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Stepped Care Treatment for Binge-Eating

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ClinicalTrials.gov Identifier: NCT00965705
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eunice Chen, Temple University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Binge Eating Disorder Behavioral: Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dialectical Behavior Therapy for Early Non-Responders to CBT
Actual Study Start Date : June 2009
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources

Arm Intervention/treatment
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: Dialectical Behavioral Therapy Behavioral: Therapy
Individual Therapy and Group Therapy



Primary Outcome Measures :
  1. Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month [ Time Frame: Up to 12 months after randomization ]
    Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965705


Locations
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Temple University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Eunice Y Chen, PHD Temple University

Additional Information:
Publications of Results:
Responsible Party: Eunice Chen, Study Principal Investigator, Temple University
ClinicalTrials.gov Identifier: NCT00965705     History of Changes
Other Study ID Numbers: 20472
K23MH081030-01 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Eunice Chen, Temple University:
Binge Eating Disorder
overeating
binge eating
women
overweight
compulsive overeating

Additional relevant MeSH terms:
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms