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

This study has been completed.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Kaiser Permanente

ClinicalTrials.gov Identifier:

NCT00158340

First received: September 7, 2005

Last updated: November 4, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

November 4, 2011

Start Date ^ICMJE

August 2004

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of binge eating [ Time Frame: Measured at post-treatment, Week 12, Month 6, and Year 1 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Frequency of binge eating at baseline, Week 12, Month 6, and Month 12

Change History

Complete list of historical versions of study NCT00158340 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
Body weight [ Time Frame: Measured at post-treatmentand Year 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Frequency of inappropriate compensatory behaviors, dietary restraint, overevaluation of weight/shape, functional impairment, self-esteem, and social impairment assessed at baseline, 12 weeks, 6 months, and 12 months
body weight assessed at baseline and 12 months

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Guided Self-Help Treatment for Binge Eating Disorder

Official Title ^ICMJE

Binge Eating Self-Guided Treatment (BEST)

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Eating Disorders
Bulimia

Intervention ^ICMJE

Behavioral: Guided self-help cognitive behavioral therapy (CBT)
Participants receive eight sessions of guided self-help CBT.
Behavioral: Usual clinical care
Control group participants receive treatment as usual.

Study Arm (s)

Experimental: 1
Participants will receive guided self-help cognitive behavioral therapy

Intervention: Behavioral: Guided self-help cognitive behavioral therapy (CBT)
Active Comparator: 2
Participants will receive treatment as usual

Intervention: Behavioral: Usual clinical care

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

284

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00158340

Other Study ID Numbers ^ICMJE

R01 MH66966, R01MH066966, DSIR 83-ATAS

Has Data Monitoring Committee

Yes

Responsible Party

Kaiser Permanente

Study Sponsor ^ICMJE

Kaiser Permanente

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)

Investigators ^ICMJE

Principal Investigator:

Ruth H. Striegel-Moore, PhD

Wesleyan University

Information Provided By

Kaiser Permanente

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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