Research Paper

How do placebo effects contribute to mindfulness-

based analgesia? Probing acute pain effects and
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interactions using a randomized balanced

placebo design
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Jonathan N. Daviesa,b,*, Louise Sharpea, Melissa A. Dayb,c, Ben Colagiuria

Abstract
Recent sham-controlled studies suggest placebo effects contribute to acute pain relief after mindfulness interventions. However, the
specific effects of mindfulness processes and their interaction with placebo effects remain unclear. This study aimed to characterize
the role of mindfulness and placebo processes underlying mindfulness-based pain attenuation. Both treatment (focused attention
mindfulness vs sham) and instruction (told mindfulness vs told sham) were manipulated in a balanced placebo design. Changes in
acute heat pain were evaluated in 153 healthy adults randomized to receive 6 3 20 minutes of 1 of 4 treatment by instruction
interventions or no treatment. Participants receiving any intervention demonstrated improved pain outcomes (unpleasantness,
intensity, and tolerance) relative to those receiving no treatment. The instruction manipulation increased expectation for pain relief in
those told mindfulness relative to those told sham, but there were no main effects or interactions of treatment or instruction on pain
outcomes. However, irrespective of actual intervention received, the belief of receiving mindfulness predicted increased pain
threshold and tolerance, with expectancy fully mediating the effect on pain tolerance. These findings suggest a lack of specific
effects of mindfulness and instruction on acute pain. Nonetheless, participants’ expectancies and beliefs about the treatment they
received did predict pain relief. Together with the overall improvement after any intervention, these findings suggest that expectancy
and belief may play a stronger role in attenuating acute pain in novices following brief mindfulness interventions than the actual
mindfulness-specific processes or instructions delivered.
Keywords: Sham mindfulness, Placebo effect, Placebo analgesia, Balanced placebo design, Expectancy, Acute pain, Pain
intensity, Pain tolerance, Pain unpleasantness, RCT

1. Introduction outcomes.9 Studies of placebo analgesia demonstrate well-

Mindfulness is a popular treatment for acute32 and chronic
pain.22 Recent reviews32 and meta-analyses40 in acute clinical
and experimental pain suggest mindfulness-based interventions
increase pain threshold and tolerance, with mixed evidence for
pain intensity and pain-related distress. However, most trials of
mindfulness for acute pain do not include sham control
conditions, meaning the contribution of placebo effects is poorly
understood.
Sham control conditions are essential for controlling for
nonspecific effects, particularly the placebo effect.15,43 Placebo
effects arise when the expectation of benefit, rather than specific
components of treatment, drives improvements in health
a
School of Psychology, University of Sydney, Sydney, Australia, b School of
Psychology, University of Queensland, Brisbane, Australia, c Department of
Rehabilitation Medicine, University of Washington, Seattle, WA, United States
*Corresponding author. Address: School of Psychology, A18 University of Sydney,
NSW 2006, Australia. Tel.: 161 2 9351 7950; fax: 161 2 9351 2603. E-mail
address: jndavies.au@gmail.com (J.N. Davies).
Supplemental digital content is available for this article. Direct URL citations appear
in the printed text and are provided in the HTML and PDF versions of this article on
the journal’s Web site (www.painjournalonline.com).
PAIN 163 (2022) 1967–1977
© 2022 International Association for the Study of Pain
http://dx.doi.org/10.1097/j.pain.0000000000002593
characterized effects of expectancy on reducing pain intensity
and increasing pain threshold and tolerance.28,39 We recently
developed a sham mindfulness intervention and found that it
produced similar improvements in acute experimental pain to an
established mindfulness intervention.12 Other researchers have
found that both mindfulness and sham reduce pain unpleasant-
ness and intensity, relative to no treatment,46 with some evidence
that mindfulness may be superior at reducing pain unpleasant-
ness.45 Such findings suggest placebo effects contribute to
improvements in acute pain after mindfulness training, with
possible additive effects of mindfulness processes and placebo
processes on pain unpleasantness. However, the specific effects
of mindfulness training in the presence and absence of
expectancy have not been explored.
Balanced placebo designs provide a method of disentangling
active treatment effects from placebo effects.4,10 In this design,
both treatment (active vs sham) and instruction (told active vs told
sham) are manipulated in a 2 3 2 factorial design (see Fig. 1) to
create 4 unique interventions: active with expectancy, active
without expectancy, sham with expectancy, and sham without
expectancy. This allows the specific effects of the active
treatment (which should be effective irrespective of expectancy)
to be distinguished from those of the sham (which should only be
effective with expectancy) and whether the sum of these effects
adds quantitatively without interaction (purely additive), is less

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J.N. Davies et al. 163 (2022) 1967–1977
than the sum of these effects in isolation (subadditive), or greater
than (superadditive) the sum of these effects in isolation (for
review, see Refs. 4 and 10). Balanced placebo designs have been
used to study analgesic medications2,37 and mindfulness for
cognitive function,38 but have never been applied to mindfulness
for pain.
This study sought to disentangle mindfulness and placebo
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effects in acute experimental pain using a balanced placebo
design. Three possible, nonmutually exclusive outcomes were
considered. First, if mindfulness has unique effects on pain
outcomes and these are additive with placebo effects, then
receiving mindfulness training should improve pain outcomes
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relative to receiving sham training, irrespective of instructions.
Second, if mindfulness training is purely driven by placebo
effects, then the belief of receiving mindfulness training (ie, told
mindfulness) should improve pain outcomes relative to the belief
of receiving sham training (ie, told sham), irrespective of actual
training. Third, if mindfulness and placebo effects are non-
additive, then an interaction should emerge whereby the efficacy
of mindfulness for improving pain outcomes depends on the
instructions.
2. Methods
2.1. Preregistration
The study was preregistered in the Australian New Zealand
Clinical Trials Registry (ACTRN12619000537156).
2.2. Design
The study was a double-blind, 5-arm, parallel-group, randomized
trial in a mixed 5 3 (2) design with intervention (between-subjects)
and time (pretreatment vs posttreatment, within-subjects) as factors.
The balanced placebo design was nested within the 5-level
intervention factor. As shown in Figure 1, across 4 of the groups,
treatment (mindfulness vs sham) and instruction (told mindfulness vs
told sham) were manipulated in a 2 3 2 factorial design to create 4
unique interventions: mindfulness with expectancy (MM1; ie,
mindfulness treatment and told mindfulness), mindfulness without
expectancy (MM2; ie, mindfulness treatment and told sham),
SHAM1 (ie, sham treatment and told mindfulness), and SHAM2 (ie,
sham treatment and told sham), with an additional comparison
against a no treatment control (NTC) group.
2.3. Participants
One hundred fifty-three healthy young adults completed the
study, receiving partial course credit (n 5 90) or AUD$50 (n 5 63)
for their participation. Participants receiving credit were first-year
undergraduate psychology students. Paid participants were
recruited through the university community, of which approxi-
mately half were also university students. To be included,
participants had to be fluent in English, pain free (,3/10 on a
numeric rating scale), and mindfulness naive (,20 minutes
practice per week over the past 6 months; never attended a
mindfulness course, eg, mindfulness-based stress reduction and
Vipassana) and not be pregnant, breastfeeding, or taking
analgesic or psychotropic medications. We excluded participants
reporting an average of less than 3/10 for a P50 stimulus (ie, 50%
of their pain tolerance) to avoid potential floor effects in
subsequent pain perception testing. All participants provided
informed consent, acknowledging that they would receive painful
heat stimuli and they were free to withdraw from the study at any
Copyright © 2022 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.
PAIN®
time. Data were collected in the period between March 2019 and
November 2019 at the School of Psychology, University of
Sydney. All procedures were approved by University of Sydney
Human Research Ethics Committee (HREC 2017/640).
2.4. Intervention conditions
The intervention included 6 3 20-minute daily sessions of audio-
guided training. This was delivered as a balanced placebo design
that systematically manipulated treatment (mindfulness vs sham)
and instruction (told mindfulness vs told sham), alongside a NTC
group (Fig. 1). Sessions 1 and 6 were completed in the
laboratory, whereas sessions 2, 3, 4, and 5 were completed as
home practice. Adherence was monitored (through the Qualtrics
system) to ensure that differences in treatment dose did not
influence intervention effects across groups. Participants were
deemed a priori not to have completed a home practice session
when surveys were incomplete, completed in less than 20
minutes, or more than 45 minutes.
2.4.1. Treatment manipulation (mindfulness vs sham)
We used the mindfulness and sham mindfulness interventions
that were developed and evaluated in an earlier study (see Ref. 12
for full details). In brief, the mindfulness intervention used an
established focused attention meditation practice (mindfulness of
breath and body)13 that has been shown to attenuate acute pain
unpleasantness and intensity in experimental settings.19,46 This
practice aims to teach participants to develop attentional stability
and build mindful meta-awareness by focusing attention on the
sensations of the breath and body with a sense of openness,
acceptance, and nonjudgement. The sham mindfulness in-
tervention was specifically developed to be structurally equivalent
to the mindfulness of breath and body practice while lacking
mindfulness-specific instruction in developing attentional stability
and mindful meta-awareness. Sham instructions vaguely en-
couraged participants to stay in the here and now and to come
back to the present moment as they sit in mindfulness meditation.
Our earlier evaluation of the sham suggested that it closely
matched the bona fide mindfulness practice regarding credibility
and expectancy while remaining inert to mindfulness pro-
cesses.12 The NTC group completed a filler task during laboratory
visits (listening to podcasts) to maintain experimenter blinding,
but these participants completed no additional home practice.
2.4.2. Instruction manipulation (told mindfulness vs told
sham)
An additional instruction manipulation was performed such that
participants were told they had been allocated to either a newly
developed mindfulness intervention that was expected to be highly
effective for pain or a sham mindfulness intervention that lacked
specific active elements of the new mindfulness intervention and that
therefore would be relaxing but should not have any effect on pain.
The intention of this instruction manipulation was to manipulate
expectancy such that those told mindfulness would expect greater
reductions in pain than those told sham.
2.5. Materials and measures
2.5.1. Sham credibility
We assessed sham credibility with 2 manipulation checks during
the second laboratory visit after posttreatment testing was
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completed. The first manipulation check assessed perceived

treatment allocation, “I think I am in the ….. group” with 4
response options: mindfulness, sham (placebo) mindfulness, no
treatment, and not sure. The second manipulation (credibility)
check assessed whether participants believed they were re-
ceiving mindfulness, “Did your training include mindfulness?” with
3 response options: yes, no, and not sure.
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2.5.2. Pain
We evaluated pretreatment to posttreatment changes in self-report
measures of pain unpleasantness (primary outcome) and pain
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intensity and sensory measures of threshold and tolerance (second-

ary outcomes) in response to an established12 experimental model of
thermal heat pain. The experimental pain paradigm included a series
of 12 heat stimuli (described further) to the participant’s nondominant
medial forearm, midway between the wrist and elbow. The stimulus
was delivered by a Medoc Pathway device using a 27-mm diameter
CHEPS thermal probe (Medoc, Israel).
2.5.2.1. Pain threshold and tolerance
Pain threshold and tolerance were assessed first by the method
of limits using a series of 6 ramping (0.5˚C/second) stimuli during
which the participant clicked a button to indicate their pain
threshold (ie, when they first felt any pain; first 3 trials) or pain
tolerance (when they felt they could no longer tolerate the pain;
last 3 trials).
2.5.2.2. Pain unpleasantness and intensity
Pain unpleasantness and intensity ratings were calculated as the
mean of 3 P50 stimuli (ie, midpoint between each participant’s
threshold and tolerance) that ramped at 2˚C/second and plateaued
at the target temperature for 4 seconds before a 10˚C/second return
to baseline. After each trial, participants were asked to rate the
unpleasantness and intensity of the preceding stimulus on an 11-
point pain visual analogue scale with scores ranging from 0 (no pain/
not at all unpleasant) to 10 (most intense pain imaginable/most
unpleasant pain imaginable). The analogy of listening to a song on
the radio was used to help participants differentiate between
intensity (the volume the song is playing at) and unpleasantness (how
the song makes you feel).46 The 3 P50 (target) stimuli were flanked by
3 additional stimuli delivered in the following order: (1) low (pain
threshold minus 1˚C); (2) P50; (3) neutral (32˚C); (4) P50; (5) high (pain
tolerance); and (6) P50. The additional 3 stimuli served to make the
target stimuli seem less predictable.
Figure 1. Balanced placebo design. Balanced placebo designs allow for the
systematic manipulation of both treatment and instruction (expectation) to
characterize the individual, additive and interactive contributions of the active
treatment, and the placebo effect. In this study, participants received either the
active treatment (mindfulness, MM) or placebo (sham mindfulness, SHAM).
Instruction was also manipulated such that participants were either told they
were receiving the active treatment (which was expected to have a strong
effect on reducing pain, 1) or told they were receiving the sham treatment
(which was not expected to have an effect on pain, 2). This resulted in 4 unique
active interventions: MM1 (get mindfulness, told mindfulness); MM2 (get
mindfulness, told sham), SHAM1 (get sham, told mindfulness), and SHAM2
(get sham, told sham), which were compared against each other and an
additional no treatment control (NTC) group. MM1, mindfulness with
expectancy; MM2, mindfulness without expectancy; SHAM1, sham with
expectancy; SHAM2, sham without expectancy.
scale used to assess changes in 5 facets of mindfulness:
observing, describing, acting with awareness, nonjudging of
inner experience, and nonreactivity to inner experience.3 The
short-form version has adequate internal consistency (Cronbach
a 5 0.69-0.83) and consistent factor structure relative to the
longer FFMQ-39 scale.20 In this study, Cronbach a ranged from
0.81 (observing) to 0.87 (nonjudging). Higher subscale (out of 15)
scores indicate increased skill in specific facets of mindfulness.
2.6.3. Pain catastrophizing
Pain catastrophizing was measured at baseline as a potential
confound. The Pain Catastrophizing Scale41 is a 13-item
questionnaire used to assess responses to pain based on past
painful experiences. It has adequate to excellent internal
consistency (a 5 0.87).34,35 Higher total (out of 52) scores
indicate a higher propensity to catastrophize pain.

2.6. Expectancy, mindfulness, and process measures

2.6.1. Expectancy
Expectancy was measured twice (following Kirsch conceptualiza-
tion23) to capture: 1. general response expectancy (hereinafter general
expectancy) at baseline (“How effective do you think mindfulness
meditation is for reducing pain?”; 100-point Visual Analogue Scale
[VAS]); and 2. specific response expectancy (hereinafter specific
expectancy; ie, predictions of one’s own automatic responses to
those events) again immediately after the final (sixth) training session
but before the final pain test (“How effective do you think your training
will be for reducing pain?”; 100-point VAS).
2.6.2. Mindfulness
Mindfulness processes were measured using the Five Facet
Mindfulness Questionnaire short-form (FFMQ-15), a 15-item
2.6.4. Pain-related cognitive processes, depression, anxiety,
and stress
Pain-related cognitive processes, depression, anxiety, and stress
were preregistered outcomes as part of broader aims to explore
generalized effects and mechanisms of mindfulness vs sham;
however, results were unremarkable and are reported in
Supplementary Material for the sake of brevity (available as
supplemental digital content at http://links.lww.com/PAIN/
B570).
2.7. Procedure
The study involved a cover story to maintain participant blinding
and allow investigation of the placebo effect. Details of the cover
story and actual study are described further.

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Figure 2. Participant flow diagram. Participants were randomized to receive 1 of 5 interventions: MM1 (get mindfulness, told mindfulness); MM2 (get mindfulness,
told sham); SHAM1 (get sham, told mindfulness); SHAM2 (get sham, told sham); or NTC (no treatment control). LTFU, loss to follow-up; MM1, mindfulness with
expectancy; MM2, mindfulness without expectancy; SHAM1, sham with expectancy; SHAM2, sham without expectancy.

2.7.1. Cover story (3 groups)
The cover story that was described to participants suggested that
the aim of the study was to evaluate a new evidence-based
mindfulness technique that the researchers had developed that
was expected to be highly effective for reducing pain because it
integrated the most effective elements of several existing
mindfulness-based interventions for pain. It further suggested
that participants would be randomized to receive 1 of 3 (not 5)
conditions: (1) mindfulness (highly effective for pain), (2) sham
mindfulness (no expected effect on pain), or (3) no treatment (not
at all effective for pain). The cover story was reiterated to
participants during orientation, then again on randomization to
their group (as per cover story), and then again before each of the
6 training sessions (described further). Thus, as far as participants
were concerned, they received either mindfulness, sham, or no
treatment, with no knowledge that the information they received
was also being manipulated.
2.7.2. Actual study (5 groups)
Although mindfulness, sham, and no treatment were actual
conditions in the study, the balanced placebo design entailed an
additional instruction manipulation for the 2 active treatments
(mindfulness and sham) regarding what they were told (see
Fig. 1).
Those who were told they were receiving mindfulness were
further randomized to 1 of 2 groups: (1) MM1 (ie, they were told
they were receiving mindfulness and actually received mindful-
ness, congruent with cover story), or (2) MM2 (ie, they were told
they were receiving sham, but actually received mindfulness,
incongruent with cover story). These 2 manipulations allowed us
to probe the interaction between mindfulness-specific processes
in the presence and absence of expectancy.
Similarly, those who were told they were receiving sham were
further randomized to 1 of 2 groups: (1) SHAM1 (ie, told they
were receiving mindfulness, but actually received sham, in-
congruent with cover story), or (2) SHAM2 (ie, told they were
receiving sham, and actually received sham, congruent with
cover story). These 2 manipulations allowed us to probe
generalized placebo processes in the presence and absence of
expectancy.
Participants were not asked about what group they believed they
were in until after the postintervention pain test and self-report
outcomes had been completed to avoid unblinding. All 6 sessions of
the 4 active manipulations were delivered as audio recordings, voiced
by the same experienced mindfulness instructor.
2.7.3. Session 1—baseline
Participants individually attended an initial 45-minute laboratory
session at baseline. After providing informed consent, they completed
baseline measures of mindfulness, expectancy, pain catastrophizing,
pain-related cognitive processes, and depression, anxiety, and stress
on a computer running a custom Inquisit v5.0 script (Millisecond
Software, Seattle, WA). Next, participants completed the baseline
pain assessment. Participants were then randomly allocated to 1 of
the 5 conditions and underwent the first of 6 audio-guided training
sessions. Instructions displayed on the computer screen (and
reiterated in a short audio introduction) revealed the group allocation
to the participant (ie, mindfulness, sham mindfulness, or no treatment,
as per cover story) without the researcher’s knowledge (to maintain
experimenter blinding). Participants then completed 20 minutes of
training in 1 of the 4 active interventions (MM1, MM2, SHAM1,
SHAM2) or a filler task (NTC), delivered through Inquisit.
2.7.4. Home practice
The next 4 3 20-minute training sessions were completed as home
practice. This was delivered through the Qualtrics survey platform that
sent each participant custom emails with a unique survey link each
day between laboratory sessions 1 and 2. To maintain researcher
blinding, NTC participants were also required to complete 4 3
surveys; however, these surveys contained no audio training so could
be completed in under a minute. The Qualtrics system allowed the
researchers to monitor adherence, and participants were contacted
up to 3 times if they missed 2 days of practice/surveys.
2.7.5. Session 2—posttreatment
Participants then attended a second 45-minute laboratory session.
During this visit, they completed the sixth and final training session (or
second and final filler session) as described earlier and then repeated
pain testing (using baseline P50 stimulus values) and self-report

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 October 2022
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Table 1
Baseline sample characteristics by intervention group.
MM1 MM2 SHAM1 SHAM2 NTC Test statistic P
Sample size (n) 30 31 31 31 30
Psychology 19 (63%) 16 (52%) 19 (61%) 18 (58%) 18 (60%) x(2) 5 1.02 0.907
Paid 11 (37%) 15 (48%) 12 (39%) 13 (42%) 12 (40%)
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Age (y)
(SD) 22.93 (6.29) 22.68 (6.07) 23.68 (6.28) 24.23 (10.57) 20.63 (2.11) F 5 1.22 0.304
Range 18-45 18-42 18-45 18-60 18-25
Sex
Male 9 (30%) 8 (26%) 6 (19%) 10 (32%) 9 (30%) x(2) 5 1.62 0.806
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Female 21 (70%) 23 (74%) 25 (81%) 21 (68%) 21 (70%)

Training
No. sessions (SD) 5.27 (1.02) 4.77 (0.96) 4.90 (1.27) 4.94 (1.26) — F 5 1.03 0.381
MM1, mindfulness with expectancy; MM2, mindfulness without expectancy; SHAM1, sham with expectancy; SHAM2, sham without expectancy.

outcome measures of mindfulness, expectancy, and pain-related
cognitive processes.
2.8. Sample size, randomization, and blinding
Our sample size of 30 participants per arm was based on power
analyses of recent studies of mindfulness vs active control on acute
experimentally induced pain.12,27,30,45,46,48 These studies had a mean
effect size of d 5 0.899 for pain unpleasantness (primary outcome)
and d 5 0.514 for pain intensity (secondary outcome). To be
conservative, we used the smaller of these (ie, d 5 0.514) to calculate
sample size. This indicated that 28 participants per group would be
required to have 90% power to detect a significant effect of
mindfulness vs sham of this magnitude. We therefore aimed to recruit
30 participants per group to allow for 5% to 10% attrition. We
generated a randomization sequence in a 1:1:1:1:1 allocation ratio
using block randomization, where each participant was randomly
assigned to 1 of 10 equally sized, predetermined blocks (consisting 2
3 5 group allocations), created using a computerized random
sequence generator seeded by the computer’s clock (https://www.
randomizer.org). This allocation sequence was concealed in sequen-
tially numbered opaque sealed envelopes by a researcher not involved
in the running of the experiment (B.C.). Once participants completed
baseline measures, one of the researchers opened the next envelope
in the sequence to reveal the participant’s group allocation number,
which was entered into Inquisit to automatically assign participants to
their relevant treatment group without the researcher’s knowledge. To
further ensure researcher blinding, the randomization codes were not
revealed until the final analyses were completed by J.N.D. Therefore,
the study involved researcher and analyst blinding.
2.9. Data handling and statistical analysis
Chi-squared and one-way analysis of variance tests were used to
compare baseline characteristics across the 5 groups. Primary,
secondary, and process outcomes across groups at posttreat-
ment were analysed using one-way, 5-level analysis of co-
variance tests with intervention (MM1, MM2, SHAM1, SHAM2,
and NTC) as the independent variable and baseline score on the
relevant outcome as a covariate. Orthogonal contrast analyses
were used to compare changes across groups. These contrasts
created a nested 2 3 2 analysis of variance to test the main
effects and interactions of treatment (mindfulness vs sham) and
instruction (told mindfulness vs told sham), as well as an
additional contrast comparing the effect of any intervention vs
no treatment. Specifically, the orthogonal contrasts tested the
following: (1) Whether receiving any intervention differed from no
treatment ([MM1 and MM2 and SHAM1 and SHAM2] vs NTC);
(2) whether there was an effect of treatment independent of
expectancy (mindfulness vs sham; [MM1 and MM2] vs [SHAM1
and SHAM2]); (3) whether there was an effect of instruction
independent of treatment (told mindfulness vs told sham; [MM1
and SHAM1] vs [MM2 and SHAM2]); and (4) whether there was
an interaction between treatment and instruction. Any demo-
graphic or baseline measures that differed between the 5 groups
(P , 0.1) were included as covariates in these analyses. Where
any significant differences were found between the 5 groups on
pain outcomes, we conducted mediator analysis (using the
PROCESS model21) with the relevant contrast as the indepen-
dent variable and process measures including mindfulness and
specific expectancy as the mediators. Four steps were required
to demonstrate mediation: first, that the independent variable
predicted the mediator; second, that the independent variable
predicted the outcome; third, that the mediator predicted the
dependent variable when controlling for the independent variable;
and fourth (to show full mediation), that the independent variable
no longer predicted the dependent variable when controlling for
the mediator. For the abovementioned steps, significance was
set at a 5 0.05 for direct paths and 95% confidence intervals (CIs)
based on 5000 bootstrapping resamples for indirect paths. All
analyses were conducted in SPSS v24 (IBM, Chicago, IL) with
significance set at P , 0.05. All analyses were specified at
preregistration and conducted blind to group allocation.
3. Results
3.1. Participant flow
As depicted in the Figure 2 161 individuals expressed interest and
were assessed for eligibility. Six of these individuals were excluded a
priori because of insensitivity to the painful stimulation during baseline
(ie, having average pain intensity rating of less than 3/10). This meant
that 155 participants entered the study and were randomized to 1 of
the 5 groups. Two participants were subsequently excluded, 1
because of equipment failure and the other because of withdrawal,
leaving a total of 153 participants (30-31 per group) who completed
the study and were included in the final analyses.
3.2. Baseline data
As summarized in Table 1, there were no statistically significant
differences in sample demographics across groups. As summarized
in Table 2, the only baseline measure that differed statistically between

Copyright © 2022 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.
 1972
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J.N. Davies et al. 163 (2022) 1967–1977 PAIN®

groups was the describing facet of mindfulness (F(1,145) 5 2.97, P 5

* NB, expectancy was measured using 2 distinct constructs: general response expectancy (measured preintervention) and specific response expectancy (measured immediately after the final training session but before postintervention pain testing). FFMQ, Five Facet Mindfulness Questionnaire short-form;
43.11 (1.98)
47.67 (1.73)

10.83 (2.15)
4.72 (1.76)
4.98 (1.56)

18.2 (22.6)

9.40 (1.85)
9.10 (2.35)
8.70 (2.40)
8.87 (1.83)
0.021). However, as prespecified, because baseline pain unpleas-
Post
antness had a P value ,0.1, both pain unpleasantness and describing
were used as covariates in the main (ie, pain) analyses. Sensitivity
analysis indicated that the pattern of results was identical when these
covariates were omitted. Full baseline data are available in
43.35 (1.60)
47.76 (1.70)

