Effectiveness of a Normalization of Eating Intervention Program for Treating Women With Eating Disorders
Condition: Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Normalization of Eating (NOE); Treatment As Usual (TAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anorexia Nervosa; Bulimia Nervosa; Cognitive Behavioral Therapy