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Effectiveness of Binge Eating Disorder Treatments

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ClinicalTrials.gov Identifier: NCT00060762
Recruitment Status : Completed
First Posted : May 13, 2003
Last Update Posted : May 15, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Eating Disorders Behavioral: Interpersonal Therapy Behavioral: Behavioral Weight Loss Treatment Behavioral: Guided Self Help Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Psychological Treatments for BED
Study Start Date : April 2002
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Binge eating [ Time Frame: Pre-treatment, 6, 12, and 24-months ]
    Rate of binge eating


Secondary Outcome Measures :
  1. Eating disorder psychopathology [ Time Frame: pre-treatment, 6, 12, 24 months ]
    Assessed by the Eating Disorder Examination



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Mental Health (NIMH)
Investigators
Study Director: William S Agras, MD Stanford University

Publications of Results:
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00060762     History of Changes
Other Study ID Numbers: R01MH063863 ( U.S. NIH Grant/Contract )
R01MH063863 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
First Posted: May 13, 2003    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014

Keywords provided by Stanford University:
Weight Loss

Additional relevant MeSH terms:
Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders