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Stepped Care Treatment for Binge-Eating

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00965705
Recruitment Status : Unknown
Verified March 2013 by Eunice Chen, Temple University.
Recruitment status was:  Recruiting
First Posted : August 26, 2009
Last Update Posted : March 21, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eunice Chen, Temple University

August 25, 2009
August 26, 2009
March 21, 2013
June 2009
June 2013   (Final data collection date for primary outcome measure)
symptom improvement [ Time Frame: 6-8 months ]
Same as current
Complete list of historical versions of study NCT00965705 on ClinicalTrials.gov Archive Site
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Not Provided
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Stepped Care Treatment for Binge-Eating
Dialectical Behavior Therapy for Early Non-Responders to CBT

Temple University 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.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Binge Eating Disorder
Behavioral: Therapy
Individual Therapy and Group Therapy
  • Active Comparator: Guided Self Help
    Intervention: Behavioral: Therapy
  • Active Comparator: Cognitive Behavioral Therapy
    Intervention: Behavioral: Therapy
  • Active Comparator: Dialectical Behavioral Therapy
    Intervention: Behavioral: Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
March 2014
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult female, 18 years to 60 years
  • Meets DSM-IV criteria for Binge Eating Disorder
  • Resides within commuting distance
  • 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 and if this does not work for them, that they will receive more intensive treatment including both group and individual treatment.
  • 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
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
K23MH081030-01 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Eunice Chen, Temple University
Temple University
National Institute of Mental Health (NIMH)
Principal Investigator: Eunice Y Chen, PHD Temple University
Temple University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP