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Online Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN)

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ClinicalTrials.gov Identifier: NCT00877786
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Cynthia Bulik, PhD, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE April 6, 2009
First Posted Date  ICMJE April 8, 2009
Last Update Posted Date March 29, 2018
Study Start Date  ICMJE April 2008
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
Abstinence from binge/purge episodes [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2009)
  • Abstinence from binge/purge episodes [ Time Frame: 12 months ]
  • Reduction of binge/purge episodes [ Time Frame: 12 months ]
  • Maintenance of behavior change [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
  • Reduction of binge/purge episodes [ Time Frame: 12 months ]
  • Maintenance of behavior change [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Online Cognitive Behavioral Therapy for Bulimia Nervosa
Official Title  ICMJE Optimizing Technology in the Treatment of Bulimia Nervosa
Brief Summary Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN) is a research program funded by the National Institute of Mental Health and conducted by the UNC Eating Disorders Program and the University of Pittsburgh Medical Center. Cognitive Behavioral Therapy (CBT) is an evidence-based treatment and the gold-standard for treating bulimia nervosa. The current study aims to compare two forms of CBT: face-to-face group therapy and online group therapy via cbt4bn.org.
Detailed Description

All treatment is conducted by trained professionals from either the UNC Eating Disorders Program (in Chapel Hill) or Western Psychiatric Institute (in Pittsburgh) who are experienced in the treatment of eating disorders.

Participants will participate in 16 1.5 hour long group sessions of group CBT over 20 weeks. Groups will include 5-8 participants, one or two co-therapists, and two sessions by a registered dietitian. Participants will be expected to complete self-monitoring forms which assess their mood and behavior. Groups will either take place face-to-face or online in a therapist-moderated chat group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bulimia Nervosa
Intervention  ICMJE Behavioral: Cognitive Behavioral Group Therapy
Cognitive behavioral therapy (CBT) is a form of psychotherapy that addresses the links between thoughts, emotions and behaviors.
Other Name: CBT, Cognitive Behavioral Therapy
Study Arms  ICMJE
  • Active Comparator: Face-to-face group therapy
    Intervention: Behavioral: Cognitive Behavioral Group Therapy
  • Active Comparator: Online chat group therapy
    Intervention: Behavioral: Cognitive Behavioral Group Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2016)
196
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2009)
180
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • DSM-IV criteria for BN
  • Internet access at home
  • Either off psychotropic medication for at least one month or on a stable dose of psychotropic medication

Exclusion Criteria:

  • Any major medical condition that would interfere with treatment or require alternative treatment
  • Alcohol or drug dependence in the last three months
  • Current significant suicidal ideation
  • Developmental disability that would impair the ability to use the internet program effectively
  • Psychosis, including schizophrenia, or bipolar I disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00877786
Other Study ID Numbers  ICMJE 07-2002
R01MH080065-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cynthia Bulik, PhD, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Cynthia Bulik, PhD University of North Carolina, Chapel Hill
Principal Investigator: Marsha Marcus, PhD University of Pittsburgh
PRS Account University of North Carolina, Chapel Hill
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP