Comparing Two Group Therapy Treatments for Binge Eating Disorder - Full Text View

Purpose

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

Condition	Intervention
Eating Disorders	Behavioral: Group Psychotherapy-Negative Emotion Focus Behavioral: Group Psychotherapy- Self-Esteem Focus

MedlinePlus related topics:

Eating Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:	Comparison of DBT and Supportive Therapy for BED

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	101
Study Start Date:	October 2003
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Group therapy Negative Emotion Focus	Behavioral: Group Psychotherapy-Negative Emotion Focus 20 weekly sessions, 2 hours, group format
2: Placebo Comparator Group Psychotherapy- Self Esteem Focus	Behavioral: Group Psychotherapy- Self-Esteem Focus 20 weekly sessions, 2 hours, group format

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071578

Locations


United States, California
	Stanford University Medical Center
	Stanford, California, United States, 94305-5722

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Debra L Safer, MD	Stanford University Dept of Psychiatry

More Information

Responsible Party:	Stanford University Medical Center ( Debra L. Safer MD )
Study ID Numbers:	K23 MH66330, DSIR 8K-RTAT
First Received:	October 29, 2003
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00071578
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Psychotherapy

Treatment

Study placed in the following topic categories:

Bulimia Nervosa

Mental Disorders

Bulimia

Eating Disorders

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00071578