The Effect of G-DBT on the Patients With BN : A Multicenter Randomized Controlled Study
Condition: Feeding and Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

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.
    

Intervention name(s): Dialectical Behavioral Group Therapy; Drug: fluoxetine
Intervention type(s): Behavioral; Drug
Intervention description(s): DBT is based on the model for the development of emotion regulation, designed for teaching how to regulate their adaptive emotions and behaviors cased by mood disorders , so it is valid for BN patient.; Antidepressant fluoxetine can reduce binge eating and purging behaviors in BN patients in a short time.
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment