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Cognitive Therapy for Binge-Eating Disorder

Primary Purpose

Obesity, Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Binge-eating disorder (binging an average of once per week for 6 months) Body mass index of 30 or more Regular access to an IBM-compatible computer Exclusion Criteria: Patients currently taking psychoactive medication will not be excluded provided their unhealthy eating behaviors have remained stable during treatment

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

CD-ROM based CBT

Standard Group CBT

Waiting List

Arm Description

Group is given a copy of the CD-ROM program to complete at home over 10 weeks. At the end of each week, these patients upload and transmit their encrypted tracking data to the research coordinator. At the end of the treatment, participants who have not improved are offered a course of traditional manual-based group therapy, follow-up in an ongoing maintenance group in an eating disorders program, or an alternative treatment.

Group undergoes standard group CBT. Therapy is administered over 10 weeks in five 90-minute sessions. The key topics are similar to those covered in the CD-ROM group: psychoeducation, developing a personal profile, standardizing meal times, recognizing emotional eating, increasing daily activity, learning the language of CBT, identifying automatic thoughts, restructuring thoughts, identifying cues and consequences, chaining, "surfing the urge," and preventing relapses. Therapy sessions include a didactic section followed by group interaction and discussion. All group sessions are audiotaped and monitored.

Participants in the wait list control group undergo an initial assessment but receive no active intervention for 10 weeks. After 10 weeks, these patients undergo post-treatment assessment and are offered the opportunity to either enter group treatment in an eating disorders program or enter other appropriate treatment. Three-month follow-up data are not collected from these individuals.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 20, 2002
Last Updated
April 10, 2013
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00050037
Brief Title
Cognitive Therapy for Binge-Eating Disorder
Official Title
Cognitive Therapy Via CD-Rom for Binge-Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of a CD-ROM-based cognitive-behavioral therapy (CBT) to traditional manual-based group therapy for obese individuals with binge-eating disorder (BED) and other unhealthy eating behaviors. A second goal is to encourage a healthy lifestyle in patients with BED.
Detailed Description
Although eating and weight-related disorders are treatable, most afflicted individuals never receive proper treatment. CD-ROM-based CBT may be an efficacious and cost-effective intervention, a useful adjunct to traditional psychotherapy, or an introductory step to treatment which familiarizes patients with the principles and techniques of CBT and increases their comfort and motivation to seek additional help. Potential participants undergo a brief telephone screening to ensure their understanding of the study. Individuals who meet preliminary criteria are then scheduled for an initial assessment. Patients are randomized to 1 of 3 groups. One group is given a copy of the CD-ROM program to complete at home over 10 weeks. At the end of each week, these patients upload and transmit their encrypted tracking data to the research coordinator. At the end of the treatment, participants who have not improved are offered a course of traditional manual-based group therapy, follow-up in an ongoing maintenance group in an eating disorders program, or an alternative treatment. A second group undergoes standard group CBT. Therapy is administered over 10 weeks in five 90-minute sessions. The key topics are similar to those covered in the CD-ROM group: psychoeducation, developing a personal profile, standardizing meal times, recognizing emotional eating, increasing daily activity, learning the language of CBT, identifying automatic thoughts, restructuring thoughts, identifying cues and consequences, chaining, "surfing the urge," and preventing relapses. Therapy sessions include a didactic section followed by group interaction and discussion. All group sessions are audiotaped and monitored. Participants in the wait list control group undergo an initial assessment but receive no active intervention for 10 weeks. After 10 weeks, these patients undergo post-treatment assessment and are offered the opportunity to either enter group treatment in an eating disorders program or enter other appropriate treatment. Three-month follow-up data are not collected from these individuals. Assessments occur at study start, at the end of treatment, and at a 3-month follow-up. Assessments include height and weight measurements and measurements of changes in exercise- and nonexercise-related activity. All participants are given tests and interviews to assess eating disorder symptoms, depression, psychoactive substance abuse and dependence, and functioning. Patients complete self-report questionnaires to assess their cognitive restraint, hunger, disinhibition, strength of urges to binge, and degree of confidence in their ability to resist a binge. Patients also rate the suitability of treatment both prior to and following completion of the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Eating Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD-ROM based CBT
Arm Type
Experimental
Arm Description
Group is given a copy of the CD-ROM program to complete at home over 10 weeks. At the end of each week, these patients upload and transmit their encrypted tracking data to the research coordinator. At the end of the treatment, participants who have not improved are offered a course of traditional manual-based group therapy, follow-up in an ongoing maintenance group in an eating disorders program, or an alternative treatment.
Arm Title
Standard Group CBT
Arm Type
Active Comparator
Arm Description
Group undergoes standard group CBT. Therapy is administered over 10 weeks in five 90-minute sessions. The key topics are similar to those covered in the CD-ROM group: psychoeducation, developing a personal profile, standardizing meal times, recognizing emotional eating, increasing daily activity, learning the language of CBT, identifying automatic thoughts, restructuring thoughts, identifying cues and consequences, chaining, "surfing the urge," and preventing relapses. Therapy sessions include a didactic section followed by group interaction and discussion. All group sessions are audiotaped and monitored.
Arm Title
Waiting List
Arm Type
No Intervention
Arm Description
Participants in the wait list control group undergo an initial assessment but receive no active intervention for 10 weeks. After 10 weeks, these patients undergo post-treatment assessment and are offered the opportunity to either enter group treatment in an eating disorders program or enter other appropriate treatment. Three-month follow-up data are not collected from these individuals.
Intervention Type
Procedure
Intervention Name(s)
CBT
Other Intervention Name(s)
Cognitive Behavioral Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Binge-eating disorder (binging an average of once per week for 6 months) Body mass index of 30 or more Regular access to an IBM-compatible computer Exclusion Criteria: Patients currently taking psychoactive medication will not be excluded provided their unhealthy eating behaviors have remained stable during treatment
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Cognitive Therapy for Binge-Eating Disorder

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