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

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Mental Health Center
• Collaborators: Peking University Sixth Hospital; Shanghai Tongji Hospital, Tongji University School of Medicine
• Treatments: Fluoxetine

Criteria

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;