Online Cognitive Behavioral Therapy for Bulimia Nervosa - Full Text View

Sponsored by:	The University of North Carolina, Chapel Hill
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00877786

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Optimizing Technology in the Treatment of Bulimia Nervosa

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

Primary Outcome Measures:

Abstinence from binge/purge episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Face-to-face group therapy: Active Comparator	Behavioral: Cognitive Behavioral Group Therapy Cognitive behavioral therapy (CBT) is a form of psychotherapy that addresses the links between thoughts, emotions and behaviors.
Online chat group therapy: Active Comparator	Behavioral: Cognitive Behavioral Group Therapy Cognitive behavioral therapy (CBT) is a form of psychotherapy that addresses the links between thoughts, emotions and behaviors.

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

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

Contacts

Contact: Stephanie C Zerwas, PhD

919-966-2882

zerwas@med.unc.edu

Locations

United States, North Carolina
University of North Carolina at Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27510
Contact: Stephanie Zerwas, PhD 919-966-2882 cbt4bn@unc.edu
Principal Investigator: Cynthia Bulik, PhD
United States, Pennsylvania
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Joanna Gould, MSW 412-578-9338 cbt4bn@pitt.edu
Principal Investigator: Marsha Marcus, PhD

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

Investigators

Principal Investigator:	Cynthia Bulik, PhD	The University of North Carolina, Chapel Hill
Principal Investigator:	Marsha Marcus, PhD	University of Pittsburgh

More Information

Additional Information:

CBT4BN: The Cognitive Behavioral Solution This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of North Carolina Chapel Hill ( Cynthia Bulik, PhD )
Study ID Numbers:	R01 MH080065-01A1
Study First Received:	April 6, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00877786 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Bulimia Nervosa
Signs and Symptoms, Digestive
Mental Disorders

Bulimia
Eating Disorders
Hyperphagia

Additional relevant MeSH terms:

Signs and Symptoms
Bulimia Nervosa
Signs and Symptoms, Digestive
Mental Disorders

Bulimia
Eating Disorders
Hyperphagia

ClinicalTrials.gov processed this record on May 07, 2009