An interventional study of Normalization of Eating (NOE) and Treatment As Usual (TAU) in Eating Disorders, sponsored by Drexel University. Completed at 1 site in United States. Open to female participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2013-09-06.
Sponsored by Drexel University · Not applicable, Interventional, and Treatment
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.
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.
753 studies on the registry are indexed under Feeding and Eating Disorders; 160 are open to participants now.
This study's enrollment of 280 is above the median of 74 across 551 interventional studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →Drexel University is the lead sponsor of 113 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Participants will receive the normalization of eating program
Behavioral: Normalization of Eating (NOE)
Participants will receive treatment as usual
Behavioral: Treatment As Usual (TAU)
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.
Treatment as usual will include standard care for a person with an eating disorder.
Body weight
Time frame: Measured at baseline, discharge, and 6 month follow-up
Structured Clinical Interview
Time frame: Measured at baseline
Self-report
Time frame: Measured at baseline, discharge, and 6 month follow-up
Eating Disorders Examination
Time frame: Measured at baseline, discharge, and 6 month follow-up
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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