Harmful outcomes of psychological interventions are under-researched, including in mindfulness-based interventions (MBI) for psychosis. This systematic review summarizes reporting and prevalence of 8 harm indices (death, adverse events, hospitalisation, study drop out, noncompletion of therapy, side effects of therapy, symptom deterioration and crisis service use) in Randomised Controlled Trials (RCTs) of MBIs for psychosis. Meta-analyses of risk differences were also calculated for each harm index. The review included 39 studies, with a total of 2684 participants across studies. The percentage of studies reporting on each index of harm, and the prevalence of harm, varied greatly across each index. 0% of studies reported on side effects of interventions compared to 92% of studies reporting on study dropout. Meta-analyses of risk differences (RD) found a higher risk of hospitalisation (RD (95% CI) = −0.136 (−0.23 to −0.05), = 0.003) and crisis service use (RD (95% CI) = −0.160 (−0.299, −0.024), = 0.02) in control arms compared to intervention arms, and no significant difference in adverse events, death, symptom deterioration, noncompletion of therapy, drop out and side effects of therapy. Overall, reporting of harm was inconsistent across studies and the quality of data collection and reporting varied. MBIs for psychosis appear to be safe and may reduce the risk of hospitalisation and use of crisis services. However, the absence of thorough reporting on harm precludes a balanced analysis of benefits versus harms. Future research into the effectiveness of MBIs should consistently operationalise, monitor and report data on harm.

中文翻译：

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基于正念的精神病干预措施安全性的系统评价


心理干预的有害后果尚未得到充分研究，包括针对精神病的正念干预（MBI）。本系统综述总结了 MBI 治疗精神病的随机对照试验 (RCT) 中 8 种危害指数（死亡、不良事件、住院、研究退出、未完成治疗、治疗副作用、症状恶化和危机服务使用）的报告和患病率。还计算了每个危害指数的风险差异荟萃分析。该评价包括 39 项研究，所有研究共有 2684 名参与者。报告每个危害指数的研究百分比以及每个指数的危害发生率差异很大。 0% 的研究报告了干预措施的副作用，而 92% 的研究报告了研究中途退出。风险差异 (RD) 的荟萃分析发现住院风险 (RD (95% CI) = -0.136 (-0.23 至 -0.05), = 0.003) 和危机服务使用风险 (RD (95% CI) = -0.160 (-0.299, -0.024), = 0.02) 与干预组相比，对照组在不良事件、死亡、症状恶化、未完成治疗、退出和治疗副作用方面没有显着差异。总体而言，各研究对伤害的报告不一致，数据收集和报告的质量也各不相同。 MBI 治疗精神病似乎是安全的，可以降低住院和使用危机服务的风险。然而，由于缺乏对危害的全面报告，无法对效益与危害进行平衡分析。未来对 MBI 有效性的研究应持续实施、监测和报告危害数据。