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Accepted: Cognitive Behavioral Therapy For Chronic Pain Is Effective, But For Whom?
Accepted: Cognitive Behavioral Therapy For Chronic Pain Is Effective, But For Whom?
DOI: 10.1097/j.pain.0000000000000626
Cognitive behavioral therapy for chronic pain is effective, but for whom?
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a
Center for Self-Report Science
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Center for Economic & Social Research
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University of Southern California
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Department of Psychiatry and Behavioral Sciences
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Department of Psychiatry and Behavioral Science
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School of Nursing
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g
Department of Medicine, Rheumatology Division
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Department of Radiology
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Abstract
Moderator analyses are reported for post-treatment outcomes in a large,
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randomized, controlled effectiveness trial for chronic pain for hip and knee osteoarthritis (OA)
(N=256). Pain Coping Skills Training, a form of cognitive behavioral therapy, was compared
to usual care. Treatment was delivered by nurse practitioners in patients’ community doctors’
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offices. Consistent with meta-analyses of pain CBT efficacy, treatment effects in this trial
were significant for several primary and secondary outcomes, but tended to be small. This
study was designed to examine differential response to treatment for patient subgroups to
guide clinical decision making for treatment. Based on existing literature, demographic (age,
sex, race/ethnicity, education) and clinical variables (disease severity, BMI, patient treatment
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expectations, depression, and patient pain coping style) were specified a priori as potential
moderators. Trial outcome variables (N=15) included pain, fatigue, self-efficacy, quality of life,
catastrophizing, and use of pain medication. Results yielded five significant moderators for
outcomes at post-treatment: pain coping style, patient expectation for treatment response,
radiographically-assessed disease severity, age, and education. Thus, sex, race/ethnicity,
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BMI, and depression at baseline were not associated with level of treatment response. In
contrast, patients with interpersonal problems associated with pain coping did not benefit
much from the treatment. Although most patients projected positive expectations for the
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treatment prior to randomization, only those with moderate to high expectations benefited.
Patients with moderate to high OA disease severity showed stronger treatment effects.
Finally, the oldest and most educated patients showed strong treatment effects, while
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Introduction
During the last 30 years, well over 100 treatment studies for managing pain have
been conducted using cognitive behavioral therapy (CBT) and disease self-management
interventions [73]. In general, meta-analyses report small to moderate beneficial effects for
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pain, disability, mood, pain catastrophizing, and self-efficacy immediately after treatment
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Despite the large number of CBT clinical trials, very few reports of predictors
(moderators) of the treatment effects have been published. This is unfortunate, since
investigation of moderators can identify patient subgroups that exhibit different treatment
responses. Turk argued that the field needs to advance beyond conceptualizing chronic pain
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as homogeneous and applying the same interventions to everyone [66]. He cited many
papers that observed important psychological and biological heterogeneity among patients
with persistent pain. Jamison conducted some of the early work on psychosocial distinctions,
identifying three patient clusters generated by the Multidimensional Pain Inventory [28].
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These data suggested the possibility of tailoring treatment to address the specific patient
features to yield improved outcomes. In contrast, others have argued that multimodal
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therapies deliver generic benefits irrespective of patients’ individual psychosocial profiles [14;
24].
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pain is widely recognized. Recently, the Nijmegen Decision Tool was published to guide
recommendations for surgical or non-surgical interventions for chronic back pain [69]. At pre-
compensation claims were found to bode poorly for surgical outcomes. In a 2009 review,
older age and longer duration of pain as well as somatization, depression, anxiety, and poor
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coping were pre-treatment factors associated with poorer outcomes for back surgery and
implanted spinal cord stimulation [13]. Regarding CBT treatment for chronic pain, Vlaeyen &
Morley suggest that the next generation of research should be determining “what works for
whom” [70]. Moreover, the personalized medicine movement argues for more tailored
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demographic variables moderating treatment response. Education, marital status, and pain
duration were not significant predictors [50]. Higher treatment expectations were associated
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with more improvement [23; 40]. The literature on depression is mixed with some studies
finding that depression is associated with greater improvements [68], while others find
depression results in poorer outcomes [51; 67]. While some studies examining pain coping
profiles found that MPI “dysfunctional” patients benefited the most from treatment,
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“interpersonally distressed” somewhat less, and “adaptive” patients showed little or no
improvement [59; 63-65]; other studies found no differential treatment response. Baseline
catastrophizing, a maladaptive form of coping, was found in one study to be associated with
demographic and three clinical variables in one of the largest randomized controlled
effectiveness trials of CBT for chronic pain [10]. Outcomes reported are for the change from
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Methods
Study Design
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practitioners (NP) in community primary care and rheumatology offices [10]. Patients
with osteoarthritis (OA) were randomized in equal numbers to one of two conditions:
PCST (treatment condition) or Usual Care (control condition). Patients in the PCST
promote the use of cognitive-behavioral pain management coping skills. Patients in the
control condition continued with their usual care for OA. Consistent with usual care,
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patients in both conditions were provided with an OA informational brochure from the
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and aquatic exercise classes) offered in the community.
Participants
Patients with chronic pain due to OA of the knee or hip were recruited from
community primary care and rheumatology practices in New York, Virginia, and North
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Carolina. Advertisements with information about the study were posted in the waiting
participate in the clinical trial at the time of a regular office visit. Patients were told that
the purpose of the study was to evaluate the effectiveness of a 10-session program for
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coping with persistent pain delivered by nurses in their doctor’s office. Patients randomly
assigned to the control group would continue with their usual care and participate in the
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periodic assessments. Interested patients were invited to contact the research office for
further details and to be screened by telephone for eligibility. Eligibility criteria were (1)
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physician-confirmed diagnosis of hip or knee OA, (2) 21 years of age or older, (3) usual
pain ≥ 4 on a 10-point scale for a duration of at least 6 months, (4) ability to read, write,
and understand English, (5) ability to attend 10 treatment sessions at the doctor’s office
participation, (7) no expected joint replacement surgery in the next two years.
Measures
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baseline interview, sex, race/ethnicity, body mass index, and level of highest education.
Lawrence system for osteoarthritis joint damage based on radiographs was used to
grade disease severity at baseline [37]. Patients were not informed of their grade.
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Severity was graded from 0 (no radiographic findings of OA) to 4 (definite osteophytes
with severe joint space narrowing and subchondral sclerosis). Scoring based on
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radiographs has been shown to correlate moderately with articular surface grading
during knee arthroscopy [39]. All X-rays were graded using K-L criteria by two
independent raters, and a third rating was obtained in cases where the ratings disagreed
and Krippendorff's [26] ordinal alpha = 0.76 (95% CI = 0.71 to 0.80). Reliability was
slightly improved by the third rating (ordinal alpha = 0.78, 95% CI = 0.75 to 0.81).
Baseline treatment expectations. A 5-item questionnaire was modified for this study
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a 10-point scale whether PCST seems logical, if they feel confident about the training,
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whether the training will help to control their pain, if they expect the nurse delivering the
training to be helpful, and if they would recommend this training to others. The overall
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scale score for this measure showed good internal consistency (Cronbach α=0.87) [9].
cognitive, affective, and somatic aspects of depressed mood [5; 6]. It is widely used as a
treatment outcome measure and is sensitive to the range of depressed mood in chronic
pain patients [20; 27; 74]. The BDI has demonstrated validity and sensitivity to treatment
change [4]. The internal consistency of the BDI total score was 0.89 in the present study.
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evaluates the impact of and adaptation to chronic pain. Section one addresses patients’
pain severity, pain-related interference, appraisals of social support, life control, and
positive and negative behaviors in response to patient pain. Section three assesses
patients’ general activity level [38]. Internal consistencies for the subscales assessed at
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baseline ranged from 0.71 to 0.92 in the present sample. There are two scoring systems.
The classical MPI scoring system uses 9 of the 13 subscales to classify patients into 3
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main adaptational styles: adaptive, dysfunctional, and interpersonally distressed patients
[38]. In addition, a more recent scoring method based on Rasch modeling yields two
score [58].
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Outcome Measures
the health status of patients with arthritis and has been used extensively in survey and
treatment outcomes research [25; 52]. The AIMS2 addresses pain, mobility, walking and
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bending, extremity functioning, self-care, household tasks, social activities and support,
work, tension, and mood. The recall period for this instrument was changed from “in the
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past month” to a 2-week period. Internal consistency subscale estimates ranged from
Brief Pain Inventory (BPI). Four items from the BPI were used to measure current pain
and “average”, “worst”, and “least” pain in the past two weeks. The inventory is reliable,
valid and has achieved widespread use among medical conditions with chronic pain [15;
17]. The internal consistency of the four-item scale was 0.89 in the present study.
WOMAC is the most widely used outcome measure in hip and knee arthritis
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pharmaceutical and surgical studies. Several studies support the reliability and validity of
the WOMAC [7; 46]. The instrument has 24 items covering three domains: pain,
stiffness, and physical function experienced during the past 48 hours. Internal
consistency estimates ranged from 0.70 to 0.95 for the three subscales in the present
study.
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the CSQ [35; 57] was used to assess how often a patient engages in seven different
coping strategies when they feel pain: coping self-statements, praying or hoping,
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ignoring pain sensations, reinterpreting pain sensations, increasing behavioral activities,
treatment change in various chronic pain samples [21; 48] as well as good internal
consistency and construct validity [35]. Internal consistency estimates for the seven
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subscales ranged from 0.77 to 0.86 in the present study. Since the catastrophizing
ability to perform specific behaviors aimed at controlling arthritis pain and disability
(ranging from 1=very uncertain to 10=very certain) [22]. The scale was adapted from the
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20-item questionnaire developed by Lorig and colleagues [47] that has shown sensitivity
to increases in a sense of mastery over arthritis pain in many outcome trials [45; 61].
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The 8-item version has shown adequate reliability and validity [22]. The internal
Quality of Life Scale. This 16-item instrument measures quality of life across different
life domains in patients with chronic illness. The measure is reliable and content-valid;
among medical patients, internal consistency coefficients are above 0.85, and 6-week
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test-retest reliability is 0.76 [12]. The internal consistency of the total score was 0.91 in
Brief Fatigue Inventory (BFI). Like the BPI after which it was modeled, the BFI was
designed to measure fatigue in cancer patients, but its use has expanded to many
medical conditions [3; 53]. Four items from the BFI were used to measure current fatigue
and “average”, “worst”, and “least” fatigue; the recall period was changed from the past
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24 hours to the past two weeks. A factor analysis determined that the BFI assesses a
single fatigue dimension with good internal consistency and adequate correlations with
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other fatigue scales [53; 75]. The internal consistency of the four items was 0.86 in the
present study.
key constructs that are central to the arthritis pain experience were measured via IVR (a
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telephone computer interface) for seven consecutive days at each assessment period
of pain intensity, interference with physical, work, and social activities due to pain,
fatigue, satisfaction with the day’s accomplishments, and pain medication usage. IVR
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data capture is reliable and valid when compared to paper-and-pencil assessment, and
self-efficacy, and quality of life. Given the multiple scales administered for several
domains, and to reduce Type 1 error, composite measures were created for four of the
primary outcomes (pain, physical functioning, psychological distress, and coping). The
other outcomes were measured with single scales. The pain composite was comprised
of the BPI pain, AIMS2 pain, and WOMAC pain subscales (average inter-correlation
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across scales at baseline = 0.70). Physical functioning was composed of the AIMS2
Psychological distress was comprised of the BDI and AIMS2 affect (tension and mood)
scales (r = 0.70). A coping strategies composite was created by averaging the CSQ
its own right. In each case, scale scores were first standardized based on the baseline
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means and standard deviations (SDs) across all patients, and then were averaged into
composites. Thus, the composite z-scores at each assessment time point indicate where
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a patient scored in relation to all patients at pre-treatment.
Procedure
All study procedures were approved by the Stony Brook University and Duke
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University Medical Center Institutional Review Boards. The study was registered at
visit at the patient’s participating community clinic site. Prior to initiating study
procedures, patients provided written informed consent. During the baseline visit,
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the Interactive Voice Recording (IVR) telephone system for the seven daily ratings
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following the baseline visit and had their weight and height measured. Patients were also
sent for an X-ray of their most painful OA-diagnosed joint at no cost to them to determine
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their baseline disease severity. If a recent X-ray (within the past 9 months) was already
available, the research staff obtained a copy and no new x-ray was obtained. Patients
were informed that they needed to complete their daily ratings and provide an X-ray
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(PCST or usual care) was done using a permuted block randomization algorithm with
block sizes of 6 and 8. The study statistician created a randomization program accessed
assignment was only provided after the patient’s unique identifier and initials were
entered into the randomization program. The study coordinator then called patients and
informed them of their assignment to study treatment group. Patients assigned to PCST
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were then scheduled for their first appointment with a NP who provided 10 individual
weekly sessions at the patient’s doctor’s office (window for treatment completion 10 to
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20 weeks from randomization). Patients assigned to usual care were instructed to
continue with their regular treatment for their OA. Both study groups were asked to
assessment. As in the baseline assessment, research assistants met with patients for
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each assessment when patients completed outcome measures, had height and weight
measures, and completed the seven daily IVR ratings. The research team maintained
assessor blinding, but patients sometimes revealed their experimental condition. Data
PCST interventions teach patients cognitive and behavioral skills to manage their
pain and enhance their perception of pain control. Four broad coping skills were taught
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techniques, altering activity and rest patterns as a way of increasing activity level, and
reducing negative pain-related thoughts and emotions. The sessions were outlined in
detail in a treatment manual and followed a format of review of home practice assigned
at the previous session, instruction in a new coping skill, guided practice in that skill, and
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Consistent with the goal of testing the effectiveness of NPs delivering PCST in
the patients’ doctors’ offices, all treatment sessions were conducted in the clinics or by
some discretion on the part of the NP and patient. The first 3 sessions and the last
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session had to be conducted in person. Patients were provided with a treatment binder
divided into sections for each session. These sections included handouts and logs to
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record home practice of the skill, which were reviewed by the NP at each session.
Treatment sessions with a patient were stopped if they were not completed within 20
weeks of randomization.
Study nurses received 2-3 days of intensive training in PCST and individual supervision
of their cases for several months. Additional oversight for purposes of quality assurance
Analytic Strategy
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covariance models for categorical moderator variables and using multiple regression
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procedures as outlined by Aiken and West [2] for continuous moderator variables. In
each case, post-treatment scores on the outcome variable were regressed on the
baseline scores of that variable, group (treatment versus control), the moderator
variable, and the group by moderator interaction term. Clinic site was included as an
additional covariate. Thus, the interaction term tests whether the treatment effect, as the
group difference in change from pre-treatment, differs across levels of the moderator,
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analyses probed the group difference in change for high (1 SD above the mean),
average (at the mean) and low (1 SD below the mean) values of the moderator variable
report effect sizes (Cohen’s d) for high, average, and low values of the moderator,
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computed as the group difference in change on the outcome relative to the standard
deviation at baseline (scaled such that positive effect sizes indicate improvement in the
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treatment group relative to the control group). Unstandardized group mean changes and
moderated treatment effects in raw scale scores are provided in the supplemental
standard errors under the assumption that the data are either Missing Completely at
Random (MCAR) or Missing at Random (MAR) [60]. The significance level was set at
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.05, consistent with the suggestion by Kraemer [41] that these moderator analyses are
Results
The treatment and control groups (N=256) were not significantly different on
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demographic and health variables at baseline with the exception of employment status in
which the control group had a higher rate of employment than the treatment group (see
Table 1). Likewise, the groups did not differ on any of the outcome measures at
baseline; and comparisons of treatment effects across the two clinical sites did not yield
related variables including pain intensity, coping with pain, self-efficacy for controlling
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pain, activity interference due to pain, and reduced use of pain medication when
Demographics
outcome. Sex, race/ethnicity, and body mass index were not significant moderators for
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Age (M = 67.2 years; range = 36-100) significantly moderated post-treatment pain
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(p <.05) and daily ratings of “Quality of Days” (p = 0.004). Specifically, the youngest
patients (age = 57.7) experienced no reduction in pain from treatment, whereas the
treatment effect for the average-age (age = 67.2) was d = 0.19 and for the oldest
patients (age = 76.7) d = 0.37. More pronounced effect modification by age was
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observed for Quality of Days: the youngest patients reported poorer Quality of Days after
treatment (d = -0.25), the average age patient reported a small improvement (d = 0.14),
and the oldest patients experienced a much larger improvement (d = 0.52) in the
even within a sample that tended to be more educated (up to high school: 28%; college:
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51%; post-grad: 21%). A marked treatment effect for catastrophizing (d = 0.57) was
observed in the highly educated patients (post-graduate), whereas there was little
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improvement for the college educated (d = 0.08) and a worsening in the high school
educated (d = -0.20).
Clinical Variables
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(p = 0.004), quality of life scale (p = 0.05), and daily quality of days (p = 0.03). Close to
25% of the sample was classified into each of the four K-L severity groups. With a good
deal of consistency, as shown in Table 2, patients with the most severe organic disease
0.40) and fatigue (d = 0.75) . Those patients with little joint damage reported no
improvement on these variables and a worsening for quality of life and daily quality of
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day measures.
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Baseline ratings of treatment expectation significantly moderated five outcome
(p = 0.05), fatigue (p = 0.03), and daily IVR pain ratings (p = 0.03). Patients with lower
(d = 0.37) (see Table 3). The highest expectations were associated with the greatest
0.83), and fatigue (d = 0.60). Those with “average” (still strong) expectations
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Our measure of depression at baseline, the BDI, did not moderate treatment
response on any outcome. This may be due to very low levels of depressive symptoms
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The Multidimensional Pain Inventory (MPI) is scored using the original method of
assigning patients to three pain coping styles based on classical test theory: adaptive,
interpersonally distressed, and dysfunctional [38], and a more recent method based on
Item Response Theory (IRT) that yields two Rasch Scale composite scores:
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methods. Using the original clusters, 46% of our patients were identified as Adaptive,
in our treatment and control groups. The remaining 20% of patients could not be
classified into one of the three clusters, as is common with the MPI, and were not
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Distressed was comparable to that observed in prior research with various
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contrast, the proportion of patients with an adaptive coping style was slightly higher, and
the proportion classified as having a dysfunctional coping style was lower than
previously observed [8; 31; 65]. All patients’ data could be analyzed for the Rasch
scoring. Our patients’ mean Dysfunctional score was, on average, lower (M = 42.1, SD =
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10.33) than in the large chronic pain “normative” sample (M = 55.1, SD = 12.0) reported
in the MPI Version 3 Handbook [58]. In contrast, the patients in our sample had
somewhat higher Interpersonal Distress scores (M = 43.3, SD = 12.3) than the MPI
The traditional MPI cluster groups yielded no significant moderator effects for the
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primary composites and other outcome variables. The newer Rasch Scale Score for
accomplishments (p = 0.02), and need to take additional medication for pain (p = 0.03)
were moderated by the MPI Interpersonal Distress score. Specifically, the higher the
Interpersonally Distressed Coping score, the poorer the treatment response for these
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outcomes (see Table 4 showing effect sizes for various scores). The MPI Rasch
Discussion
osteoarthritis patients with chronic pain [10] who received either Pain Coping Skills
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Training, a form of CBT, or usual care. Overall, RCT treatment effects were significant
for several of the primary and secondary outcomes; however, they tended to be small as
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has been found in meta-analyses of CBT for pain [70; 73]. Thus, the question of
substantially more or less than the average? Is there evidence that this treatment can be
As noted earlier, only a few published trials have examined moderators of treatment
