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The Impact of A Cognitive Behavioral Pain Management Program On Sleep in Patients With Chronic Pain Results of A Pilot Study
The Impact of A Cognitive Behavioral Pain Management Program On Sleep in Patients With Chronic Pain Results of A Pilot Study
doi: 10.1111/pme.12903
REHABILITATION SECTION
Original Research Article
The Impact of a Cognitive Behavioral Pain
Management Program on Sleep in Patients with
Chronic Pain: Results of a Pilot Study
C 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
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evidence suggests a deteriorating cycle of pain and answered, written consent was obtained. Participants
sleep. Pain can lead to poor sleep which in turn may then completed a PSQI, and individuals with a PSQI
result in increased next day pain, leading to further prob- score of more than five were assigned to either the
lems with next night sleep, as reported in other pain con- treatment group or the waiting list control group based
ditions such as burns and fibromyalgia [6–8]. upon their position on the waiting list. Individuals having
to wait for more than 6 months were used in the control
Cognitive behavioral therapy pain management pro- condition, while individuals having to wait less than 6
grams (CBT-PMP) are widely used in the nonpharmaco- months were used in the treatment condition.
logical treatment of chronic nonmalignant pain [9–11].
The efficacy of this model of care in terms of improving Group membership was concealed from the principal
QOL, reducing the pain experience, improving pain investigator who completed all the assessments.
behaviors and general daily functioning has been estab-
This pilot study was undertaken to determine the impact The Cognitive Behavioral Therapy Pain Management
of a CBT-PMP on sleep quality compared with a waiting Program
list control (WLC) group. The aim of this pilot is to 1) to
determine the relationship between subjective and The multidisciplinary CBT-PMP provides the patient with
objective sleep variables and other outcome measures multiple therapies involving comprehensive rehabilitation
(physical and psychological) measures, 2) to explore in each of the specialized areas [19]. The core multidis-
between group differences in changes to objective and ciplinary team includes a pain management physician, a
self-report sleep measures in patients two months after senior occupational therapist, a senior physiotherapist
completion of a CBT-PMP, AND 3) to evaluate the feasi- and a senior clinical psychologist. All have specialist
bility of using equipment to measure sleep in an RCT. training in the management of patients with chronic
pain.
Methods
The program runs 3 days a week (6 hours per day) for
This prospective nonrandomized between-groups pilot 4 weeks (six to eight patients per group) with review
study with two time points (baseline, two month follow- sessions held 2 and 6 months postprogram completion.
up) involved patients who fulfilled the inclusion criteria Routinely patient assessment occurs at baseline, on
for the CBT-PMP and were on the waiting list. Full ethi- completion of the 4 week program, and two and six
cal approval was granted from the Ethics Committee, months later. Outside of the three days of the program
Adelaide and Meath Hospital, Tallaght, Dublin 24. Whilst patients are expected to practice cognitive behavioral
formal power calculations are not required for a pilot therapy (CBT) skills, for example, pacing, goal setting,
study we aimed to recruit 24 patients for each study and undertake daily relaxation and exercise sessions,
arm. and note these in a weekly diary. The program is based
on principles of Fordyce [19] and Turk [20], and incor-
All individuals currently on the waiting list for the CBT- porates operant and cognitive behavioral principles
PMP were eligible for inclusion in our study. Potential across all specialties. The program aims to identify and
participants were given written and verbal information change unhelpful thoughts and beliefs; promote relaxa-
regarding the study and invited back to the pain clinic 1 tion, and help to change habits that contribute to dis-
week later where, after all questions had been ability [21,22].
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Blake et al.
Data Analysis
Outcome Measures
All data were coded, entered into SPSS v20 [35], and
In line with best practice recommendations, a broad subsequently cleaned. Raw data from the Actiwatch
range of categories were measured. Pain [numerical rat- were screened prior to analysis for missing values and/
ing scale, (NRS)] [23], physical function (Simmond’s or malfunction of the device. The sleep variables were
functional tests) [24], emotional function [Hospital automatically calculated using the Actiwatch software
Anxiety and Depression Scale (HAD-A and HAD-D) [25], (Sleep V7.27 analysis software b), using the 30 second
Tampa scale of Kinesophobia, (TSK)] [26], QOL [Short epoch length sensitivity.
Form 36 (SF-36)] [27], participant global impression of
change and satisfaction [28,29], and adverse events Continuous data were screened for normality and no
and compliance (attendance at follow-ups). significant deviations from the normal distribution were
noted except for sleep latency (Kolmorogov Smirnov
Sleep test). Pearson’s correlation coefficients assessed base-
line associations between the subjective and objective
Both subjective and objective sleep assessments meth- sleep measures (actiwatch and PSQI) and between the
ods were included due to the only modest correlation sleep measures and other constructs. The correlation
scores between them and the need to capture both matrix was reported, with statistical significance set at
dimensions of sleep disturbance [30,31]. P 0.05. Stepwise backwards regression models were
then constructed to identify combinations of variables
associated with the PSQI and fragmentation index with
The Pittsburgh Sleep Quality Index R2 values representing the proportion of variance of the
dependent variable explained by the predictors. Models
The Pittsburgh sleep quality index (PSQI) assesses sleep were selected on the basis of fit (F test; variable
quality [32]. It comprises seven subscales: sleep quality, excluded if P > 0.1) and parsimony.
sleep onset latency, sleep duration, sleep efficiency,
sleep disturbances, use of sleep medications and day- To assess differences in sleep variables two months
time dysfunction. It is scored between zero and 21, with after completion of the PMP, between the CBT-PMP
a global score of greater than five indicative of a sleep and WLC control groups, Cohen’s d effect sizes were
disorder. The tool has a sensitivity of 98.7 and specific- calculated for change between groups and a MANOVA
ity of 84.4 [33]. model assessed the overall difference between the
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Pain Management Programs and Sleep
groups in the multivariate sleep construct comprised of any pain medication. Fidelity to the program was high
subjective and objective measure, following which differ- with all CBT-PMP patients completing the intervention,
ences in individual measures were explored with two and all bar one attended the 12 week follow-up
factor ANOVA models. The pre to follow up measures session.
represented a repeated time factor and treatment the
group factor. A significant group time interaction was Twenty-two WLC patients were included in this study:
taken to demonstrate difference in response between male (n ¼ 6), female (n ¼ 16). The mean age was 46.8
the intervention and WLC groups. Correlation (613.2) years, with a history of chronic pain for
(Spearman’s Rank Order) was also performed to assess 7.9(65.4) years. More than three quarters of patients
relationship between change in sleep outcomes and (77%, n ¼ 17) had pain in two or more locations, with
patient satisfaction. low back pain frequently involved (n ¼ 13, 59%). Again,
only a minority reporting taking any pain medication.
Participant flow and retention are summarized in Participant’s baseline demographics according to group
Figure 1. Twenty-four patients were included in the allocation are summarized in Table 1.
CBT-PMP group: male (n ¼ 11), females (n ¼ 13). The
mean age was 47.7 (611.5) years, with a history of Baseline Data
chronic pain for 6.9 (66.6) years. More than three quar-
ters (79%, n ¼ 19) of patients reported having pain in No significant difference was found between the CBT-
two or more locations, with low back pain frequently PMP and the WLC group in terms of demographics
involved (n ¼ 19, 79%). Only a minority reported taking (age, gender, number of years with pain, smoking and
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Blake et al.
