Effectiveness of a Normalization of Eating Intervention Program for Treating Women With Eating Disorders
Adaptation of a CBT Intervention for Eating Disorders
2 other identifiers
interventional
280
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 4, 2006
CompletedFirst Posted
Study publicly available on registry
January 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedSeptember 6, 2013
September 1, 2013
3.1 years
January 4, 2006
September 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Body weight
Measured at baseline, discharge, and 6 month follow-up
Structured Clinical Interview
Measured at baseline
Self-report
Measured at baseline, discharge, and 6 month follow-up
Eating Disorders Examination
Measured at baseline, discharge, and 6 month follow-up
Study Arms (2)
1
EXPERIMENTALParticipants will receive the normalization of eating program
2
ACTIVE COMPARATORParticipants will receive treatment as usual
Interventions
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 will include standard care for a person with an eating disorder.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Drexel Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
The Renfrew Center of Radnor
Radnor, Pennsylvania, 19087, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R. Lowe, PhD
Drexel University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2006
First Posted
January 6, 2006
Study Start
January 1, 2006
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
September 6, 2013
Record last verified: 2013-09