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Stepped Care Treatment for Binge-Eating

Primary Purpose

Binge Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapy
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder focused on measuring Binge Eating Disorder, overeating, binge eating, women, overweight, compulsive overeating

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Guided Self Help

Cognitive Behavioral Therapy

Dialectical Behavioral Therapy

Arm Description

Outcomes

Primary Outcome Measures

Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month

Secondary Outcome Measures

Full Information

First Posted
August 25, 2009
Last Updated
April 18, 2018
Sponsor
Temple University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00965705
Brief Title
Stepped Care Treatment for Binge-Eating
Official Title
Dialectical Behavior Therapy for Early Non-Responders to CBT
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Temple University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder
Keywords
Binge Eating Disorder, overeating, binge eating, women, overweight, compulsive overeating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Self Help
Arm Type
Active Comparator
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Title
Dialectical Behavioral Therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Therapy
Intervention Description
Individual Therapy and Group Therapy
Primary Outcome Measure Information:
Title
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Psychotropics are acceptable if the doses are stable for at least 3 months prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eunice Y Chen, PHD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27852348
Citation
Chen EY, Cacioppo J, Fettich K, Gallop R, McCloskey MS, Olino T, Zeffiro TA. An adaptive randomized trial of dialectical behavior therapy and cognitive behavior therapy for binge-eating. Psychol Med. 2017 Mar;47(4):703-717. doi: 10.1017/S0033291716002543. Epub 2016 Nov 17.
Results Reference
result
PubMed Identifier
24235091
Citation
Southward MW, Christensen KA, Fettich KC, Weissman J, Berona J, Chen EY. Loneliness mediates the relationship between emotion dysregulation and bulimia nervosa/binge eating disorder psychopathology in a clinical sample. Eat Weight Disord. 2014 Dec;19(4):509-13. doi: 10.1007/s40519-013-0083-2.
Results Reference
result
Links:
URL
http://sites.temple.edu/tedp
Description
Temple University Eating Disorders (TED) Website

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Stepped Care Treatment for Binge-Eating

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