11.07 (1.96)
Supplementary Table S1 (available at http://links.lww.com/PAIN/
4.73 (1.37)
5.11 (1.02)

65.3 (15.0)

9.17 (2.20)
9.73 (1.89)
9.63 (2.46)
9.77 (2.00)
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B570).
NTC
Pre

3.3. Pain
3.3.1. Pain unpleasantness and intensity
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43.30 (1.93)
47.95 (1.69)

10.68 (2.14)
10.81 (2.52)

10.06 (2.76)
4.06 (1.71)
4.28 (1.52)

43.7 (20.1)

9.16 (1.99)

9.29 (2.34)
Figure 3 and Table 2 present pretreatment and posttreatment pain
Post

unpleasantness (primary outcome) and pain intensity (secondary

outcome) across groups. For pain unpleasantness, receiving any
intervention significantly reduced pain unpleasantness relative to no
treatment (F(1,145) 5 5.53, P 5 0.02, h2p 5 0.04, d 5 0.39); however,
43.02 (1.60)
47.57 (1.52)

10.58 (2.06)
10.35 (2.36)

10.03 (2.69)
4.59 (1.59)
5.07 (1.01)

64.8 (16.3)

8.71 (2.04)

9.35 (1.92)

there were no main effects of either treatment (mindfulness vs sham:

SHAM2

F(1,145) 5 1.03, P 5 0.31, h2p 5 0.01, d 5 0.17) or instruction (told

Pre

mindfulness vs told sham: F(1,145) 5 0.09, P 5 0.77, h2p ,

0.001, d 5 0.06) and no interaction effect between treatment and
instruction (F(1,145) , 0.001, P 5 0.95, h2p , 0.001, d , 0.01).
42.83 (1.95)
47.67 (1.71)

11.06 (1.65)
10.52 (1.73)

10.97 (2.92)

Similarly, for pain intensity, receiving any intervention significantly

3.81 (1.73)
4.23 (1.54)

67.6 (21.6)

9.68 (2.14)

9.58 (2.06)

reduced pain intensity relative to no treatment (F(1,145) 5 4.27, P 5

0.041, h2p 5 0.03, d 5 0.35); however, there were also no main effects
Post

of either treatment (F(1,145) 5 1.01, P 5 0.32, h2p 5 0.01, d 5 0.17) or

Pretreatment and posttreatment mean values and standard deviations for pain and process outcomes.

instruction (F(1,145) 5 0.12, P 5 0.735, h2p , 0.001, d 5 0.06) and no

MM1, mindfulness with expectancy; MM2, mindfulness without expectancy; NTC, no treatment control; SHAM1, sham with expectancy; SHAM2, sham without expectancy.

interaction effect between treatment and instruction (F(1,145) 5 0.16,

42.61 (1.57)
47.23 (1.73)

10.71 (2.00)
10.97 (2.03)

10.65 (2.65)
4.25 (1.33)
4.77 (0.85)

67.1 (14.0)

9.58 (2.45)

9.65 (2.54)

P 5 0.69, h2p , 0.001, d 5 0.06).

SHAM1
Pre

3.3.2. Pain threshold and tolerance

Figure 3 and Table 2 summarize pretreatment and posttreatment
42.52 (1.95)
47.32 (1.71)

10.55 (2.11)
10.39 (2.25)

10.00 (2.31)

pain threshold and pain tolerance (secondary outcomes) across

4.04 (1.71)
4.45 (1.54)

43.4 (25.4)

8.81 (1.89)

9.06 (2.45)

groups. For pain threshold, there were no significant effects on pain

Post

threshold for receiving any intervention vs no treatment and no main

effects of treatment (mindfulness vs sham), instruction (told mindful-
ness vs told sham), or interaction between treatment and instruction
(Fs , 1.13, ps . 0.29). For pain tolerance, receiving any intervention
42.70 (1.70)
47.15 (1.68)

10.48 (2.00)
10.16 (2.40)
5.03 (1.14)
5.22 (0.90)

63.2 (21.7)

9.10 (2.15)
9.84 (2.34)
9.23 (2.14)

significantly increased pain tolerance relative to no treatment (F(1,145)

5 4.40, P 5 0.038, h2p 5 0.03, d 5 0.35); however, there were no
MM2
Pre

main effects of either treatment (F(1,145) 5 0.01, P 5 0.92, h2p ,

0.001, d , 0.01) or instruction (F(1,145) 5 0.08, P 5 0.78, h2p ,
0.001, d 5 0.06) and no interaction effect between them (F(1,145) 5
43.05 (1.96)
48.27 (1.71)

10.93 (1.87)
11.33 (2.25)

11.30 (2.56)
10.23 (2.25)

0.31, P 5 0.58, h2p , 0.001, d 5 0.09). Full pain data and analyses are
3.44 (1.72)
4.23 (1.54)

58.2 (22.9)

9.33 (2.28)

available in Supplementary Tables S1 and S2 (available at http://links.

Post

lww.com/PAIN/B570).

3.4. Process measures

42.68 (1.11)
47.76 (1.45)

10.43 (1.48)
10.73 (2.10)

10.80 (2.83)
4.14 (1.01)
4.79 (0.88)

68.3 (10.2)

9.03 (2.33)

9.73 (2.03)

3.4.1. Expectancy
MM1

As shown in Figure 4, there were no significant baseline differences

Pre

in pretreatment general expectancy across groups (F(4,148) 5 0.48, P

5 0.75) with participants in all 5 groups reporting similar expectation
that mindfulness would be at least moderately (approximately 66%)
Unpleasantness (VAS; -/10)

effective for reducing pain. However, there was a large effect of any
Nonreactivity (-/15)
Nonjudging (-/15)
Intensity (VAS; -/10)

Awareness (-/15)

intervention vs no treatment, with expectancy for pain relief after

Mindfulness (FFMQ)

Describing (-/15)
Observing (-/15)

treatment (ie, specific expectancy) being significantly higher for any

Expectancy (%)*
Process outcomes
Threshold (˚C)
Tolerance (˚C)

intervention (53%) relative to no treatment (18%; F(1,145) 5 57.90, P

Pain outcomes

, 0.001, h2p 5 0.28, d 5 1.25) after completing their final training

Table 2

session but immediately before the posttreatment pain test. The

treatment manipulation (mindfulness vs sham) had no effect on
specific expectancy (F(1,145) 5 1.40, P 5 0.24, h2p 5 0.01, d 5 0.19)

