The Effect of G-CBT on the Patients With AN

NCT03684239 | Unknown

• 1 other identifier: 16411965200
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Feeding and Eating Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.

Secondary Outcomes (3)

• Eating Disorder Inventory(EDI)

  Change from Baseline eating attitudes and behaviors at 12weeks,24weeks,36weeks.

• Beck Depression Inventory（BDI-II）

  Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.

• Beck Anxiety Inventory（BAI）

  Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.

Study Arms (2)

G-CBT group

EXPERIMENTAL

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; Other: Conventional treatment

Conventional treatment group

ACTIVE COMPARATOR

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

Interventions

G-CBT BEHAVIORAL

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.

G-CBT group

Conventional treatment OTHER

Conventional treatment including nutritional advice, encouragement, and routine treatment by a psychiatrist with work experience with eating disorders.

Conventional treatment group; G-CBT group

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (10)

• Wonderlich S, Mitchell JE, Crosby RD, Myers TC, Kadlec K, Lahaise K, Swan-Kremeier L, Dokken J, Lange M, Dinkel J, Jorgensen M, Schander L. Minimizing and treating chronicity in the eating disorders: a clinical overview. Int J Eat Disord. 2012 May;45(4):467-75. doi: 10.1002/eat.20978. Epub 2012 Jan 23.

  PMID: 22271525 BACKGROUND

• Groff SE. Is enhanced cognitive behavioral therapy an effective intervention in eating disorders? A review. J Evid Inf Soc Work. 2015;12(3):272-88. doi: 10.1080/15433714.2013.835756. Epub 2015 Jan 30.

  PMID: 25661898 BACKGROUND

• Brown TA, Keel PK. Current and emerging directions in the treatment of eating disorders. Subst Abuse. 2012;6:33-61. doi: 10.4137/SART.S7864. Epub 2012 Mar 29.

  PMID: 22879753 BACKGROUND

• Costa MB, Melnik T. Effectiveness of psychosocial interventions in eating disorders: an overview of Cochrane systematic reviews. Einstein (Sao Paulo). 2016 Apr-Jun;14(2):235-77. doi: 10.1590/S1679-45082016RW3120.

  PMID: 27462898 BACKGROUND

• de Zwaan M, Hilbert A, Swan-Kremeier L, Simonich H, Lancaster K, Howell LM, Monson T, Crosby RD, Mitchell JE. Comprehensive interview assessment of eating behavior 18-35 months after gastric bypass surgery for morbid obesity. Surg Obes Relat Dis. 2010 Jan-Feb;6(1):79-85. doi: 10.1016/j.soard.2009.08.011. Epub 2009 Sep 3.

  PMID: 19837012 BACKGROUND

• Fairburn CG, Cooper Z, Doll HA, O'Connor ME, Palmer RL, Dalle Grave R. Enhanced cognitive behaviour therapy for adults with anorexia nervosa: a UK-Italy study. Behav Res Ther. 2013 Jan;51(1):R2-8. doi: 10.1016/j.brat.2012.09.010. Epub 2012 Oct 22.

  PMID: 23084515 BACKGROUND

• Watson HJ, Allen K, Fursland A, Byrne SM, Nathan PR. Does enhanced cognitive behaviour therapy for eating disorders improve quality of life? Eur Eat Disord Rev. 2012 Sep;20(5):393-9. doi: 10.1002/erv.2186. Epub 2012 Jun 22.

  PMID: 22730260 BACKGROUND

• Dalle Grave R, El Ghoch M, Sartirana M, Calugi S. Cognitive Behavioral Therapy for Anorexia Nervosa: An Update. Curr Psychiatry Rep. 2016 Jan;18(1):2. doi: 10.1007/s11920-015-0643-4.

  PMID: 26689208 BACKGROUND

• Polnay A, James VA, Hodges L, Murray GD, Munro C, Lawrie SM. Group therapy for people with bulimia nervosa: systematic review and meta-analysis. Psychol Med. 2014 Aug;44(11):2241-54. doi: 10.1017/S0033291713002791. Epub 2013 Nov 15.

  PMID: 24238470 BACKGROUND

• Gu L, Zou Y, Huang Y, Liu Q, Chen H, Chen J. The effect of group cognitive behavior therapy on Chinese patients with anorexia nervosa: an open label trial. J Eat Disord. 2021 Sep 15;9(1):114. doi: 10.1186/s40337-021-00469-7.

  PMID: 34526151 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jue Chen, PHD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jue Chen, PHD

CONTACT

8618017311203; chenjue2088@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Psychosomatic Department in Shanghai Mental Health Center

Study Record Dates

• First Submitted: September 23, 2018
• First Posted: September 25, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: when the investigators ended the experiment at 2019, the investigators will share the data.
• Access Criteria: CBT;Cognitive Behavioral Group Therapy; AN; Anorexia Nervosa

Locations

CN (1)