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

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normalization of Eating (NOE)
Treatment As Usual (TAU)
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Anorexia Nervosa, Bulimia Nervosa, Cognitive Behavioral Therapy

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Renfrew Center of Radnor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive the normalization of eating program

Participants will receive treatment as usual

Outcomes

Primary Outcome Measures

Body weight
Structured Clinical Interview
Self-report
Eating Disorders Examination

Secondary Outcome Measures

Full Information

First Posted
January 4, 2006
Last Updated
September 4, 2013
Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00272545
Brief Title
Effectiveness of a Normalization of Eating Intervention Program for Treating Women With Eating Disorders
Official Title
Adaptation of a CBT Intervention for Eating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Anorexia Nervosa, Bulimia Nervosa, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive the normalization of eating program
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Normalization of Eating (NOE)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual (TAU)
Intervention Description
Treatment as usual will include standard care for a person with an eating disorder.
Primary Outcome Measure Information:
Title
Body weight
Time Frame
Measured at baseline, discharge, and 6 month follow-up
Title
Structured Clinical Interview
Time Frame
Measured at baseline
Title
Self-report
Time Frame
Measured at baseline, discharge, and 6 month follow-up
Title
Eating Disorders Examination
Time Frame
Measured at baseline, discharge, and 6 month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R. Lowe, PhD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Renfrew Center of Radnor
City
Radnor
State/Province
Pennsylvania
ZIP/Postal Code
19087
Country
United States

12. IPD Sharing Statement

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

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