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

Eating Disorders Clinical Trial

Official title:

Adaptation of a CBT Intervention for Eating Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272545
• Other study ID #: R34MH071691
• Secondary ID: R34MH071691DATR
• Status: Completed
• Phase: N/A
• First received: January 4, 2006
• Last updated: September 4, 2013
• Start date: January 2006
• Est. completion date: February 2009

Study information

• Verified date: September 2013
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eating Disorders

Intervention

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.
• Treatment As Usual (TAU)
Treatment as usual will include standard care for a person with an eating disorder.

Locations

Country	Name	City	State
United States	The Renfrew Center of Radnor	Radnor	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		Measured at baseline, discharge, and 6 month follow-up	No
Primary	Structured Clinical Interview		Measured at baseline	No
Primary	Self-report		Measured at baseline, discharge, and 6 month follow-up	No
Primary	Eating Disorders Examination		Measured at baseline, discharge, and 6 month follow-up	No