Comparing Two Group Therapy Treatments for Binge Eating Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Debra L. Safer, Stanford University
ClinicalTrials.gov Identifier:
NCT00071578
First received: October 29, 2003
Last updated: June 26, 2013
Last verified: June 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Dialectical Behavior Therapy and Supportive Therapy for Binge Eating Disorder

Resource links provided by NLM:


Further study details as provided by Stanford University:

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
Experimental: 1
Group therapy Negative Emotion Focus
Behavioral: Group Psychotherapy-Negative Emotion Focus
20 weekly sessions, 2 hours, group format
Placebo Comparator: 2
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
Stanford University
Investigators
Principal Investigator: Debra L Safer, MD Stanford University Dept of Psychiatry
  More Information

No publications provided

Responsible Party: Debra L. Safer, Asst professor, Stanford University
ClinicalTrials.gov Identifier: NCT00071578     History of Changes
Other Study ID Numbers: K23 MH66330, K23MH066330, DSIR 8K-RTAT
Study First Received: October 29, 2003
Last Updated: June 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Psychotherapy
Treatment

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014