Chronic Pain Therapy Comparison
Chronic Pain Therapy Comparison
Francis Keefef
Abstract
Trials of cognitive therapy (CT), mindfulness-based stress reduction (MBSR), and behavior therapy (BT) suggest that all 3 treatments
produce reductions in pain and improvements in physical function, mood, and sleep disturbance in people with chronic pain
conditions. Fewer studies have compared the relative efficacies of these treatments. In this randomized controlled study, we compared
CT, MBSR, BT, and treatment as usual (TAU) in a sample of people with chronic low back pain (N 5 521). Eight individual sessions were
administered with weekly assessments of outcomes. Consistent with the prior work, we found that CT, MBSR, and BT produced similar
pretreatment to posttreatment effects on all outcomes and revealed similar levels of maintenance of treatment gains at 6-month follow-
up. All 3 active treatments produced greater improvements than TAU. Weekly assessments allowed us to assess rates of change; ie,
how quickly a given treatment produced significant differences, compared with TAU, on a given outcome. The 3 treatments differed
significantly from TAU on average by session 6, and this rate of treatment effect was consistent across all treatments. Results suggest
the possibility that the specific techniques included in CT, MBSR, and BT may be less important for producing benefits than people
participating in any techniques rooted in these evidence-based psychosocial treatments for chronic pain.
Keywords: Comparative treatments, Outcomes, Rates of change, Chronic low back pain
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of pleasure related to these accomplishments. Patients were skills, they were taught to identify possible problems and
trained in brief relaxation and taught how to use brief relaxation develop solutions to meet CT goals. Finally, patients de-
sessions (eg, 2-5 minutes) to reward their accomplishment of veloped a written maintenance plan that included a list of
their activity goals. To help patients deal with obstacles, they short-term and long-term goals for applying cognitive restruc-
were taught problem-solving skills to meet behavior change turing and a plan for dealing with possible setbacks in their
goals. Patients were also trained in communication skills to cognitive change efforts.
enable them to communicate more effectively with others about
the progress they were making and problems they were
2.3.3. Mindfulness-based stress reduction
experiencing. Finally, patients developed a written maintenance
plan that included a list of short-term and long-term activity Participants assigned to the MBSR condition received training
goals and a plan for dealing with possible setbacks. in mindfulness through (1) body scan meditation, a gradual
moving of attention through the body, accompanied by
awareness of bodily sensations including sensations of
2.3.2. Cognitive Therapy
breathing while in a lying position; (2) sitting meditation,
Cognitive therapy (also known as cognitive restructuring)35 focusing on awareness of breathing, bodily sensations,
was used to help patients recognize the relationships between thoughts, and emotions, while sitting on a chair or cushion;
thoughts, feelings, and behaviors. These techniques helped and (3) gentle movement exercises intended to develop
patients (1) identify automatic pain-related thoughts; (2) awareness (mindfulness) during movement. Each session
evaluate automatic thoughts for accuracy, identify sources of included practice of one or more of these techniques. In-
distorted thoughts, and recognize connection between auto- class didactic material and discussion of patients’ experiences
matic thoughts and emotional/physical shifts; (3) challenge of developing and applying mindfulness in everyday life were
negative, distorted automatic thoughts using “evidence”; (4) also part of each session. In-class activities included sugges-
develop new realistic alternative cognitive appraisals re- tions for application of mindfulness as a method for responding
sponses; and (6) practice applying new rational appraisals positively to stress, dealing with the challenges of pain, and
and beliefs. To help patients deal with obstacles in applying CT exercises focusing on the challenges and achievements
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Table 1
Baseline characteristics of study participants by the treatment group.
Demographics TAU (n 5 129) BT (n 5 120) CT (n 5 129) MBSR (n 5 143) All (n 5 521)
Mean age in years (SD) 52.78 (11.99) 53.39 (12.27) 52.71 (12.85) 52.71 (11.68) 52.88 (12.16)
Female, n (%) 77 (59.7) 69 (58) 72 (55.8) 83 (58) 301 (57.9)
Education, n (%)
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patients experience in integrating mindfulness into their lives 2.4. Study therapists, therapist training, adherence,
and the stressful situations they encounter. Additional discus- and quality
sion focused on stress reactivity. Patients were taught 2.4.1. Study therapists
problem-solving skills for identifying possible problems and
developing solutions for dealing with obstacles related to All study therapists were postdoctoral level clinical psychologists
practicing mindfulness. Finally, patients developed a written with prior experience delivering psychosocial interventions for
maintenance plan that included a list of short-term and long- pain. Over the course of the five-year study, 10 therapists were
term goals for applying mindfulness methods and a plan for trained to administer all 3 active treatments. We chose not to
dealing with possible setbacks. assign one therapist to perform only one treatment to avoid
confounding results of condition with results because of quality of
therapists. Instead, we closely monitored treatment integrity with
2.3.4. Treatment as usual
procedures described below.
