Comparing Two Group Therapy Treatments for Binge Eating Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

October 29, 2003

Last Updated Date

February 8, 2008

Start Date ^ICMJE

October 2003

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

frequency of binge eating [ Time Frame: prior 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00071578 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Emotional Eating Scale [ Time Frame: prior 7 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Comparing Two Group Therapy Treatments for Binge Eating Disorder

Official Title ^ICMJE

Comparison of DBT and Supportive Therapy for BED

Brief Summary

This study will compare two different approaches for the treatment for Binge Eating Disorder.

Detailed Description

Binge Eating Disorder (BED) is associated with impairments in physical, psychological, and social functioning. Research has revealed relationships between disordered eating and both low self-esteem and negative emotional states.

Participants in this study will complete assessment interviews regarding their eating disorder and associated problems. Similar assessments will be conducted at the end of the study. Participants will then be randomly assigned to one of two therapy groups. Participants in one group will focus on the role of self-esteem, self-awareness, and personal effectiveness in binge eating. Participants in the other group will focus on the role of negative emotions and binge eating. Both treatments will involve a 30 to 40 minute pre-treatment individual orientation session, followed by 20 weeks of weekly group therapy. Sessions will take place over 22 weeks, or approximately 6 months (18 weekly sessions followed by 2 biweekly sessions). Follow-up assessments will take place at 3 months, 6 months, and 12 months after study completion to assess maintenance of treatment effects.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Eating Disorders

Intervention ^ICMJE

Behavioral: Group Psychotherapy-Negative Emotion Focus
Behavioral: Group Psychotherapy- Self-Esteem Focus

Study Arms / Comparison Groups

Experimental: Group therapy Negative Emotion Focus
Placebo Comparator: Group Psychotherapy- Self Esteem Focus

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

101

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of Binge Eating Disorder
Reside in the San Francisco Bay Area
Willing to commit to the study requirements

Exclusion Criteria:

Unstable medical problems
History of bipolar illness or schizophrenia
Receiving treatment for an eating disorder (or unwillingness to discontinue treatment upon study entry)
Membership in weight-loss groups such as Weight Watchers or Jenny Craig (or unwillingness to discontinue membership upon study entry)
Use of medications affecting weight or appetite. Antidepressants are acceptable, but doses of any psychiatric medication must have been stable for at least 3 months prior to study start
Breast-feeding
Require gastric-bypass surgery

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00071578

Responsible Party

Debra L. Safer MD, Stanford University Medical Center

Study ID Numbers ^ICMJE

K23 MH66330, DSIR 8K-RTAT

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Debra L Safer, MD

Stanford University Dept of Psychiatry

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP