Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032760
Status:
COMPLETED
Last Update Posted:
2007-10-02
First Post:
2002-04-01
Brief Title:
Meditation-Based Treatment for Binge Eating Disorder
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Meditation-Based Treatment for Binge Eating Disorder
Status:
COMPLETED
Status Verified Date:
2007-09
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 assess the relative effectiveness of a mindfulness meditation-based intervention for binge eating disorder in comparison to a psycho-educational intervention and a waiting-list control group
Detailed Description:
As many as 30 of individuals seeking treatment for obesity meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition DSM-IV criteria for binge eating disorder BED BED is marked by recurrent episodes of bingeing accompanied by feelings of loss of control and involves chronic disregulation of physiological emotional and behavioral systems Meditation-based interventions have been used successfully to treat disorders with similar addictive and disregulatory characteristics but have not been applied to treating BED Data from an uncontrolled pilot study suggests that such an intervention can have marked immediate impact on decreasing episodes of binge eating and other associated characteristics in obese women Therefore this study incorporates appropriate comparison conditions to further investigate the efficacy of a mindfulness meditation-based intervention as a treatment component for treating BED symptoms Exploratory aspects include further development of a manual establishment of effect size in comparison to appropriate comparison groups inclusion of a more diverse population and of measures that address 1 individual differences in treatment response 2 possible mechanisms 3 time course of response and 3 impact on medicalhealth variables
Women from two communities will be randomly assigned to 3 conditions 1 an 8-week manualized meditation-based group intervention 2 a psychoeducational comparison condition or 3 a waiting-list control Primary outcome variables will be changes in binge eating behaviors and associated measures of depression anxiety self-esteem and diet secondary variables include medical variables sensitive to dietary change ie weight blood pressure lipid profile blood glucose levels and process variables related to meditation practice such as the Tellegen Absorption Scale perceived value and use of the meditation practice and experiences of increased control and awareness Participants will be evaluated pre- and post-treatment and at 1 3 and 6 months followup This data would then support the further investigation of a meditation-based intervention as part of a more comprehensive treatment program for BED
Women from two communities will be randomly assigned to 3 conditions 1 an 8-week manualized meditation-based group intervention 2 a psychoeducational comparison condition or 3 a waiting-list control Primary outcome variables will be changes in binge eating behaviors and associated measures of depression anxiety self-esteem and diet secondary variables include medical variables sensitive to dietary change ie weight blood pressure lipid profile blood glucose levels and process variables related to meditation practice such as the Tellegen Absorption Scale perceived value and use of the meditation practice and experiences of increased control and awareness Participants will be evaluated pre- and post-treatment and at 1 3 and 6 months followup This data would then support the further investigation of a meditation-based intervention as part of a more comprehensive treatment program for BED
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