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:
Participant gender:
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
Details
Lead Sponsor:
Shanghai Mental Health Center
Collaborators:
Peking University Sixth Hospital Shanghai Tongji Hospital, Tongji University School of Medicine