Trial record 9 of 24 for:    Open Studies | "Binge-Eating Disorder"

Stepped Care Treatment for Binge-Eating

This study is currently recruiting participants.
Verified March 2013 by Temple University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Chen, Temple University
ClinicalTrials.gov Identifier:
NCT00965705
First received: August 25, 2009
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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 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: Dialectical Behavior Therapy for Early Non-Responders to CBT

Resource links provided by NLM:


Further study details as provided by Temple University:

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

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: June 2013 (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: Dialectical 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965705

Contacts
Contact: Eunice Y Chen, PhD (215) 204-2645 eunice.chen@temple.edu

Locations
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Eunice Y Chen, PhD    215-204-2645    eunice.chen@temple.edu   
Principal Investigator: Eunice Y Chen, PhD         
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Eunice Y Chen, PHD Temple University
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Chen, Study Principal Investigator, Temple University
ClinicalTrials.gov Identifier: NCT00965705     History of Changes
Other Study ID Numbers: 20472, K23MH081030-01
Study First Received: August 25, 2009
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014