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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00158340
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 6, 2011
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kaiser Permanente

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

Condition or disease Intervention/treatment Phase
Eating Disorders Bulimia Behavioral: Guided self-help cognitive behavioral therapy (CBT) Behavioral: Usual clinical care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Binge Eating Self-Guided Treatment (BEST)
Study Start Date : August 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of binge eating [ Time Frame: Measured at post-treatment, Week 12, Month 6, and Year 1 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Body weight [ Time Frame: Measured at post-treatmentand Year 1 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158340


Locations
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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
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Principal Investigator: Ruth H. Striegel-Moore, PhD Wesleyan University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00158340    
Other Study ID Numbers: R01MH066966 ( U.S. NIH Grant/Contract )
R01MH066966 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 6, 2011
Last Verified: November 2011
Keywords provided by Kaiser Permanente:
Binge Eating
Overeating
Compulsive Eating
Hyperphagia
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
 Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive