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Meditation-Based Treatment for Binge Eating Disorder
This study has been completed.
Study NCT00032760   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: April 1, 2002   Last Updated: September 28, 2007   History of Changes

April 1, 2002
September 28, 2007
March 2002
 
 
 
Complete list of historical versions of study NCT00032760 on ClinicalTrials.gov Archive Site
 
 
 
Meditation-Based Treatment for Binge Eating Disorder
Meditation-Based Treatment for Binge Eating Disorder

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.

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 medical/health 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 (i.e., 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.

Phase II, Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
  • Binge Eating Disorder
  • Obesity
Behavioral: Meditation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
160
March 2004
 

Inclusion Criteria:

  • Clinical diagnosis of binge eating disorder;
  • BMI at least 30;
  • Fluent English speaker/reader;
  • Able and willing to attend 9 weekly group sessions over two months, plus followup for 6 months, either in geographic area of Terre Haute, Indiana, or Durham, North Carolina.

Exclusion Criteria:

  • Psychiatric or other condition that would preclude appropriate group participation;
  • On a structured diet program;
  • Unstable related medical syndrome (e.g., diabetes, hypertension);
  • Medication that affects weight or appetite that is still being adjusted or that is likely to change during the course of the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00032760
 
R21 AT000416-01
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Jean L. Kristeller, PhD Indiana State University
Principal Investigator: Ruth Quillian-Wolever, PhD Duke University Department of Psychiatry/Center for Integrated Medicine
National Center for Complementary and Alternative Medicine (NCCAM)
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP