Effectiveness of Binge Eating Disorder Treatments

Eating Disorders Clinical Trial

Official title:

Effectiveness of Psychological Treatments for BED

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00060762
• Other study ID #: R01MH063863
• Secondary ID: R01MH063863DSIR
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2003
• Last updated: May 14, 2014
• Start date: April 2002
• Est. completion date: March 2007

Study information

• Verified date: May 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the long-term effectiveness of interpersonal psychotherapy, behavioral weight loss interventions, and guided self help treatments in treating binge eating disorder (BED).

Description:

BED is a serious condition that is associated with psychiatric comorbidity, psychosocial impairment, and obesity. Interpersonal psychotherapy (IPT), behavioral weight loss (BWL) interventions, and guided self help (GSH) treatments for BED have been evaluated, but the safest and most effective treatment has not yet been identified. This study will determine which of these three treatments is most effective in treating BED.

Participants are stratified by negative affect subtype and are randomly assigned for 6 months to one of three treatment groups: IPT, BWL, or GSH. IPT focuses on current interpersonal problems which are hypothesized to increase negative affect and lead to binge eating. BWL interventions involve the adoption of weight loss inducing behaviors. GSH is a shortened version of cognitive behavioral therapy that focuses directly on eating behavior. IPT and BWL patients have 20 treatment sessions; those receiving GSH have 10 sessions. Assessments are made pre-treatment, post-treatment, and at 6, 12, 18, and 24 months after treatment is complete.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• DSM-IV criteria for Binge Eating Disorder

• Body Mass Index (BMI) between 27 and 45

Exclusion criteria:

• Body Mass index > 45

• Current psychosis

• Current bipolar disorder

• Alcohol or drug dependence within last 6-months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eating Disorders

Intervention

Behavioral:
• Interpersonal Therapy
20 sessions of interpersonal therapy were provided over a 6-month period
• Behavioral Weight Loss Treatment
20 sessions of behavioral weight loss treatment were provided over a 6-month period
• Guided Self Help
10 sessions of guided self help were provided over a 6-month period

Locations

Country	Name	City	State
United States	Rutgers University Eating Disorder Clinic	Piscataway	New Jersey
United States	Washington University School of Medicine	St. Louis	Missouri
United States	W. Stewart Agras	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wilson GT, Wilfley DE, Agras WS, Bryson SW. Psychological treatments of binge eating disorder. Arch Gen Psychiatry. 2010 Jan;67(1):94-101. doi: 10.1001/archgenpsychiatry.2009.170. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge eating	Rate of binge eating	Pre-treatment, 6, 12, and 24-months	No
Secondary	Eating disorder psychopathology	Assessed by the Eating Disorder Examination	pre-treatment, 6, 12, 24 months	No