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Web-based Guided Self-help CBT-E vs Online G-CBT-E for Binge Eating Behavior

Primary Purpose

Feeding and Eating Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
web-based guided self-help Enhanced Cognitive Behavioral therapy
online Enhanced Cognitive Behavioral therapy
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding and Eating Disorders

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

web-based guided self-help CBT-E

online group CBT-E

waiting group

Arm Description

After randomization, 8-10 patients were assigned to self-help CBT-E group each time.

After randomization, 8-10 patients were assigned to online CBT-E group each time.

After randomization, 8-10 patients were assigned to the waiting list each time, and they would be allocated to web-based guided self-help CBT-E or online group CBT-E randomly after a 12-week waiting period.

Outcomes

Primary Outcome Measures

Change in Eating Disorder Examination Questionnaire (EDE-Q) at Post-Treatment and During Follow-Up
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 Outcome Measures

Barratt Impulsivity Scale-Version 11 (BIS-11)
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)
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)
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.

Full Information

First Posted
April 23, 2023
Last Updated
May 15, 2023
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05873127
Brief Title
Web-based Guided Self-help CBT-E vs Online G-CBT-E for Binge Eating Behavior
Official Title
A Randomized Controlled Study of Web-based Guided Self-help CBT-E Versus Online Group CBT-E for Binge Eating Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
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.

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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
web-based guided self-help CBT-E
Arm Type
Experimental
Arm Description
After randomization, 8-10 patients were assigned to self-help CBT-E group each time.
Arm Title
online group CBT-E
Arm Type
Experimental
Arm Description
After randomization, 8-10 patients were assigned to online CBT-E group each time.
Arm Title
waiting group
Arm Type
No Intervention
Arm Description
After randomization, 8-10 patients were assigned to the waiting list each time, and they would be allocated to web-based guided self-help CBT-E or online group CBT-E randomly after a 12-week waiting period.
Intervention Type
Behavioral
Intervention Name(s)
web-based guided self-help Enhanced Cognitive Behavioral therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
online Enhanced Cognitive Behavioral therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Eating Disorder Examination Questionnaire (EDE-Q) at Post-Treatment and During Follow-Up
Description
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.
Time Frame
Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
Secondary Outcome Measure Information:
Title
Barratt Impulsivity Scale-Version 11 (BIS-11)
Description
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.
Time Frame
Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
Title
Beck Depression Inventory-Version 2 (BDI-2)
Description
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.
Time Frame
Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Baseline, Week 12 (at the end of treatment), Week 16 (1 month after treatment), week 24 (3 months after treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jue Chen
Phone
18017311203
Email
chenjue2088@163.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
Researchers will share data when the study is completed in December 2024.
IPD Sharing Access Criteria
CBT-E; bulimia nervosa; binge eating; online CBT-E
Citations:
PubMed Identifier
31046920
Citation
Agras WS. Cognitive Behavior Therapy for the Eating Disorders. Psychiatr Clin North Am. 2019 Jun;42(2):169-179. doi: 10.1016/j.psc.2019.01.001. Epub 2019 Apr 2.
Results Reference
background
PubMed Identifier
35610603
Citation
Hay P, Palavras MA, da Luz FQ, Dos Anjos Garnes S, Sainsbury A, Touyz S, Appolinario JC, Claudino AM. Physical and mental health outcomes of an integrated cognitive behavioural and weight management therapy for people with an eating disorder characterized by binge eating and a high body mass index: a randomized controlled trial. BMC Psychiatry. 2022 May 24;22(1):355. doi: 10.1186/s12888-022-04005-y.
Results Reference
background
PubMed Identifier
31840285
Citation
Atwood ME, Friedman A. A systematic review of enhanced cognitive behavioral therapy (CBT-E) for eating disorders. Int J Eat Disord. 2020 Mar;53(3):311-330. doi: 10.1002/eat.23206. Epub 2019 Dec 16.
Results Reference
background
PubMed Identifier
33350574
Citation
da Luz FQ, Hay P, Wisniewski L, Cordas T, Sainsbury A. The treatment of binge eating disorder with cognitive behavior therapy and other therapies: An overview and clinical considerations. Obes Rev. 2020 Dec 17. doi: 10.1111/obr.13180. Online ahead of print.
Results Reference
background

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Web-based Guided Self-help CBT-E vs Online G-CBT-E for Binge Eating Behavior

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