NCT00158340

Brief Summary

This study will determine the effectiveness of guided self-help treatment in treating individuals with binge eating disorder (BED).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

November 7, 2011

Status Verified

November 1, 2011

Enrollment Period

3.9 years

First QC Date

September 7, 2005

Last Update Submit

November 4, 2011

Conditions

Keywords

Binge EatingOvereatingCompulsive EatingHyperphagia

Outcome Measures

Primary Outcomes (1)

  • Frequency of binge eating

    Measured at post-treatment, Week 12, Month 6, and Year 1

Secondary Outcomes (2)

  • Frequency of inappropriate compensatory behaviors, dietary restraint, over-valuation of weight/shape, functional impairment, self-esteem, and social impairment

    Measured at post-treatment, Week 12, Month 6, and Year 1

  • Body weight

    Measured at post-treatmentand Year 1

Study Arms (2)

1

EXPERIMENTAL

Participants will receive guided self-help cognitive behavioral therapy

Behavioral: Guided self-help cognitive behavioral therapy (CBT)

2

ACTIVE COMPARATOR

Participants will receive treatment as usual

Behavioral: Usual clinical care

Interventions

Participants receive eight sessions of guided self-help CBT.

1

Control group participants receive treatment as usual.

2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of binge eating disorder (BED) bulimia nervosa (BN), or spectrum BN, defined as recurrent binge eating at least once a week for 3 months
  • Body mass index (BMI) between 18 and 45
  • Continuous membership in the Kaiser Permanente Northwest Division for at least 12 months prior to study entry

You may not qualify if:

  • Diagnosis of anorexia nervosa or psychotic disorder
  • Significant organic brain syndromes, retardation, pervasive developmental disorder, or autism
  • At risk for suicide
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wesleyan University Department of Psychology

Middletown, Connecticut, 06459, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (1)

  • Lynch FL, Striegel-Moore RH, Dickerson JF, Perrin N, Debar L, Wilson GT, Kraemer HC. Cost-effectiveness of guided self-help treatment for recurrent binge eating. J Consult Clin Psychol. 2010 Jun;78(3):322-33. doi: 10.1037/a0018982.

MeSH Terms

Conditions

Feeding and Eating DisordersBulimiaHyperphagiaFood Addiction

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Ruth H. Striegel-Moore, PhD

    Wesleyan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

August 1, 2004

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 7, 2011

Record last verified: 2011-11

Locations