Binge eating is a common problem associated with obesity and with increased risk for psychiatric and medical morbidity and is recognized as a significant health problem. Cognitive behavioral therapy (CBT) and certain medications have been found to be effective for treating binge eating in several controlled studies at specialized research clinics. Whether such treatments can be effectively administered in non-specialist primary care settings is unknown. Research has documented that recurrent binge eating in obese persons is associated with high healthcare utilization but infrequently with receipt of treatments with demonstrated efficacy. This study aims to examine whether such efficacious treatments, if suitably adapted, can be effectively administered in primary care settings. The study will test the effectiveness of two treatments: CBT using a pure-self help approach (CBTsh) and sibutramine (anti-obesity medication) also found to be effective for reducing binge eating. 150 obese patients with recurrent binge eating (without inappropriate weight control behaviors) will be treated by non-specialist clinicians in primary care settings. Participants will be randomized to one of four treatments (balanced 2-by-2 factorial design) for 16 weeks: (1) sibutramine (15 mg/d) (2) placebo;(3) CBTsh and sibutramine (15 mg/d) placebo;or (4) CBTsh and placebo. Medication will be given in double-blind fashion with minimal clinical management. Thus, treatments are closely matched in clinical time to control partly for attention and, more importantly, to reflect the clinical reality of their potential use in busy primary care settings. Changes throughout the course of treatments will be evaluated and major outcome assessments will be performed by independent evaluators at the end of active treatment (4 months) and at 6- and 12-months after ending treatments (10 and 16 months after randomization). Comprehensive evaluations will assess both binge eating and obesity and their associated outcomes (features of eating disorders, psychological functioning, biological variables) and will allow for exploration of mediators and moderators of outcomes. This study, only the second controlled trial of CBT and a medication alone and in combination for binge eating in obese patients, will provide important information about the utility of specific treatments for use by non-specialists in primary care settings. This study will provide needed information about the durability or maintenance of these treatments for the year following treatment completion.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK073542-05
Application #
8130890
Study Section
Adult Psychopathology and Disorders of Aging Study Section (APDA)
Program Officer
Kuczmarski, Robert J
Project Start
2007-09-01
Project End
2013-08-31
Budget Start
2011-09-01
Budget End
2013-08-31
Support Year
5
Fiscal Year
2011
Total Cost
$325,873
Indirect Cost
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Lydecker, Janet A; White, Marney A; Grilo, Carlos M (2017) Form and formulation: Examining the distinctiveness of body image constructs in treatment-seeking patients with binge-eating disorder. J Consult Clin Psychol 85:1095-1103
Udo, Tomoko; White, Marney A; Lydecker, Janet L et al. (2016) Biopsychosocial Correlates of Binge Eating Disorder in Caucasian and African American Women with Obesity in Primary Care Settings. Eur Eat Disord Rev 24:181-6
Grilo, Carlos M; White, Marney A; Masheb, Robin M et al. (2015) Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. J Consult Clin Psychol 83:387-94
Reas, Deborah L; Grilo, Carlos M (2014) Current and emerging drug treatments for binge eating disorder. Expert Opin Emerg Drugs 19:99-142
Udo, Tomoko; McKee, Sherry A; White, Marney A et al. (2014) The factor structure of the metabolic syndrome in obese individuals with binge eating disorder. J Psychosom Res 76:152-7
Udo, Tomoko; McKee, Sherry A; White, Marney A et al. (2014) Menopause and metabolic syndrome in obese individuals with binge eating disorder. Eat Behav 15:182-5
Grilo, Carlos M; Masheb, Robin M; White, Marney A et al. (2014) Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: randomized placebo-controlled clinical trial of self-help and medication. Behav Res Ther 58:1-9
Balodis, Iris M; Grilo, Carlos M; Kober, Hedy et al. (2014) A pilot study linking reduced fronto-Striatal recruitment during reward processing to persistent bingeing following treatment for binge-eating disorder. Int J Eat Disord 47:376-84
Barnes, Rachel D; Ivezaj, Valentina; Grilo, Carlos M (2014) An examination of weight bias among treatment-seeking obese patients with and without binge eating disorder. Gen Hosp Psychiatry 36:177-80
Gianini, Loren M; White, Marney A; Masheb, Robin M (2013) Eating pathology, emotion regulation, and emotional overeating in obese adults with Binge Eating Disorder. Eat Behav 14:309-13

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