NCT00050037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

4.9 years

First QC Date

November 20, 2002

Last Update Submit

April 10, 2013

Conditions

Study Arms (3)

CD-ROM based CBT

EXPERIMENTAL

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

Standard Group CBT

ACTIVE COMPARATOR

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

Waiting List

NO INTERVENTION

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.

Interventions

CBTPROCEDURE
Also known as: Cognitive Behavioral Therapy
CD-ROM based CBTStandard Group CBT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients currently taking psychoactive medication will not be excluded provided their unhealthy eating behaviors have remained stable during treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

ObesityFeeding and Eating Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2002

First Posted

November 21, 2002

Study Start

April 1, 2001

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations