Guided Self-Help Treatment for Binge Eating Disorder - Full Text View

Sponsor:	Kaiser Permanente
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00158340

Purpose

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

Condition	Intervention
Eating Disorders Bulimia	Behavioral: Guided self-help cognitive behavioral therapy (CBT) Behavioral: Usual clinical care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Binge Eating Self-Guided Treatment (BEST)

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	284
Study Start Date:	August 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Participants will receive guided self-help cognitive behavioral therapy	Behavioral: Guided self-help cognitive behavioral therapy (CBT) Participants receive eight sessions of guided self-help CBT.
Active Comparator: 2 Participants will receive treatment as usual	Behavioral: Usual clinical care Control group participants receive treatment as usual.

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158340

Locations

United States, Connecticut
Wesleyan University Department of Psychology
Middletown, Connecticut, United States, 06459
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227

Sponsors and Collaborators

Kaiser Permanente

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Ruth H. Striegel-Moore, PhD

Wesleyan University

More Information

No publications provided by Kaiser Permanente

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00158340 History of Changes
Other Study ID Numbers:	R01 MH66966, R01MH066966, DSIR 83-ATAS
Study First Received:	September 7, 2005
Last Updated:	November 4, 2011
Health Authority:	United States: Federal Government

Keywords provided by Kaiser Permanente:

Binge Eating
Overeating
Compulsive Eating
Hyperphagia

Additional relevant MeSH terms:

Bulimia
Bulimia Nervosa
Binge-Eating Disorder
Eating Disorders

Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012