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Effectiveness of a Normalization of Eating Intervention Program for Treating Women With Eating Disorders
This study has been completed.
Study NCT00272545   Information provided by National Institute of Mental Health (NIMH)
First Received: January 4, 2006   Last Updated: March 25, 2009   History of Changes

January 4, 2006
March 25, 2009
January 2006
February 2009   (final data collection date for primary outcome measure)
  • Body weight [ Time Frame: Measured at baseline, discharge, and 6 month follow-up ] [ Designated as safety issue: No ]
  • Structured Clinical Interview [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
  • Self-report [ Time Frame: Measured at baseline, discharge, and 6 month follow-up ] [ Designated as safety issue: No ]
  • Eating Disorders Examination [ Time Frame: Measured at baseline, discharge, and 6 month follow-up ] [ Designated as safety issue: No ]
  • Body weight
  • Structured Clinical Interview
  • Self-report
  • Eating Disorders Examination (measured at Week 6 and 6 months post-treatment)
Complete list of historical versions of study NCT00272545 on ClinicalTrials.gov Archive Site
 
 
 
Effectiveness of a Normalization of Eating Intervention Program for Treating Women With Eating Disorders
Adaptation of a CBT Intervention for 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.

 
Interventional
Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Eating Disorders
  • Behavioral: Normalization of Eating (NOE)
  • Behavioral: Treatment As Usual (TAU)
  • Experimental: Participants will receive the normalization of eating program
  • Active Comparator: Participants will receive treatment as usual
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
280
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of an eating disorder or eating disorder not otherwise specified (except for binge eating disorder), as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association
  • Agrees to remain in IOP treatment for at least 3 weeks
  • Seeking treatment in one of the Renfrew Center's outpatient programs located in the Philadelphia area

Exclusion Criteria:

  • Diagnosis of eating disorder not otherwise specified, including binge eating disorder
  • Diagnosis of a psychotic disorder
  • Transferred to inpatient treatment during the IOP stay because of worsening health
Female
15 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00272545
Michael R. Lowe, PhD, Drexel University
R34 MH071691, DATR A2-AIR
National Institute of Mental Health (NIMH)
 
Principal Investigator: Michael R. Lowe, PhD Drexel University
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP