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

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

MedlinePlus related topics:

Eating Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Binge Eating Self-Guided Treatment (BEST)

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:	280
Study Start Date:	August 2004
Estimated Study Completion Date:	July 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Ruth H. Striegel-Moore, PhD	Wesleyan University

More Information

Responsible Party:	Wesleyan University ( Dr. Ruth H. Striegel-Moore )
Study ID Numbers:	R01 MH66966, DSIR 83-ATAS
First Received:	September 7, 2005
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00158340
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Binge Eating

Overeating

Compulsive Eating

Hyperphagia

Study placed in the following topic categories:

Signs and Symptoms

Bulimia Nervosa

Signs and Symptoms, Digestive

Mental Disorders

Bulimia

Eating Disorders

Hyperphagia

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00158340