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 October 2022
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· Number 10 www.painjournalonline.com 1973

suggesting that both treatments were equally credible. By contrast,
the instruction manipulation (told mindfulness vs told sham) had a
large effect on specific expectancy (F(1,145) 5 22.61, P , 0.001, h2p
5 0.13, d 5 0.78) such that being told mindfulness (63%) led to higher
specific expectancy than being told sham (44%). There was no
significant interaction between treatment and instruction (F(1,145) 5
1.27, P 5 0.26, h2p 5 0.01, d 5 0.19).
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ps . 0.16). Nonjudging increased for any intervention relative to
no treatment (F(1,145) 5 13.01, P , 0.001, h2p 5 0.08, d 5 0.66),
but there were no effects of treatment or instruction and no
interaction effects between treatment and instruction (Fs , 1.84,
ps . 0.18). Similarly, nonreactivity increased for any intervention
relative to no treatment (F(1,145) 5 9.12, P 5 0.003, h2p 5
0.06, d 5 0.47), but there were no effects of treatment or

instruction, and no interaction effects between treatment and

instruction (Fs , 2.66, ps . 0.11).
3.4.2. Mindfulness
Table 2 summarizes pretreatment and posttreatment scores for
each of the 5 groups on each of the 5 facets of mindfulness: 3.5. Possible mediators
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observing, describing, (acting with) awareness, nonjudging (of
inner experience), and nonreactivity (to inner experience). For
observing, there were no effects of treatment, instruction, or any
intervention vs no treatment and no interaction effects between
treatment and instruction (Fs , 0.1.15, ps . 0.29). For
describing, there were no effects of treatment, instruction, or
any intervention vs no treatment (Fs , 0.1.73, ps . 0.19). There
was an interaction effect between treatment and instruction
(F(1,145) 5 5.88, P 5 0.017, h2p 5 0.04), which was probed with
simple effects analysis. This revealed a significant effect of
instruction for those receiving sham mindfulness in which being
told mindfulness reduced describing relative to being told sham
(F(1,119) 5 5.88, P 5 0.017, h2p 5 0.047). This effect was not
observed for those receiving mindfulness (F(1,119) 5 0.99, P 5
0.32, h2p 5 0.008). For awareness, there were no effects of
treatment, instruction, or any intervention vs no treatment and no
interaction effects between treatment and instruction (Fs , 1.97,
We investigated whether specific expectancy or mindfulness
processes mediated the effects of receiving any intervention vs no
treatment on pain outcomes where significant effects were
observed. As the preliminary step toward establishing mediation,
we ran correlations between possible mediators and pain
unpleasantness, pain intensity, and pain tolerance. As listed in
Table 3, the only statistically significant correlations were for pain
unpleasantness with specific expectancy and nonreactivity, pain
intensity with specific expectancy, and pain tolerance with
specific expectancy, meaning that only these processes could
potentially mediate changes in those pain outcomes.
The next step was to establish whether the potential mediators
continued to predict changes in pain when controlling for any
intervention vs no treatment. As shown in Figure 5, this revealed
that specific expectancy continued to predict changes in pain
unpleasantness and pain tolerance; however, specific expec-
tancy no longer predicted changes in pain intensity, and

Figure 3. Pain outcomes pretreatment and posttreatment changes in primary (pain unpleasantness) and secondary (pain intensity, pain threshold, and pain
tolerance) outcomes (all expressed as mean 6 SEM) were assessed to test the main effects and interactions between treatment (mindfulness, MM vs sham
mindfulness, SHAM), instruction (told mindfulness, 1 vs told sham, 2), and no treatment control (NTC). Pain threshold (bottom left) and tolerance (bottom right)
values (˚C) were taken as the mean of 3 trials in which participants indicated the temperature at which they first felt pain (threshold) and at which they could no
longer tolerate pain (tolerance) from a ramping heat stimulus. Pain intensity (top left) and unpleasantness (top right) ratings (11-point VAS) were taken as the mean
of 3 target stimuli at the midpoint between each participant’s pain threshold and tolerance at baseline.

