NCT03455088

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

Completed NA Last updated 4 October 2022

What this trial tests

NA trial testing Dialectical Behavioral Group Therapy in Feeding and Eating Disorders in 101 participants. Completed in 30 December 2021.

Timeline

13 June 2018

Primary endpoint
30 December 2020

30 December 2021

Quick facts

Lead sponsor	Shanghai Mental Health Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	101
Start date	13 June 2018
Primary completion	30 December 2020
Estimated completion	30 December 2021
Sites	1 location across China

Drugs / interventions tested

• Dialectical Behavioral Group Therapy
• Drug: fluoxetine — full drug profile →

Conditions studied

• Feeding and Eating Disorders — all drugs for Feeding and Eating Disorders →

Sponsor

Shanghai Mental Health Center — full company profile →

Who can join

Adults 18 to 40, female only, with Feeding and Eating Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.