The STRATOB study: design of a randomized controlled clinical trial of Cognitive Behavioral Therapy and Brief Strategic Therapy with telecare in patients with obesity and binge-eating disorder referred to residential nutritional rehabilitation
The STRATOB study: design of a randomized controlled clinical trial of Cognitive Behavioral Therapy and Brief Strategic Therapy with telecare in patients with obesity and binge-eating disorder referred to residential nutritional rehabilitation
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DOI：
10.1186/1745-6215-12-114
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发表时间：
2011-05-09
期刊：
影响因子：
2.5
通讯作者：
Molinari, Enrico
中科院分区：
文献类型：
--
作者：
Castelnuovo, Gianluca;Manzoni, Gian Mauro;Molinari, Enrico
背景：超重和肥胖与暴食症（BED）有关。有效的干预措施，以显着降低体重，保持体重减轻和管理相关的病理，如床是tipically组合治疗方案（饮食，营养，物理，行为，认知行为，药理学，手术）。在可获得性、费用、坚持治疗和长期疗效方面存在重大困难。特别是认知行为疗法（CBT）是一种治疗方法，适用于住院患者和门诊患者。近年来，系统和系统策略的心理治疗已被实施，以治疗肥胖和BED患者涉及熟悉的问题。特别是一个简短的协议，系统的战略治疗床，利用整体的战略对话，最近已经制定。此外，远程医疗，一个新的有前途的低成本的方法，已被用于肥胖症与床在门诊设置，以避免复发后，住院治疗步骤，并保持连续性的护理与参与相同的临床住院team.Methods：CBT和简短的战略治疗（BST）之间的比较将在两个手臂的随机对照临床试验进行评估。由于BST在BED治疗中应用的新奇（尚未开展包括BST在内的其他RCT），因此在开展大规模随机对照临床试验（RCT）之前，将先开展先导性研究。CBT组和BST组均接受住院治疗（饮食、体力活动、营养师咨询、8次心理咨询），并接受8次门诊电话心理支持和监测，由同一位住院心理治疗师进行。随机试验的主要结局指标是结局问卷（OQ-45.2）的总体指数的变化。次要结局指标将是考虑到每周暴饮暴食发作次数和体重减轻，缓解的BED患者百分比。将在基线、出院时（c. a. 1个月后）和住院治疗结束后6-12-24个月后。随访时间点的数据将通过电话会议收集。STRATOB（肥胖症的系统和战略心理治疗），一个全面的两阶段逐步下降的计划，通过远程心理学增强，用于BED寻求减肥干预的肥胖人群的中期治疗，将阐明BST与金标准CBT的有效性比较，以及使用低-远程护理水平（移动的电话）。
Background: Overweight and obesity are linked with Binge Eating Disorder (BED). Effective interventions to significantly reduce weight, maintain weight loss and manage associated pathologies like BED are tipically combined treatment options (dietetic, nutritional, physical, behavioral, cognitive-behavioral, pharmacological, surgical). Significant difficulties with regard to availability, costs, treatment adherence and long-term efficacy are present. Particularly Cognitive Behavioral Therapy (CBT) is the therapeutic approach indicated both in in-patient and in out-patient settings for BED. In recent years systemic and systemic-strategic psychotherapies have been implemented to treat patients with obesity and BED involved in familiar problems. Particularly a brief protocol for the systemic-strategic treatment of BED, using overall the strategic dialogue, has been recently developed. Moreover telemedicine, a new promising low cost method, has been used for obesity with BED in out-patient settings in order to avoid relapse after the in-patient step of treatment and to keep on a continuity of care with the involvement of the same clinical in-patient team.Methods: The comparison between CBT and Brief Strategic Therapy (BST) will be assessed in a two-arm randomized controlled clinical trial. Due to the novelty of the application of BST in BED treatment (no other RCTs including BST have been carried out), a pilot study will be carried out before conducting a large scale randomized controlled clinical trial (RCT). Both CBT and BST group will follow an in-hospital treatment (diet, physical activity, dietitian counseling, 8 psychological sessions) plus 8 out-patient telephone-based sessions of psychological support and monitoring with the same in-patient psychotherapists. Primary outcome measure of the randomized trial will be the change in the Global Index of the Outcome Questionnaire (OQ-45.2). Secondary outcome measures will be the percentage of BED patients remitted considering the number of weekly binge episodes and the weight loss. Data will be collected at baseline, at discharge from the hospital (c. a. 1 month after) and after 6-12-24 months from the end of the in-hospital treatment. Data at follow-up time points will be collected through tele-sessions.Discussion: The STRATOB (Systemic and STRATegic psychotherapy for OBesity), a comprehensive two-phase stepped down program enhanced by telepsychology for the medium-term treatment of obese people with BED seeking intervention for weight loss, will shed light about the comparison of the effectiveness of the BST with the gold standard CBT and about the continuity of care at home using a low-level of telecare (mobile phones).