Stepped Care Treatment for Binge-Eating

April 18, 2018 updated by: Eunice Chen, Temple University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive Behavioral Therapy
Behavioral: Therapy
Individual Therapy and Group Therapy
Active Comparator: Guided Self Help
Behavioral: Therapy
Individual Therapy and Group Therapy
Active Comparator: Dialectical Behavioral Therapy
Behavioral: Therapy
Individual Therapy and Group Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2009

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20472 (Other Identifier: City of Hope Comprehensive Cancer Center)
  • K23MH081030-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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