Research on the adverse effects of mindfulness-based programs (MBPs) has been sparse and hindered by methodological imprecision. The 44-item Meditation Experiences Interview (MedEx-I) was used by an independent assessor to measure meditation-related side effects (MRSEs) following three variants of an 8-week program of mindfulness-based cognitive therapy (n = 96). Each item was queried for occurrence, causal link to mindfulness meditation practice, duration, valence, and impact on functioning. Eighty-three percent of the MBP sample reported at least one MRSE. Meditation-related adverse effects with negative valences or negative impacts on functioning occurred in 58% and 37% of the sample, respectively. Lasting bad effects occurred in 6% to 14% of the sample and were associated with signs of dysregulated arousal (hyperarousal and dissociation). Meditation practice in MBPs is associated with transient distress and negative impacts at similar rates to other psychological treatments.
AgbabiakaT. B.SavovicJ.ErnstE. (2008). Methods for causality assessment of adverse drug reactions: A systematic review. Drug Safety, 31(1), 21–37.
2.
AllenE. N.ChandlerC. I.MandimikaN.LeisegangC.BarnesK. (2018). Eliciting adverse effects data from participants in clinical trials. Cochrane Database of Systematic Reviews. https://doi.org/10.1002/14651858.MR000039.pub2
3.
American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.).
4.
AndersonT.SureshM.FarbN. A. (2019). Meditation benefits and drawbacks: Empirical codebook and implications for teaching. Journal of Cognitive Enhancement, 3, 207–220. https://doi.org/10.1007/s41465-018-00119-y
5.
ArbisiP.Ben-PorathY. (1995). An MMPI-2 infrequent response scale for use with psychopathological populations: The infrequency-psychopathology scale, F(p). Psychological Assessment, 7(4), 424–431.
6.
BaerR.CraneC.MillerE.KuykenW. (2019). Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. Clinical Psychology Review, 71, 101–114. https://doi.org/10.1016/j.cpr.2019.01.001
7.
BaerR.CraneC.Montero-MarinJ.PhillipsA.TaylorL.TickellA.KuykenW. (2021). Frequency of self-reported unpleasant events and harm in a mindfulness-based program in two general population samples. Mindfulness, 12, 763–774. https://doi.org/10.1007/s12671-020-01547-8
8.
BentS.PadulaA.AvinsA. L. (2006). Brief communication: Better ways to question patients about adverse medical events: A randomized, controlled trial. Annals of Internal Medicine, 144(4), 257–261.
9.
BraunholtzD. A.EdwardsS. J.LilfordR. J. (2001). Are randomized clinical trials good for us (in the short term)? Evidence for a “trial effect.” Journal of Clinical Epidemiology, 54(3), 217–224. https://doi.org/10.1016/s0895-4356(00)00305-x
10.
BrittonW. B. (2019). Can mindfulness be too much of a good thing? The value of a middle way. Current Opinion in Psychology, 28, 159–165. https://doi.org/10.1016/j.copsyc.2018.12.011
11.
BrittonW. B.DavisJ. H.LoucksE. B.PetersonB.CullenB. H.ReuterL.RandoA.RahrigH.LipskyJ.LindahlJ. R. (2018). Dismantling Mindfulness-Based Cognitive Therapy: Creation and validation of 8-week focused attention and open monitoring interventions within a 3-armed randomized controlled trial. Behaviour Research and Therapy, 101, 92–107. https://doi.org/10.1016/j.brat.2017.09.010
12.
BrittonW. B.HaynesP. L.FridelK. W.BootzinR. R. (2010). Polysomnographic and subjective profiles of sleep continuity before and after mindfulness-based cognitive therapy in partially remitted depression. Psychosomatic Medicine, 72(6), 539–548. https://doi.org/10.1097/PSY.0b013e3181dc1bad
13.
BrittonW. B.LindahlJ. R.TreleavenD. (2017). First, do no harm. 20-hour meditation safety training for mindfulness teachers and clinicians. Cheetah House. https://www.cheetahhouse.org/fdnh
14.
CebollaA.DemarzoM.MartinsP.SolerJ.Garcia-CampayoJ. (2017). Unwanted effects: Is there a negative side of meditation? A multicentre survey. PLOS ONE, 12(9), Article e0183137. https://doi.org/10.1371/journal.pone.0183137
15.
ChouR.AronsonN.AtkinsD.IsmailaA. S.SantaguidaP.SmithD. H.WhitlockE.WiltT. J.MoherD. (2010). AHRQ series paper 4: Assessing harms when comparing medical interventions: AHRQ and the effective health-care program. Journal of Clinical Epidemiology, 63(5), 502–512. https://doi.org/10.1016/j.jclinepi.2008.06.007
16.
ChouR.FuR.CarsonS.SahaS.HelfandM. (2007). Methodological shortcomings predicted lower harm estimates in one of two sets of studies of clinical interventions. Journal of Clinical Epidemiology, 60(1), 18–28. https://doi.org/10.1016/j.jclinepi.2006.02.021
17.
CorsoD. M.PucinoF.DeLeoJ. M.CalisK. A.GallelliJ. F. (1992). Development of a questionnaire for detecting potential adverse drug reactions. Annals of Pharmacotherapy, 26(7–8), 890–896.
18.
Council for International Organizations of Medical Sciences. (2010). CIOMS Working Group XIII: Practical aspects of signal detection in pharmacovigilance.
19.
CrawfordM. J.ThanaL.FarquharsonL.PalmerL.HancockE.BassettP.ClarkeJ.ParryG. D. (2016). Patient experience of negative effects of psychological treatment: Results of a national survey. British Journal of Psychiatry, 208(3), 260–265. https://doi.org/10.1192/bjp.bp.114.162628
CuijpersP.ReijndersM.KaryotakiE.de WitL.EbertD. D. (2018). Negative effects of psychotherapies for adult depression: A meta-analysis of deterioration rates. Journal of Affective Disorders, 239, 138–145. https://doi.org/10.1016/j.jad.2018.05.050
22.
CullenB.EichelK.LindahlJ. R.RahrigH.KiniN.FlahiveJ.BrittonW. B. (2021). The contributions of focused attention and open monitoring in mindfulness-based cognitive therapy for affective disturbances: A 3-armed randomized dismantling trial. PLOS ONE, 16(1), Article e0244838. https://doi.org/10.1371/journal.pone.0244838
23.
DimidjianS.HollonS. D. (2010). How would we know if psychotherapy were harmful?American Psychologist, 65(1), 21–33.
24.
DimidjianS.SegalZ. V. (2015). Prospects for a clinical science of mindfulness-based intervention. American Psychologist, 70(7), 593–620. https://doi.org/10.1037/a0039589
25.
DugganC.ParryG.McMurranM.DavidsonK.DennisJ. (2014). The recording of adverse events from psychological treatments in clinical trials: Evidence from a review of NIHR-funded trials. Trials, 15, Article 335. https://doi.org/10.1186/1745-6215-15-335
26.
EdwardsI. R. (2012). Considerations on causality in pharmacovigilance. International Journal of Risk & Safety in Medicine, 24(1), 41–54. https://doi.org/10.3233/JRS-2012-0552
FariasM.MaraldiE.WallenkampfK. C.LucchettiG. (2020). Adverse events in meditation practices and meditation-based therapies: A systematic review. Acta Psychiatrica Scandinavica, 142(5), 374–393. https://doi.org/10.1111/acps.13225
29.
Food and Drug Administration. (2010). Safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans (Federal Register). Department of Health and Human Services, Food and Drug Administration. http://edocket.access.gpo.gov/2010/pdf/2010-24296.pdf
30.
FowlerF. (1998). Mode effects in a survey of Medicare prostate surgery patients. Public Opinion Quarterly, 62, 29–46.
31.
FreedlandK. E.KingA. C.AmbrosiusW. T.Mayo-WilsonE.MohrD. C.CzajkowskiS. M.ThabaneL.CollinsL. M.RebokG. W.TreweekS. P.CookT. D.EdingerJ. D.StoneyC. M.CampoR. A.Young-HymanD.RileyW. T., & National Institutes of Health Office of Behavioral and Social Sciences Research Expert Panel on Comparator Selection in Behavioral and Social Science Clinical Trials. (2019). The selection of comparators for randomized controlled trials of health-related behavioral interventions: Recommendations of an NIH expert panel. Journal of Clinical Epidemiology, 110, 74–81. https://doi.org/10.1016/j.jclinepi.2019.02.011
32.
