Effectiveness of a Normalization of Eating Intervention Program for Treating Women With Eating Disorders
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.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Normalization of Eating (NOE), Treatment As Usual (TAU)
The Renfrew Center of Radnor
National Institute of Mental Health (NIMH)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00272545
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A disorder associated with three or more of the following: eating until feeling uncomfortably full; eating large amounts of food when not physically hungry; eating much more rapidly than normal; eating alone due to embarrassment; feeling of disgust, DEPRESSION, or guilt after overeating. Criteria includes occurrence on average, at least 2 days a week for 6 months. The binge eating is not associated with the regular use of inappropriate compensatory behavior (i.e. purging, excessive exercise, etc.) and does not co-occur exclusively with BULIMIA NERVOSA or ANOREXIA NERVOSA. (From DSM-IV, 1994)
Feeding And Eating Disorders Of Childhood
Mental disorders related to feeding and eating that are usually diagnosed in infancy or early childhood.
Behavioral responses or sequences associated with eating including modes of feeding, rhythmic patterns of eating, and time intervals.
A genus of tapeworms of the family Diphyllobothriidae, which are parasites of fish-eating cats, dogs, and birds. Infection in man is caused by eating undercooked fish. The larval form is called SPARGANUM.
A group of disorders characterized by physiological and psychological disturbances in appetite or food intake.
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