Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa

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. Identifier: NCT00733525
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : November 1, 2019
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
This study will compare the medical and cost effectiveness of a stepped approach, including self-help and drug therapies, to the current best available care for bulimia nervosa.

Condition or disease Intervention/treatment Phase
Eating Disorders Behavioral: Cognitive Behavioral Therapy Drug: Fluoxetine Behavioral: Guided Self-Help Not Applicable

Detailed Description:

The eating disorder bulimia nervosa (BN) is estimated to exist in 1 % to 2 % of women from the ages of 15 to 30, and bulimic behaviors occur in many more who do not develop the disorder. Characteristic symptoms include binge eating and self-induced vomiting. Research indicates that cognitive behavioral therapy (CBT), paired with use of the antidepressant fluoxetine, is the treatment of choice for BN. However, a survey of doctoral level psychologists dealing with eating disorders found that 78% of clinicians had no training in CBT for eating disorders, with 72% also untrained in the alternative, interpersonal therapy. Self-help manuals based on CBT have been developed as a treatment option for those without access to a clinician trained in CBT for eating disorders. Studies of these manuals suggest that self-guided therapy is as effective as CBT for some individuals. Additionally, although little research has examined cost effectiveness for treatment of eating disorders, a self-help approach may be more cost effective than CBT. This study will test whether self-help therapy, in the context of a stepped treatment plan involving check-ins with a clinician and possible drug treatment, can be an effective alternative, medically and economically, to traditional CBT.

Participants at four treatment sites will be screened for diagnosis, health, and presence of other conditions through assessments in standardized questionnaires, clinical interviews, and a blood test. Participants who pass the screening will be randomly assigned to one of two treatment sequences. In the first sequence, participants will be given twenty 50-minute sessions of individual CBT treatment over 18 weeks, focusing on altering eating behaviors. If participants do not have an adequate initial response to treatment by session six, they will be offered a trial of fluoxetine in addition to their continued CBT treatment. If they do not meet response criteria at the end of the 18 weeks of CBT treatment, they will again be given the option of taking or continuing to take fluoxetine until the termination of the study. The second sequence will begin with a specially designed self-help program aimed at teaching the same skills that will be taught in CBT sessions. Participants will have nine 30-minute checkup sessions with a therapist over 18 weeks. Participants who do not respond adequately to the treatment after 10 weeks will be given the option of taking fluoxetine. Participants without sufficient recovery at the end of 18 weeks will be given the option of undergoing the first treatment sequence.

Assessments of costs and health will be made at five points: the beginning of the study, and at the study visits on Week 10, Week 18, Week 36, and Week 62. Multiple assessments will be used to test health, including eating disorder symptoms, presence of other psychopathology and personality factors, social and interpersonal functioning, and quality of life. Eating disorder symptoms will be evaluated through clinical interview, questionnaires, and weight fluctuations. Treatment variables will also be assessed, with particular interest in the measure of patient knowledge of CBT techniques, to determine how much information from the self-help manual is used and absorbed. For the cost benefit analysis, assessments will include cost of health care visits, medications, treatments, and time lost due to illness. Data on cost will be collected at study visits, except for time lost, which will be measured through a questionnaire completed by a family member once at baseline and once after 18 weeks of treatment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 293 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stepped Care vs Best Available Care for Bulimia Nervosa
Study Start Date : September 2000
Actual Primary Completion Date : April 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Experimental: Stepped Care
Participants will receive guided self-help with nine clinician checkups, followed by fluoxetine if nonresponsive, followed by cognitive behavioral therapy if still nonresponsive.
Behavioral: Cognitive Behavioral Therapy
Therapy focusing on skills needed to alter eating patterns

Drug: Fluoxetine
20 mg/day of fluoxetine, which can be incrementally increased to 80 mg/day
Other Name: Prozac

Behavioral: Guided Self-Help
Manual designed to impart teachings of cognitive behavioral therapy

Active Comparator: Cognitive Behavioral Therapy
Participants will receive 20 sessions of cognitive behavioral therapy with the addition of fluoxetine at interim points.
Behavioral: Cognitive Behavioral Therapy
Therapy focusing on skills needed to alter eating patterns

Drug: Fluoxetine
20 mg/day of fluoxetine, which can be incrementally increased to 80 mg/day
Other Name: Prozac

Primary Outcome Measures :
  1. Eating disorders examination [ Time Frame: Measured at baseline and Weeks 10, 18, 36, and 62 ]

Secondary Outcome Measures :
  1. Records of health care, medications, and treatments [ Time Frame: Measured at baseline and Weeks 10, 18, 36, and 62 ]
  2. Height, weight, and body mass index [ Time Frame: Measured at baseline, Week 8, and Week 62 ]
  3. Battery of self-report questionnaires [ Time Frame: Measured at baseline and Weeks 10, 18, 36, and 62 ]
  4. Questionnaire on time lost to bulimia, completed by a family member [ Time Frame: Measured at baseline and after 18 weeks of treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of bulimia nervosa

Exclusion Criteria:

  • Weight less than 85% of ideal
  • Current substance abuse or dependence
  • Pregnant
  • Currently receiving psychotherapy

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 identifier (NCT number): NCT00733525

Layout table for location information
United States, California
Stanford University
Palo Alto, California, United States, 94305
United States, Minnesota
University of Minnesota Minneapolis, MN
Minneapolis, Minnesota, United States, 55455
United States, New York
Cornell University; White Plains, NY
White Plains, New York, United States, 10605
United States, North Dakota
University of North Dakota / Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
University of Minnesota
National Institute of Mental Health (NIMH)
Layout table for investigator information
Study Chair: Stewart Agras, MD Stanford University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Minnesota Identifier: NCT00733525    
Other Study ID Numbers: 9802M00108
R01MH059304 ( U.S. NIH Grant/Contract )
R01MH059303 ( U.S. NIH Grant/Contract )
R01MH059301 ( U.S. NIH Grant/Contract )
R01MH059100 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS ( Other Grant/Funding Number: Foundation )
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Keywords provided by University of Minnesota:
Bulimia Nervosa
Additional relevant MeSH terms:
Layout table for MeSH terms
Feeding and Eating Disorders
Bulimia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors