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Home > "M" Clinical Trials Conditions > Meditation-Based Treatment for Binge Eating Disorder  Meditation-Based Treatment for Binge Eating Disorder
Meditation-Based Treatment for Binge Eating Disorder
For Condition: Obesity,Binge Eating Disorder
Status: No longer recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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.
Details: 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 (approximate N=162) 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 160
Location and Contact Information:
Overall Study Official:
RuthQuillian-Wolever, , Duke University Deptartment of Psychiatry/Center for Integrated Medicine
Duke Center for Integrative Medicine
Durham, North Carolina, 27710
United States
Indiana State University
Terre Haute, Indiana, 47809
United States
Additional Information:
Study ID Numbers: 1 R21 AT00416-01;
Study Start Date: January 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032760
Other Binge Eating Disorder Studies:
1. Meditation-Based Treatment for Binge Eating Disorder
2. Treatment of Binge Eating Disorder
Related Studies:
Other Binge Eating Disorder Clinical Trials
Other Indiana Clinical Trials
Other Terre Haute Clinical Trials
Meditation-Based Treatment for Binge Eating Disorder
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