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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00877786
Other study ID # 07-2002
Secondary ID R01MH080065-01A1
Status Completed
Phase N/A
First received April 6, 2009
Last updated March 26, 2018
Start date April 2008
Est. completion date May 2016

Study information

Verified date March 2018
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive Behavioral Group Therapy
Cognitive behavioral therapy (CBT) is a form of psychotherapy that addresses the links between thoughts, emotions and behaviors.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abstinence from binge/purge episodes 12 months
Secondary Reduction of binge/purge episodes 12 months
Secondary Maintenance of behavior change 12 months
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