effects for CBT for pain. Variables that have been examined include demographics,
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treatment expectation, disease severity, depression, and style of coping with pain (MPI);
and we specified these variables a priori for moderation analyses. In our study, five
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The MPI coping style variable was the strongest moderator. Prior literature
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examining moderation by MPI clusters usually found that the Interpersonally Distressed
patients benefited less from treatment than Dysfunctional patients. Often, Adaptive
patients showed little treatment response due to positive baseline coping. In this trial, we
found no differences in treatment response among the three MPI clusters. In the revised
MPI scoring, the new Rasch approach assigns each patient a score for the two
maladaptive coping style. Dysfunctional scores did not moderate outcomes indicating
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that degree of Dysfunctional coping did not influence treatment response. However, our
patients with mid to higher Interpersonally Distressed styles of coping with pain benefited
significantly less from the treatment on the following outcomes: psychological distress
with accomplishments, quality of day, and need for pain medication. In fact, with one
exception, only patients with relatively low Interpersonally Distressed ratings showed
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benefit on these outcome variables. The exception was self-efficacy in which all patients
showed improvement, but the effects were much stronger for those with less
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Interpersonal Distress. On a positive note, patients’ treatment responses for pain and
physical functioning did not vary by level of Interpersonal Distress coping style.
These data are consistent with prior research that usually found that patients,
classified as Interpersonally Distressed in their pain coping, benefit the least from pain
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treatment [59; 63-65]. This refines and underscores the importance of Interpersonal
Distress in pain coping. Patients with a strong Interpersonally Distressed pain coping
response to their pain compared to other patients. In addition, these patients report less
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social support from their significant others. As such, their experiences of chronic pain are
usually a focus of CBT protocols for pain, including the one implemented in the present
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study. As noted by Turk, addressing social relationships (e.g., guidance for interpersonal
problem solving and assertion training) might be particularly beneficial for patients with
an Interpersonally Distressed pain coping style [65; 66]. Importantly, some research,
including our own, has demonstrated the utility of including spouses and family members
in chronic pain treatment [32-34; 49]. The emerging consistency of the association of the
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Interpersonally Distressed coping style with poorer outcomes suggests these patients
Second, patients’ baseline expectation of the benefit of the PCST (assessed prior to
catastrophizing. This was evident even in the context of overall positive treatment
expectations in the recruited sample. Patients with relatively lower (scores of 6.4 on 10-
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point scale) experienced very little benefit from treatment, while patients with average to
high expectations experienced moderate to large effects. This finding is also observed in
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two prior studies [23; 40]. Perhaps, some patients are not inclined toward self-
management approaches to deal with their pain; that is, they recognize that the
treatment is not a good fit for them, although, they did agree to participate and accept a
50% probability of being randomly assigned to the treatment group. Or, they may require
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preliminary work using motivational interviewing to enhance their “readiness for change”
30% of patients with the most severe joint disease (Kellgren-Lawrence ratings of greater
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than 3) experienced moderate to large treatment benefits for pain, fatigue, quality of life,
and daily quality of day. In contrast, the 22% of patients with the lowest levels of
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objective disease (KL ratings of 0-1) showed no benefit or worsening. Mid-level disease
severity patients (49%; KL ratings of 2-3) experienced some treatment effects, especially
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for fatigue and quality of day. This result is likely of interest to rheumatologists and
primary care clinicians who are frequently involved in the management of pain in OA
patients with severe disease [36]. It is very encouraging that patients with the most
severe disease benefit from this intervention to better manage their disease. We believe
that this is the first report of the relationship of disease severity with PCST pain
outcomes.
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The outcomes for demographic variables were encouraging in that for both men and
women, patients of different race and ethnicity, as well as BMI, all benefited equivalently
from the treatment. This speaks to the generalizability of treatment efficacy across a
range of patient groups. However, age and education did moderate outcomes on three
variables. The oldest patients showed the most robust treatment effect for pain and daily
quality of day, whereas the younger patients did not. Our most highly educated patients
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showed improvement on catastrophizing, whereas high school and college educated
patients did not; though our PCST treatment protocol did not specifically target
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catastrophizing. It is possible that PCST protocols that do target catastrophizing may
yield a more universal effect. Overall, the results for moderation by demographic
conclusions of a 2002 review that age, sex, and education did not moderate treatment
effects [51]. Nevertheless, the results that show older patients experience the best
improvements in pain suggest that this treatment can be provided to even the very old
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The differences in treatment effect sizes observed across the continuums of the
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moderator variables are important. While the overall trial’s effect sizes are modest, for
subgroups the effects rise substantially and warrant consideration in clinical decision-
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making [44]. Results from two of the moderators, pain coping style and treatment
requires examination of the social environment of the patient and the role of the patient’s
pain in those relationships. This style of coping with pain may reflect a more
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may benefit from some involvement of the patient’s significant other(s) [32-34]. As such,
these patients might benefit from PCST delivered by health professionals who can be
trained to augment PCST with interventions focused on the social context of pain [56].
management approaches for managing their condition [29; 30]. However, the factors
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underlying expectations are not well elucidated. Therefore, when patients present with
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preferences and barriers.
