Improving Physical Functional Status in Patients with

Fibromyalgia: A Brief Cognitive Behavioral

Intervention
DAVID A. WILLIAMS, MEREDITH A. CARY, KIMBERLY H. GRONER, WILLIAM CHAPLIN, LARA J. GLAZER,
ALYSSA M. RODRIGUEZ, and DANIEL J. CLAUW

ABSTRACT. Objective. Sustained improvement in physical functional status was the primary goal of a brief, 6 ses-
sion cognitive behavioral therapy (CBT) protocol for fibromyalgia (FM).
Methods. One hundred forty-five patients with FM were randomly assigned to either (1) standard med-
ical care that included pharmacological management of symptoms and suggestions for aerobic fitness,
or (2) the same standard medical treatment plus 6 sessions of CBT aimed at improving physical func-
tioning. Outcome measures included the Medical Outcome Study Short Form-36 Physical Component
Score and McGill ratings of pain. Outcomes were treated dichotomously using a preestablished criteri-
on for clinically significant success based upon the reliability of change index from baseline to one year
posttreatment.
Results. Twenty-five percent of the patients receiving CBT were able to achieve clinically meaningful
levels of longterm improvement in physical functioning, whereas only 12% of the patients receiving
standard care achieved the same level of improvement. There were no lasting differences on pain rat-
ings between groups.
Conclusion. Lasting improvements in physical functioning have been among the most difficult out-
comes to obtain in studies of FM. These data suggest that the inclusion of CBT to a standard medical
regimen for FM can favorably influence physical functioning in a subset of patients. (J Rheumatol
2002;29:1280–6)

Key Indexing Terms:

FIBROMYALGIA CHRONIC PAIN FATIGUE
COGNITIVE BEHAVIORAL THERAPY RANDOMIZED CONTROLLED TRIAL

Fibromyalgia (FM) is a common clinical syndrome defined on that FM is a complex entity, with abnormal sensory process-
the basis of diffuse pain and tenderness1. Early attempts to ing as the primary neurobiological substrate, and that subsets
understand FM sought to link the presenting symptoms with a of patients display psychological, behavioral, and other fac-
single underlying pathophysiological process, such as inflam- tors that also play a role in symptom expression2,3.
mation of the muscles or disrupted sleep. It has become clear Given the complexity of the disorder, it is not surprising
that the treatment of FM is similarly complex. There is evi-
From the Departments of Psychiatry and Medicine, Georgetown dence that pharmacological therapy such as tricyclic com-
University Medical Center, Washington, DC, USA.
pounds can lead to modest short term symptomatic improve-
Supported by a grant from the National Institutes of Health
(R29MH54877) and DAMD 17-00-02-0018. ments4-6. Several nonpharmacological interventions have also
D.A. Williams, PhD, Associate Professor, Departments of Psychiatry and been shown to be helpful in the management of FM, includ-
Medicine, Chronic Pain and Fatigue Research Center, Georgetown ing aerobic fitness7-9 and cognitive behavioral therapy
University Medical Center, and Department of Medical and Clinical
Psychology, Uniformed Services University of the Health Sciences,
(CBT)10,11.
Bethesda, MD; M. Cary, PsyD, Assistant Professor, Departments of CBT is recognized as an efficacious treatment for psychi-
Psychiatry and Medicine, Chronic Pain and Fatigue Research Center; atric concerns such as depression and anxiety12. It has also
K.H. Groner, MSN, RN, CANP, Department of Medicine, Chronic Pain
and Fatigue Research Center; L.J. Glazer, BA, Department of Psychiatry,
been successfully applied in the management of some medical
Chronic Pain and Fatigue Research Center; A.M. Rodriguez, MPhil, conditions. For example, in patients who had heart attack,
Department of Psychiatry, Chronic Pain and Fatigue Research Center; CBT has been shown to reduce the risk of subsequent attacks
D.J. Clauw, MD, Associate Professor, Department of Medicine, Chronic
Pain and Fatigue Research Center, Georgetown University Medical
to an extent greater than standard medical care or exercise13.
Center; W.F. Chaplin, PhD, Chronic Pain and Fatigue Research Center, Increased survival rates have also been found in patients with
Associate Professor, Department of Psychology, University of Alabama at cancer who have used CBT14. For many years, CBT has been
Tuscaloosa.
successfully applied to chronic pain conditions such as low
Address reprint requests to Dr. D.A. Williams, Departments of Psychiatry
and Medicine, Georgetown University Medical Center, 3750 Reservoir
back pain, and rheumatological conditions such as osteoarthri-
Rd., NW, Washington, DC 20007. E-mail: [email protected] tis and rheumatoid arthritis15-20. The rationale for using CBT
Submitted August 3, 2001; revision accepted December 31, 2001. with chronic pain conditions stems from the assumption that

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pain and suffering are the result of complex interplay involv- outcomes are possible when CBT is delivered in a group for-
ing pathophysiology, cognition, affect, and behavior21. mat, which can be more efficient and less costly than individ-
Modification of any one of these 4 factors can positively or ual sessions29,31.
negatively affect the course of an individual’s medical condi- From the literature, it cannot be stated that CBT cures FM,
tion. nor that all who receive it will benefit significantly. It does,
Several investigators have applied CBT in the management however, appear that in this syndrome characterized by chron-
of FM. The outcomes have been mixed, but generally modest ic pain and diminished functioning, a subset of patients will
positive effects have been reported. For example, one study experience some or even substantial improvements if offered
applied a stress reduction based version of CBT in 79 patients CBT30,31.
with FM compared to a waitlist control group (n = 49)22. This We carried out an initial test of the efficacy of a CBT pro-
study found significant improvements in pain, functional sta- tocol specifically targeting sustained improvements in physi-
tus, and psychological status. A second study that applied a cal functional status. A brief 6 session group-formatted inter-
problem solving based version of CBT in combination with vention was tested, emphasizing CBT skills focused on
exercise and suggestions for healthy lifestyle changes similar- improving physical functioning and deemphasizing CBT
ly found a 6 month sustained reduction in pain intensity23. A skills that could be applied to more time-consuming aspects of
third study found reductions in pain intensity along with the FM clinical spectrum (e.g., depression).
improvements in life interference, self-efficacy to control
pain, and emotional distress24. This study and a companion MATERIALS AND METHODS
article25 described that CBT could produce both short (3 Objectives. The primary objective was to determine if a sustained, clinically
meaningful improvement in physical functional status could be realized by a
weeks) and longterm (30 months) improvements in symptoms
greater proportion of patients with FM if they were exposed to a brief 6 ses-
of FM. sion protocol of CBT in addition to their usual and customary medical care.
Three studies compared CBT for FM against credible The secondary objectives were to identify similar improvements in pain and
active treatment or attention controls, with each revealing pos- to explore the role of treatment adherence in achieving improvements in
itive treatment effects for CBT; but each also failed to prove a physical functional status.
clear superiority of CBT over the other interventions. One Procedures and randomization. All patients who satisfied the eligibility crite-
ria and gave written informed consent were asked to complete baseline
study found significant improvements in pain coping and pain
assessment questionnaires. Following the baseline assessment, patients were
control, but these improvements were not significantly differ- randomized into one of 2 groups: (1) standard pharmacological management
ent from those obtained in an educational control group26. A of symptoms plus suggestions to engage in aerobic fitness (usual and cus-
second randomized controlled trial found improvements in tomary care control group) or (2) usual and customary care plus CBT. Once
depression, pain behaviors, and tenderness when a behav- randomized, if assigned to CBT, treatment began within 30 days and was
delivered within a 4 week time frame. Participants in both groups were con-
iorally and socially based version of CBT was delivered. Like
tacted monthly by phone to track health care use and CBT skill use in patients
the previous study, these findings, while positive, were not assigned to CBT. At 12 months posttreatment, a final followup questionnaire
significantly different from those obtained in the educational similar to that administered at baseline was administered.
control condition27. A third randomized controlled trial com- Subject selection. Eligible patients were identified from a patient registry of
pared an education control group to 3 versions of active treat- individuals being followed medically in a tertiary care rheumatology clinic
ment: a relaxation based version of CBT, exercise, and a com- specializing in FM. To be included in the study, potential subjects needed to
bination of relaxation and exercise28. In this study, the educa- meet the study inclusion and exclusion criteria.
tion group showed a modest deterioration over time, whereas Inclusion criteria. All subjects needed to fulfill the 1990 diagnostic criteria1
for FM of the American College of Rheumatology (ACR), be 18 years of age,
the 3 intervention groups each resulted in positive treatment
and needed to have been in standard medical care with the clinic for at least
outcomes. The combination group of CBT and exercise 6 months.
showed the best maintenance of functional gains over 2 years. Exclusion criteria. Subjects were excluded from participation if they had any
As is evident from the literature sited, CBT is not a uni- of the following: (1) severe physical impairment that precluded receiving
form intervention but rather is composed of many different cognitive behavioral therapy (e.g., complete blindness or deafness); (2)
skills that can be offered alone or in combination. While there comorbid medical illnesses capable of causing a worsening of physical func-
is little agreement over what skills should be included in a tional status independent of FM, e.g., morbid obesity, autoimmune diseases,
cardiopulmonary disorders (angina, congestive heart failure, chronic obstruc-
CBT intervention for FM, there is some evidence that CBT tive pulmonary disease, chronic asthma), uncontrolled endocrine or allergic
works better when specific outcomes are targeted and skills disorders (e.g., thyroid dysfunction, Type I diabetes), and malignancy within
are selected that specifically address those targets. In one 2 years; (3) any present psychiatric disorder involving a history of psychosis
study that compared “targeted” versus “nontargeted” out- (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder,
comes for FM, only the outcomes that were specifically tied delusional disorder, etc.), current suicide risk or attempt within 2 years of the
study, or substance abuse within 2 years. Subjects with mood disorders were
to CBT content (i.e., targeted) revealed sustained change24.
not excluded.
The literature also shows that positive outcomes can be The inclusion criteria were chosen to select patients who were taking sta-
obtained with CBT when as many as 24 or as few as 6 sessions ble doses of therapy, in contrast to new patients, where changes in medica-
are used29,30. There is also evidence suggesting that positive tions or the addition of other nonpharmacological therapies such as exercise