364
Table 2 Baseline correlations between sleep quality measures and physical and psychological scores
N ¼ 46 Actual Sleep Sleep Wk Mean FI WASO PSQI HADA HADD NRS TSK STS RO SF36MCS SF3PCS
sleep % Efficiency Latency bouts act
Sleep % –
Sleep Eff 0.84** –
Sleep Lat 0.43** 0.83** –
Wk bout 0.65** 0.46** – –
Mean act 0.89** 0.74** 0.36* 0.40** –
FI 0.81** 0.75** 0.48** 0.58** 0.65** –
WASO 0.99** 0.83** 0.43** .65** 0.90** 0.81** –
PSQI – 0.31* – – – 0.34* – –
HADA – – – – – 0.37* – 0.41** –
HADD 0.30* – – – – 0.39** 0.29* 0.40* 0.55** –
NRS – – – – – – – 0.23** – 0.36* –
TSK – – – – – 0.30* – 0.40** – – – –
STS – – – – – – – – – – – 0.39** –
RO – – – – – – – – – – 0.68** –
SF36MCS – – – – 0.34* – 0.37** 0.62** 0.55** – 0.41** – – –
SF36PCS – – – – – – – 0.33* – 0.40** 0.39** – 0.32* - – –
% ¼ Percentage, Eff. ¼ Efficiency, LAT ¼ Latency, Wk Bouts ¼ Wake bouts, act ¼ Activity, FI ¼ Fragmentation Index, WASO ¼ Wake after sleep onset, PSQI ¼ Pittsburgh sleep quality
index, HADA ¼ Hospital anxiety and depression scale – Anxiety, HADD ¼ Hospital anxiety and depression scale – Depression, NRS ¼ Numerical rating scale, TSK ¼ Tampa scale
of kinesophobia, STS ¼ Sit to stand, RO ¼ Rollover, SF36MCS ¼ Short form 36 mental component score, SF36PCS ¼ Short form 36 physical component score.
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Table 3 Relationship between sleep, physical CBT-PMP. With regards to sleep measurement only two
and psychological outcome measures of the seven objective sleep measures (actigraphy) cor-
related with the self-report measure of sleep (PSQI).
Regression Standard t statistic P value R2 Participants who completed the CBT-PMP had signifi-
coefficient error of cantly fewer number of wake bouts than the WLC. We
coefficient also report on the feasibility of using actigraphy as a
means of measuring sleep in patients with chronic pain.
Global PSQI
Constant 1.394 2.902 0.480 All patients screened were classified as having sleep
HADSA 0.267 0.109 2.370 0.022 disturbance (PSQI > 5), demonstrating that sleep is a
NRS 0.525 0.240 2.190 0.034 significant issue for patients with chronic pain and
TSK 0.142 0.068 2.098 0.042 0.354 reflect rates reported elsewhere [13,36,37]. This would
Impact of CBT-PMP on Function and Mood The low pattern of correlations between baseline self-
report (PSQI) and objective sleep measures (actigraphy)
found in our study is clinically important, and suggests
While not the main focus of this investigation, changes the need to measure both aspects when investigating
in secondary outcome measures from baseline to two sleep disturbance, as one quantifies sleep, while the
month follow up were compared between CBT-PMP other assesses a person’s perception of their sleep pat-
and WLC groups to provide context for exploration of tern which has been shown to correlates with their pain
sleep measures (Table 4). The CBT-PMP group had sig- scores that is, if a person feels sleep deprived their pain
nificant improvements in the HADS-A, HADS-D and is worse. Other authors have reported similar low corre-
TSK (P < 0.05) compared with the WLC. lations between both aspects of sleep measurement in
patients with primary insomnia and in recovering alco-
Satisfaction with CBT-PMP holics [42–44]. Of interest is that this pattern is similar to
Improved sleep quality (PSQI) was associated with that reported in other core outcome measures used in
increased patient satisfaction with the CBT-PMP in that research of chronic pain, for example, physical function
satisfaction rating were correlated with changes in and mood where self-report and objective measures
patient’s PSQI scores (Spearman’s rho ¼ 0.42, P ¼ 0.04). correlate moderately at best [25,45].