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 1974
·
J.N. Davies et al. 163 (2022) 1967–1977
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Figure 4. Ratings of expected pain relief before and after the intervention.
Expectancy was measured using 2 constructs: (1) general response
expectancy (ratings of expected pain relief from mindfulness before exposure;
100-point VAS) at baseline (before the pretreatment pain test and before
randomization to interventions); and (2) specific response expectancy (ratings
of anticipated response to the treatment; 100-point VAS) at posttreatment
(immediately after completing the intervention and before the posttreatment
pain test). Orthogonal contrasts tested the main effects of specific expectancy
and any interactions between treatment (mindfulness, MM vs sham
mindfulness, SHAM), instruction (told mindfulness, 1vs told sham, 2), and
no treatment control (NTC).
nonreactivity no longer predicted changes in pain unpleasant-
ness. Hence, we ran 2 regressions, testing whether specific
expectancy significantly predicted pain unpleasantness and pain
tolerance when controlling for any intervention vs no treatment as
the independent variable. These regressions revealed significant
effects of specific expectancy on pain unpleasantness (b 5
20.170, t1,153 5 22.08, P 5 0.039) and pain tolerance (b 5
0.152, t1,153 5 2.87, P 5 0.005) when controlling for any
intervention vs no treatment (Fig. 5). Finally, when controlling for
the mediator (specific expectancy), the independent variable (any
intervention vs no treatment) no longer predicted changes in pain
unpleasantness and pain tolerance (ps . 0.24), suggesting full
mediation of the effect (pain unpleasantness indirect path: b 5
20.21, 95% CI: 20.76 to 20.04; pain tolerance indirect path:
b 5 0.19, 95% CI: 0.14-0.57).
3.6. Sham credibility
The manipulation check (“I think I am in the …. group”) indicated
that participants seemed to believe their instructions about group
allocation, as expected (x2(12, N 5 153) 5 269.28, P , 0.001).
Specifically, of those told mindfulness (ie, MM1 and SHAM1),
83% (51/61) reported being allocated to the mindfulness group,
10% reported being in the sham group (SHAM1: 7%; 4/61 vs
MM1: 3%; 2/61), 2% reported being in the no treatment group
Table 3
Pearson correlation coefficients (r) between pain outcomes and possible mediators.
Specific expectancy
Pain unpleasantness 20.244 (0.002)
Pain intensity 20.213 (0.008)
Pain tolerance 0.285 (<0.001)
P values shown in brackets.
Significance shown in bold.
Copyright © 2022 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.
PAIN®
(SHAM1: 0%; 0/61 vs MM1: 2%; 1/61), and 5% were not sure of
their group allocation (SHAM1: 2%; 1/61 vs MM1: 3%; 2/61).
Similarly, of those told sham (ie, MM2 and SHAM-groups), 98%
(61/62) reported being allocated to the sham group, with 1
participant (2%; 1/62) not sure of their group allocation.
Furthermore, the credibility check (“Did your training include
mindfulness?”) revealed no significant differences in response
between the 4 active interventions (x2(6, N 5 123) 5 8.71, P 5
0.19), suggesting that the sham mindfulness training (SHAM1
and SHAM2; 79%, 49/62) maintained equal credibility to the
mindfulness training (MM1 and MM2; 71%, 43/61). However, it
is important to note that 20% to 30% of participants across
groups did not believe they were receiving mindfulness training.
Full manipulation check data and analyses are available in
Supplementary Table S3 (available at http://links.lww.com/PAIN/
B570).
3.7. Pain outcomes by perceived treatment
Placebo research shows that what participants believe they are
receiving is a strong indicator of treatment response, regardless
of what they actually receive.8,25 Hence, based on the above-
mentioned finding that: (1) the credibility check revealed 20% to
30% of respondents believed they were receiving a treatment
other than what was instructed and (2) only specific expectancy
mediated effects on decreasing pain unpleasantness and
increasing pain tolerance, we decided to conduct post hoc linear
regression analyses26 to assess whether perceived treatment
affected pain outcomes and specific expectancy. These analyses
considered participant responses to the credibility item: “Did your
training include mindfulness?” (yes 5 3, n 5 93; not sure 5 2, n 5
23; no 5 1, n 5 37) as the predictor. This revealed that perceived
treatment predicted changes in pain threshold (b 5 0.174, t1,130
5 2.17, P 5 0.032), pain tolerance (b 5 0.253, t1,130 5 3.21, P 5
0.002), and specific expectancy (b 5 0.533, t1,130 5 7.75, P ,
0.001) but not pain unpleasantness or pain intensity (bs .
20.132, ps , 0.104). Full data and analyses are available in
Supplementary Table S4 (available at http://links.lww.com/PAIN/
B570).
We then explored specific expectancy as a potential mediator
of the effects of perceived treatment allocation on pain threshold
and pain tolerance. In step 1 of the mediation model, perceived
treatment predicted specific expectancy (b 5 1.752, t1,130 5
7.75, P , 0.001). In step 2, perceived treatment predicted
changes in pain threshold (b 5 0.362, t1,130 5 2.17, P 5 0.032)
and pain tolerance (b 5 0.304, t1,130 5 3.21, P 5 0.002). In step
3, specific expectancy continued to predict changes in pain
tolerance when controlling for perceived treatment (b 5 0.085,
t1,130 5 2.54, P 5 0.012); however, specific expectancy no longer
predicted changes in pain threshold (b 5 0.057, t1,130 5 0.948,
P 5 0.345). Finally, when controlling for the mediator, perceived
treatment no longer predicted changes in pain tolerance (b 5
0.155, t1,130 5 1.41, P 5 0.16), suggesting that specific
Nonjudging Nonreactivity
20.034 (0.679) 0.160 (0.049)
20.016 (0.844) 0.156 (0.056)
0.100 (0.221) 20.012 (0.879)
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Figure 5. Standardized regression coefficients for the relationship between
any intervention and pain unpleasantness and pain tolerance, mediated by
specific expectancy. Specific expectancy mediated the effect of all 4 active
interventions (any intervention; ie, MM1, MM2, SHAM1, and SHAM2) on
reducing pain unpleasantness (b 5 20.24, top pane) and increasing pain
tolerance (b 5 0.08, bottom pane). All values are standardized regression
coefficients. *P , 0.05. SHAM1, sham with expectancy; SHAM2, sham
without expectancy; MM1, mindfulness with expectancy; MM2, mindfulness
without expectancy.
expectancy fully mediated the effect of perceived treatment on
changes in pain tolerance. Thus, specific expectancy fully
mediated the relationship between perceived treatment and
changes in pain tolerance but did not mediate changes in pain
threshold.
4. Discussion
This study sought to evaluate the roles of mindfulness and
placebo processes in attenuating acute experimental pain after a
brief focused attention mindfulness intervention. Contrary to
predictions, there was no effect of manipulating treatment or
instruction on pain outcomes. However, there was clear evidence
that receiving any of the 4 interventions led to significant
decreases in pain unpleasantness and intensity and increases
in pain tolerance relative to no treatment. Specific expectancy
was the strongest predictor of these changes, fully mediating the
relationship between any intervention and both pain unpleasant-
ness and pain tolerance. Specific expectancy was also the
strongest predictor of changes in pain threshold and pain
tolerance by perceived treatment allocation (what participants
believed they were receiving—irrespective of what they actually
received). Taken together, these findings suggest that placebo
effects may contribute substantially to improvements in pain
outcomes following certain types of brief mindfulness-based
interventions for acute pain; however, these outcomes may be
insensitive to treatment and instruction manipulations.
The treatment manipulation revealed small to medium effects
of mindfulness and sham treatment on reducing pain unpleas-
antness and intensity and increasing pain tolerance relative to no
treatment, with no effect on pain threshold. These effects were
Copyright © 2022 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.
www.painjournalonline.com 1975
comparable in magnitude with mindfulness and sham mindful-
ness effects observed in previous studies by our group12 and
others1,46 and are consistent with the effects on clinical and
experimental acute pain reported in recent reviews32 and meta-
analyses.40 There were, however, no differences between
mindfulness and sham (ie, no observed treatment effect) on any
pain outcome. This was not surprising for secondary pain
outcomes, that is, pain intensity, threshold, and tolerance, but
did not support our prediction that mindfulness would be superior
to sham at reducing pain unpleasantness.45 Improvements in
pain acceptance, stress, depression, and pain catastrophizing
are theorized to underlie the superior effect of mindfulness on
acute pain in expert meditators relative to nonmeditators18,29;
however, we found no support for these processes underlying
effects in this study, possibly due to floor effects (see
Supplementary material, available at http://links.lww.com/PAIN/
B570). It is possible, however, that sustained mindfulness
