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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

May 12, 2003
May 14, 2014
April 2002
March 2007   (final data collection date for primary outcome measure)
Binge eating [ Time Frame: Pre-treatment, 6, 12, and 24-months ] [ Designated as safety issue: No ]
Rate of binge eating
Not Provided
Complete list of historical versions of study NCT00060762 on ClinicalTrials.gov Archive Site
Eating disorder psychopathology [ Time Frame: pre-treatment, 6, 12, 24 months ] [ Designated as safety issue: No ]
Assessed by the Eating Disorder Examination
Not Provided
Not Provided
Not Provided
 
Effectiveness of Binge Eating Disorder Treatments
Effectiveness of Psychological Treatments for BED

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Eating Disorders
  • Behavioral: Interpersonal Therapy
    20 sessions of interpersonal therapy were provided over a 6-month period
    Other Name: IPT
  • 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
  • Behavioral: Guided Self Help
    10 sessions of guided self help were provided over a 6-month period
    Other Name: GSH
  • Experimental: Interpersonal Therapy
    Interpersonal Therapy is a psychotherapy aimed at resolving interpersonal difficulties
    Intervention: Behavioral: Interpersonal Therapy
  • 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
    Intervention: Behavioral: Behavioral Weight Loss Treatment
  • Active Comparator: Guided Self Help
    Guided Self-Help is a brief psychotherapy based on cognitive-behavioral treatment
    Intervention: Behavioral: Guided Self Help
Wilson GT, Wilfley DE, Agras WS, Bryson SW. Psychological treatments of binge eating disorder. Arch Gen Psychiatry. 2010 Jan;67(1):94-101. doi: 10.1001/archgenpsychiatry.2009.170.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00060762
R01 MH63863, R01MH063863, DSIR 83-ATAS
Yes
Stanford University
Stanford University
National Institute of Mental Health (NIMH)
Study Director: William S Agras, MD Stanford University
Stanford University
May 2014

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