The data from this study also suggest that age and educational level impact
treatment outcomes for reasons that are not apparent. Older and very educated patients
benefited more from the treatment. As Internet-based interventions for pain management
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are developed, it will be interesting to see how demographics moderate those treatment
effects compared with in-person interventions. The next generation of PCST treatment
should consider approaches that may be more relevant for younger, and perhaps busier,
Finally, this study has several important health economic implications. First, there is
growing concern about the long-term costs and benefits of biological treatments for OA
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[71; 72]. There is also growing agreement about the need to identify patients who will
and will not respond to biologic therapy in order to efficiently manage medical resources
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[62; 71]. Likewise, the ability to identify patients who might respond best to behavioral
approaches may be particularly useful to clinicians working with patients who fail to
respond adequately to biologic approaches. And, finally, our results are the first to
document the high levels of PCST effectiveness among patients with the most severe
disease as assessed by imaging. Treatment options for these older patients often are
very limited, i.e., medications contraindicated, or the patient is not a surgical candidate
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because of co-morbid conditions [1; 55]. Thus, patients who must delay joint
replacement or who are unable to receive replacement are particularly good candidates
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Acknowledgments
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Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health
under Award Number AR054626 and General Clinical Research Center Grant
#M01RR10710. The content is solely the responsibility of the authors and does not
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References
[1] Abdulla A, Adams N, Bone M, Elliott AM, Gaffin J, Jones D, Knaggs R, Martin D,
Sampson L, Schofield P. Guidance on the management of pain in older people.
Age Ageing 2013;42(Suppl 1):i1-57. doi: 10.1093/ageing/afs1200.
[2] Aiken L, West S. Multiple Regression: Testing and Interpreting Interactions. Newbury
Park, CA: Sage Publications, 1991.
[3] Anderson KO, Getto CJ, Mendoza TR, Palmer SN, Wang XS, Reyes-Gibby CC,
Cleeland CS. Fatigue and sleep disturbance in patients with cancer, patients with
D
clinical depression, and community-dwelling adults. J Pain Symptom Manage
2003;25(4):307-318.
[4] Beck A, Steer R, Garbin M. Psychometric properties of the Beck Depression
Inventory: Twenty-five years of evaluation. Clinical Psychology Review
TE
1988;8(1):77-100.
[5] Beck AT, Steer RA, Brown GK. Beck Depression Inventory®—II Manual. San
Antonio, Texas: Harcourt Assessment, Inc, 1996.
[6] Beck AT, Steer RA, Garbin MG. Psychometric properties of the Beck Depression
Inventory: Twenty-five years of evaluation. Clinical Psychology Review
1988;8(1):77-100.
[7] Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of
WOMAC: a health status instrument for measuring clinically important patient
EP
relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of
the hip or knee. Journal of Rheumatology 1988;15(12):1833-1840.
[8] Bergstrom C, Jensen I, Hagberg J, Busch H, Bergstrom G. Effectiveness of different
interventions using a psychosocial subgroup assignment in chronic neck and
back pain patients: a 10-year follow-up. Disabil Rehabil 2012;34(2):110-118. doi:
110.3109/09638288.09632011.09607218. Epub 09632011 Oct 09638211.
[9] Broderick JE, Junghaenel DU, Schneider S, Bruckenthal P, Keefe FJ. Treatment
expectation for pain coping skills training: relationship to osteoarthritis patients'
C
[12] Burckhardt C, Woods S, Schultz A, Ziebarth D. Quality of life of adults with chronic
illness: A psychometric study. Research in Nursing & Health 1989;12:347-354.
[13] Celestin J, Edwards RR, Jamison RN. Pretreatment psychosocial variables as
predictors of outcomes following lumbar surgery and spinal cord stimulation: a
systematic review and literature synthesis. Pain Med 2009;10(4):639-653. doi:
610.1111/j.1526-4637.2009.00632.x.
[14] Chapman SL, Pemberton JS. Prediction of treatment outcome from clinically derived
MMPI clusters in rehabilitation for chronic low back pain. Clin J Pain
1994;10(4):267-276.
[15] Cleeland CS, Ryan KM. Pain assessment: Global use of the Brief Pain Inventory.
Annals of the Academy of Medicine, Singapore 1994;23(2):129-138.
Copyright Ó 2016 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.
24
[16] Cohen J, Cohen P. Applied multiple regression/correlation analysis for the social
sciences. Hillsdale, NJ: Erlbaum, 1983.
[17] Daut RL, Cleeland CS. The prevalence and severity of pain in cancer. Cancer
1982;50(9):1913-1918.
