Treatment of Bulimia Nervosa in a Primary Care Setting

NCT ID: NCT00009178

Last Updated: 2010-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-03-31
• Study Completion Date: 2001-12-31

Brief Summary

Bulimia Nervosa is a frequent problem for young women. It is widely assumed that this disorder cannot be treated effectively in a primary care setting. This assumption has never been tested empirically, and is probably incorrect.

In the last 15 years, effective treatment interventions for Bulimia Nervosa have been developed and validated in specialized treatment centers. The broad aim of this proposal is to examine whether these treatments, suitably adapted, can be usefully transferred to general health care settings. Specifically, the proposed study will determine the relative and combined effectiveness of the two leading treatments for Bulimia Nervosa in a primary care setting. The two major interventions are treatment with an antidepressant medication, fluoxetine, and with a form of cognitive behavioral therapy, guided self-help, designed for use in primary care.

Conditions

Bulimia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Fluoxetine

Intervention Type: DRUG

Guided Self-Help

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• DSM-IV criteria for bulimia nervosa with a modified frequency criterion of at least once a week

Exclusion Criteria

• Physical disorder requiring hospitalization or ongoing treatment likely to affect eating and/or weight
• Significant suicidal ideation or behavior
• Subjects judged unable to tolerate four-month treatments available in the study because of comorbid psychiatric conditions
• Current drug or alcohol dependence
• Current anorexia nervosa
• Pregnancy or any physical condition or treatments known to influence eating and weight
• Current psychiatric treatment or medication known to affect eating or weight
• Previous course of fluoxetine at a dose of 60 mg. per day for at least four weeks
• Allergy to fluoxetine
• Previous course of cognitive behavioral therapy for Bulimia Nervosa at a qualified center

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Principal Investigators

B. T. Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

Waller D, Fairburn CG, McPherson A, Kay R, Lee A, Nowell T. Treating bulimia nervosa in primary care: a pilot study. Int J Eat Disord. 1996 Jan;19(1):99-103. doi: 10.1002/(SICI)1098-108X(199601)19:13.0.CO;2-L.

Reference Type: BACKGROUND

PMID: 8640208 (View on PubMed)

Other Identifiers

R01DK053635-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Walsh (completed)

Identifier Type: -

Identifier Source: org_study_id