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Meditation-Based Treatment for Binge Eating Disorder

This study has been completed.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00032760
  Purpose

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.


Condition Intervention Phase
Binge Eating Disorder
Obesity
Behavioral: Meditation
Phase II
Phase III

Genetics Home Reference related topics:   Obesity  

MedlinePlus related topics:   Eating Disorders   Obesity  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:   Meditation-Based Treatment for Binge Eating Disorder

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:   160
Study Start Date:   March 2002
Study Completion Date:   March 2004

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 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032760

Locations
United States, Indiana
Indiana State University    
      Terre Haute, Indiana, United States, 47809
United States, North Carolina
Duke Center for Integrative Medicine    
      Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Investigators
Principal Investigator:     Jean L. Kristeller, PhD     Indiana State University    
Principal Investigator:     Ruth Quillian-Wolever, PhD     Duke University Department of Psychiatry/Center for Integrated Medicine    
  More Information

Publications:
Kristeller, J.L., Hallett, B. Effects of a meditation-based intervention in the treatment of binge eating. Journal of Health Psychology. 4(3):357-363, 1999.

Study ID Numbers:   R21 AT000416-01
First Received:   April 1, 2002
Last Updated:   September 28, 2007
ClinicalTrials.gov Identifier:   NCT00032760
Health Authority:   United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
binge eating disorder  
human therapy evaluation  
meditation  
obesity  
nutrition education  
psychotherapy
racial /ethnic difference
adult human
alternative medicine
patient oriented research

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Signs and Symptoms, Digestive
Overweight
Hyperphagia
Body Weight
Bulimia Nervosa
Signs and Symptoms
Bulimia
Nutrition Disorders
Overnutrition
Metabolic disorder
Eating Disorders

Additional relevant MeSH terms:
Mental Disorders
Nutritional and Metabolic Diseases
Pathological Conditions, Signs and Symptoms

ClinicalTrials.gov processed this record on May 08, 2008