Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa
Stepped Care vs Best Available Care for Bulimia Nervosa
6 other identifiers
interventional
293
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2000
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 12, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedNovember 1, 2019
October 1, 2019
4.6 years
August 12, 2008
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eating disorders examination
Measured at baseline and Weeks 10, 18, 36, and 62
Secondary Outcomes (4)
Records of health care, medications, and treatments
Measured at baseline and Weeks 10, 18, 36, and 62
Height, weight, and body mass index
Measured at baseline, Week 8, and Week 62
Battery of self-report questionnaires
Measured at baseline and Weeks 10, 18, 36, and 62
Questionnaire on time lost to bulimia, completed by a family member
Measured at baseline and after 18 weeks of treatment
Study Arms (2)
Stepped Care
EXPERIMENTALParticipants will receive guided self-help with nine clinician checkups, followed by fluoxetine if nonresponsive, followed by cognitive behavioral therapy if still nonresponsive.
Cognitive Behavioral Therapy
ACTIVE COMPARATORParticipants will receive 20 sessions of cognitive behavioral therapy with the addition of fluoxetine at interim points.
Interventions
Therapy focusing on skills needed to alter eating patterns
20 mg/day of fluoxetine, which can be incrementally increased to 80 mg/day
Manual designed to impart teachings of cognitive behavioral therapy
Eligibility Criteria
You may qualify if:
- Diagnosis of bulimia nervosa
You may not qualify if:
- Weight less than 85% of ideal
- Current substance abuse or dependence
- Pregnant
- Currently receiving psychotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Stanford University
Palo Alto, California, 94305, United States
University of Minnesota Minneapolis, MN
Minneapolis, Minnesota, 55455, United States
Cornell University; White Plains, NY
White Plains, New York, 10605, United States
University of North Dakota / Neuropsychiatric Research Institute
Fargo, North Dakota, 58103, United States
Related Publications (1)
Mitchell JE, Agras S, Crow S, Halmi K, Fairburn CG, Bryson S, Kraemer H. Stepped care and cognitive-behavioural therapy for bulimia nervosa: randomised trial. Br J Psychiatry. 2011 May;198(5):391-7. doi: 10.1192/bjp.bp.110.082172. Epub 2011 Mar 17.
PMID: 21415046DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stewart Agras, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2008
First Posted
August 13, 2008
Study Start
September 1, 2000
Primary Completion
April 1, 2005
Study Completion
August 1, 2005
Last Updated
November 1, 2019
Record last verified: 2019-10