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

Feeding and Eating Disorders Clinical Trial

Official title:

The Effect of Dialectical Behavioral Group Therapy on the Patients With Bulimia Nervosa : A Multicenter Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455088
• Other study ID #: CRC2017YB02
• Status: Completed
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2022
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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;

Related Conditions & MeSH terms

• Feeding and Eating Disorders

Intervention

Behavioral:
• Dialectical Behavioral Group Therapy
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.

Drug:
• Drug: fluoxetine
Antidepressant fluoxetine can reduce binge eating and purging behaviors in BN patients in a short time.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Peking University Sixth Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (2)

Fischer S, Peterson C. Dialectical behavior therapy for adolescent binge eating, purging, suicidal behavior, and non-suicidal self-injury: a pilot study. Psychotherapy (Chic). 2015 Mar;52(1):78-92. doi: 10.1037/a0036065. Epub 2014 Apr 28. — View Citation

Klein AS, Skinner JB, Hawley KM. Adapted group-based dialectical behaviour therapy for binge eating in a practicing clinic: clinical outcomes and attrition. Eur Eat Disord Rev. 2012 May;20(3):e148-53. doi: 10.1002/erv.2165. Epub 2012 Feb 24. — View Citation

Outcome

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