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Guided Self-Help Treatment for Binge Eating Disorder (BEST)

Primary Purpose

Eating Disorders, Bulimia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided self-help cognitive behavioral therapy (CBT)
Usual clinical care
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Binge Eating, Overeating, Compulsive Eating, Hyperphagia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wesleyan University Department of Psychology
  • Kaiser Permanente Center for Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive guided self-help cognitive behavioral therapy

Participants will receive treatment as usual

Outcomes

Primary Outcome Measures

Frequency of binge eating

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2005
Last Updated
November 4, 2011
Sponsor
Kaiser Permanente
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00158340
Brief Title
Guided Self-Help Treatment for Binge Eating Disorder
Acronym
BEST
Official Title
Binge Eating Self-Guided Treatment (BEST)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will determine the effectiveness of guided self-help treatment in treating individuals with binge eating disorder (BED).
Detailed Description
Binge eating disorder (BED) is a serious condition characterized by compulsive overeating and feelings of powerlessness. The condition often has a negative impact on both physical and emotional health. This study will examine ways to help people determine whether they have BED and will test whether guided self-help (GSH) treatment is effective in treating BED. Participants will be randomly assigned to receive either GSH treatment or usual clinical care (which may include general support and talk therapy) for 3 months. The GSH treatment is a cognitive behavioral therapy-based program that will be administered over 8 sessions. Participants receiving GSH will be given a book that focuses on dealing with BED; they will also meet with a therapist regularly to have their progress monitored. The Eating Disorders Examination (EDE), self-reports, questionnaires, and surveys will be used to assess participants. Assessments will be conducted at study entry, at Weeks 2 and 4 of the treatment, at the end of the treatment, and at 6 and 12 months post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Bulimia
Keywords
Binge Eating, Overeating, Compulsive Eating, Hyperphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive guided self-help cognitive behavioral therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Guided self-help cognitive behavioral therapy (CBT)
Intervention Description
Participants receive eight sessions of guided self-help CBT.
Intervention Type
Behavioral
Intervention Name(s)
Usual clinical care
Intervention Description
Control group participants receive treatment as usual.
Primary Outcome Measure Information:
Title
Frequency of binge eating
Time Frame
Measured at post-treatment, Week 12, Month 6, and Year 1
Secondary Outcome Measure Information:
Title
Frequency of inappropriate compensatory behaviors, dietary restraint, over-valuation of weight/shape, functional impairment, self-esteem, and social impairment
Time Frame
Measured at post-treatment, Week 12, Month 6, and Year 1
Title
Body weight
Time Frame
Measured at post-treatmentand Year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Diagnosis of anorexia nervosa or psychotic disorder Significant organic brain syndromes, retardation, pervasive developmental disorder, or autism At risk for suicide Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth H. Striegel-Moore, PhD
Organizational Affiliation
Wesleyan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wesleyan University Department of Psychology
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06459
Country
United States
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20515208
Citation
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.
Results Reference
derived

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Guided Self-Help Treatment for Binge Eating Disorder

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