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could introduce confounding factors. The exclusion criteria were selected so For this study, however, this technique was introduced in a very brief form for
that all subjects would be likely to understand and potentially implement use specifically with symptoms of FM and to assist in the removal of barriers
CBT, and to isolate the physical functional impairments caused by FM. impeding functional status.
Treatment procedures. Usual and customary care. All patients in both arms of Session 6 focused upon general principles of stress management and
the study received the clinic’s usual and customary care. The treating physi- problem solving43. These skills were taught to assist patients in anticipating
cian and nurse practitioner that were delivering standard care were blinded to and solving problems that might impede future functioning and the use of the
group assignment. In this clinic, the usual and customary care consisted of skills covered in this therapy. This session also allowed patients to develop
symptom based pharmacological therapy, usually including low dose tricyclic their Personally Tailored Symptom Management Plan (PTSMP). This plan
compounds, analgesics, and/or antidepressants. In addition, all patients allowed patients to select their own goals for using the various CBT skills
received instructions on aerobic exercise, and were regularly encouraged to over the longterm maintenance phase of the study. The importance of main-
exercise. taining regular practice with their chosen skills was emphasized.
Cognitive behavioral therapy. CBT was delivered in a group format. The Outcome assessment. Primary outcome measure. The primary endpoint and
group leader was a doctoral level clinical psychologist with 5 years’ experi- study outcome measure was the proportion of patients with FM who
ence conducting CBT groups for chronic pain patients. The therapist followed improved more than 6.5 units at 12 months relative to baseline on the Physical
a standardized session-by-session treatment manual for all groups and met Health Summary Scale (Physical Component Summary Score, PCS) of the 36
regularly in supervision with the study principal investigator to ensure proto- item Medical Outcome Study Short-Form Health Survey (SF-36). The SF-36
col adherence. The entire therapy was delivered in 6 one-hour sessions dur- is a brief, well established, self-administered patient questionnaire for the
ing a 4 week time frame. Groups consisted of between 4 and 8 participants. assessment of health status44. The SF-36 measures 8 domains of health status:
Each therapy session followed a format that included (1) reviewing the physical functioning, role limitations because of physical problems, bodily
previous session’s homework, (2) introducing new content through brief lec- pain, general health perceptions, energy/vitality, social functioning, role lim-
tures and group discussion, and (3) discussing the homework assignment to itations due to emotional problems, and mental health. A summary score for
be completed before the next session. Each session built upon the content of physical functional status (the PCS) can be calculated by combining and
the previous session and patients were assigned protocol based goals for the weighting the various individual scales. The PCS score has been standardized
use of each skill during the therapy. During the 12 month followup period, to have a mean = 50, SD = 10 in the general US population45. Internal con-
participants were given the choice of adhering to the goals for each skill as sistency reliability for the PCS is r = 0.91 with test-retest reliability r = 0.89.
discussed during therapy or choosing personally tailored goals for each skill. Subjects were grouped into one of 2 categories based upon the direction
The content of the sessions (e.g., the skills chosen) was selected because and magnitude of change in PCS between baseline and 12 months’ followup.
of their ability to be applied in such a manner as to improve physical func- Categorization followed the method outlined by Ware, et al46, where subjects
tioning. While each of the skills can also be applied to treat other concerns were considered “better” if their PCS scores improved by 6.5 points or more.
with relevance to FM, (e.g., cognitive restructuring for depression), the skills Patients were considered “unimproved” if their PCS scores were within 6.5
as taught in this study had a primary focus on functional status. points of baseline, or declined. The criterion of a 6.5 unit change in PCS is the
The first session involved introductions, ground rules for group therapy, a magnitude of change necessary to exceed the 95% confidence interval for any
rationale for treatment based upon the gate control theory of pain32, and an individual score. The 95% CI is based upon 2 standard errors of measurement
introduction to progressive muscle relaxation as a means of learning the (SEM), which incorporate the test-retest reliability and standard deviation of
relaxation response. Subjects were given a standardized relaxation tape for the measure. This criterion, similar to the reliability of change index47, is
practice33 and instructed in its use. Learning the relaxation response has highly conservative but given the difficulty in obtaining symptom changes of
strong support as a method to manage pain and can lead to improved func- this magnitude on the PCS, such changes may be assumed to be and have
tioning15,34. been considered to be clinically and socially relevant46. The one-year time
Session 2 focused on methods to gradually increase function without point was chosen as the primary study endpoint because previous clinical tri-
increasing pain or fatigue. This session introduced time based pacing skills als of CBT have shown better longterm than short-term results, and because
(i.e., graded activation)35,36 based on a model that encourages time cued rest longterm efficacy has become a common benchmark against which many
breaks as a means of preventing symptom flares and increasing physical func- clinical investigations in this area are being compared.
tioning. Visual imagery techniques were also discussed in session 2 as a com- Secondary outcome measures. Secondary study outcomes explored the effect
plementary skill for progressive muscle relaxation37. of brief CBT on sensory and affective symptoms of pain. Pain ratings were
Session 3 introduced pleasant activity scheduling38. This was a comple- measured using the short form of the McGill Pain Questionnaire48, which
mentary skill taught with time based pacing in which patients learned to measures the quality of pain by asking patients to rate the intensity of 15 ver-
broaden their range of pleasurable activities. Using time based pacing with bal descriptors of pain on a 0 to 3 rating scale. Two scores were derived from
pleasant activities can be easier to learn than when pacing is attempted first this instrument for use in this study, a sensory pain score and an affective pain
with work responsibilities. Brief relaxation skills (i.e., mini-practices) were score. In a separate sample of patients with FM, we determined the 4 week
also introduced in this session39. These briefer forms of progressive muscle test-retest reliability of the McGill short form to be r = 0.57 (SD 6.5) for the
relaxation were taught as tools that could be generalized for use throughout sensory scale and r = 0.55 (SD 3.9) for the affective scale (unpublished data).
the day and in public. Based upon these figures, the reliability of change index would require a
Session 4 introduced communication skills and assertiveness training40. change of 12 points on sensory and a change of 5 points in affective scores to
These skills provided patients with tools for social interactions that could constitute a sustained meaningful change from baseline to 12 month fol-
improve self-confidence, control, and efficacy in the acquisition of needed lowup. As with the PCS score, patients were dichotomously categorized as
assistance with factors that can worsen pain and fatigue and serve as barriers “improved” or “unimproved” on these measures of pain between baseline and
to physical functioning. An additional brief relaxation strategy known as the 12 months posttreatment.
mini-TRIP (tension-reducing imagery practice) was also introduced in this Adherence to treatment measures. All subjects in the CBT group were asked
session as a means of gaining control over pain while in public41. to monitor their use of the 9 CBT skills presented in therapy for 12 months.
Session 5 introduced cognitive restructuring principles42. These tech- In the last treatment session, patients were asked to choose a goal for practic-
niques were chosen to provide patients with tools for managing negative auto- ing each CBT skill over the followup period. Patients recorded their use of
matic thinking processes, appraisals, and beliefs that could sabotage coping skills on a daily diary form that was relayed to a study research assistant by
attempts and diminish gains in functional status. In a more expanded form phone on a monthly basis. From these data, a rating of “met or exceeded the
than used in this study, this skill can be used in the treatment of depression. goal” or “under the goal” was calculated on a monthly basis for each skill.