Participants assigned to TAU did not receive any additional
psychosocial treatment beyond the other treatments they were
2.4.2. Therapist training
receiving before enrolling in this study. Treatment as usual
participants continued with their ongoing treatment regimens for All study therapists received training before conducting treatment
pain, including psychotropic and analgesic medications. sessions with study subjects. Initial training consisted of a 4-day
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didactic and experiential course conducted by the authors. research.46 In the present sample, the Cronbach’s alpha was
Therapists were provided detailed manuals and outlines of 0.88 at the baseline assessment.
treatment protocols, and the treatment strategies were taught
by didactic instruction and role-play of common scenarios. All
instruction sessions were digitally videotaped for reference and/ 2.6. Power analysis
or education of new therapists. Therapists were certified to deliver Because a closed form approximation of power calculations
each treatment by having supervisors (ie, the authors) rate audio- would be difficult to derive, we conducted a series of mathemat-
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recordings of practice role-play sessions before their working with ical simulations under a variety of situations (eg, different effect
study participants. Mastery of each protocol was required for sizes, extent of missing data, and assuming each theoretical
therapists to deliver treatment in the research protocol. model is true). Simulations were informed by our experience with
clinical trials and the outcomes under study. We originally planned
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2.4.3. Procedures to ensure consistency of treatment to recruit 460 participants, assuming 15% attrition. Assuming that
the TAU group could still exhibit a small reduction in pain
To ensure that the study therapists consistently followed the interference (d 5 0.10 SD pre–post change), whereas the other
appropriate treatment protocol, 4 steps were taken: (1) use of a treatments would exhibit larger effects (d;0.85), the omnibus
detailed treatment manual; (2) weekly supervision sessions; (3) tests of intervention effectiveness had adequate statistical power
audio recording of sessions for treatment adherence ratings (see (power $ 0.90) under all of the considered patterns of missing
below), with these recordings and feedback from the adherence data, even taking into account a 15% attrition rate.
raters reviewed during the weekly supervision meetings con-
ducted by the authors; and (4) provision of therapist feedback on
treatment consistency and further didactics and role plays to 2.7. Statistical analysis
correct “drift” if needed.
2.7.1. Primary analyses
Given the longitudinal and nested nature of the data (observations
2.4.4. Treatment adherence and quality
[level I] nested within participants [level II]), linear mixed models
Treatment adherence refers to the extent to which a therapist were conducted to examine (1) within-group and between-group
uses interventions prescribed by a protocol.41 Treatment quality changes in outcomes over time from baseline through posttreat-
refers to therapist competence in delivering the treatment. A total ment (Session #8), (2) within-group and between-group changes
of 72 sessions (20%) were rated by an author and a research from posttreatment to 6-month follow-up, and (3) within-group
assistant. The Therapy Adherence and Competence Scale is an and between-group changes from baseline through 6-month
adapted version of the Cognitive Adherence and Competence follow-up. Intent-to-treat procedures were conducted using
Scale2 and was used to measure adherence and quality of linear mixed models. These models were estimated with full
treatment. Adherence ratings were provided on the basis of maximum likelihood estimation methods; a procedure which
demonstrated delivery of unique elements and treatment allows all randomly assigned participants to be included in
components for each session. The mean adherence rating was analyses, thereby yielding unbiased parameter estimates for
98%. Each session received a quality rating based on a 4-point missing data (MCAR/MAR).1,6,14,33
scale with end points ranging from “0 5 poor to 3 5 excellent.”
The mean quality rating was 2.03 (SD 5 0.13), indicating that
ratings of all 3 conditions were in the good to excellent range. 2.7.2. Group 3 Time analyses
To determine whether groups differed significantly in degrees of
change in outcomes variables over time, linear mixed models that
2.5. Measures
included a cross-level interaction between group (level II factor;
We evaluated the effects of the treatments on 5 outcome BT, CT, MBSR, and TAU) and time (level I, covariate) were
domains: pain interference (primary outcome), pain intensity, estimated with a diagonal covariance structure and included a
depressive symptoms, physical function, and sleep disturbance fixed and random intercept for each outcome. Significant Group
(secondary outcomes). The Pain Interference Subscale of the 3 Time interactions were dissected by estimating pairwise
Multidimensional Pain Inventory24 assessed interference with comparison linear mixed models for each group pairing (BT vs
general functioning due to pain. The scale has shown excellent TAU; CT vs TAU; MBSR vs TAU; BT vs CT; BT vs MBSR; and CT
psychometric characteristics in past research.29 In the present vs MBSR). Those comparisons with a significant interaction were
sample, the Cronbach’s alpha was 0.92 at the baseline then plotted and probed to determine the significance of simple
assessment. Pain intensity was assessed with a 0 to 10 numerical slopes and the region of significance for the interaction.30
rating scale of average pain over the past week.20 It also shows
excellent psychometric characteristics. Depressive symptoms
2.7.3. Regions of significance
were assessed with the Center for Epidemiologic Studies–
Depression (CESD) Scale Short Form, also reported to have Analyzing regions of significance allowed us to examine the relative
excellent psychometric qualities in past research.8 In the present rates in which the change occurred between the active treatments.
sample, the Cronbach’s alpha was 0.83 at the baseline Although the treatments may produce similar degrees of change
assessment. The level of physical activity was assessed with by the end of treatment, a given treatment may produce the final
the PF-10 Physical Functioning scale from the SF36,42 again, a degree of posttreatment change before the final session, whereas
psychometrically excellent measure. In the present sample, the another treatment may not produce this degree of change until the
Cronbach’s alpha was 0.88 at the baseline assessment. Sleep final session. The former treatment may be seen as superior to the
disturbance was assessed with the 6-item the Patient-Reported other, slower treatment for producing the final level of pretreatment
Outcomes Measurement Information System Sleep Disturbance to posttreatment effects sooner and thus incurring less cost and
Scale. It has shown excellent psychometric characteristics in past patient burden. We hypothesized that one or more treatments
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could produce more rapid change than the other treatment(s). A third series of multilevel models were conducted to evaluate
“Rate of change” is defined here as how quickly a given treatment baseline to 6-month follow-up effects. These analyses were
will produce significant differences compared with TAU on a given conducted in a similar fashion to the baseline to posttreatment
outcome. For instance, CT may significantly differ from TAU on pain analyses.
intensity changes by session 5, whereas BT may not differ from
TAU until session 8. Such effects could be taken as evidence that
CT was superior to BT on this new metric. 3. Results
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Table 2
Baseline outcome measures, means (SDs).
Baseline Outcome Mean (SD) TAU (n 5 129) BT (n 5 120) CT (n 5 129) MBSR (n 5 143) All (n 5 521)
Pain interference 3.67 (1.24) 3.69 (1.36) 3.72 (1.21) 3.64 (1.31) 3.68 (1.27)
Pain intensity 4.54 (2.11) 5.68 (2.08) 5.48 (2.14) 5.51 (2.16) 5.55 (2.12)
Physical function 18.88 (4.97) 18.82 (5.14) 18.72 (4.86) 19.13 (4.52) 18.88 (4.85)
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Depressive symptoms 9.38 (6.04) 9.46 (5.55) 9.86 (5.95) 9.24 (5.68) 9.48 (5.81)
Sleep disturbance 57.12 (8.71) 55.09 (8.14) 56.45 (9.43) 54.95 (9.04) 55.89 (8.88)
BT, behavioral therapy; CT, cognitive therapy; MBSR, mindfulness-based stress reduction; TAU, treatment as usual.
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TAU participants beginning at session 5, that CT participants (d 5 20.21), that BT participants differed significantly from TAU
differed significantly from TAU beginning at session 6, and that participants beginning at session 7 (d 5 20.26), and that CT
MBSR participants differed significantly from TAU participants participants differed significantly from TAU participants begin-
beginning at session 6. Effect sizes comparing TAU at session ning at session 8 (d 5 20.23). Effect sizes comparing TAU at
8 to the other groups ranged from Cohen’s d 5 0.30 session 8 with the other groups ranged from Cohen’s d 5 2
to d 5 0.48. 0.21 to d 5 20.26.
Figure 2. Marginal means and standard errors from linear mixed models for pain interference. BT, behavioral therapy; CT, cognitive therapy; MBSR, mindfulness-
based stress reduction; TAU, treatment as usual.
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Figure 3. Marginal means and standard errors from linear mixed models for pain intensity. BT, behavioral therapy; CT, cognitive therapy; MBSR, mindfulness-
based stress reduction; TAU, treatment as usual.
participants’ beginning at session 7 (d 5 0.43), and that MBSR Group 3 Time interactions among 3 active treatment groups
participants’ Depression scores differed significantly from TAU (range B 5 [20.01] to [20.06]), but, again, significant interactions
participants beginning at session 8 (d 5 0.26). Effect sizes were observed when each treatment group was compared with
comparing TAU at session 8 with the other groups ranged from TAU. As shown in Table 3, all 4 groups demonstrated significant
Cohen’s d 5 0.26 to d 5 0.53. reductions in Sleep Disturbance over the course of treatment.
However, BT, CT, and MBSR groups showed larger reductions in
Sleep Disturbance scores at posttreatment than the TAU group.
3.2.5. Sleep disturbance
The region of significance calculated for each interaction
Finally, a significant overall Group 3 Time interaction was indicated that Sleep Disturbance scores from BT participants
observed for Sleep Disturbance scores (F[3,1730.09] 5 5.59 began to differ significantly from TAU participants after session 1,
P , 0.05). Pairwise comparison analyses showed no significant that CT participants’ Sleep Disturbance scores differed
Figure 4. Marginal means and standard errors from linear mixed models for depressive symptoms. BT, behavioral therapy; CT, cognitive therapy; MBSR,
mindfulness-based stress reduction; TAU, treatment as usual.
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Figure 5. Marginal means and standard errors from linear mixed models for physical function. BT, behavioral therapy; CT, cognitive therapy; MBSR, mindfulness-
based stress reduction; TAU, treatment as usual.
significantly from TAU participants’ beginning at session 3, and Physical Function, Depression, or Sleep Disturbance. Within-group
that MBSR participants’ Sleep Disturbance scores differed analyses showed that the MBSR group’s Pain Interference ratings
significantly from TAU participants beginning at session 2. Effect significantly increased from post-treatment to six-month follow-up
sizes comparing TAU at session 8 with the other groups ranged (mean difference 5 20.27, SE 5 0.12, 95% C.I. [20.51 to 20.03],
from Cohen’s d 5 0.26 to d 5 0.61. P , 0.05). The other groups did not have a significant difference in
marginal means between posttreatment and six-month follow-up for
any other outcome variable. The nonsignificant Group 3 Time
3.3. Treatment effects on outcomes from posttreatment to 6- interactions for the posttreatment to six-month follow-up epoch
month follow-up coupled with the mostly nonsignificant effects of time for the
There were no significant between-group interactions for posttreat- individual groups strongly suggested that the 3 active treatment
ment to six-month follow-up on Pain Interference, Pain Intensity, groups preserved their pretreatment to posttreatment gains.
Figure 6. Marginal means and standard errors from linear mixed models for sleep disturbance. BT, behavioral therapy; CT, cognitive therapy; MBSR, mindfulness-
based stress reduction; TAU, treatment as usual.
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Table 3
Linear mixed models results and effect sizes, baseline through session #8.
