Effectiveness of Binge Eating Disorder Treatments

NCT ID: NCT00060762

Last Updated: 2014-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2007-03-31

Brief Summary

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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

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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.

Conditions

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Eating Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Interpersonal Therapy

Interpersonal Therapy is a psychotherapy aimed at resolving interpersonal difficulties

Group Type EXPERIMENTAL

Interpersonal Therapy

Intervention Type BEHAVIORAL

20 sessions of interpersonal therapy were provided over a 6-month period

Behavioral Weight Loss Treatment

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

Group Type ACTIVE_COMPARATOR

Behavioral Weight Loss Treatment

Intervention Type BEHAVIORAL

20 sessions of behavioral weight loss treatment were provided over a 6-month period

Guided Self Help

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

Group Type ACTIVE_COMPARATOR

Guided Self Help

Intervention Type BEHAVIORAL

10 sessions of guided self help were provided over a 6-month period

Interventions

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Interpersonal Therapy

20 sessions of interpersonal therapy were provided over a 6-month period

Intervention Type BEHAVIORAL

Behavioral Weight Loss Treatment

20 sessions of behavioral weight loss treatment were provided over a 6-month period

Intervention Type BEHAVIORAL

Guided Self Help

10 sessions of guided self help were provided over a 6-month period

Intervention Type BEHAVIORAL

Other Intervention Names

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IPT BWL; Weight loss treatment GSH

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William S Agras, MD

Role: STUDY_DIRECTOR

Stanford University

Locations

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W. Stewart Agras

Stanford, California, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Rutgers University Eating Disorder Clinic

Piscataway, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20048227 (View on PubMed)

Other Identifiers

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R01MH063863

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 83-ATAS

Identifier Type: -

Identifier Source: secondary_id

R01MH063863

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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