Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT00733525

Collaborator

National Institute of Mental Health (NIMH) (NIH)

293

Enrollment

Locations

Arms

Duration (Months)

73.3

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Sep 1, 2000

Actual Primary Completion Date :

Apr 1, 2005

Actual Study Completion Date :

Aug 1, 2005

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Eating disorders examination [Measured at baseline and Weeks 10, 18, 36, and 62]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94305
2	University of Minnesota Minneapolis, MN	Minneapolis	Minnesota	United States	55455
3	Cornell University; White Plains, NY	White Plains	New York	United States	10605
4	University of North Dakota / Neuropsychiatric Research Institute	Fargo	North Dakota	United States	58103