Effectiveness of a Normalization of Eating Intervention Program for Treating Women With Eating Disorders

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Drexel University
ClinicalTrials.gov Identifier:
NCT00272545
First received: January 4, 2006
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Eating Disorders
Behavioral: Normalization of Eating (NOE)
Behavioral: Treatment As Usual (TAU)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptation of a CBT Intervention for Eating Disorders

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 280
Study Start Date: January 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive the normalization of eating program
Behavioral: Normalization of Eating (NOE)
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.
Active Comparator: 2
Participants will receive treatment as usual
Behavioral: Treatment As Usual (TAU)
Treatment as usual will include standard care for a person with an eating disorder.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272545

Locations
United States, Pennsylvania
The Renfrew Center of Radnor
Radnor, Pennsylvania, United States, 19087
Sponsors and Collaborators
Drexel University
Investigators
Principal Investigator: Michael R. Lowe, PhD Drexel University
  More Information

No publications provided

Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT00272545     History of Changes
Other Study ID Numbers: R34 MH071691, R34MH071691, DATR A2-AIR
Study First Received: January 4, 2006
Last Updated: September 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Drexel University:
Anorexia Nervosa
Bulimia Nervosa
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Disease
Eating Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014