Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00733525
First received: August 12, 2008
Last updated: August 21, 2008
Last verified: August 2008
  Purpose

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 Intervention
Eating Disorders
Behavioral: Cognitive Behavioral Therapy
Drug: Fluoxetine
Behavioral: Guided Self-Help

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stepped Care vs Best Available Care for Bulimia Nervosa

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Eating disorders examination [ Time Frame: Measured at baseline and Weeks 10, 18, 36, and 62 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Records of health care, medications, and treatments [ Time Frame: Measured at baseline and Weeks 10, 18, 36, and 62 ] [ Designated as safety issue: No ]
  • Height, weight, and body mass index [ Time Frame: Measured at baseline, Week 8, and Week 62 ]
  • Battery of self-report questionnaires [ Time Frame: Measured at baseline and Weeks 10, 18, 36, and 62 ] [ Designated as safety issue: No ]
  • Questionnaire on time lost to bulimia, completed by a family member [ Time Frame: Measured at baseline and after 18 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 293
Study Start Date: September 2000
Study Completion Date: August 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of bulimia nervosa

Exclusion Criteria:

  • Weight less than 85% of ideal
  • Current substance abuse or dependence
  • Pregnant
  • Currently receiving psychotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733525

Locations
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
Investigators
Study Chair: Stewart Agras, MD Stanford University
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott Crow, MD, University of Minnesota
ClinicalTrials.gov Identifier: NCT00733525     History of Changes
Other Study ID Numbers: R01 MH059304, R01 MH 59303, R01 MH 59301, R01 MH 59100, DSIR 83-ATAS
Study First Received: August 12, 2008
Last Updated: August 21, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Bulimia Nervosa

Additional relevant MeSH terms:
Bulimia
Eating Disorders
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014