Online Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cynthia Bulik, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00877786
First received: April 6, 2009
Last updated: June 10, 2014
Last verified: May 2013
  Purpose

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.


Condition Intervention
Bulimia Nervosa
Behavioral: Cognitive Behavioral Group Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Technology in the Treatment of Bulimia Nervosa

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Abstinence from binge/purge episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of binge/purge episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Maintenance of behavior change [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: April 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Face-to-face group therapy 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
Active Comparator: Online chat group therapy 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877786

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27510
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Cynthia Bulik, PhD University of North Carolina, Chapel Hill
Principal Investigator: Marsha Marcus, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Cynthia Bulik, PhD, Distinguished Professor of Eating Disorders, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00877786     History of Changes
Other Study ID Numbers: IRB # 07-2002, R01MH080065-01A1
Study First Received: April 6, 2009
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Bulimia
Bulimia Nervosa
Eating Disorders
Hyperphagia
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014