Clinical trial NCT00032760: Meditation-Based Treatment for Binge Eating Disorder
Official title: Meditation-Based Treatment for Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Binge Eating Disorder
Obesity
Keywords: binge eating disorder
human therapy evaluation
meditation
obesity
nutrition education
psychotherapy
racial /ethnic difference
adult human
alternative medicine
patient oriented research
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-04-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Terre Haute
country: United States
facility: Indiana State University
state: Indiana
city: Durham
country: United States
facility: Duke Center for Integrative Medicine
state: North Carolina
Study officials:
affiliation: Indiana State University
name: Jean L. Kristeller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Department of Psychiatry/Center for Integrated Medicine
name: Ruth Quillian-Wolever, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.