The Effect of G-DBT on the Patients With BN : A Multicenter Randomized Controlled Study

Not Applicable

Completed

• Conditions: Feeding and Eating Disorders
• Interventions: Behavioral: Dialectical Behavioral Group Therapy

• Registration Number: NCT03455088
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

This study is to examine whether the efficacy of DBT for BN is comparable with drug treatment, whether short-term and long-term efficacy of DBT combined with drug treatment of BN is better than single DBT or single drug treatment, and trying to explore predictable biological indicators of short-term and long-term efficacy of DBT for BN. Our study will use multi-center randomized controlled study design. 165 outpatients with BN will be recruited from Shanghai Mental Health Center, No.6 Hospital of Peking University and Shanghai Tongji Hospital. There will be three groups: DBT treatment group, Fluoxetine treatment group, DBT combined with fluoxetine treatment group. We prepare to recruit 165 patients with BN ,and each group is 55, and then three groups will be given standard intervention for 12 weeks. To assess the eating disorder symptoms, impulsive and emotional change, clinical symptom scales, psychological scales and the security indexs will be used at baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 16weeks(1 month after treatment),24 weeks (3 months after treatment) and 36 weeks (6 months after treatment follow-up). Furthermore, brain MRI will be used for DBT treatment group at baseline, and 36 weeks.

Detailed Description

Bulimia nervosa(BN) is a chronic and refractory mental disorder characteristic of recurrent binge eating and weight control which mostly occur in adolescents and young women. The life-time prevalence ranges from 1.0%-4.2%, while in middle school and university, the prevalence can be 4.7-17%, and keep increasing. The recurrence rate of BN is also high, which can reach 25-63% six months after recovery. The nature cause can last several years showing a chronic feature. Patients with BN can also suffer from other severe psychosomatic complications, which harm the patients physical and mental health, thus lead to a mortality of 1% and negative impact on patients life and his/her family.

Antidepressant fluoxetine can reduce binge eating and purging behaviors in BN patients in a short time. It is the only drug approved by the US FDA for the treatment of BN, and also helps to prevent recurrence. However, there are still a considerable proportion of patients who keep a poor response to the medication. Cognitive behavioral therapy, Interpersonal therapy and other traditional psychotherapy are effective for BN patients, however, as many as 50% of BN patients still have ED symptoms. Therefore, it is necessary to develop a more effective new treatment method. Dialectical behavior therapy as a new and effective psychological therapy in the treatment of BN, proven to reduce binge eating, purging behaviors and non-suicidal act of self harm in adolescents and adults in foreign countries, now shows its superiority in the treatment of BN. At present, because of an acute shortage of psychotherapists in China, carrying out the DBT group is significant. However, currently there are no related research reports in china.

This study is to examine whether the efficacy of DBT for BN is comparable with drug treatment, whether short-term and long-term efficacy of DBT combined with drug treatment of BN is better than single DBT or single drug treatment, and trying to explore predictable biological indicators of short-term and long-term efficacy of DBT for BN. This study will use multi-center randomized controlled study design. 165 outpatients with BN will be recruited from Shanghai Mental Health Center, No.6 Hospital of Peking University and Shanghai Tongji Hospital. This study will use multi-center randomized controlled study design. 165 outpatients with BN will be recruited from Shanghai Mental Health Center, No.6 Hospital of Peking University and Shanghai Tongji Hospital. There will be three groups: DBT treatment group, Fluoxetine treatment group, DBT combined with fluoxetine treatment group. The investigator prepare to recruit 165 patients with BN ,and each group is 55, and then three groups will be given standard intervention for 12 weeks. To assess the eating disorder symptoms, impulsive and emotional change, clinical symptom scales, psychological scales and the security indexs will be used at baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 16weeks(1 month after treatment),24 weeks (3 months after treatment) and 36 weeks (6 months after treatment follow-up). Furthermore, brain MRI will be used for DBT treatment group at baseline, and 36 weeks.

This study was designed with sufficient consideration about innovation as well as feasibility, and is to be operated on well proved theoretical basis and guidance of an operation manual. If successful, results of this study may bring great improvement to clinical practice of this refractory mental disorder.

Study Timeline

• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-03-06
• Study Start: 2018-06-13
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-02
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

Inclusion Criteria

• Female;
• Han nationality;
• Aged 18-40 years;
• right handedness;
• above primary education;
• met DSM-IV criteria for BN;

Exclusion Criteria

• diagnosed with a mental illness;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DBT group	Dialectical Behavioral Group Therapy	DBT group has 55 patients, maybe will be divided them into 6 groups. Every group has 8-10 patients. Every group receive 12 times DBT group therapy and 1 times a week for 120 minutes each time.
DBT and drug therapy group	Dialectical Behavioral Group Therapy	DBT and drug therapy group has 55 patients, maybe the investigator can divide them into 7 groups. Every group has 8-10 patients. Every group receive 12 times DBT group therapy and 1 times a week for 120 minutes each time. At the same time, the investigator use fluoxetine as treatment drug.

Primary Outcome Measures

Name	Time	Method
Eating Disorder Examination(EDE-Q)	Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,36weeks,60weeks.	EDE-Q can evaluate the eating disorder behavior and psychology characteristics and assess their frequency and intensity, which can assess the severity of eating disorders.

Secondary Outcome Measures

Name	Time	Method
Eating Disorder Inventory(EDI-II)	Change from Baseline eating attitudes, behaviors and pathologic psychological characteristics at 4 weeks,8weeks,12weeks,36weeks,60weeks.	EDI-II can assess the eating attitudes and behaviors. It can evaluate the pathologic psychological characteristics of BN patients.
Barratt Impulsiveness Scale(BIS-II)	Change from Baseline the severity of impulse suppression orientation at 4 weeks,8weeks,12weeks,36weeks,60weeks.	This tool can measure the severity of impulse suppression orientation.
Hamilton Depression Scale(HAMD)	Change from Baseline the severity of the symptoms of depression at 4 weeks,8weeks,12weeks,36weeks,60weeks.	Measurement of the severity of the symptoms of depression.
Hamilton Anxiety Scale(HAMA)	Change from Baseline the severity of the symptoms of anxiety at 4 weeks,8weeks,12weeks,36weeks,60weeks.	Measurement of the severity of the symptoms of anxiety.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China