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Online Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN)

Primary Purpose

Bulimia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Group Therapy
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina at Chapel Hill
  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Face-to-face group therapy

Online chat group therapy

Arm Description

Outcomes

Primary Outcome Measures

Abstinence from binge/purge episodes

Secondary Outcome Measures

Reduction of binge/purge episodes
Maintenance of behavior change

Full Information

First Posted
April 6, 2009
Last Updated
March 26, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00877786
Brief Title
Online Cognitive Behavioral Therapy for Bulimia Nervosa
Acronym
CBT4BN
Official Title
Optimizing Technology in the Treatment of Bulimia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Face-to-face group therapy
Arm Type
Active Comparator
Arm Title
Online chat group therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Group Therapy
Other Intervention Name(s)
CBT, Cognitive Behavioral Therapy
Intervention Description
Cognitive behavioral therapy (CBT) is a form of psychotherapy that addresses the links between thoughts, emotions and behaviors.
Primary Outcome Measure Information:
Title
Abstinence from binge/purge episodes
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Reduction of binge/purge episodes
Time Frame
12 months
Title
Maintenance of behavior change
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Bulik, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marsha Marcus, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27510
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29228517
Citation
Watson HJ, McLagan N, Zerwas SC, Crosby RD, Levine MD, Runfola CD, Peat CM, Moessner M, Zimmer B, Hofmeier SM, Hamer RM, Marcus MD, Bulik CM, Crow SJ. Cost-Effectiveness of Internet-Based Cognitive-Behavioral Treatment for Bulimia Nervosa: Results of a Randomized Controlled Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):16m11314. doi: 10.4088/JCP.16m11314.
Results Reference
derived
PubMed Identifier
28277735
Citation
Levinson CA, Zerwas S, Calebs B, Forbush K, Kordy H, Watson H, Hofmeier S, Levine M, Crosby RD, Peat C, Runfola CD, Zimmer B, Moesner M, Marcus MD, Bulik CM. The core symptoms of bulimia nervosa, anxiety, and depression: A network analysis. J Abnorm Psychol. 2017 Apr;126(3):340-354. doi: 10.1037/abn0000254. Epub 2017 Mar 9.
Results Reference
derived

Learn more about this trial

Online Cognitive Behavioral Therapy for Bulimia Nervosa

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