Treatment for Binge-eating Disorder - Full Text View

Sponsor:	University of Chicago
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00965705

Purpose

The University of Chicago is looking for women to participate in a study to evaluate the treatment options available to women living with binge eating disorder.

Binge-Eating Disorder is a significant public health problem for women. Despite this, there is limited research on how best to treat this disorder at varying levels of severity. The purpose of this NIMH-funded study is to enroll individuals in a brief form of cognitive-behavior therapy. If more intense treatment is needed, individuals will be randomly assigned to more intensive group and individual treatments (Cognitive-Behavior Therapy or Dialectical Behavior Therapy). Both of these treatments are talking therapies that have been adapted for women living with binge-eating disorder and are free of charge.

Condition	Intervention
Binge Eating Disorder	Behavioral: Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Treatment for Difficult to Treat Eating and Weight Disorders

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

symptom improvement [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Guided Self Help	Behavioral: Therapy Individual Therapy and Group Therapy
Active Comparator: Cognitive Behavioral Therapy	Behavioral: Therapy Individual Therapy and Group Therapy
Active Comparator: Dialetical Behavioral Therapy	Behavioral: Therapy Individual Therapy and Group Therapy

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adult female, 18 years to 60 years
Meets DSM-IV criteria for Binge Eating Disorder
Resides within commuting distance to the UC
Consents to research protocol, i.e.
18-24 months in assessment and treatment
willing to be part of a biological assessment/physiological assessment
have to be prepared that they will receive a brief individual treatment (4 sessions of guided self-help 30 minutes per session) and if this does not work for them, that they will receive more intensive treatment including both groups (2 hours) and individual (50 minutes) treatment (group and individual involves 24-30 weeks of treatment). If they respond well to individual treatment alone, they will continue in individual treatment for the remaining 6 months of the study.
agreement not to see other health professionals unless recommended
seeing their own Primary care Physician/Nurse Practitioner for medical screening prior to study (i.e., before being allocated a guided self-help therapist)
payment for their own medical assessment, monitoring, and medication if needed

Exclusion Criteria:

Anorexia nervosa
Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS, or Bipolar Mood Disorder
Needs priority treatment for other debilitating conditions, e.g. current substance dependence requiring inpatient detox
chronic absence of shelter
IQ less than 70
Impending jail/prison, court order to treatment, court order to treatment or to jail, or agency order to treatment or to loss of child custody (due to consequent inability to freely drop-out of treatment)
Is pregnant, plans to become pregnant during treatment, or becomes pregnant before random assignment to study condition
Medical instability
Has had or is seeking Gastric bypass surgery
On anti-seizure medication, beta-blockers, asthma medication, medication for heart disease, or any other medication that affects appetite or weight
Psychotropics are acceptable if the doses are stable for at least 3 months prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965705

Contacts

Contact: Jessica Weissman, BA	773-834-9120	jweissman@yoda.bsd.uchicago.edu
Contact: Karla Fettich, MA	773-834-9120	kfettich@yoda.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago Hospital	Recruiting
Chicago, Illinois, United States, 60637
Contact: Karla Fettich, MA 773-834-9120 kfettich@yoda.bsd.uchicago.edu
Contact: Stephanie Harold, BA 773-834-9120 sharold@yoda.bsd.uchicago.edu
Principal Investigator: Eunice Y Chen, PhD

Sponsors and Collaborators

University of Chicago

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Eunice Y Chen, PHD

University of Chicago

More Information

Additional Information:

description of Binge Eating Disorder study This link exits the ClinicalTrials.gov site

University of Chicago Eating and Weight Disorders website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr. Eunice Chen, Assistant Professor, University of Chicago
ClinicalTrials.gov Identifier:	NCT00965705 History of Changes
Other Study ID Numbers:	15150A
Study First Received:	August 25, 2009
Last Updated:	June 22, 2010
Health Authority:	Institutional Review Board: United States

Keywords provided by University of Chicago:

Binge Eating Disorder
overeating
binge eating

women
overweight
compulsive overeating

Additional relevant MeSH terms:

Bulimia
Bulimia Nervosa
Binge-Eating Disorder
Eating Disorders

Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2012