NCT00060762

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

4.9 years

First QC Date

May 12, 2003

Last Update Submit

May 14, 2014

Conditions

Keywords

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Binge eating

    Rate of binge eating

    Pre-treatment, 6, 12, and 24-months

Secondary Outcomes (1)

  • Eating disorder psychopathology

    pre-treatment, 6, 12, 24 months

Study Arms (3)

Interpersonal Therapy

EXPERIMENTAL

Interpersonal Therapy is a psychotherapy aimed at resolving interpersonal difficulties

Behavioral: Interpersonal Therapy

Behavioral Weight Loss Treatment

ACTIVE COMPARATOR

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

Behavioral: Behavioral Weight Loss Treatment

Guided Self Help

ACTIVE COMPARATOR

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

Behavioral: Guided Self Help

Interventions

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

Also known as: IPT
Interpersonal Therapy

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

Also known as: BWL; Weight loss treatment
Behavioral Weight Loss Treatment

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

Also known as: GSH
Guided Self Help

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Body Mass index \> 45
  • Current psychosis
  • Current bipolar disorder
  • Alcohol or drug dependence within last 6-months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

W. Stewart Agras

Stanford, California, 94305, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63100, United States

Location

Rutgers University Eating Disorder Clinic

Piscataway, New Jersey, 08854, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding and Eating DisordersWeight Loss

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBody Weight ChangesBody Weight

Study Officials

  • William S Agras, MD

    Stanford University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2003

First Posted

May 13, 2003

Study Start

April 1, 2002

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

May 15, 2014

Record last verified: 2014-05

Locations