Clinical trial NCT03684239: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Feeding and Eating Disorders
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Eating Disorder Examination Questionnaire(EDE-Q)
timeFrame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Secondary outcomes:
measure: Eating Disorder Inventory(EDI)
timeFrame: Change from Baseline eating attitudes and behaviors at 12weeks,24weeks,36weeks.
measure: Beck Depression Inventory（BDI-II）
timeFrame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
measure: Beck Anxiety Inventory（BAI）
timeFrame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Jue Chen, PHD
role: PRINCIPAL_INVESTIGATOR
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