BACKGROUND Antipsychotic drug-induced weight gain puts individuals with schizophrenia at increased cardiometabolic risk. As a potential intervention for this problem, we describe the theoretical background and a protocol for a feasibility randomised controlled trial (RCT) of approach bias modification (ABM) training combined with real versus sham (placebo) transcranial direct current stimulation (tDCS). The primary aim of this trial is to obtain information that will guide decision making and protocol development in relation to a future large-scale RCT of ABM and tDCS in this group of participants. Second, the study will assess the preliminary efficacy of ABM + tDCS in reducing food cravings in people who take antipsychotic medication. METHODS Thirty adults with a DSM-V diagnosis of schizophrenia or schizoaffective disorder treated with anti-psychotic medication will be randomly allocated to receive five sessions that will combine ABM and real or sham tDCS, in a parallel group design. In this feasibility study, a broad range of outcome variables will be examined. Measures will include food craving, psychopathology (e.g. symptoms of schizophrenia and depression), neuropsychological processes (such as attentional bias and impulsiveness), and the tolerability and acceptability of tDCS. The feasibility of conducting a large-scale RCT of ABM + tDCS and appropriateness of tDCS as a treatment for antipsychotic drug-induced weight gain will be evaluated by assessment of recruitment and retention rates, acceptability of random allocation, blinding success (allocation concealment), completion of treatment sessions and research assessments (baseline, post-treatment and follow-up). DISCUSSION The effect sizes generated and other findings from this trial will inform a future large-scale RCT with respect to decisions on primary outcome measures and other aspects of protocol development. In addition, results from this study will provide a preliminary indication of the efficacy of ABM + tDCS treatment for antipsychotic drug-induced weight gain. TRIAL REGISTRATION ISRCTN Registry, ISRCTN13280178. Registered on 16 October 2018.

中文翻译：

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经颅直流电刺激 (tDCS) 和方法偏差修正 (ABM) 训练对服用抗精神病药物的人的食物渴望的影响。


背景抗精神病药物引起的体重增加使精神分裂症患者的心脏代谢风险增加。作为该问题的潜在干预措施，我们描述了方法偏差修正（ABM）训练与真实与假（安慰剂）经颅直流电刺激（tDCS）相结合的可行性随机对照试验（RCT）的理论背景和协议。该试验的主要目的是获得信息，以指导与该组参与者未来大规模 ABM 和 tDCS 随机对照试验相关的决策和方案开发。其次，该研究将评估 ABM + tDCS 在减少服用抗精神病药物的人的食物渴望方面的初步功效。方法 30 名经 DSM-V 诊断为精神分裂症或分裂情感性障碍并接受抗精神病药物治疗的成年人将被随机分配接受 5 次平行组设计中结合 ABM 和真实或假 tDCS 的治疗。在这项可行性研究中，将审查广泛的结果变量。衡量标准将包括对食物的渴望、精神病理学（例如精神分裂症和抑郁症的症状）、神经心理过程（例如注意力偏差和冲动）以及经颅直流电刺激的耐受性和可接受性。将通过评估招募和保留率、随机分配的可接受性、盲法成功（分配隐藏）、完成治疗疗程和研究评估（基线、治疗后和随访）。 讨论 该试验产生的效应大小和其他结果将为未来的大规模随机对照试验提供关于主要结果测量和方案开发其他方面的决策的信息。此外，这项研究的结果将为 ABM + tDCS 治疗抗精神病药物引起的体重增加的疗效提供初步指示。试用注册 ISRCTN 注册中心，ISRCTN13280178。注册日期：2018 年 10 月 16 日。