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

NCT03455088 | Completed

• 1 other identifier: CRC2017YB02
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Feeding and Eating Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Eating Disorder Inventory(EDI-II)

  Change from Baseline eating attitudes, behaviors and pathologic psychological characteristics at 4 weeks,8weeks,12weeks,36weeks,60weeks.

• Barratt Impulsiveness Scale(BIS-II)

  Change from Baseline the severity of impulse suppression orientation at 4 weeks,8weeks,12weeks,36weeks,60weeks.

• Hamilton Depression Scale(HAMD)

  Change from Baseline the severity of the symptoms of depression at 4 weeks,8weeks,12weeks,36weeks,60weeks.

• Hamilton Anxiety Scale(HAMA)

  Change from Baseline the severity of the symptoms of anxiety at 4 weeks,8weeks,12weeks,36weeks,60weeks.

Study Arms (3)

DBT group

EXPERIMENTAL

DBT group has 55 patients, maybe will be divided them into 6 groups. Every group has 8-10 patients. Every group receive 12 times DBT group therapy and 1 times a week for 120 minutes each time.

Behavioral: Dialectical Behavioral Group Therapy

Drug therapy group

ACTIVE COMPARATOR

Drug therapy group has 55 patients, and the investigator may use fluoxetine as treatment drug.

Drug: Drug: fluoxetine

DBT and drug therapy group

EXPERIMENTAL

DBT and drug therapy group has 55 patients, maybe the investigator can divide them into 7 groups. Every group has 8-10 patients. Every group receive 12 times DBT group therapy and 1 times a week for 120 minutes each time. At the same time, the investigator use fluoxetine as treatment drug.

Behavioral: Dialectical Behavioral Group Therapy; Drug: Drug: fluoxetine

Interventions

Dialectical Behavioral Group Therapy BEHAVIORAL

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.

DBT and drug therapy group; DBT group

Drug: fluoxetine DRUG

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

DBT and drug therapy group; Drug therapy group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female;
• Han nationality;
• Aged 18-40 years;
• right handedness;
• above primary education;
• met DSM-IV criteria for BN;

You may not qualify if:

• diagnosed with a mental illness;

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Peking University Sixth Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related 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.

  PMID: 24773094 BACKGROUND

• 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.

  PMID: 22367862 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Jue Chen, PHD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Psychosomatic Department in Shanghai Mental Health Center

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: March 6, 2018
• Study Start: June 13, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: when we ended the experiment at 2019, we will share the data.
• Access Criteria: DBT;Dialectical Behavioral Group Therapy; BN; Bulimia Nervosa

Locations

CN (1)