Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cognitive Therapy for Binge-Eating Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cynthia Bulik, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00050037
First received: November 20, 2002
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Obesity
Eating Disorders
Procedure: CBT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Therapy Via CD-Rom for Binge-Eating Disorder

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Enrollment: 60
Study Start Date: April 2001
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD-ROM based CBT
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.
Procedure: CBT
Other Name: Cognitive Behavioral Therapy
Active Comparator: Standard Group CBT
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.
Procedure: CBT
Other Name: Cognitive Behavioral Therapy
No Intervention: Waiting List
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050037

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Cynthia Bulik, PhD, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00050037     History of Changes
Other Study ID Numbers: R21 MH62053, R21MH062053, DSIR AT-AS
Study First Received: November 20, 2002
Last Updated: April 10, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014