practice would be protective against the transition from acute
to chronic pain by buffering those processes, which would be
worth testing in future research.
The instruction manipulation was associated with a predicted
large effect on specific expectancy, which was higher for those
told mindfulness than for those told sham, which in turn was
higher than those told they were receiving no treatment.
However, as with treatment, there was no effect of instruction
on any pain outcome. Although at first glance, this may suggest
evidence against a role of the placebo effect in mindfulness
outcomes, an analysis of the relationship between specific
expectancy and pain suggests otherwise. Specifically, specific
expectancy itself predicted changes in pain unpleasantness,
intensity, and tolerance between any intervention and no
treatment. Thus, it may be that the instruction manipulation did
not elicit a large enough change in expectancies (19%) between
told mindfulness and told sham to induce a placebo effect on pain
outcomes, compared with the larger change in expectancies
(36%) between any intervention and no treatment. Another
possibility could relate to the distinction between expectations
and beliefs, with the implicit belief about a beneficial treatment (ie,
mindfulness) being more important for outcomes than the explicit
expectation of benefit itself.8,24 Consistent with this distinction,
when reanalysing the data by perceived treatment allocation, we
found that, irrespective of what they actually received, partic-
ipants who believed they were receiving mindfulness had higher
pain threshold and tolerance levels compared with participants
who did not believe they were receiving mindfulness or were
unsure. Furthermore, for perceived treatment, specific expec-
tancy predicted changes in pain threshold and tolerance. Thus,
although changes in specific expectancy due to the instruction
manipulation itself were not associated with changes in pain
outcomes, there was clear evidence that treatment, expectan-
cies, and beliefs influenced pain outcomes, consistent with the
placebo effect.
Regarding mindfulness-related processes, we observed only
small (#4%) increases in 2 of 5 mindfulness processes (non-
judging and nonreactivity) in both mindfulness and sham
treatments, which likely represent demand characteristics in
those who believed (either through explicit instruction or deduced
during training) that they were receiving mindfulness. Although
nonreactivity correlated weakly with pain unpleasantness, there
was no mediation effect. Hence, based on the present findings,
we found no evidence that the effect of mindfulness treatment on
pain unpleasantness is mediated by mindfulness processes.
Taken together, these findings provide clear evidence that
placebo effects may play a more dominant role in producing
 1976
·
J.N. Davies et al. 163 (2022) 1967–1977
analgesia and reducing pain unpleasantness in novice meditators
after a brief focussed attention mindfulness intervention than
theoretically derived mindfulness-specific processes themselves.
However, other trials of established mindfulness-based interven-
tions have flagged the FFMQ as having poor discriminant validity
when active controls are used17; hence, potential measurement-
related influences cannot be ruled out.
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Balanced placebo designs are routinely used in studies of
analgesic medications2,37 to characterize the isolated roles of
active treatment effects and placebo effects, as well as their
interactions: subadditive, additive, or superadditive. They have
also been successfully applied in settings where the treatment is
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psychological42 rather than pharmacological, including one study
of mindfulness for cognitive performance.38 However, proving
that psychological treatments such as mindfulness are verum (ie,
produce therapeutic benefits through their proposed specific
mechanisms) is difficult, and there is an active debate about the
extent to which the concept of placebo applies in such
cases.6,15,44 Gaab et al.5 argue the mere possibility of psycho-
logical interventions being anything other than verum has serious
ethical consequences that need to be actively addressed in
research and practice. Furthermore, they propose a taxonomy in
which psychological treatments may involve substantial additivity,
such that beyond verum or placebo, the verum (in this case,
mindfulness) might interact with placebo effects in ways that
either substantially augment specific (superverum) or nonspecific
(superplacebo) treatment processes. The difficulties inherent in
characterizing these processes and their interactions amid the
effects of common factors43 are evident in this study, where no
evidence was found of an interaction between treatment and
instruction on any outcome, but receiving anything was better
than receiving nothing.16 This complexity underscores the
importance of pursuing such research questions in well-
controlled studies using different methodological approaches.
This study had a number of strengths, including the use of a
double-blind balanced placebo design with a highly credible
sham treatment (as evidenced by the manipulation check data
that both treatments were rated equally credible), the inclusion of
a NTC group, and direct assessment of specific expectancy,
perceived treatment, and mindfulness processes. Nonetheless, 3
limitations are worth noting. First, we used a focussed attention
mindfulness intervention, which is only one of many different
types of mindfulness practices.31 Focused attention training is
considered to be the most appropriate for novice meditators
because it allows them to develop attentional stability by
anchoring their attention to salient aspects of their present
moment experience such as the breath or body sensations.33
Building attentional stability is a prerequisite for bringing mindful
qualities of acceptance and equanimity to present moment
experience,11,47 with recent evidence suggesting that these shifts
in metacognition may underlie the effects of mindfulness training
on pain.7,14 Focused attention interventions have well-
characterized effects on acute pain,32, 46 and these effects were
replicated here. However, although this specific intervention12,19
failed to show superiority over a well-matched sham, we are
unable to say whether this result would generalize to other forms
of mindfulness practice, eg, open monitoring36 or even other
focused attention interventions. Second, our study was powered
to detect moderate effects based on observations from previous
research27,30,45,46,48 that only included a treatment manipulation.
If treatment and instruction manipulations did have unique but
subtle effects, this study may have been underpowered to detect
them. At the same time, however, if the unique effects are so
subtle that they require exceptionally large sample sizes to
Copyright © 2022 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.
PAIN®
demonstrate, then their clinical significance may be limited. Third,
participants were predominantly undergraduate university stu-
dents, and thus, it is unclear how these results would generalize
to other healthy or clinical populations.
Thus overall, although pain outcomes seemed to be insensitive
to treatment type and instruction manipulation, receiving either
mindfulness or sham treatment equally reduced pain unpleas-
antness and intensity and increased pain tolerance relative to no
treatment. Of most interest, specific expectancy was the
strongest predictor of changes in pain unpleasantness and pain
tolerance by any treatment and pain threshold and pain tolerance
by perceived treatment. This provides clear evidence of placebo
effects contributing to pain effects in a mindfulness-based
intervention. As such, expectancies and beliefs about mindful-
ness training may play a more prominent role in attenuating acute
pain in novice meditators than the treatment or instructions
themselves. Future research should test whether the current
results generalize to other types of mindfulness training, and
studies evaluating the efficacy of mindfulness-based interven-
tions for pain should incorporate appropriately matched shams,
ideally alongside a NTC, to account for and understand the role
placebo effects play in pain relief after mindfulness.
Conflict of interest statement
The authors have no conflicts of interest to declare.
Acknowledgements
The authors thank Kathrin Kachel, Raffaela Thüring, and Rika
Etteldorf for their assistance in conducting this study. This
research was supported by an Australian Government Research
Training Program, Mind & Life Institute IRI and The Chen Family
Research Scholarships awarded to Jonathan Davies, and
Australian Research Council Grants (DP180102061) awarded to
Ben Colagiuri.
Trial registration: Australian New Zealand Clinical Trials Registry
(ACTRN12619000537156).
Appendix A. Supplemental digital content
Supplemental digital content associated with this article can be
found online at http://links.lww.com/PAIN/B570.
Article history:
Received 8 July 2021
Received in revised form 8 November 2021
Accepted 14 December 2021
Available online 25 January 2022
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