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

September 4, 2013 updated by: Drexel University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Radnor, Pennsylvania, United States, 19087
        • The Renfrew Center of Radnor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: Measured at baseline, discharge, and 6 month follow-up
Measured at baseline, discharge, and 6 month follow-up
Structured Clinical Interview
Time Frame: Measured at baseline
Measured at baseline
Self-report
Time Frame: Measured at baseline, discharge, and 6 month follow-up
Measured at baseline, discharge, and 6 month follow-up
Eating Disorders Examination
Time Frame: Measured at baseline, discharge, and 6 month follow-up
Measured at baseline, discharge, and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 4, 2006

First Submitted That Met QC Criteria

January 4, 2006

First Posted (Estimate)

January 6, 2006

Study Record Updates

Last Update Posted (Estimate)

September 6, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH071691 (U.S. NIH Grant/Contract)
  • DATR A2-AIR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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