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


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Eating Disorders

Anorexia; Binge Eating; Bulimia; Eating Disorder 




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

This study is not yet open for patient recruitment.
Verified by National Institute of Mental Health (NIMH) December 2005

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 (NOE) program, based on principles of cognitive-behavioral therapy, in treating women with anorexia nervosa or bulimia nervosa.
Condition Intervention
Eating Disorders
 Behavior: Normalization of Eating

MedlinePlus related topics:  Eating Disorders

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 Outcomes: Body weight; Structured Clinical Interview; Self-report; Eating Disorders Examination (measured at Week 6 and 6 months post-treatment)
Expected Total Enrollment:  280

Study start: January 2006

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 cognitive-behavioral therapy, 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.

Eligibility

Ages Eligible for Study:  15 Years   -   40 Years,  Genders Eligible for Study:  Female
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

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00272545

Michael R. Lowe, PhD      215-762-4948    lowe@drexel.edu

Pennsylvania
      The Renfrew Center of Bryn Mawr, Bryn Mawr,  Pennsylvania,  19010,  United States
Susan M. Ice, MD  215-254-1636    s.ice@renfrewcenter.com 
Michael R. Lowe, PhD,  Principal Investigator

      The Renfrew Center of Philadelphia - Ridge Avenue - Outpatient, Philadelphia,  Pennsylvania,  19128,  United States
Susan M. Ice, MD  215-254-1636    s.ice@renfrewcenter.com 
Michael R. Lowe, PhD,  Principal Investigator

Study chairs or principal investigators

Michael R. Lowe, PhD,  Principal Investigator,  Drexel University   

More Information

Study ID Numbers:  R34 MH71691; DATR A2-AIR
Last Updated:  January 5, 2006
Record first received:  January 4, 2006
ClinicalTrials.gov Identifier:  NCT00272545
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10

Resources



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