The Effect of G-CBT on the Patients With AN
Primary Purpose
Feeding and Eating Disorders
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
G-CBT
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Feeding and Eating Disorders
Eligibility Criteria
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
Sites / Locations
- Shanghai Mental Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
G-CBT group
Conventional treatment group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Eating Disorder Examination Questionnaire(EDE-Q)
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.
Secondary Outcome Measures
Eating Disorder Inventory(EDI)
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
Beck Depression Inventory(BDI-II)
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.
Beck Anxiety Inventory(BAI)
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
Full Information
NCT ID
NCT03684239
First Posted
September 23, 2018
Last Updated
December 31, 2019
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT03684239
Brief Title
The Effect of G-CBT on the Patients With AN
Official Title
The Effect of G-CBT on the Patients With AN : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding and Eating Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
G-CBT group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
G-CBT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Conventional treatment including nutritional advice, encouragement, and routine treatment by a psychiatrist with work experience with eating disorders.
Primary Outcome Measure Information:
Title
Eating Disorder Examination Questionnaire(EDE-Q)
Description
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.
Time Frame
Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Secondary Outcome Measure Information:
Title
Eating Disorder Inventory(EDI)
Description
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
Time Frame
Change from Baseline eating attitudes and behaviors at 12weeks,24weeks,36weeks.
Title
Beck Depression Inventory(BDI-II)
Description
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.
Time Frame
Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Title
Beck Anxiety Inventory(BAI)
Description
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
Time Frame
Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jue Chen, PHD
Phone
8618017311203
Email
chenjue2088@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jue Chen, PHD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jue Chen, Ph.D
Phone
021-34773549
Email
chenjue2088@163.com
First Name & Middle Initial & Last Name & Degree
Yunling Zou
Phone
8613621796576
Email
flattop1989@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
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22271525
Citation
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Results Reference
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Results Reference
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The Effect of G-CBT on the Patients With AN
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