[18] Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy
questionnaire. Journal of Behavior Therapy and Experimental Psychiatry
2000;31(2):73-86.
[19] Eccleston C, Williams AC, Morley S. Psychological therapies for the management of
chronic pain (excluding headache) in adults. Cochrane Database Syst Rev
2009(2):CD007407. doi: 007410.001002/14651858.CD14007407.pub14651852.
[20] Frank R, Beck N, Parker J, Kashani J, Elliott T, Haut A, Smith E, Atwood C,
D
Brownlee-Duffeck M, Kay D. Depression in rheumatoid arthritis. Journal of
Rheumatology 1988;15:920-925.
[21] Gil KM, Abrams MR, Phillips G, Keefe FJ. Sickle cell disease pain: relation of coping
strategies to adjustment. Journal of Consulting and Clinical Psychology
TE
1989;57(6):725-731.
[22] Gonzalez VM, Stewart A, Ritter PL, Lorig K. Translation and validation of arthritis
outcome measures into Spanish. Arthritis Rheum 1995;38(10):1429-1446.
[23] Goossens ME, Vlaeyen JW, Hidding A, Kole-Snijders A, Evers SM. Treatment
expectancy affects the outcome of cognitive-behavioral interventions in chronic
pain. Clinical Journal of Pain 2005;21(1):18-26; discussion 69-72.
[24] Guck TP, Meilman PW, Skultety FM, Poloni LD. Pain-patient Minnesota Multiphasic
Personality Inventory (MMPI) subgroups: evaluation of long-term treatment
EP
outcome. J Behav Med 1988;11(2):159-169.
[25] Haavardsholm EA, Kvien TK, Uhlig T, Smedstad LM, Guillemin F. A comparison of
agreement and sensitivity to change between AIMS2 and a short form of AIMS2
(AIMS2-SF) in more than 1,000 rheumatoid arthritis patients. Journal of
Rheumatology 2000;27(12):2810-2816.
[26] Hayes A, K K. Answering the call for a standard reliability measure for coding data.
Communication Methods and Measures 2007;1(1):77-89.
[27] Holzberg AD, Robinson ME, Geisser ME, Gremillion HA. The effects of depression
C
Copyright Ó 2016 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.
25
D
Rheumatic Disease 1957;16(4):494-502.
[38] Kerns R, Turk D, Rudy T. The West Haven-Yale Multidimensional Pain Inventory
(WHYMPI). Pain 1985;23:345-356.
[39] Kijowski R, Blankenbaker D, Stanton P, Fine J, De Smet A. Arthroscopic validation
TE
of radiographic grading scales of osteoarthritis of the tibiofemoral joint. AJR
American Journal of Roentgenology 2006;187(3):794-799.
[40] Kole-Snijders AM, Vlaeyen JW, Goossens ME, Rutten-van Molken MP, Heuts PH,
van Breukelen G, van Eek H. Chronic low-back pain: what does cognitive coping
skills training add to operant behavioral treatment? Results of a randomized
clinical trial. J Consult Clin Psychol 1999;67(6):931-944.
[41] Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of
treatment effects in randomized clinical trials. Archives of General Psychiatry
EP
2002;59(10):877-883.
[42] Kranzler HR, Abu-Hasaballah K, Tennen H, Feinn R, Young K. Using daily
interactive voice response technology to measure drinking and related behaviors
in a pharmacotherapy study. Alcoholism, Clinical and Experimental Research
2004;28(7):1060-1064.
[43] Kratz AL, Molton IR, Jensen MP, Ehde DM, Nielson WR. Further evaluation of the
Motivational Model of Pain Self-Management: coping with chronic pain in multiple
sclerosis. Ann Behav Med 2011;41(3):391-400. doi: 310.1007/s12160-12010-
C
19249-12166.
[44] Lazaridou A, Edwards RR. Getting personal: the role of individual patient
preferences and characteristics in shaping pain treatment outcomes. Pain
2016;157(1):1-2.
C
[45] Lefebvre JC, Keefe FJ, Affleck G, Raezer LB, Starr K, Caldwell DS, Tennen H. The
relationship of arthritis self-efficacy to daily pain, daily mood, and daily pain
coping in rheumatoid arthritis patients. Pain 1999;80(1-2):425-435.
[46] Lingard EA, Katz JN, Wright RJ, Wright EA, Sledge CB. Validity and responsiveness
A
of the Knee Society Clinical Rating System in comparison with the SF-36 and
WOMAC. Journal of bone and joint surgery American volume 2001;83-
A(12):1856-1864.
[47] Lorig K, Chastain R, Ung E, Shoor S, Holman H. Development and evaluation of a
scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum
1989;32(1):37-44.
[48] Main CJ, Waddell G. A comparison of cognitive measures in low back pain:
statistical structure and clinical validity at initial assessment. Pain
1991;46(3):287-298.
[49] Martire L, Schulz R, Helgeson V, Small B, Saghafi E. Review and meta-analysis of
couple-oriented interventions for chronic illness. Ann Behav Med 2010;40(3):325-
342.
