Guided Self-Help Treatment for Binge Eating Disorder

Eating Disorders Clinical Trial

— BEST  

Official title:

Binge Eating Self-Guided Treatment (BEST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158340
• Other study ID #: R01MH066966
• Secondary ID: R01MH066966DSIR
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: November 4, 2011
• Start date: August 2004
• Est. completion date: July 2008

Study information

• Verified date: November 2011
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Wesleyan University Department of Psychology	Middletown	Connecticut
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of binge eating		Measured at post-treatment, Week 12, Month 6, and Year 1	No
Secondary	Frequency of inappropriate compensatory behaviors, dietary restraint, over-valuation of weight/shape, functional impairment, self-esteem, and social impairment		Measured at post-treatment, Week 12, Month 6, and Year 1	No
Secondary	Body weight		Measured at post-treatmentand Year 1	No