Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050037
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2002-11-20
Brief Title:
Cognitive Therapy for Binge-Eating Disorder
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Cognitive Therapy Via CD-Rom for Binge-Eating Disorder
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21MH062053 | NIH | None | None |
| DSIR AT-AS | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH062053 |