Copyright Ó 2016 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.
26
[50] McCracken LM, Spertus IL, Janeck AS, Sinclair D, Wetzel FT. Behavioral
dimensions of adjustment in persons with chronic pain: pain-related anxiety and
acceptance. Pain 1999;80(1-2):283-289.
[51] McCracken LM, Turk DC. Behavioral and cognitive-behavioral treatment for chronic
pain: outcome, predictors of outcome, and treatment process. Spine (Phila Pa
2002;27(22):2564-2573.
[52] Meenan RF, Mason JH, Anderson JJ, Guccione AA, Kazis LE. AIMS2. The content
and properties of a revised and expanded Arthritis Impact Measurement Scales
Health Status Questionnaire. Arthritis Rheum 1992;35(1):1-10.
[53] Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber
SL. The rapid assessment of fatigue severity in cancer patients: Use of the Brief
D
Fatigue Inventory. Cancer 1999;85(5):1186-1196.
[54] Mundt JC, Bohn MJ, King M, Hartley MT. Automating standard alcohol use
assessment instruments via interactive voice response technology. Alcoholism,
Clinical and Experimental Research 2002;26(2):207-211.
TE
[55] O'Neil CK, Hanlon JT, Marcum ZA. Adverse effects of analgesics commonly used
by older adults with osteoarthritis: focus on non-opioid and opioid analgesics. Am
J Geriatr Pharmacother 2012;10(6):331-342. doi:
310.1016/j.amjopharm.2012.1009.1004. Epub 2012 Oct 1012.
[56] Porter LS, Keefe FJ, Wellington C, de Williams A. Pain communication in the
context of osteoarthritis: patient and partner self-efficacy for pain communication
and holding back from discussion of pain and arthritis-related concerns. Clin J
Pain 2008;24(8):662-668. doi: 610.1097/AJP.1090b1013e31816ed31964.
EP
[57] Rosenstiel AK, Keefe FJ. The use of coping strategies in chronic low back pain
patients: relationship to patient characteristics and current adjustment. Pain
1983;17(1):33-44.
[58] Rudy TE. Multiaxial assessment of pain: Multidimensional Pain Inventory computer
program and user’s manual. Version 3 Pittsburgh, PA: University of Pittsburgh,
2004.
[59] Rudy TE, Turk DC, Kubinski JA, Zaki HS. Differential treatment responses of TMD
C
Copyright Ó 2016 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.
27
D
for whom? Clinical Journal of Pain 2005;21(1):1-8.
[71] Wenham C, McDermott M, Conaghan PG. Biological therapies in osteoarthritis.
Current Pharmaceutical Design 2015;21:2206-2215.
[72] Wenham CY, Conaghan PG. New horizons in osteoarthritis. Age Ageing
TE
2013;42(3):272-278. doi: 210.1093/ageing/aft1043. Epub 2013 Apr 1098.
[73] Williams AC, Eccleston C, Morley S. Psychological therapies for the management of
chronic pain (excluding headache) in adults. Cochrane Database Syst Rev
2012;11:CD007407.(doi):10.1002/14651858.CD14007407.pub14651853.
[74] Wilson K, Eriksson M, D'Eon J, Mikail S, Emery P. Major depression and insomnia
in chronic pain. Clinical Journal of Pain 2002;18(2):77-83.
[75] Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and
other anemia-related symptoms with the Functional Assessment of Cancer
EP
Therapy (FACT) measurement system. Journal of Pain and Symptom
Management 1997;13(2):63-74.
C
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Table 1.
P for diff.
Control group Treatment group between
(N = 128) (N = 129) groups
na M (SD) or % na M (SD) or %
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Years with OA 121 13.59 (9.09) 128 13.95 (10.63) .77
BMI 123 32.87 (8.00) 124 33.77 (8.24) .38
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Disease severity (K-L grading) 122 125 .22
0-1 27.0% 16.8%
>1 - 2 20.5% 27.2%
>2 - 3 23.0% 26.4%
>3 - 4 29.5% 29.6%
EP
Female 128 78.9% 129 74.4% .40
White race 128 85.9% 129 87.6% .69
Married/living with partner 123 62.6% 126 64.3% .78
Education 126 127 .18
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Table 2.
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Quality of life -.20 .08 .07 .40
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IVR quality of days -.34 .29 .41 .20
Note: Intervention effects are standardized based on the pooled baseline standard
deviation. Positive values indicate treatment benefits. IVR = Interactive voice recording
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3
Table 3.
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Pain intensity composite .00 .20 .40
TE
Self-efficacy .37 .60 .83
Note: Intervention effects are standardized based on the pooled baseline standard
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deviation. Positive values indicate treatment benefits. IVR = Interactive voice recording
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Table 4.
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Psychological distress composite .35 .15 -.04
TE
Self-efficacy .86 .63 .40
Note: Intervention effects are standardized based on the pooled baseline standard
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