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OpenTrials
Completed

NCT Number: NCT00272545

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.

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Key information

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Renfrew Center of Radnor

Radnor, Pennsylvania, 19087, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normalization of Eating (NOE)

Behavioral

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 (TAU)

Behavioral

Treatment as usual will include standard care for a person with an eating disorder.

Primary outcomes

  1. Body weight

    Time frame: Measured at baseline, discharge, and 6 month follow-up

  2. Structured Clinical Interview

    Time frame: Measured at baseline

  3. Self-report

    Time frame: Measured at baseline, discharge, and 6 month follow-up

  4. Eating Disorders Examination

    Time frame: Measured at baseline, discharge, and 6 month follow-up

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Adaptation of a CBT Intervention for Eating Disorders

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 6, 2006
Registry last updated
Sep 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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