FrewenP. A.LaniusR. A. (2006). Toward a psychobiology of posttraumatic self-dysregulation: Reexperiencing, hyperarousal, dissociation, and emotional numbing. Annals of the New York Academy of Sciences, 1071, 110–124. https://doi.org/10.1196/annals.1364.010
33.
FristM. (1997). Structured Clinical Interview for DSM-IV Axis II Personality Disorders, (SCID-II). American Psychiatric Press.
34.
FurukawaT. A.NomaH.CaldwellD. M.HonyashikiM.ShinoharaK.ImaiH.ChenP.HunotV.ChurchillR. (2014). Waiting list may be a nocebo condition in psychotherapy trials: A contribution from network meta-analysis. Acta Psychiatrica Scandinavica, 130(3), 181–192. https://doi.org/10.1111/acps.12275
35.
GitlinL. N. (2013). Introducing a new intervention: An overview of research phases and common challenges. American Journal of Occupational Therapy, 67(2), 177–184. https://doi.org/10.5014/ajot.2013.006742
36.
GoldbergS. B.TuckerR. P.GreeneP. A.DavidsonR. J.WampoldB. E.KearneyD. J.SimpsonT. L. (2018). Mindfulness-based interventions for psychiatric disorders: A systematic review and meta-analysis. Clinical Psychology Review, 59, 52–60. https://doi.org/10.1016/j.cpr.2017.10.011
37.
GoldbergS. B.TuckerR. P.GreeneP. A.SimpsonT. L.KearneyD. J.DavidsonR. J. (2017). Is mindfulness research methodology improving over time? A systematic review. PLOS ONE, 12(10), Article e0187298. https://doi.org/10.1371/journal.pone.0187298
38.
GolombB. A.McGrawJ. J.EvansM. A.DimsdaleJ. E. (2007). Physician response to patient reports of adverse drug effects: Implications for patient-targeted adverse effect surveillance. Drug Safety, 30(8), 669–675. https://doi.org/10.2165/00002018-200730080-00003
39.
HammadT. A.PinheiroS. P.NeyarapallyG. A. (2011). Secondary use of randomized controlled trials to evaluate drug safety: A review of methodological considerations. Clinical Trials, 8(5), 559–570. https://doi.org/10.1177/1740774511419165
40.
HannanC.LambertM. J.HarmonC.NielsenS. L.SmartD. W.ShimokawaK.SuttonS. W. (2005). A lab test and algorithms for identifying clients at risk for treatment failure. Journal of Clinical Psychology, 61(2), 155–163. https://doi.org/10.1002/jclp.20108
41.
HansenN.LambertM.FormanE. (2002). The psychotherapy dose-response effect and its implications for treatment delivery services. Clinical Psychology: Science and Practice, 9(3), 329–343.
42.
HatfieldD.McCulloughL.FrantzS. H.KriegerK. (2010). Do we know when our clients get worse? An investigation of therapists’ ability to detect negative client change. Clinical Psychology & Psychotherapy, 17(1), 25–32. https://doi.org/10.1002/cpp.656
43.
HaubenM.AronsonJ. K. (2007). Gold standards in pharmacovigilance: The use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore. Drug Safety, 30(8), 645–655. https://doi.org/10.2165/00002018-200730080-00001
44.
HealyD.ManginD. (2019). Clinical judgments, not algorithms, are key to patient safety-an essay by David Healy and Dee Mangin. The BMJ, 367, Article l5777. https://doi.org/10.1136/bmj.l5777
45.
HillA. B. (2015). The environment and disease: Association or causation?Journal of the Royal Society of Medicine, 108(1), 32–37. https://doi.org/10.1177/0141076814562718
46.
HinzA.ErnstJ.GlaesmerH.BrahlerE.RauscherF. G.PetrowskiK.KocaleventR. D. (2017). Frequency of somatic symptoms in the general population: Normative values for the Patient Health Questionnaire-15 (PHQ-15). Journal of Psychosomatic Research, 96, 27–31. https://doi.org/10.1016/j.jpsychores.2016.12.017
47.
HirshbergM. J.GoldbergS. B.RosenkranzM.DavidsonR. J. (2020). Prevalence of harm in mindfulness-based stress reduction. Psychological Medicine. Advance online publication. https://doi.org/10.1017/S0033291720002834
48.
HofmannS. G.SawyerA. T.WittA. A.OhD. (2010). The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. Journal of Consulting and Clinical Psychology, 78(2), 169–183. https://doi.org/10.1037/a0018555
49.
HolmesE. A.GhaderiA.HarmerC. J.RamchandaniP. G.CuijpersP.MorrisonA. P.RoiserJ. P.BocktingC.O’ConnorR. C.ShafranR.MouldsM. L.CraskeM. G. (2018). The Lancet Psychiatry Commission on psychological treatments research in tomorrow’s science. Lancet Psychiatry, 5(3), 237–286. https://doi.org/10.1016/S2215-0366(17)30513-8
50.
HopewellS.AltmanD. G.MoherD.SchulzK. F. (2008). Endorsement of the CONSORT Statement by high impact factor medical journals: A survey of journal editors and journal ‘Instructions to Authors.’ Trials, 9, Article 20. https://doi.org/10.1186/1745-6215-9-20
51.
HorigianV. E.RobbinsM. S.DominguezR.UchaJ.RosaC. L. (2010). Principles for defining adverse events in behavioral intervention research: Lessons from a family-focused adolescent drug abuse trial. Clinical Trials, 7(1), 58–68. https://doi.org/10.1177/1740774509356575
52.
HrobjartssonA.EmanuelssonF.Skou ThomsenA. S.HildenJ.BrorsonS. (2014). Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies. International Journal of Epidemiology, 43(4), 1272–1283. https://doi.org/10.1093/ije/dyu115
53.
IoannidisJ. P. (2009). Adverse events in randomized trials: Neglected, restricted, distorted, and silenced. Archives of Internal Medicine, 169(19), 1737–1739. https://doi.org/10.1001/archinternmed.2009.313
54.
IoannidisJ. P.EvansS. J.GotzscheP. C.O’NeillR. T.AltmanD. G.SchulzK.MoherD. (2004). Better reporting of harms in randomized trials: An extension of the CONSORT statement. Annals of Internal Medicine, 141(10), 781–788.
55.
JohnsonC.BurkeC.BrinkmanS.WadeT. (2016). Effectiveness of a school-based mindfulness program for transdiagnostic prevention in young adolescents. Behaviour Research and Therapy, 81, 1–11. https://doi.org/10.1016/j.brat.2016.03.002
56.
JonssonU.AlaieI.ParlingT.ArnbergF. K. (2014). Reporting of harms in randomized controlled trials of psychological interventions for mental and behavioral disorders: A review of current practice. Contemporary Clinical Trials, 38(1), 1–8. https://doi.org/10.1016/j.cct.2014.02.005
57.
KramerM. S. (1981). Difficulties in assessing the adverse effects of drugs. British Journal of Clinical Pharmacology, 11(Suppl. 1), 105S–110S.
58.
KuijpersH.van der HeijdenF.TuinierS.VerhoevenW. (2007). Meditation-induced psychosis. Psychopathology, 40, 461–464.
59.
KuykenW.CraneW.WilliamsJ. M. (2012). Mindfulness-Based Cognitive Therapy (MBCT) implementation resources. Oxford University, University of Exeter, Bangor University.
60.
LambertM.WhippleJ. L.HawkinsE. J.VermeerschD. A.NielsenS. L.SmartD. W. (2003). Is it time for clinicians to routinely track patient outcome? A meta-analysis. Clinical Psychology: Science and Practice, 10, 288–301.
61.
LambertM. J. (2013). The efficacy and effectiveness of psychotherapy. In LambertM. (Ed.), Bergin and Garfield’s handbook of psychotherapy and behavior change (6th ed., pp. 69–218). Wiley.
LindahlJ. R.BrittonW. B. (2019). ‘I have this feeling of not really being here’: Buddhist meditation and changes in sense of self. Journal of Consciousness Studies, 26(7–8), 157–183.
64.
LindahlJ. R.BrittonW. B.CooperD. J.KirmayerL. (2019). Challenging and adverse meditation experiences: Toward a person-centered approach. In FariasM.LalljeeM.BrazierD. (Eds.), The Oxford handbook of meditation. Oxford University Press. https://doi.org/10.1093/oxfordhb/9780198808640.013.51
65.
LindahlJ. R.CooperD. J.FisherN. E.KirmayerL.BrittonW. (2020). Progress or pathology? Differential diagnosis and Intervention criteria for meditation-related challenges: Perspectives from Buddhist meditation teachers and practitioners. Frontiers in Psychology, 11, Article 1905. https://doi.org/10.3389/fpsyg.2020.01905
66.
LindahlJ. R.FisherN. E.CooperD. J.RosenR. K.BrittonW. B. (2017). The varieties of contemplative experience: A mixed-methods study of meditation-related challenges in Western Buddhists. PLOS ONE, 12(5), Article e0176239. https://doi.org/10.1371/journal.pone.0176239
67.
LindenM. (2013). How to define, find and classify side effects in psychotherapy: From unwanted events to adverse treatment reactions. Clinical Psychology & Psychotherapy, 20(4), 286–296. https://doi.org/10.1002/cpp.1765
68.
LineberryN.BerlinJ. A.MansiB.GlasserS.BerkwitsM.KlemC.BhattacharyaA.CitromeL.EnckR.FletcherJ.HallerD.ChenT-T.LaineC. (2016). Recommendations to improve adverse event reporting in clinical trial publications: A joint pharmaceutical industry/journal editor perspective. The BMJ, 355, Article i5078. https://doi.org/10.1136/bmj.i5078
69.
LomasT.CartwrightT.EdgintonT.RidgeD. (2015). A qualitative summary of experiential challenges associated with meditation practice. Mindfulness, 6(4), 848–860. https://doi.org/10.1007/s12671-014-0329-8
70.
LomasT.MedinaJ. C.IvtzanI.RupprechtS.HartR.Eiroa-OrosaF. J. (2017). The impact of mindfulness on well-being and performance in the workplace: An inclusive systematic review of the empirical literature. European Journal of Work and Organizational Psychology, 26(4), 492–513. https://doi.org/10.1080/1359432X.2017.1308924
71.
LustykM.ChawlaN.NolanR.MarlattG. (2009). Mindfulness meditation research: Issues of participant screening, safety procedures, and researcher training. Advances in Mind-Body Medicine, 24(1), 20–30.
72.
Mayo-WilsonE.FuscoN.LiT.HongH.CannerJ. K.DickersinK., for the MUDS Investigators. (2019). Harms are assessed inconsistently and reported inadequately part 1: Systematic adverse events. Journal of Clinical Epidemiology, 113, 20–27. https://doi.org/10.1016/j.jclinepi.2019.04.022
73.
MoherD.SchulzK. F.AltmanD. (2001). The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA, 285(15), 1987–1991.
MoritzS.FiekerM.HottenrottB.SeeralanT.CludiusB.KolbeckK. G. J.NestoriucY. (2015). No pain, no gain? Adverse effects of psychotherapy in obsessive–compulsive disorder and its relationship to treatment gains. Journal of Obsessive-Compulsive and Related Disorders, 5, 61–66.
76.
MoroneN. E.MooreC. G.GrecoC. M. (2017). Characteristics of adults who used mindfulness meditation: United States, 2012. Journal of Alternative and Complementary Medicine, 23(7), 545–550. https://doi.org/10.1089/acm.2016.0099
NicholsA. L.ManerJ. K. (2008). The good-subject effect: Investigating participant demand characteristics. Journal of General Psychology, 135(2), 151–165. https://doi.org/10.3200/GENP.135.2.151-166
79.
ParkerG.FletcherK.BerkM.PatersonA. (2013). Development of a measure quantifying adverse psychotherapeutic ingredients: The Experiences of Therapy Questionnaire (ETQ). Psychiatry Research, 206(2–3), 293–301. https://doi.org/10.1016/j.psychres.2012.11.026
80.
ParsonsC. E.CraneC.ParsonsL. J.FjorbackL. O.KuykenW. (2017). Home practice in Mindfulness-Based Cognitive Therapy and Mindfulness-Based Stress Reduction: A systematic review and meta-analysis of participants’ mindfulness practice and its association with outcomes. Behaviour Research and Therapy, 95, 29–41. https://doi.org/10.1016/j.brat.2017.05.004
81.
PetersonA. L.RoacheJ. D.RajJ., & Young-McCaughan, for the STRONG STAR Consortium. (2013). The need for expanded monitoring of adverse events in behavioral health clinical trials. Contemporary Clinical Trials, 34(1), 152–154. https://doi.org/10.1016/j.cct.2012.10.009
82.
ReynoldsL.BissettI.PorterD.ConsedineN. (2017). A brief mindfulness intervention is associated with negative outcomes in a randomised controlled trial among chemotherapy patients. Mindfulness, 8(5), 1291–1303.
83.
RhekerJ.BeiselS.KralingS.RiefW. (2017). Rate and predictors of negative effects of psychotherapy in psychiatric and psychosomatic inpatients. Psychiatry Research, 254, 143–150. https://doi.org/10.1016/j.psychres.2017.04.042
84.
RozentalA.CastonguayL.DimidjianS.LambertM.ShafranR.AnderssonG.CarlbringP. (2018). Negative effects in psychotherapy: Commentary and recommendations for future research and clinical practice. BJPsych Open, 4(4), 307–312. https://doi.org/10.1192/bjo.2018.42
85.
RozentalA.KottorpA.ForsstromD.ManssonK.BoettcherJ.AnderssonG.FurmarkT.CarlbringP. (2019). The Negative Effects Questionnaire: Psychometric properties of an instrument for assessing negative effects in psychological treatments. Behavioural and Cognitive Psychotherapy, 47(5), 559–572. https://doi.org/10.1017/S1352465819000018
86.
RushA. J.GullionC. M.BascoM. R.JarrettR. B.TrivediM. H. (1996). The Inventory of Depressive Symptomatology (IDS): Psychometric properties. Psychological Medicine, 26(3), 477–486.
87.
SantorelliS.Meleo-MeyerF.KoerbelL.Kabat-ZinnJ.BlackerM.HerbetteG.FulwilerC. (2017). Mindfulness-Based Stress Reduction (MBSR) authorized curriculum guide. Center for Mindfulness in Medicine, Health Care, and Society (CFM), University of Massachusetts Medical School.
88.
Schermuly-HauptM.LindenM.RushJ. (2018). Unwanted events and side effects in cognitive behavior therapy. Cognitive Therapy and Research, 42, 219–229.
89.
SchlosserM.SparbyT.VorosS.JonesR.MarchantN. L. (2019). Unpleasant meditation-related experiences in regular meditators: Prevalence, predictors, and conceptual considerations. PLOS ONE, 14(5), Article e0216643. https://doi.org/10.1371/journal.pone.0216643
90.
SchneibelR.WilbertzG.ScholzC.BeckerM.BrakemeierE. L.BschorT.ZobelI.SchmollD. (2017). Adverse events of group psychotherapy in the in-patient setting: Results of a naturalistic trial. Acta Psychiatrica Scandinavica, 136(3), 247–258. https://doi.org/10.1111/acps.12747
91.
SchunemannH.HillS.GuyattG.AklE. A.AhmedF. (2011). The GRADE approach and Bradford Hill’s criteria for causation. Journal of Epidemiology and Community Health, 65(5), 392–395. https://doi.org/10.1136/jech.2010.119933
92.
SegalZ. V.TeasdaleJ.WilliamsJ.GemarM. (2002). The Mindfulness-Based Cognitive Therapy Adherence Scale: Inter-rater reliability, adherence to and treatment distinctiveness. Clinical Psychology & Psychotherapy, 9, 131–138. https://doi.org/10.1002/cpp.320
93.
SegalZ. V.WilliamsJ. M. G.TeasdaleJ. D. (2002). Mindfulness-Based Cognitive Therapy for Depression: A new approach to preventing relapse. Guilford Press.
94.
SheskinD. (2004). Handbook of parametric and nonparametric statistical procedures (3rd ed.). Chapman & Hall/CRC.
95.
SiegerinkB.RohmannJ. L. (2018). Impact of your results: Beyond the relative risk. Research and Practice in Thrombosis and Haemostasis, 2(4), 653–657. https://doi.org/10.1002/rth2.12148
96.
SinghS.LokeY. K. (2012). Drug safety assessment in clinical trials: Methodological challenges and opportunities. Trials, 13, Article 138. https://doi.org/10.1186/1745-6215-13-138
97.
TalbotJ.AronsonJ. (Eds.). (2012). Stephens’ detection and evaluation of adverse drug reactions: Principles and practice (6th ed.). Wiley-Blackwell.
98.
TreleavenD. (2018). Trauma-sensitive mindfulness: Practices for safe and transformative healing. W.W. Norton.
99.
TurnerW. M. (1984). The Food and Drug Administration algorithm. Special workshop: Regulatory. Drug Information Journal, 18(3–4), 259–266.
100.
Van DamN. T.GalanteJ. (2020). Underestimating harm in mindfulness-based stress reduction. Psychological Medicine. Advance online publication. https://doi.org/10.1017/S003329172000447X
101.
Van DamN. T.van VugtM. K.VagoD. R.SchmalzlL.SaronC. D.OlendzkiA.MeissnerT.LazarS. W.KerrC. E.GorchovJ.FoxK.FieldB. A.BrittonW. B.Brefczynski-LewisJ. A.MeyerD. E. (2018). Mind the Hype: A critical evaluation and prescriptive agenda for research on mindfulness and meditation. Perspectives on Psychological Science, 13(1), 36–61. https://doi.org/10.1177/1745691617709589
102.
VandenbrouckeJ. P. (2006). What is the best evidence for determining harms of medical treatment?Canadian Medical Association Journal, 174(5), 645–646. https://doi.org/10.1503/cmaj.051484
103.
VaughanB.GoldsteinM. H.AlikakosM.CohenL. J.SerbyM. J. (2014). Frequency of reporting of adverse events in randomized controlled trials of psychotherapy vs. psychopharmacotherapy. Comprehensive Psychiatry, 55(4), 849–855. https://doi.org/10.1016/j.comppsych.2014.01.001
104.
WalfishS.McAlisterB.O’DonnellP.LambertM. J. (2012). An investigation of self-assessment bias in mental health providers. Psychological Reports, 110(2), 639–644. https://doi.org/10.2466/02.07.17.PR0.110.2.639-644
105.
WardenD.TrivediM. H.WisniewskiS. R.LesserI. M.MitchellJ.BalasubramaniG. K.FavaM.Shores-WilsonK.StegmanD.RushA. J. (2009). Identifying risk for attrition during treatment for depression. Psychotherapy and Psychosomatics, 78(6), 372–379. https://doi.org/10.1159/000235977
106.
WeissmanJ. S.SchneiderE. C.WeingartS. N.EpsteinA. M.David-KasdanJ.FeibelmannS.AnnasC. L.RidleyN.KirleL.GatsonisC. (2008). Comparing patient-reported hospital adverse events with medical record review: Do patients know something that hospitals do not?Annals of Internal Medicine, 149(2), 100–108.
107.
WongS.ChanJ.ZhangD.LeeE.TsoiK. (2018). The safety of mindfulness-based interventions: A systematic review of randomized controlled trials. Mindfulness, 9, 1344–1357. https://doi.org/10.1007/s12671-018-0897-0
108.
World Health Organization. (2010). Conceptual framework for the International Classification for Patient Safety.
109.
World Health Organization. (2016). The use of the WHO-UMC system for standardized case causality assessment. World Health Organization, Uppsala Monitoring Centre.
110.
YorstonG. (2001). Mania precipitated by meditation: A case report and literature review. Mental Health, Religion & Culture, 4, 209–214.
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
