Feeding and Eating Disorders
Conditions
Brief summary
Eating disorders with binge eating as the core feature include bulimia nervosa (BN) and binge eating disorder (BED). In recent years, the prevalence rate has increased rapidly, mostly among women, accompanied by emotional problems, physiological complications and increased risks of obesity and depression, which bring great pain to patients. Enhanced Cognitive Behavioral therapy (CBT-E) for eating disorders is an evidence-based and effective first-line psychotherapy for BN and BED. CBT-E is implemented in various forms. In addition to face-to-face therapy, online group CBT-E and guided self-help CBT-E can significantly reduce binge eating in BN and BED patients. However, there are no relevant clinical studies in China. Since 2008, the applicant has carried out CBT treatment and research on eating disorders, translated and published the self-help book "Overcoming Overeating", and accumulated rich clinical research experience. This study intends to establish a set of CBT-E self-help therapy courses suitable for Chinese binge eating patients, and conduct a randomized controlled study of web-based guided self-help CBT-E and online group CBT-E to compare the effectiveness of the treatment modalities in the treatment of binge eating and the feasibility of online guided self-help CBT-E and online group CBT-E in the treatment of binge eating.
Interventions
BEHAVIORALweb-based guided self-help Enhanced Cognitive Behavioral therapy
The subjects would learn and practice CBT-E course through the online learning platform for 12 times, and were required to complete the course once a week.
BEHAVIORALonline Enhanced Cognitive Behavioral therapy
A closed structured group would be established by online video conference for group CBT-E therapy. Each group would receive 12 group sessions, once a week for 120 minutes each time. Each group would be led by two CBT therapists, all of whom are nationally registered psychotherapists with systematic professional training.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Han nationality, aged 18-35 years old; * Students with junior high school education or above; * Meet the diagnostic criteria of BN or BED in DSM-5, body mass index (BMI)≥18.5 kg/m2; * no systematic nutritional treatment, psychiatric drug treatment or any form of psychological treatment was received within 1 month before enrollment; * Each patient must understand the nature of this study and sign informed consent.
Exclusion criteria
* Persons meeting other DSM-5 diagnoses other than BN and BED, such as substance abuse/dependence, depression, bipolar disorder, anxiety disorder, obsessive-compulsive disorder, etc., persons at high risk of suicide, persons with strong destructive impulses or antisocial behaviors; * The patient has severe primary or secondary physical disease or cognitive impairment, which makes the patient unable to complete the required symptom assessment and psychological tests; * Have received systematic nutritional therapy, individual and group psychotherapy; * Those who have taken neuroblockers, antidepressants, lithium salts, stimulants, antiepileptics and other psychotropic drugs within the past 1 month; * Participation in this clinical trial was deemed inappropriate by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eating Disorder Examination Questionnaire (EDE-Q) at Post-Treatment and During Follow-Up | Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment) | Questions 13 to 15 of the Eating Disorder Survey Scale (EDE-Q) were used to assess the proportion of patients with no binge eating behavior in the last 28 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barratt Impulsivity Scale-Version 11 (BIS-11) | Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment) | To evaluate the changes in impulse suppression ability of patients before and after treatment, the Barratt Impulsivity Scale-11 (BIS-11) comprises 30 questions. Each question is on a 4-point scale from 1 to 4. Scores range from 30 to 120, with higher scores indicating higher levels of impulsivity. |
| Beck Depression Inventory-Version 2 (BDI-2) | Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment) | To assess the changes of depressive mood before and after treatment, the Beck Depression Inventory-Version 2 (BDI-2) comprises 21 questions. Each question is on a 4-point scale from 0 to 3. Scores range from 0 to 63, with higher scores indicating higher levels of depression. |
| Beck Anxiety Inventory (BAI) | Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment) | To assess the changes of anxiety mood before and after treatment, the Beck Anxiety Inventory (BAI) comprises 21 questions. Each question is on a 4-point scale from 0 to 3. Scores range from 0 to 63, with higher scores indicating higher levels of anxiety. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJue Chen, PHD
Shanghai Mental Health Center
Outcome results
None listed