Treatment of Binge Eating in Obese Patients in Primary Care

描述（由申请人提供）：暴饮暴食是一种与肥胖相关的常见问题，并且增加了精神和医学发病率的风险，被认为是一个重大的健康问题。在一些专门研究诊所的对照研究中，认知行为疗法（CBT）和某些药物被发现对治疗暴饮暴食有效。这些治疗是否能在非专科初级保健机构中有效实施尚不清楚。研究表明，肥胖患者反复暴饮暴食与高医疗保健利用率有关，但很少与接受有效治疗有关。这项研究的目的是检查是否这种有效的治疗，如果适当调整，可以有效地管理在初级保健设置。该研究将测试两种治疗方法的有效性：CBT使用纯自助方法（CBTsh）和西布曲明（抗肥胖药物）也被发现对减少暴饮暴食有效。150例反复暴饮暴食的肥胖患者（无不适当的体重控制行为）将由初级保健机构的非专业临床医生治疗。参与者将被随机分配到四种治疗（平衡2 × 2因子设计）中的一种，持续16周：(1)西布曲明（15 mg/d）；(3) CBTsh联合西布曲明（15 mg/d）安慰剂；(4) CBTsh和安慰剂。药物将以双盲方式给予，临床管理最少。因此，治疗在临床时间上是密切匹配的，部分是为了控制注意力，更重要的是，反映了它们在繁忙的初级保健环境中潜在使用的临床现实。在积极治疗结束（4个月）和治疗结束后6个月和12个月（随机化后10个月和16个月），将对整个治疗过程中的变化进行评估，主要结果评估将由独立评估人员进行。综合评估将评估暴饮暴食和肥胖及其相关结果（饮食失调的特征、心理功能、生物变量），并将允许探索结果的调节因子和调节因子。这项研究是第二次针对肥胖患者暴饮暴食的CBT和药物单独或联合治疗的对照试验，它将为初级保健机构非专业人员使用特定治疗方法提供重要信息。这项研究将提供有关治疗完成后一年这些治疗的持久性或维持性的必要信息。

DESCRIPTION (provided by applicant): 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.