Frequency of Self-reported Unpleasant Events and Harm in a Mindfulness-Based Program in Two General Population Samples

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Responses at T1 and T2 were similar and are combined.

“Responses at T1 and T2 were similar and are combined.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

Mean levels of global distress decreased from pre- to post-course and the decrease was maintained at 6-week follow-up.

“Mean levels of global distress decreased from pre- to post-course and the decrease was maintained at 6-week follow-up (see Table 1).”

May combine two claims.

Two of the six free-text responses about harm mentioned potential overall positive impact, one noted that the harm was not long-term, and the other three described only negative outcomes.

“Two mentioned potential overall positive impact, one noted that the harm was not long-term, and the other three described only negative outcomes.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

Three of these four participants reported that they had unpleasant experiences "occasionally", one had them "daily or almost daily".

“Three of these four participants reported that they had unpleasant experiences “occasionally”, one had them “daily or almost daily”.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

Of these four, two had shown this deterioration at post-course whereas two had not.

“Of these, two had shown this deterioration at post-course whereas two had not.”

May combine two claims.

At baseline, 45 participants (52%) met the clinical cut-off for global distress on the CORE-10; this decreased to 31 (42%) post-course and to 17 (27%) at 6-week follow-up.

“At baseline, 45 participants (52%) met the clinical cut-off for global distress on the CORE-10; this decreased to 31 (42%) post-course and to 17 (27%) at 6-week follow-up.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

A few noted that their experience was not unpleasant but provided related observations; others described benefits along with the difficulties.

“A few noted that their experience was not unpleasant but provided related observations; others described benefits along with the difficulties.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

Fifty-six (93%) participants reported being "not at all" harmed by the mindfulness course, 3 (5%) reported being "somewhat" harmed, and 1 reported being "quite a bit" harmed.

“Fifty-six (93%) participants reported being “not at all” harmed by the mindfulness course, 3 (5%) reported being “somewhat” harmed, and 1 reported being “quite a bit” harmed.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

From pre- to post-course, 10 participants (14%) showed reliable and clinical improvement; 4 (5%) showed reliable improvement; 57 (77%) presented no reliable change; and 3 (4%) showed reliable and clinical deterioration.

“From pre- to post-course, 10 participants (14%) showed reliable and clinical improvement; 4 (5%) showed reliable improvement; 57 (77%) presented no reliable change; and 3 (4%) showed reliable and clinical deterioration.”

May combine two claims.

Those reporting harm and those showing reliable deterioration on questionnaires were largely separate subgroups; only one participant fell in both.

“Those reporting harm and those showing reliable deterioration on questionnaires were largely separate subgroups; only one participant fell in both.”

• Also stated in: § Results · plain

  “All seven participants described the course as “not at all” harmful.”

• AssumptionRests on an assumption: The self-report survey questions developed for this study accurately capture participants' unpleasant experiences and harm.

May combine two claims.

Ten sought support, most from a family member, friend, or healthcare professional.

“Ten sought support, most from a family member, friend, or healthcare professional.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

Many free-text responses involved difficult thoughts, emotions, and physical sensations; others described recognition of personal patterns.

“As in study 1, many of these involved difficult thoughts, emotions, and physical sensations; others described recognition of personal patterns.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

All six free-text responses about harm described increased stress levels, difficult thoughts, and awareness of distress and unhappiness.

“These described increased stress levels, difficult thoughts, and awareness of distress and unhappiness.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

At follow-up, 9 participants (15%) showed reliable and clinical improvement; 2 (3%) showed reliable improvement; 45 (75%) presented no reliable change; and 4 (7%) showed reliable and clinical deterioration.

“At follow-up, 9 participants (15%) showed reliable and clinical improvement; 2 (3%) showed reliable improvement; 45 (75%) presented no reliable change; and 4 (7%) showed reliable and clinical deterioration.”

May combine two claims.

Most (97%) reported being unharmed; two reported being "somewhat" harmed.

“Most (97%) reported being unharmed; two reported being “somewhat” harmed.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

One of these participants reported that course had been "quite a bit" harmful and wrote that it brought awareness to distressing thoughts and thought patterns that were difficult to deal with and felt overwhelming.

“One of these participants reported that course had been “quite a bit” harmful and wrote that it brought awareness to distressing thoughts and thought patterns that were difficult to deal with and felt overwhelming.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Two rated these unpleasant experiences as "not at all" upsetting, two as "somewhat" upsetting.

“Two rated these unpleasant experiences as “not at all” upsetting, two as “somewhat” upsetting.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

Probably not a substantial claim: may not pass S3 (load-bearing).

A few participants who rated the course as harmful on the Likert item contradicted themselves in the free-text responses, suggesting that their understanding of "harm" may not have been clear.

“As noted earlier, a few participants who rated the course as harmful on the Likert item contradicted themselves in the free-text responses, suggesting that their understanding of “harm” may not have been clear.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

In study 1 and study 2 at post-course, all participants who showed reliable deterioration in questionnaire scores described the mindfulness program as not at all harmful, suggesting that they did not attribute their increase in symptoms to the mindfulness program, or did not perceive their symptom increases as harmful.

“In study 1 and study 2 at post-course, all participants who showed reliable deterioration in questionnaire scores described the mindfulness program as not at all harmful, suggesting that they did not attribute their increase in symptoms to the mindfulness program, or did not perceive their symptom increases as harmful.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

Probably not a substantial claim: may not pass S3 (load-bearing).

Several participants volunteered information about benefits arising from the unpleasant experiences.

“Even so, several participants volunteered information about benefits arising from the unpleasant experiences.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

Probably not a substantial claim: may not pass S3 (load-bearing).

Evidence-based mindfulness programs have well-established benefits for a wide range of populations and outcome variables.

“The benefits of mindfulness-based programs (MBPs) for a wide range of populations and outcome variables are well supported in meta-analytic reviews (Dawson et al. 2019; Demarzo et al. 2015; Goldberg et al. 2018; Khoury et al. 2013).”

• cites Dawson et al. 2019 sourceNot checked yet

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• cites Demarzo et al. 2015 sourceNot checked yet

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• cites Goldberg et al. 2018 sourceNot checked yet

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Probably not a substantial claim: may not pass S2 (checkable).

Any program or intervention powerful enough to have substantial benefits might also cause harm.

“it is widely recognized that any program or intervention powerful enough to have substantial benefits might also cause harm (Dimidjian and Hollon 2010)”

• cites Dimidjian and Hollon 2010 sourceNot checked yet

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Classified as probably not a substantial claim.

The literature on harmful effects of mindfulness-based programs is sparse.

“The literature on harmful effects of MBPs is sparse.”

• cites Brooker et al. 2012 sourceNot checked yet

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• cites Johnson et al. 2016 sourceNot checked yet

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• cites Reynolds et al. 2017 sourceNot checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing).

A few trials have reported deterioration on some variables in clinical and nonclinical samples, including stressed workers, adolescents in a school setting, and cancer patients.

“A few trials have reported deterioration on some variables in clinical and nonclinical samples, including stressed workers (Brooker et al. 2012), adolescents in a school setting (Johnson et al. 2016), and cancer patients (Reynolds et al. 2017).”

• cites Brooker et al. 2012 sourceNot checked yet

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• cites Johnson et al. 2016 sourceNot checked yet

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• cites Reynolds et al. 2017 sourceNot checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Study 1, the mindfulness courses were well attended: 51% attended all 8 sessions, 32% attended 7, 10% attended 6, 6% attended 5, and 1% attended 4.

“The mindfulness courses were well attended: 51% of participants attended all 8 sessions (n = 43), 32% attended 7 sessions (n = 27), 10% attended 6 sessions (n = 8), 6% attended 5 sessions (n = 5), and 1% attended 4 sessions (n = 1).”

Probably not a substantial claim: may not pass S3 (load-bearing).

The study was overseen by a Data Monitoring and Ethics Committee.

“The study was also overseen by a Data Monitoring and Ethics Committee.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The study was approved by the University of Oxford Medical Sciences Interdivisional Research Ethics Committee.

“The study was approved by the University of Oxford Medical Sciences Interdivisional Research Ethics Committee (20/03/2015; ref.: MS-IDREC-C1-2015-048).”

May combine two claims.

Overall, the practice of mindfulness meditation in evidence-based mindfulness-based programs can be uncomfortable and difficult, but harm is probably rare.

“Overall, these findings suggest that the practice of mindfulness meditation in evidence-based MBPs can be uncomfortable and difficult, but that harm is probably rare.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Study 2, 296 students took part in ten mindfulness courses; 86 (29%) consented to participate, 74 provided post-course data, and 60 provided 6-week follow-up data.

“During the study period, 296 students took part in ten mindfulness courses. Of these, 86 (29%) consented to participate in the study; 74 of them provided post-course data and 60 provided data at 6-week follow-up.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Study 1, internal reliability of the PHQ-9 was acceptable (T0 alpha = .75, T1 alpha = .76).

“Internal reliability was acceptable in the current sample (T0: alpha = .75, T1: alpha = .76).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Study 2, the research team provided information and obtained consent via an online form.

“The research team emailed information to those who expressed interest and provided an opportunity to ask questions and consent to the study via an online form.”

Probably not a substantial claim: may not pass S4 (based).

The current literature includes no established methods for asking participants in mindfulness-based programs about harmful outcomes.

“The current literature includes no established methods for asking participants in MBPs about harmful outcomes.”

May combine two claims.

Adverse and harmful effects are often not reported in studies of psychological therapies broadly and mindfulness-based program studies specifically.

“First, adverse and harmful effects are often not reported in studies of psychological therapies broadly and MBP studies specifically.”

• cites Peterson et al. 2013 sourceNot checked yet

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Classified as probably not a substantial claim.

A recent review (Baer et al. 2019) proposed a framework for research and recommended increased monitoring of both expected and unexpected unpleasant experiences and harm in evidence-based MBPs.

“A recent review (Baer et al. 2019) proposed a framework for research and recommended increased monitoring of both expected and unexpected unpleasant experiences and harm in evidence-based MBPs.”

• cites Baer et al. 2019 sourceNot checked yet

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May combine two claims.

Adverse events may not be spontaneously reported and will not come to light without systematic assessment methods.

“Finally, Duggan et al. (2014) noted that adverse events may not be spontaneously reported and will not come to light without systematic assessment methods.”

• cites Duggan et al. 2014 sourceNot checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing).

The cluster-randomized feasibility study from which these data were drawn was registered at the ISRCTN prior to obtaining participant consent to randomization.

“The cluster-randomized feasibility study from which these data were drawn was registered at the ISRCTN (24/11/2015), prior to obtaining participant consent to randomization, 10.1186/ISRCTN18013311.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Study 1, internal reliability of the GAD-7 was good (T0 alpha = .89, T1 alpha = .84).

“Internal reliability in the current sample was good (T0: alpha = .89, T1: alpha = .84).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Study 2, potential participants were provided with information about the course and contraindications and were asked to make an informed choice about suitability.

“Potential participants were provided with information about the course and contraindications to participation (such as serious mental or physical health concerns or recent bereavement) and were asked to make an informed choice about whether the course was suitable for them.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The CORE-10 has shown good validity, internal consistency, and sensitivity to change.

“The CORE-10 has shown good validity, internal consistency, and sensitivity to change (Connell and Barkham 2007).”

• cites Connell and Barkham 2007Not checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing).

In a review of adverse effects of mindfulness-based programs, Baer et al. (2019) found that many papers do not report on harmful outcomes.

“In a review of adverse effects of MBPs, Baer et al. (2019) found that many papers do not report on harmful outcomes.”

• cites Baer et al. 2019 sourceNot checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing).

Internal consistencies of the CORE-10 in the current sample were good at T0 (alpha = .84), T1 (alpha = .81), and T2 (alpha = .82).

“Internal consistencies in the current sample were good (T0: alpha = .84, T1: alpha = .81, T2: alpha = .82).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Meta-analyses have concluded that most studies show beneficial effects of mindfulness-based programs in these populations.

“However, meta-analyses have concluded that most studies show beneficial effects of MBPs in these populations (Dunning et al. 2019; Lomas et al. 2019; Piet et al. 2012).”

• cites Dunning et al. 2019 sourceNot checked yet

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• cites Lomas et al. 2019 sourceNot checked yet

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• cites Piet et al. 2012 sourceNot checked yet

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Classified as probably not a substantial claim.

Adverse effects are sometimes narrowly defined, drawing on definitions from medical research, such that general deterioration in mental state or the appearance of new psychological symptoms might not be included.

“Second, adverse effects are sometimes narrowly defined, drawing on definitions from medical research, such that general deterioration in mental state or the appearance of new psychological symptoms might not be included (Duggan et al. 2014).”

• cites Duggan et al. 2014 sourceNot checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The questions about unpleasant experiences and harm were added to two larger studies, each designed for its own purposes and using different outcome measures.

“Fourth, the questions about unpleasant experiences and harm were added to two larger studies, each designed for its own purposes (described elsewhere) and using different outcome measures.”

May combine two claims.

These percentages are also similar to those reported in the psychotherapy literature, which has consistently found that between 3 and 10% of clients show deterioration in symptoms or functioning, and in the meditation literature, where adverse events were reported in 0-10.6% of participants.

“These percentages are also similar to those reported in the psychotherapy literature, which has consistently found that between 3 and 10% of clients show deterioration in symptoms or functioning (Lambert 2013), and in the meditation literature, where Baer et al. (2019) found that adverse events were reported in 0–10.6% of participants.”

• cites Lambert 2013Not checked yet

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• cites Baer et al. 2019 sourceNot checked yet

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May combine two claims.

These percentages are consistent with the findings for deterioration on the symptom questionnaires: 2% for depression and 6% for anxiety in study 1 (reliable but not clinical deterioration), and 4-7% for global distress in study 2 (reliable and clinical deterioration).

“These percentages are consistent with the findings for deterioration on the symptom questionnaires: 2% for depression and 6% for anxiety in study 1 (reliable but not clinical deterioration), and 4–7% for global distress in study 2 (reliable and clinical deterioration).”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.

Such experiences are expected because establishing a regular practice is difficult and because mindfulness practice cultivates increased awareness of whatever is happening in the present, whether it is pleasant, unpleasant, or neutral.

“Such experiences are expected because establishing a regular practice is difficult and because mindfulness practice cultivates increased awareness of whatever is happening in the present, whether it is pleasant, unpleasant, or neutral.”

May combine two claims.

Although both samples included some participants with significant mental health symptoms, the study used general population samples and findings may not generalize to clinical populations.

“First, although both samples included some participants with significant mental health symptoms, the study used general population samples and findings may not generalize to clinical populations.”

Classified as probably not a substantial claim.

Our findings add to the literature on unpleasant and harmful effects of MBPs by asking participants in two samples about their experiences with such effects using open-ended opportunities to describe them in combination with Likert scales.

“In summary, our findings add to the literature on unpleasant and harmful effects of MBPs by asking participants in two samples about their experiences with such effects using open-ended opportunities to describe them in combination with Likert scales.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

The minimal overlap between participants who reported that the MBP was harmful and those showing reliable deterioration on symptom questionnaires suggest that the experience of harm is not necessarily captured by outcome questionnaires and should be explicitly assessed in other ways.

“Moreover, the minimal overlap between participants who reported that the MBP was harmful and those showing reliable deterioration on symptom questionnaires suggest that the experience of harm is not necessarily captured by outcome questionnaires and should be explicitly assessed in other ways.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

Probably not a substantial claim: may not pass S3 (load-bearing).

The study was not designed to investigate sources of harm.

“Third, the study was not designed to investigate sources of harm.”

Classified as probably not a substantial claim. May combine two claims.

The questions we developed for this study asked only about unpleasant and harmful experiences and included no questions about pleasant experiences or benefits.

“The questions we developed for this study asked only about unpleasant and harmful experiences and included no questions about pleasant experiences or benefits.”

May combine two claims.

Most participants who reported unpleasant experiences rated them as not at all or only somewhat upsetting, suggesting that they found these difficulties to be manageable.

“Most participants who reported unpleasant experiences rated them as not at all or only somewhat upsetting, suggesting that they found these difficulties to be manageable.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

May combine two claims.

Our findings suggest that self-criticism and negative emotions about mindfulness practice occur despite the fact that teachers attempt to work constructively with difficulties in finding time to practice and often say that there are no right or wrong experiences during mindfulness meditation.

“Our findings also suggest that self-criticism and negative emotions about mindfulness practice occur despite the fact that teachers attempt to work constructively with difficulties in finding time to practice and often say that there are no right or wrong experiences during mindfulness meditation.”

• AssumptionRests on an assumption: The set of questions used to assess unpleasant experiences and harm is a valid measure of those constructs.

Probably not a substantial claim: may not pass S3 (load-bearing).

Baer et al. (2019) reviewed the literature on harm in MBPs and suggested three potential sources of harm which are likely to be interacting: program factors, participant factors, and teacher factors.

“Baer et al. (2019) reviewed the literature on harm in MBPs and suggested three potential sources of harm which are likely to be interacting: program factors, participant factors, and teacher factors.”

• cites Baer et al. 2019 sourceNot checked yet

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