Department of Psychiatry, Centre for Mindfulness, Radboud University Medical Centre, Nijmegen, The Netherlands.
Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands.
PLoS One. 2021 Nov 4;16(11):e0259167. doi: 10.1371/journal.pone.0259167. eCollection 2021.
Mindfulness-Based Interventions (MBIs) are widely used in clinical and non-clinical populations, but little attention has been given to potential adverse effects (AEs).
This study aimed to gain insight in the prevalence and course of AEs during Mindfulness-Based Cognitive Therapy (MBCT) for patients with bipolar disorder (BD).
The current mixed-methods study was conducted as part of a RCT on (cost-) effectiveness of MBCT in 144 patients with BD (Trial registered on 25th of April 2018, ClinicalTrials.gov, NCT03507647). During MBCT, occurrence of AEs was monitored prospectively, systematically, and actively (n = 72). Patients who reported AEs were invited for semi-structured interviews after completing MBCT (n = 29). Interviews were analysed with directed content analysis, using an existing framework by Lindahl et al.
AEs were reported by 29 patients, in seven of whom the experiences could not be attributed to MBCT during the interview. AEs were reported most frequently up to week 3 and declined afterwards. Baseline anxiety appeared to be a risk factor for developing AEs. Seven existing domains of AEs were observed: cognitive, perceptual, affective, somatic, conative, sense of self, and social. Influencing factors were subdivided into predisposing, precipitating, perpetuating, and mitigating factors. With hindsight, more than half of patients considered the reported AEs as therapeutic rather than harmful.
Although the occurrence of AEs in MBCT for patients with BD is not rare, even in this population with severe mental illness they were not serious or had lasting bad effects. In fact, most of them were seen by the patients as being part of a therapeutic process, although some patients only experienced AEs as negative.
正念干预（MBIs）广泛应用于临床和非临床人群，但对其潜在不良反应（AEs）关注甚少。
本研究旨在深入了解双相障碍（BD）患者接受正念认知疗法（MBCT）时 AEs 的发生率和病程。
本混合方法研究是一项关于 MBCT 在 BD 患者中的（成本）有效性的 RCT 的一部分（于 2018 年 4 月 25 日在 ClinicalTrials.gov 上注册，NCT03507647）。在 MBCT 期间，前瞻性、系统地和主动监测 AEs 的发生（n=72）。完成 MBCT 后，对报告 AEs 的患者进行半结构式访谈（n=29）。使用 Lindahl 等人的现有框架对访谈进行定向内容分析。
29 名患者报告了 AEs，其中 7 名患者在访谈中无法将这些经历归因于 MBCT。AEs 报告最频繁的时间是在第 3 周之前，之后逐渐减少。基线焦虑似乎是发生 AEs 的一个危险因素。观察到 7 个现有的 AEs 领域：认知、知觉、情感、躯体、意志、自我意识和社会。影响因素分为易患、诱发、持续和减轻因素。事后看来，超过一半的患者认为报告的 AEs 是治疗性的，而不是有害的。
尽管 MBCT 治疗 BD 患者时发生 AEs 并不罕见，即使在这群患有严重精神疾病的患者中，它们也不严重或没有持久的不良影响。事实上，大多数患者认为这些 AEs 是治疗过程的一部分，尽管有些患者仅将其视为负面体验。
