Meditation-Based Treatment for Binge Eating Disorder

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00032760
First received: April 1, 2002
Last updated: September 28, 2007
Last verified: September 2007
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Meditation-Based Treatment for Binge Eating Disorder

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.

ClinicalTrials.gov Identifier: NCT00032760     History of Changes
Other Study ID Numbers: R21 AT000416-01
Study First Received: April 1, 2002
Last Updated: September 28, 2007
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

Additional relevant MeSH terms:
Obesity
Eating Disorders
Binge-Eating Disorder
Bulimia
Disease
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014