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Clinical Trials/NCT00965705
NCT00965705
Completed
Not Applicable

Dialectical Behavior Therapy for Early Non-Responders to CBT

Temple University1 site in 1 country109 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Binge Eating Disorder
Sponsor
Temple University
Enrollment
109
Locations
1
Primary Endpoint
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
March 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eunice Chen

Study Principal Investigator

Temple University

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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