Clinical trial NCT00272545: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Keywords: Anorexia Nervosa
Bulimia Nervosa
Cognitive Behavioral Therapy
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-01-06
Enrollment: 280
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body weight
timeFrame: Measured at baseline, discharge, and 6 month follow-up
measure: Structured Clinical Interview
timeFrame: Measured at baseline
measure: Self-report
timeFrame: Measured at baseline, discharge, and 6 month follow-up
measure: Eating Disorders Examination
timeFrame: Measured at baseline, discharge, and 6 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Radnor
country: United States
facility: The Renfrew Center of Radnor
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Michael R. Lowe, PhD
role: PRINCIPAL_INVESTIGATOR
References: