Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa

Stepped Care vs Best Available Care for Bulimia Nervosa

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.

Study Overview

• Status: Completed
• Conditions: Eating Disorders
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Drug: Fluoxetine; Behavioral: Guided Self-Help

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.

• Study Type: Interventional
• Enrollment (Actual): 293
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Minneapolis, MN
  • New York
    • White Plains, New York, United States, 10605
      • Cornell University; White Plains, NY
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • University of North Dakota / Neuropsychiatric Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosis of bulimia nervosa

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Prozac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eating disorders examination	Measured at baseline and Weeks 10, 18, 36, and 62

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Stewart Agras, MD, Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (ACTUAL): April 1, 2005
• Study Completion (ACTUAL): August 1, 2005

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (ESTIMATE): August 13, 2008

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Bulimia Nervosa
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Bulimia Nervosa; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: 9802M00108; DSIR 83-ATAS (NIMH Program Class Code); R01MH059304 (NIH); R01MH059303 (NIH); R01MH059301 (NIH); R01MH059100 (NIH)