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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00272545 |
This study will evaluate the effectiveness of a new approach to a normalization of eating program, based on principles of cognitive-behavioral therapy, in treating women with anorexia nervosa or bulimia nervosa.
Condition | Intervention |
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Eating Disorders |
Behavioral: Normalization of Eating (NOE) Behavioral: Treatment As Usual (TAU) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Adaptation of a CBT Intervention for Eating Disorders |
Estimated Enrollment: | 280 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive the normalization of eating program
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Behavioral: Normalization of Eating (NOE)
The NOE is a 6-week program based on principles of CBT. Participants will receive individual therapy, as well as take part in group and family therapy sessions. In addition, participants will be supervised while eating meals.
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2: Active Comparator
Participants will receive treatment as usual
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Behavioral: Treatment As Usual (TAU)
Treatment as usual will include standard care for a person with an eating disorder.
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Eating disorders are real, treatable medical illnesses. They are often characterized by disturbances in eating behavior, such as drastic reduction of food intake or extreme overeating, as well as feelings of distress or extreme concern about body shape or weight. The two main types of eating disorders are anorexia nervosa and bulimia nervosa. A third type, binge-eating disorder, is pending approval as a formal psychiatric diagnosis. Eating disorders frequently develop during adolescence or early adulthood, and they occur more often in females than in males. Studies have shown cognitive behavioral therapy (CBT) to be the most effective approach to treating eating disorders. However, the applicability of these findings to clinical settings and intensive outpatient therapy programs (IOPs) remains unknown. This study will evaluate the effectiveness of a new approach to a normalization of eating (NOE) program, based on principles of CBT, in treating women with anorexia nervosa or bulimia nervosa.
Participants in this open-label study will be assigned to receive either treatment-as-usual (TAU) or NOE. Participants admitted to the study in the first 8 months of the trial will receive TAU. Those admitted after the first 8 months will take part in the NOE program. Participants may begin receiving treatment as soon as they enter the study and will continue receiving their assigned treatments for 6 weeks. All participants in the NOE group will be required to report to the study site three evenings a week. They will receive individual therapy, as well as take part in group and family therapy sessions. In addition, they will be supervised while eating a meal. Body weight, results of the Eating Disorders Examination and the Structured Clinical Interview for DSM-IV Axis I disorders, and self-report measures will be assessed post-treatment and at the Month 6 follow-up visit.
Note: Participants are recruited from the Renfrew Center's outpatient programs located in the Philadelphia area. Individuals outside of Renfrew cannot volunteer for this study. For more information about the Renfrew Center's inpatient or outpatient treatment programs, please call 1-800-RENFREW.
Ages Eligible for Study: | 15 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael R. Lowe, PhD | 215-762-1190 | lowe@drexel.edu |
United States, Pennsylvania | |
The Renfrew Center of Radnor | Recruiting |
Radnor, Pennsylvania, United States, 19087 | |
Contact: Susan M. Ice, MD 215-254-1636 s.ice@renfrewcenter.com | |
Principal Investigator: Michael R. Lowe, PhD |
Principal Investigator: | Michael R. Lowe, PhD | Drexel University |
Responsible Party: | Drexel University ( Michael R. Lowe, PhD ) |
Study ID Numbers: | R34 MH71691, DATR A2-AIR |
Study First Received: | January 4, 2006 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00272545 |
Health Authority: | United States: Federal Government |
Anorexia Nervosa Bulimia Nervosa Cognitive Behavioral Therapy |
Bulimia Nervosa Mental Disorders Bulimia |
Anorexia Anorexia Nervosa Eating Disorders |
Pathologic Processes Disease |