PMID- 34735517
OWN - NLM
STAT- MEDLINE
DCOM- 20211222
LR  - 20240404
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 16
IP  - 11
DP  - 2021
TI  - Adverse or therapeutic? A mixed-methods study investigating adverse effects of 
      Mindfulness-Based Cognitive Therapy in bipolar disorder.
PG  - e0259167
LID - 10.1371/journal.pone.0259167 [doi]
LID - e0259167
AB  - 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.
FAU - Hanssen, Imke
AU  - Hanssen I
AUID- ORCID: 0000-0001-5562-2999
AD  - Department of Psychiatry, Centre for Mindfulness, Radboud University Medical 
      Centre, Nijmegen, The Netherlands.
AD  - Donders Institute for Brain, Cognition and Behaviour, Radboud University, 
      Nijmegen, The Netherlands.
FAU - Scheepbouwer, Vera
AU  - Scheepbouwer V
AD  - Department of Psychiatry, Centre for Mindfulness, Radboud University Medical 
      Centre, Nijmegen, The Netherlands.
AD  - Donders Institute for Brain, Cognition and Behaviour, Radboud University, 
      Nijmegen, The Netherlands.
FAU - Huijbers, Marloes
AU  - Huijbers M
AD  - Department of Psychiatry, Centre for Mindfulness, Radboud University Medical 
      Centre, Nijmegen, The Netherlands.
FAU - Regeer, Eline
AU  - Regeer E
AD  - Altrecht institute for Mental Health Care, Outpatient Clinic For Bipolar 
      Disorder, Utrecht, The Netherlands.
FAU - Lochmann van Bennekom, Marc
AU  - Lochmann van Bennekom M
AD  - Donders Institute for Brain, Cognition and Behaviour, Radboud University, 
      Nijmegen, The Netherlands.
AD  - Pro Persona Mental Health Care, Outpatient Clinic for Bipolar Disorder, Nijmegen, 
      The Netherlands.
FAU - Kupka, Ralph
AU  - Kupka R
AD  - Altrecht institute for Mental Health Care, Outpatient Clinic For Bipolar 
      Disorder, Utrecht, The Netherlands.
AD  - Amsterdam UMC, Vrije Universiteit, Amsterdam Public Health Research Institute, 
      Department of Psychiatry, Amsterdam, The Netherlands.
FAU - Speckens, Anne
AU  - Speckens A
AD  - Department of Psychiatry, Centre for Mindfulness, Radboud University Medical 
      Centre, Nijmegen, The Netherlands.
AD  - Donders Institute for Brain, Cognition and Behaviour, Radboud University, 
      Nijmegen, The Netherlands.
LA  - eng
SI  - ClinicalTrials.gov/NCT03507647
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20211104
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
SB  - IM
MH  - Adult
MH  - Aged
MH  - Bipolar Disorder/*therapy
MH  - Cognitive Behavioral Therapy
MH  - Female
MH  - Humans
MH  - Interviews as Topic
MH  - Male
MH  - Middle Aged
MH  - Mindfulness/*methods
MH  - Prospective Studies
MH  - Psychotherapy/*methods
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
PMC - PMC8568103
COIS- AS and MH receive grants from the Netherlands Organization of Scientific Research 
      during the conduct of this study. AS is the director of the Radboudumc Centre for 
      Mindfulness, department of psychiatry. MH and IH are mindfulness teachers at the 
      Radboudumc Centre for Mindfulness, department of psychiatry. This does not alter 
      our adherence to PLOS ONE policies on sharing data and materials.
EDAT- 2021/11/05 06:00
MHDA- 2021/12/24 06:00
PMCR- 2021/11/04
CRDT- 2021/11/04 17:28
PHST- 2021/06/09 00:00 [received]
PHST- 2021/10/08 00:00 [accepted]
PHST- 2021/11/04 17:28 [entrez]
PHST- 2021/11/05 06:00 [pubmed]
PHST- 2021/12/24 06:00 [medline]
PHST- 2021/11/04 00:00 [pmc-release]
AID - PONE-D-21-18959 [pii]
AID - 10.1371/journal.pone.0259167 [doi]
PST - epublish
SO  - PLoS One. 2021 Nov 4;16(11):e0259167. doi: 10.1371/journal.pone.0259167. 
      eCollection 2021.