Variable Within-group change Treatment vs. TAU
Intercept, B Change over time, B P Effect size [95% Interaction treatment vs TAU, P Effect size of interaction Region of
(SE) [95% C.I.] (SE) [95% C.I.] C.I.] B (SE) [95% C.I.] (Cohen’s d) [95% C.I.] significance
Pain
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interference
BT 3.74 (0.12) 20.10 (0.01) 0.01 20.35 0.04 (0.01) [0.02 to 0.06] 0.01 0.25 [0.13 to 0.36] Session #8
[3.49-3.98] [20.12 to 20.08] [20.43 to 20.26]
CT 3.74 (0.11) 20.10 (0.01) 0.01 20.36 0.04 (0.01) [0.02 to 0.06] 0.01 0.26 [0.13 to 0.39] Session #8
[3.53-3.96] [20.11 to 20.08] [20.43 to 20.29]
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MBSR 3.63 (0.11) 20.10 (0.01) 0.01 20.37 0.04 (0.01) [0.02 to 0.06] 0.02 0.25 [0.13 to 0.38] Session #7
[3.41-3.84] [20.11 to 20.08] [20.45 to 20.29]
TAU 3.64 (0.12) 20.06 (0.01) 0.01 20.26
[3.41-3.88] [20.07 to 20.04] [20.35 to 20.18]
Pain
intensity
BT 5.73 (0.19) 20.17 (0.02) 0.01 20.32 0.12 (0.02) [0.08 to 0.17] 0.01 0.48 [0.32 to 0.68] Session #5
[5.36-6.09] [20.21 to 20.13] [20.39 to 20.24]
CT 5.69 (0.19) 20.16 (0.02) 0.01 20.32 0.11 (0.02) [0.07 to 0.15] 0.01 0.42 [0.27 to 0.57] Session #6
[5.30-6.07] [20.19 to 20.12] [20.39 to 20.25]
MBSR 5.54 (0.18) 20.13 (0.02) 0.01 20.29 0.08 (0.02) [0.04 to 0.13] 0.01 0.30 [0.15 to 0.49] Session #6
[5.17-5.89] [20.16 to 20.09] [20.36 to 20.22]
TAU 5.55 (0.19) 20.05 (0.01) 0.01 20.12
[5.15-5.93] [20.07 to 20.02] [20.19 to 20.04]
Physical
function
BT 18.87 (0.44) 0.18 (0.03) 0.01 0.19 20.15 (0.05) [20.24 to 20.06] 0.01 20.26 [20.41 to 20.11] Session #7
[18.00-19.75] [0.11 to 0.24] [0.11 to 0.28]
CT 18.45 (0.41) 0.16 (0.03) 0.01 0.18 20.13 (0.05) [20.22 to 20.04] 0.01 20.23 [20.39 to 20.07] Session #8
[17.65-19.25] [0.09 to 0.23] [0.10 to 0.27]
MBSR 19.41 (0.38) 0.14 (0.03) 0.01 0.15 20.11 (0.05) [20.19 to 20.02] 0.02 20.21 [20.34 to 20.04] Session #4
[18.61-20.10] [0.07 to 0.21] [0.07 to 0.23]
TAU 18.79 (0.43) 0.03 (0.03) 0.33 0.03
[17.94-19.63] [20.04 to 0.09] [20.05 to 0.11]
Depression
BT 10.39 (0.46) 20.37 (0.05) 0.01 20.27 0.33 (0.06) [0.21 to 0.46] 0.01 0.53 [0.33 to 0.73] Session #4
[9.49-11.29] [20.47 to 20.28] [20.36 to 20.19]
CT 10.76 (0.46) 20.32 (0.05) 0.01 20.25 0.28 (0.06) [0.16 to 0.39] 0.01 0.43 [0.25 to 0.61] Session #7
[9.85-11.67] [20.41 to 20.22] [20.32 to 20.17]
MBSR 10.21 (0.45) 20.21 (0.04) 0.01 20.18 0.17 (0.06) [0.05 to 0.28] 0.01 0.26 [0.08 to 0.42] Session #8
[9.32-11.09] [20.29 to 20.12] [20.26 to 20.10]
TAU 10.04 (0.51) 20.04 (0.04) 0.30 20.04
[9.04-11.04] [20.12 to 0.04] [20.11 to 0.04]
Sleep
disturbance
BT 55.83 (0.73) 20.60 (0.08) 0.01 20.24 0.44 (0.11) [0.22 to 0.65] 0.01 0.61 [0.32 to 0.90] Session #1
[54.38-57.28] [20.76 to 20.43] [20.31 to 15]
CT 56.95 (0.76) 20.46 (0.08) 0.01 20.22 0.30 (0.10) [0.10 to 0.51] 0.01 0.31 [0.10 to 0.51] Session #5
[55.46-58.44] [20.61 to 20.31] [20.30 to 20.13]
MBSR 55.61 (0.72) 20.42 (0.07) 0.01 20.22 0.26 (0.09) [0.07 to 0.46] 0.01 0.26 [0.07 to 0.45] Session #2
[54.19-57.04] [20.56 to 20.28] [20.29 to 20.15]
TAU 57.29 (0.77) 20.16 (0.07) 0.03 20.08
[55.77-58.82] [20.29 to 20.02] [20.15 to 20.01]
BT, behavioral therapy; CT, cognitive therapy; MBSR, mindfulness-based stress reduction; TAU, treatment as usual.
