PDF(Pubmed)
Abstract：
Binge-eating disorder (BED) is a psychiatric disorder characterized by recurrent episodes of eating a large amount of food in a discrete period of time while experiencing a loss of control. Cognitive behavioral therapy-enhanced (CBT-E) is a recommended treatment for binge-eating disorder and is typically offered through 20 sessions. Although binge-eating disorder is highly responsive to CBT-E, the cost of treating these patients is high. Therefore, it is crucial to evaluate the efficacy of low-intensity and low-cost treatments for binge-eating disorder that can be offered as a first line of treatment and be widely disseminated. The proposed noninferiority randomized controlled trial aims to determine the efficacy of web-based guided self-help CBT-E compared to treatment-as-usual CBT-E. Guided self-help will be based on a self-help program to stop binge eating, will be shorter in duration and lower intensity, and will require fewer therapist hours. Patients with binge-eating disorder (N = 180) will be randomly assigned to receive guided self-help or treatment-as-usual. Assessments will take place at baseline, mid-treatment, at the end of treatment, and at 20- and 40-weeks post-treatment. Treatment efficacy will be measured by examining the reduction in binge-eating days in the previous 28 days between baseline and the end of treatment between groups, with a noninferiority margin (Δ) of 1 binge-eating day. Secondary outcomes will include full remission, body shape dissatisfaction, therapeutic alliance, clinical impairment, health-related quality of life, attrition, and an economic evaluation to assess cost-effectiveness and cost-utility. The moderators examined will be baseline scores, demographic variables, and body mass index. It is expected that guided self-help is noninferior in efficacy compared to treatment-as-usual. The proposed study will be the first to directly compare the efficacy and economically evaluate a low-intensity and low-cost binge-eating disorder treatment compared to treatment-as-usual. If guided self-help is noninferior to treatment-as-usual in efficacy, it can be widely disseminated and used as a first line of treatment for patients with binge-eating disorder. The Dutch trial register number is R21.016. The study has been approved by the Medical Research Ethics Committees United on May 25th, 2021, case number NL76368.100.21.
摘要：
暴饮暴食症（BED）是一种精神疾病，其特征是在离散的时间段内反复进食大量食物，同时失去控制。认知行为疗法增强（CBT-E）是暴食症的推荐治疗方法，通常通过20个疗程提供。尽管暴饮暴食症对CBT-E有很高的反应，治疗这些患者的费用很高。因此,评估低强度和低成本治疗暴食症的疗效至关重要，这些治疗可以作为一线治疗方法提供并广泛传播。拟议的非劣效性随机对照试验旨在确定基于网络的指导自助CBT-E与照常治疗CBT-E相比的疗效。引导式自助将以自助计划为基础,停止暴饮暴食,持续时间更短，强度更低，需要更少的治疗师时间。暴饮暴食症患者（N=180）将被随机分配接受指导自助或照常治疗。评估将在基线进行，中期治疗，在治疗结束时,治疗后20周和40周。治疗效果将通过检查基线和治疗结束之间的前28天暴饮暴食天数的减少来衡量。具有1天暴饮暴食的非劣效性(Δ)。次要结果将包括完全缓解，身体形状不满意，治疗联盟，临床损害，与健康相关的生活质量，自然减员,以及评估成本效益和成本效用的经济评估。被检查的主持人将是基线分数，人口统计学变量，和体重指数。与照常治疗相比，预期引导式自助的疗效并不逊色。拟议的研究将是第一个直接比较疗效并经济评估低强度和低成本的暴饮暴食症治疗与常规治疗相比。如果引导式自助在疗效上不劣于常规治疗，它可以广泛传播，并用作暴食症患者的一线治疗。荷兰的审判登记号是R21.016。该研究已获得5月25日联合医学研究伦理委员会的批准，2021年，案例编号NL76368.100.21。
