Meditation-Based Treatment for Binge Eating Disorder

Obesity Clinical Trial

Official title:

Meditation-Based Treatment for Binge Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032760
• Other study ID #: R21AT000416-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 1, 2002
• Last updated: September 28, 2007
• Start date: March 2002
• Est. completion date: March 2004

Study information

• Verified date: September 2007
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders
• Obesity

Intervention

Behavioral:
• Meditation

Locations

Country	Name	City	State
United States	Duke Center for Integrative Medicine	Durham	North Carolina
United States	Indiana State University	Terre Haute	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kristeller JL, Hallett CB. An Exploratory Study of a Meditation-based Intervention for Binge Eating Disorder. J Health Psychol. 1999 May;4(3):357-63. doi: 10.1177/135910539900400305. — View Citation