3.4. Treatment effects on outcomes from baseline to 6- 6.92 P , 0.05). See Table 4. Pairwise comparison analyses for all
month follow-up outcome factors revealed no significant Group 3 Time interactions
Similar to the baseline to session 8 analyses, significant Group 3 among treatment groups. Significant Group 3 Time interactions for
Time interactions were observed for Pain Interference Scale scores (F each outcome factor were observed when each treatment group
[3,2104.47] 5 4.48 P , 0.05), Pain Intensity ratings (F[3,1886.97] 5 was compared with TAU, however. Effect sizes comparing TAU
11.14 P , 0.05), Physical Function Scale scores (F[3,1934.04] 5 values at 6-month follow-up with the other groups ranged from
45.08 P , 0.05), Depressive Symptom scores [F(3,1815.28) 5 Cohen’s d 5 20.18 to d 5 0.56, which were slightly attenuated from
10.10, P , 0.05], and Sleep Disturbance scores (F[3,1822.27] 5 the effect sizes observed for baseline to session 8 comparisons.
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Table 4
Linear mixed models results and effect sizes, baseline to 6-month follow-up.
Variable Within-condition Between conditions treatment vs. TAU
Intercept, B (SE) B (SE) [95% C.I.] P Effect size Interaction treatment vs TAU, B P Effect size of interaction (Cohen’s
[95% C.I.] [95% C.I.] (SE) [95% C.I.] d) [95% C.I.]
Pain
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interference
BT 3.71 (0.12) 20.08 (0.01) 0.01 20.32 0.04 (0.01) [0.01 to 0.06] 0.01 0.27 [0.07 to 0.41]
[3.51 to 3.91] [20.10 to 20.06] [20.41 to 20.25]
CT 3.71 (0.11) 20.09 (0.01) 0.01 20.34 0.04 (0.01) [0.02 to 0.06] 0.01 0.29 [0.14 to 0.43]
[3.54 to 3.91] [20.10 to 20.07] [20.41 to 20.28]
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MBSR 3.57 (0.11) 20.07 (0.01) 0.01 20.30 0.03 (0.01) [0.01 to 0.05] 0.01 0.21 [0.07 to 0.35]
[3.53 to 3.74] [20.09 to 20.05] [20.38 to 20.23]
TAU 3.62 (0.12) 20.05 (0.01) 0.01 20.23
[3.43 to 3.80] [20.07 to 20.03] [20.31 to 20.15]
Pain
intensity
BT 5.66 (0.19) 20.15 (0.02) 0.01 20.31 0.12 (0.02) [0.07 to 0.16] 0.01 0.53 [0.31 to 0.71]
[5.35 to 5.97] [20.18 to 20.11] [20.37 to 20.23]
CT 5.63 (0.19) 20.13 (0.02) 0.01 20.31 0.10 (0.02) [0.06 to 0.14] 0.01 0.43 [0.26 to 0.61]
[5.32 to 5.94] [20.17 to 20.11] [20.36 to 20.23]
MBSR 5.05 (0.18) 20.12 (0.02) 0.01 20.29 0.08 (0.02) [0.05 to 0.12] 0.01 0.34 [0.21 to 0.51]
[5.21 to 5.81] [20.15 to 20.09] [20.35 to 20.22]
TAU 5.51 (0.19) 20.04 (0.02) 0.04 20.12
[5.20 to 5.81] [20.07 to 20.01] [20.18 to 20.02]
Physical
function
BT 18.86 (0.42) 0.18 (0.04) 0.01 0.22 20.14 (0.04) [20.22 to 20.06] 0.01 20.27 [20.42 to 20.11]
[18.17 to 19.55] [0.12 to 0.24] [0.15 to 0.29]
CT 18.46 (0.41) 0.16 (0.04) 0.01 0.21 20.14 (0.05) [20.22 to 20.06] 0.01 20.27 [20.43 to 20.12]
[17.81 to 19.11] [11 to 0.22] [0.12 to 0.27]
MBSR 19.41 (0.36) 0.12 (0.04) 0.01 0.14 20.09 (0.04) [20.18 to 20.01] 0.03 20.18 [20.36 to 20.02]
[18.81 to 19.98] [0.06 to 0.19] [0.06 to 0.22]
TAU 18.82 (0.41) 0.02 (0.04) 0.46 0.02
[18.16 to 19.47] [20.05 to 0.08] [20.06 to 0.11]
Depression
BT 10.21 (0.51) [ 20.31 (0.06) 0.01 20.25 0.31 (0.06) [0.17 to 0.41] 0.01 0.56 [0.30 to 0.73]
9.36 to 11.03] [20.40 to 20.21] [20.32 to 20.18]
CT 10.68 (0.46) 20.29 (0.05) 0.01 20.25 0.27 (0.06) [0.16 to 0.38] 0.01 0.48 [0.28 to 0.67]
[9.82 to 11.54] [20.38 to 20.20] [20.32 to 20.18]
MBSR 10.19 (0.46) 20.21 (0.04) 0.01 20.19 0.18 (0.05) [0.08 to 0.28] 0.01 0.31 [0.14 to 0.48]
[9.43 to 10.95] [20.27 to 20.13] [20.26 to 20.12]
TAU 10.02 (0.50) 20.03 (0.05) 0.56 20.03
