The Effect of G-CBT on the Patients With AN

December 31, 2019 updated by: Jue CHEN, Shanghai Mental Health Center

The Effect of G-CBT on the Patients With AN : A Randomized Controlled Trial

The study is to examine whether the G-CBT for anorexia nervosa is effective or not. The study will use randomized controlled study design. 80 patients with AN will be recruited from Shanghai Mental Health Center, There will be two groups: CBT treatment group and conventional treatment group. Each group is 40 and then the CBT group will be given standard CBT intervention for 12 weeks. The control group will receive outpatient treatment. 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), 24 weeks (3 months after treatment) and 36 weeks (6 months after treatment follow-up).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Eating disorder is a chronic mental disorder characteristic of abnormal eating behaviors and psychological disorders, accompanied by significant weight changes and physiological dysfunction. Many people with EDs have cognitive disorder of their body shape or body weight. Anorexia is a subtype of EDs. The main feature of anorexia nervosa is the extreme attention to body weight and body shape. As a result of this conflict the patients could be malnutrition, metabolism and endocrine disorders with significant weight loss. And women may have amenorrhea. At the mean time, the patient will also have a lot of mental symptoms such as depression, anxiety and obsession.

The disease mostly occurs in adolescents and young women. The prevalence rates in Europe and America is 0.5%-3.7%, 90% of which are women. The course of the disease is chronic, the average duration of disease is 4-6 years. Furthermore the mortality rate is high, a 20-year follow-up data shows that the mortality rate is nearly 20%. Most of the causes of death are physical complications and depression.

However, due to the special psychological behavior mechanism, patients have almost no willingness to be treated. As well as the long duration of disease and the highrisk of drug therapy, it all causes the great difficulties in the treatment. Many patients may even suffer from eating disorders for a lifetime. On another hand, the effective treatment options are still inconclusive. Psychotherapy, especially and cognitive behavior, is one of the most effective treatments at present.

On the other hand, psychotherapy is quite expensive, requiring not only a large number of qualified therapists, but also a long treatment time. Which leads to a high treatment cost. In order to reduce the cost of treatment, group therapy is a reasonable choice. However, currently there are no related research reports in china.

Our study is to examine whether the G-CBT for anorexia nervosa is effective or not. The study will use randomized controlled study design. 80 patients with AN will be recruited from Shanghai Mental Health Center, There will be two groups: CBT treatment group and conventional treatment group. Each group is 40 and then the CBT group will be given standard CBT intervention for 12 weeks. The control group will receive outpatient treatment. 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), 24 weeks (3 months after treatment) and 36 weeks (6 months after treatment follow-up).

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 14-30 years;
  • right handedness;
  • above primary education;
  • met DSM-V criteria for AN

Exclusion Criteria:

  • diagnosed with a mental illness;
  • with severe physical or cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G-CBT group
G-CBT group has 40 patients, maybe will be divided them into 4 groups. Every group has 8-10 patients. Every group receive 10 times CBT group therapy and 1 times a week for 120 minutes each time.
Behavioral: G-CBT
CBT is based on the model that there is a interaction between cognition, emotion and behavior. The way people think affects the way they feel and the behavior they do. And then the feelings in turn affect how they think,So it is valid for AN patient.
Other: Conventional treatment
Conventional treatment including nutritional advice, encouragement, and routine treatment by a psychiatrist with work experience with eating disorders.
Active Comparator: Conventional treatment group
Conventional treatment group has 40 patients, received routine outpatient treatment. Once every two weeks for 45 minutes each time, including nutritional advice, encouragement, and routine treatment by a psychiatrist with work experience with eating disorders.
Other: Conventional treatment
Conventional treatment including nutritional advice, encouragement, and routine treatment by a psychiatrist with work experience with eating disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Disorder Examination Questionnaire(EDE-Q)
Time Frame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Eating Disorder Examination Questionnaire can evaluate the eating disorder behavior and psychology characteristics and assess their frequency and intensity, which can assess the severity of eating disorders.It is a 41 item self-report questionnaire. It retains the format of the EDE including the 4 subscales (1. Restraint; 2. Eating concern; 3. Shape concern; 4. Weight concern) and global score. It also concerns behaviors over a 28-day time period and retains the scoring system of 0-6, with 0 indicating no days, 1=1-5 days, 2=6-12 days, 3=13-15 days, 4=16-22 days, 5=23-27 days and 6= every day.The scoring method is the sum of the scores for each item divided by the number of items.
Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Disorder Inventory(EDI)
Time Frame: Change from Baseline eating attitudes and behaviors at 12weeks,24weeks,36weeks.
EDI can assess the eating attitudes and behaviors. It can evaluate the pathologic psychological characteristics of AN patients.comprises 64 questions, divided into eight subscales. Each question is on a 6-point scale (ranging from 'always' to 'never'), rated 0-3. The score for each sub-scale is then summed. There are 8 subscale scores on the EDI
Change from Baseline eating attitudes and behaviors at 12weeks,24weeks,36weeks.
Beck Depression Inventory（BDI-II）
Time Frame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Measurement of the severity of the symptoms of depression. It is consisted of twenty-one questions about how the subject has been feeling in the last week. Each question had a set of at least four possible responses, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. Higher total scores indicate more severe depressive symptoms.
Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Beck Anxiety Inventory（BAI）
Time Frame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Measurement of the severity of the symptoms of anxiety.The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms
Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Investigators

  • Principal Investigator: Jue Chen, PHD, Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

September 23, 2018

First Submitted That Met QC Criteria

September 23, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16411965200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The study protocol and baseline characteristics of participants

IPD Sharing Time Frame

when the investigators ended the experiment at 2019, the investigators will share the data.

IPD Sharing Access Criteria

CBT;Cognitive Behavioral Group Therapy; AN; Anorexia Nervosa

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Feeding and Eating Disorders

Clinical Trials on G-CBT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe