Table 4.
Summary of Findings Table using the GRADE Rating System
| Certainty assessment | Summary of findings | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Outcome | Number of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | Overall certainty of evidence | Mindfulness intervention n | Control n | Relative effect (95% CI) | Absolute effect (95% CI) |
| Mindfulness training program vs. active control | ||||||||||||
| Self-report anxiety | 2 | RCT | Seriousa | Very seriousb | Seriousc | Seriousd | Not suspectede | ⨁◯◯◯ VERY LOW | 109 | 102 | - | SMDf 0.31 lower (0.90 lower to 0.28 higher) |
| Clinician-rated anxiety | 1 | RCT | Seriousg | N/Ah | Seriousc | Not seriousi | N/Aj | ⨁⨁◯◯LOW | 48 | 41 | - | Gk 0.28 lower (0.13 lower to 0.70 higher) |
| Self-report depression | 1 | RCT | Seriousl | N/Ah | Seriousc | Not seriousi | N/Aj | ⨁⨁◯◯LOW | 61 | 61 | - | Gk 0.45 higher (0.10 higher to 0.81 higher) |
| Self-report worry | 2 | RCT | Seriousm | Not serious | Seriousc | Seriousd | Not suspectede | ⨁◯◯◯VERY LOW | 80 | 80 | - | SMDf 0.07 higher (0.26 lower to 0.40 higher) |
| Self-report trait mindfulness | 2 | RCT | Seriousn | Very seriousb | Seriousc | Seriousd | Not suspectede | ⨁◯◯◯ VERY LOW | 80 | 80 | - | SMDf 0.16 higher (0.56 lower to 0.87 higher) |
| Self-report decentering | 1 | RCT | Not seriouso | N/Ah | Seriousc | Not seriousi | N/Aj | ⨁⨁⨁◯ MODERATE | 19 | 19 | - | gk 1.31 higher (0.62 higher to 2.00 higher) |
| Blood markers of acute stress | 1 | RCT | Seriousp | N/Ah | Seriousc | Not seriousq | N/Aj | ⨁⨁◯◯ LOW | 42 | 28 | - | Not estimable. Significant mindfulness training gains found for three measures |
|
Amygdala fMRI |
1 | RCT | Seriousp | N/Ah | Seriousc | Seriousr | N/Aj | ⨁◯◯◯ VERY LOW | 15 | 11 | - | Not estimable. Significant mindfulness training gains found for amygdala connectivity with frontal regions |
|
Frontal cortex fMRI |
1 | RCT | Seriousp | N/Ah | Seriousc | Seriousr | N/Aj | ⨁◯◯◯ VERY LOW | 15 | 11 | - | Not estimable. Significant mindfulness training gains found for activation in frontal regions |
| Mindfulness training program vs. inactive or non-specified control | ||||||||||||
| Self-report anxiety | 3 | RCT | Very seriouss | Very seriousb | Seriousc | Not seriousi | Not suspectede | ⨁◯◯◯ VERY LOW | 109 | 103 | - | SMDf 1.92 lower (3.44 lower to 0.40 lower) |
| Self-report depression | 3 | RCT | Very seriouss | Very serioust | Seriousc | Seriousd | Not suspectede | ⨁◯◯◯ VERY LOW | 109 | 103 | - | SMDf 1.19 lower (3.11 lower to 0.73 higher) |
| Self-report worry | 2 | RCT | Very seriouss | Very seriousb | Seriousc | Seriousd | Not suspectede | ⨁◯◯◯ VERY LOW | 77 | 71 | - | SMDf 2.27 lower (6.32 lower to 1.79 higher) |
| Self-report trait mindfulness | 2 | RCT | Seriousu | Very seriousb | Seriousc | Not seriousi | Not suspectede | ⨁◯◯◯ VERY LOW | 93 | 88 | - | SMDf 0.85 higher (0.04 lower to 1.74 higher) |
|
Default Mode Network fMRI |
1 | Non-randomised within-subjects waitlist control | Not seriousv | N/Ah | Seriousc | Not seriousw | N/Aj | ⨁⨁⨁◯ MODERATE | 32 | 32 | - | Not estimable. Significant mindfulness training gains found for connectivity within DMN regions |
aEvidence was downgraded by 1 level because the overall risk of bias was rated as high in both studies, mainly due to missing outcome data, and there were some concerns in both studies
bEvidence was downgraded by 2 levels as p < .050 and I2 > 75%, indicating considerable heterogeneity
cEvidence was downgraded by 1 level as there was not the availability of samples defined by sub-clinical symptoms of anxiety (e.g., generalised anxiety symptoms, trait anxiety) or trials that used a non-manualised or ‘stand-alone’ mindfulness intervention
dDowngraded one level as pooled sample size meets power estimate but CI found to be wide (i.e., upper or lower limit cross SMD of 0.5 in both directions)
eEgger’s test could not be conducted but publication bias was not strongly suspected as both negative and positive trial publications were found for outcomes, and a comprehensive search for studies was employed
fSMD is the pooled estimate derived from the meta-analysis
gEvidence was downgraded by 1 level because the overall risk of bias was rated as high due to missing outcome data
hOnly one study is available for this outcome and therefore inconsistencies cannot be considered
iPooled sample size meets power estimate and CI not found to be wide (i.e., upper or lower limit do not cross SMD of 0.5 in either direction)
jCannot be assessed due to availability of only 1 study
kg is derived from calculations using data available in the study article
lEvidence was downgraded by 1 level, mainly due to missing outcome data
mEvidence was downgraded by 1 level because the overall risk of bias was rated as high in one study, mainly due to missing outcome data, and there were some concerns in both studies
nEvidence was downgraded by 1 level because the overall risk of bias was rated as high in one study, mainly due to missing outcome data, and there were some concerns in both studies
oEvidence was not downgraded as risk of bias due to the lack of a pre-analysis plan was deemed unlikely to lower confidence in the estimate of effect for the outcome of interest
pEvidence was downgraded by 1 level, mainly due to missing outcome data
qSample size meets power estimate. Numerical value for CI not available but graph in journal article shows CI is not wide (do not cross mean difference of 0.5 in either direction)
rCI not available but sample size does not meet power estimate
sEvidence was downgraded by 2 levels because the overall risk of bias was rated as high in two studies, mainly due to missing outcome data, and there were some concerns in all studies. One study had a high risk of bias or some concerns in all domains
tEvidence was downgraded by 2 levels as p < .050 and I2 > 75%, indicating considerable heterogeneity. When an outlier study that did not specify the control that was used was removed from the meta-analysis, heterogeneity was no longer observed
uEvidence was downgraded by 1 level, mainly due to missing outcome data
vEvidence was not downgraded as risk of bias due to confounding or the lack of a pre-analysis plan was deemed unlikely to lower confidence in the estimate of effect for the outcome of interest
wCI not available but sample size meets power estimate