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Effectiveness of a Normalization of Eating Intervention Program for Treating Women With Eating Disorders
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), October 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00272545
  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)

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Adaptation of a CBT Intervention for Eating Disorders

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment: 280
Study Start Date: January 2006
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.
2: Active Comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272545

Contacts
Contact: Michael R. Lowe, PhD 215-762-1190 lowe@drexel.edu

Locations
United States, Pennsylvania
The Renfrew Center of Radnor Recruiting
Radnor, Pennsylvania, United States, 19087
Contact: Susan M. Ice, MD     215-254-1636     s.ice@renfrewcenter.com    
Principal Investigator: Michael R. Lowe, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Michael R. Lowe, PhD Drexel University
  More Information

Responsible Party: Drexel University ( Michael R. Lowe, PhD )
Study ID Numbers: R34 MH71691, DATR A2-AIR
Study First Received: January 4, 2006
Last Updated: October 21, 2008
ClinicalTrials.gov Identifier: NCT00272545  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Anorexia Nervosa
Bulimia Nervosa
Cognitive Behavioral Therapy

Study placed in the following topic categories:
Bulimia Nervosa
Mental Disorders
Bulimia
Anorexia
Anorexia Nervosa
Eating Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009