Feasibility of Equipment
The current study is based on the assumption that pain
experienced in a chronic pain population is the primary
The actigraphy as a measure of sleep was successful in
cause for their poor sleep quality. The development of
measuring sleep. The patients found it easy to apply
coexisting behavioral habits surrounding their beliefs
and use, and had access to the researcher via mobile
about pain, and their coping strategies for pain may
phone if they had issues with the equipment, so almost
result in exacerbation and/or maintenance of their sleep
no issues arose. Only one patient in the WLC group
disturbance and a reduction in their QOL. The aim of a
reported a difficulty at follow-up leading to a loss of valid
CBT-PMP is not to focus on a patient’s pain, but on
Actiwatch data. The protocol of sending and receiving
these comorbid factors, and interestingly, the relation-
the actiwatches by registered post worked well and no
ship between sleep and physical and psychological
watches were lost/broken throughout the study. The
measures established in the current study provides
patients did not find the actiwatch intrusive.
further validation that treatment of these coexisting
comorbidities may have a positive effect on sleep quality
Discussion
in this patient population. Similar findings have been
Principle Findings reported in CBT-PMPs for recovering alcoholics [43].
This pilot study found that sleep disturbance is a com- We found evidence of a positive treatment effect in favor
mon problem for people with chronic pain attending a of CBT-PMP in a range of sleep variables including
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Pain Management Programs and Sleep
Table 4 Baseline and 2-month follow-up data for trial and control group
Variable Group Pre Mean (SD) Follow-up N Effect size† Significance group†
Mean (SD) Cohen’s d time interaction
HADS Anxiety Trial 11.1 (3.9) 8.9 (3.4) 24 0.61 F1,44 ¼ 4.254
WLC 8.7 (3.8 8.7 (4.8) 22 P ¼ 0.045
HADS Depression Trial 11.9 (3.7) 9.8 (3.7) 24 0.67 F1,44 ¼ 4.947
WLC 8.1 (4.9) 7.9 (4.5) 22 P ¼ 0.031
TSK Trial 42 (6.9) 36.1 (5.8) 24 1.06 F1,44 ¼ 12.676
WLC 43.2 (7.7) 43.0 (7.9) 22 P ¼ 0.001
*Test performed on log transformed data, since variable not normally distributed.
†
Difference between group change.
HADS ¼ Hospital anxiety and depression scale, TSK¼Tamps scale of kinesophobia, sf-36-short-form 36, STS-Sit to stand,
NRS ¼ Numerical rating scale, PSQI ¼ Pittsburgh sleep quality index, % ¼ Percentage, N ¼ Number, mins ¼ Minutes,
SD ¼ Standard deviation.
subjective PSQI, and objective measures (sleep effi- rather than the recommended seven nights (including
ciency, mean activity, and fragmentation index). The weekends) in order to obtain reliable patterns of sleep
greatest statistically significant effect for CBT-PMP over quality.
WLC was in mean number of wake bouts (d ¼ 0.76). In
fact, these improvements on self-report sleep and
The use of actigraphy over seven nights proved suc-
reduced number of sleep bouts through the treatment
cessful in monitoring patients sleep. This technology has
of behavioral problems demonstrates the benefits of
gained popularity in the past decade and is now quite
such a program for patients with sleep disturbance, and
justify the need for a fully powered RCT. Little previous often substituted as a less expensive, less intrusive
research into the effect of CBT-PMPs on sleep quality in alternative to the gold standard polysomnography for
patients with chronic pain has been undertaken. To our the assessment of sleep in a range of diagnoses for
knowledge the only other study is by Currie et al. [13] example, insomnia patients [46], children and adoles-
whose results are limited as they only described the cents [47], and the elderly [48]. The high level of compli-
treatment effects on one of the seven main actigraphy ance with the actigraphy in our study supports it use as
measures (mean activity which significantly improved a suitable, cheap and user-friendly apparatus for moni-
for the CBT-PMP group) over a two night period, toring sleep.
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