Abstract
BACKGROUND: Mindfulness-Based Interventions (MBIs) are widely used in clinical and non-clinical populations, but little attention has been given to potential adverse effects (AEs). AIMS: 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). METHOD: 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. RESULTS: 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. CONCLUSIONS: 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.