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Effectiveness of Binge Eating Disorder Treatments

Primary Purpose

Eating Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Therapy
Behavioral Weight Loss Treatment
Guided Self Help
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • W. Stewart Agras
  • Washington University School of Medicine
  • Rutgers University Eating Disorder Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Interpersonal Therapy

Behavioral Weight Loss Treatment

Guided Self Help

Arm Description

Interpersonal Therapy is a psychotherapy aimed at resolving interpersonal difficulties

Behavioral Weight Loss Treatment is aimed solely at weight loss, however it has been shown to decrease binge eating

Guided Self-Help is a brief psychotherapy based on cognitive-behavioral treatment

Outcomes

Primary Outcome Measures

Binge eating
Rate of binge eating

Secondary Outcome Measures

Eating disorder psychopathology
Assessed by the Eating Disorder Examination

Full Information

First Posted
May 12, 2003
Last Updated
May 14, 2014
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00060762
Brief Title
Effectiveness of Binge Eating Disorder Treatments
Official Title
Effectiveness of Psychological Treatments for BED
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal Therapy
Arm Type
Experimental
Arm Description
Interpersonal Therapy is a psychotherapy aimed at resolving interpersonal difficulties
Arm Title
Behavioral Weight Loss Treatment
Arm Type
Active Comparator
Arm Description
Behavioral Weight Loss Treatment is aimed solely at weight loss, however it has been shown to decrease binge eating
Arm Title
Guided Self Help
Arm Type
Active Comparator
Arm Description
Guided Self-Help is a brief psychotherapy based on cognitive-behavioral treatment
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Therapy
Other Intervention Name(s)
IPT
Intervention Description
20 sessions of interpersonal therapy were provided over a 6-month period
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Weight Loss Treatment
Other Intervention Name(s)
BWL; Weight loss treatment
Intervention Description
20 sessions of behavioral weight loss treatment were provided over a 6-month period
Intervention Type
Behavioral
Intervention Name(s)
Guided Self Help
Other Intervention Name(s)
GSH
Intervention Description
10 sessions of guided self help were provided over a 6-month period
Primary Outcome Measure Information:
Title
Binge eating
Description
Rate of binge eating
Time Frame
Pre-treatment, 6, 12, and 24-months
Secondary Outcome Measure Information:
Title
Eating disorder psychopathology
Description
Assessed by the Eating Disorder Examination
Time Frame
pre-treatment, 6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William S Agras, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
W. Stewart Agras
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63100
Country
United States
Facility Name
Rutgers University Eating Disorder Clinic
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20048227
Citation
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.
Results Reference
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Effectiveness of Binge Eating Disorder Treatments

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