Effectiveness of Binge Eating Disorder Treatments

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00060762
First received: May 12, 2003
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

This study will evaluate the long-term effectiveness of interpersonal psychotherapy, behavioral weight loss interventions, and guided self help treatments in treating binge eating disorder (BED).


Condition Intervention Phase
Eating Disorders
Behavioral: Interpersonal Therapy
Behavioral: Behavioral Weight Loss Treatment
Behavioral: Guided Self Help
Phase 4

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: Effectiveness of Psychological Treatments for BED

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Binge eating [ Time Frame: Pre-treatment, 6, 12, and 24-months ] [ Designated as safety issue: No ]
    Rate of binge eating


Secondary Outcome Measures:
  • Eating disorder psychopathology [ Time Frame: pre-treatment, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Assessed by the Eating Disorder Examination


Enrollment: 205
Study Start Date: April 2002
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interpersonal Therapy
Interpersonal Therapy is a psychotherapy aimed at resolving interpersonal difficulties
Behavioral: Interpersonal Therapy
20 sessions of interpersonal therapy were provided over a 6-month period
Other Name: IPT
Active Comparator: Behavioral Weight Loss Treatment
Behavioral Weight Loss Treatment is aimed solely at weight loss, however it has been shown to decrease binge eating
Behavioral: Behavioral Weight Loss Treatment
20 sessions of behavioral weight loss treatment were provided over a 6-month period
Other Name: BWL; Weight loss treatment
Active Comparator: Guided Self Help
Guided Self-Help is a brief psychotherapy based on cognitive-behavioral treatment
Behavioral: Guided Self Help
10 sessions of guided self help were provided over a 6-month period
Other Name: GSH

Detailed Description:

BED is a serious condition that is associated with psychiatric comorbidity, psychosocial impairment, and obesity. Interpersonal psychotherapy (IPT), behavioral weight loss (BWL) interventions, and guided self help (GSH) treatments for BED have been evaluated, but the safest and most effective treatment has not yet been identified. This study will determine which of these three treatments is most effective in treating BED.

Participants are stratified by negative affect subtype and are randomly assigned for 6 months to one of three treatment groups: IPT, BWL, or GSH. IPT focuses on current interpersonal problems which are hypothesized to increase negative affect and lead to binge eating. BWL interventions involve the adoption of weight loss inducing behaviors. GSH is a shortened version of cognitive behavioral therapy that focuses directly on eating behavior. IPT and BWL patients have 20 treatment sessions; those receiving GSH have 10 sessions. Assessments are made pre-treatment, post-treatment, and at 6, 12, 18, and 24 months after treatment is complete.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV criteria for Binge Eating Disorder
  • Body Mass Index (BMI) between 27 and 45

Exclusion criteria:

  • Body Mass index > 45
  • Current psychosis
  • Current bipolar disorder
  • Alcohol or drug dependence within last 6-months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060762

Locations
United States, California
W. Stewart Agras
Stanford, California, United States, 94305
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63100
United States, New Jersey
Rutgers University Eating Disorder Clinic
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Stanford University
Investigators
Study Director: William S Agras, MD Stanford University
  More Information

Publications:
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00060762     History of Changes
Other Study ID Numbers: R01 MH63863, R01MH063863, DSIR 83-ATAS
Study First Received: May 12, 2003
Last Updated: May 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Weight Loss

Additional relevant MeSH terms:
Eating Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014