Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Ospedale San Giuseppe, Verbania, Italy.
Trials. 2011 May 9;12:114. doi: 10.1186/1745-6215-12-114.
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 typically 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.
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.
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).
ClinicalTrials.gov Identifier: NCT01096251
超重和肥胖与暴食障碍（BED）有关。有效干预措施可显著减轻体重、维持体重减轻并管理与 BED 相关的病理，如通常采用综合治疗方案（饮食、营养、身体、行为、认知行为、药理学、手术）。目前存在可用性、成本、治疗依从性和长期疗效方面的重大困难。特别是认知行为疗法（CBT）是 BED 住院和门诊环境中首选的治疗方法。近年来，为了治疗涉及熟悉问题的肥胖和 BED 患者，已实施了系统和系统策略心理治疗。特别是最近开发了一种简短的系统策略治疗 BED 的方案，该方案总体上使用了战略对话。此外，为了避免治疗住院阶段后的复发，并保持与同一临床住院团队的护理连续性，已在门诊环境中使用一种新的有前途的低成本方法远程医疗来治疗肥胖和 BED。
将在一项双臂随机对照临床试验中评估 CBT 和简短策略治疗（BST）之间的比较。由于 BST 在 BED 治疗中的应用具有新颖性（尚无其他包括 BST 的 RCT），因此在进行大规模随机对照临床试验（RCT）之前，将先进行一项试点研究。CBT 和 BST 组都将接受住院治疗（饮食、体育活动、营养师咨询、8 次心理治疗），外加 8 次基于电话的心理支持和监测门诊随访，由同一名住院心理治疗师进行。随机试验的主要结局指标是生活质量问卷（OQ-45.2）的全球指数变化。次要结局指标是考虑每周暴食发作次数和体重减轻情况，BED 患者缓解的百分比。数据将在基线时、出院时（大约在 1 个月后）以及住院治疗结束后 6-12-24 个月时收集。随访时间点的数据将通过远程会议收集。
STRATOB（肥胖的系统和策略心理治疗）是一项综合的两阶段逐步降低计划，通过远程心理治疗进行强化，用于肥胖 BED 患者的中期治疗，以寻求减肥干预，该计划将阐明 BST 与黄金标准 CBT 的有效性比较以及在家中使用低水平远程护理（手机）进行护理连续性的情况。
ClinicalTrials.gov 标识符：NCT01096251
