- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877786
Online Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN)
Optimizing Technology in the Treatment of Bulimia Nervosa
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27510
- University of North Carolina at Chapel Hill
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Face-to-face group therapy
|
Cognitive behavioral therapy (CBT) is a form of psychotherapy that addresses the links between thoughts, emotions and behaviors.
Other Names:
|
ACTIVE_COMPARATOR: Online chat group therapy
|
Cognitive behavioral therapy (CBT) is a form of psychotherapy that addresses the links between thoughts, emotions and behaviors.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Abstinence from binge/purge episodes
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of binge/purge episodes
Time Frame: 12 months
|
12 months
|
Maintenance of behavior change
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marsha Marcus, PhD, University of Pittsburgh
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-2002
- R01MH080065-01A1 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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