (BIS-11), which consists of 3 dimension, 26 items. Higher scores represent stronger impulse. |
| Change of depression level | Baseline, week 12 (end of the treatment), week 16 and week 24 | Measured by Beck Depression Inventory (BDI-II), of which higher scores show deeper depression. |
| Change of anxiety level | Baseline, week 12 (end of the treatment), week 16 and week 24 | Measured by Beck Anxiety Inventory (BAI). Higher scores show deeper anxiety. |
| Change of emotion regulation ability | Baseline, week 12 (end of the treatment), week 16 and week 24 | Measured by Difficulties in Emotion Regulation Scale (DERS-16), which includes 16 items that falls into 5 factors. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJue Chen, PhD
Shanghai Mental Health Center
Outcome results
None listed