Cognitive Therapy for Binge-Eating Disorder

Obesity Clinical Trial

Official title:

Cognitive Therapy Via CD-Rom for Binge-Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050037
• Other study ID #: R21MH062053
• Secondary ID: R21MH062053DSIR
• Status: Completed
• Phase: N/A
• First received: November 20, 2002
• Last updated: April 10, 2013
• Start date: April 2001
• Est. completion date: March 2006

Study information

• Verified date: April 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Eating Disorders
• Obesity

Intervention

Procedure:
• CBT

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States,