[9.19 to 10.84] [20.12 to 0.05] [20.11 to 0.05]
Sleep
disturbance
BT 55.62 (0.71) [ 20.52 (0.09) 0.01 20.25 0.41 (0.11) [0.22 to 0.61] 0.01 0.48 [0.26 to 0.72]
54.46 to 56.78] [20.67 to 20.36] [20.32 to 20.19]
CT 56.97 (0.83) 20.46 (0.09) 0.01 20.24 0.34 (0.10) [0.15 to 0.53] 0.01 0.38 [0.17 to 0.59]
[55.61 to 58.33] [20.62 to 20.31] [20.31 to 20.18]
MBSR 55.60 (0.73) 20.41 (0.07) 0.01 20.23 0.29 (0.09) [0.11 to 0.46] 0.01 0.32 [0.12 to 0.51]
[54.40 to 56.80] [20.53 to 20.29] [20.29 to 20.17]
TAU 57.16 (0.70) 20.12 (0.07) 0.13 20.06
[56.01 to 58.32] [20.22 to 20.01] [20.12 to 0.01]
BT, behavioral therapy; CT, cognitive therapy; MBSR, mindfulness-based stress reduction; TAU, treatment as usual.
3.5. Clinically meaningful changes in pain intensity ITT approach was to include only participants who actually
participated in study procedures and who were therefore
Clinically meaningful improvement in pain intensity was assessed.
Clinically meaningful change was defined as a 30% or greater exposed to some level of dose of treatment and/or an
reduction in pain intensity from pretreatment to posttreatment. assessment session. The frequencies were as follows: TAU 5
We used a modified ITT approach in which we included in these 17.1%, BT 5 33.3%, CT 5 28.7%, and MBSR 5 24.5%.
responder analyses any participant who completed at least one Statistically significant between-group differences were found,
treatment session, or for TAU participants, who completed at such that BT and CT had a significantly larger proportion of
least one weekly assessment. The rationale for using a modified participants with 30% or greater improvement on pain intensity
Copyright © 2021 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.
February 2022
· Volume 163
· Number 2 www.painjournalonline.com 387
than TAU participants (x2 [3, 429] 5 9.42; P , 0.03). Mindfulness- noted, however, that a recent meta-analysis44 found very small
based stress reduction did not differ significantly from TAU. benefits in pain reduction for CBT compared with active control
Clinically meaningful worsening of pain intensity was also groups, such as pain education, among a collective N of 3235
assessed following recommendations of Palermo et al.34 Clini- research participants.
cally meaningful worsening was defined as a 30% or greater Condition 3 Time interaction analyses for the 8 sessions also
increase in pain intensity from pretreatment to post-treatment.17 allowed us to analyze regions of significance. These regions
The frequencies were: TAU 5 10.1%, BT 5 5.8%, CT 5 9.3%, identified the approximate treatment session at which the CT,
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and MBSR 5 7.0%. Between-group differences in these MBSR, and BT groups began to differ significantly from TAU on
increases were nonsignificant (x2 [3, 429] 5 0.41, P . 0.05]. each of the 5 outcome factors. Put otherwise, we were able to
determine the relative rates at which improvement occurred.
There was notable variability in these regions between the
4. Discussion
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388
·
J.W. Burns et al. 163 (2022) 376–389 PAIN®
operate through different mechanisms, even when they are Accepted 23 May 2021
shown to have the same or similar effects on outcomes.11,19 If Available online 1 June 2021
different treatments are found to operate by different underlying
mechanisms, then this information could be used to inform
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