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Aggregate ratings were then calculated for each skill that indicated the pattern health). In this sample, patients had tried an average of 8.6
of adherence to each skill [i.e., “never met the goal in 12 months,” “mixed” (SD 3.6) treatment modalities before starting the trial, with 7.2
(met the goals in some months and not in others), and “met the goal every
month for 12 months”].
(SD 4.1) of the interventions reported as being of at least some
benefit. The mean PCS score at baseline was 28.6 (SD 8.9),
Demographic and disease status measures. Standard demographic data
recording sheets were utilized to collect information on demographics and ill- suggesting an overall low level of self-reported functioning in
ness characteristics such as illness duration. The Duke University Severity of this sample. The mean McGill sensory pain score was 14.8
Illness scale (DUSOI)49 was used as a standardized physician rating of illness (SD 6.8) and the mean affective pain score was 4.6 (SD 3.1).
severity at baseline. This checklist employed a complex scoring procedure Subjects were randomly assigned to one of the 2 treatment
that allowed for multiple health problems (e.g., comorbidity) and produced an
conditions (n = 69 controls, n = 76 CBT) and were compara-
index of health ranging between 100 (poor health) and 0 (excellent health).
This instrument has been validated for use by clinicians at the time of patient ble to one another on the baseline characteristics. Of 145
encounter or by medical records auditors. Patients also identified the number patients who joined the trial and were randomized, 23 (15%)
of previous treatments they had tried for FM (e.g., medications, massage, dropped out over the course of the year (14 treatment condi-
acupuncture, religious counseling, psychological therapy, physical therapy, tion, 9 controls), leaving 122 subjects with complete data. The
nerve blocks, manual manipulation, braces, surgery, etc.), as well as any ben-
primary reported reasons for dropping out were moving out of
efit obtained from these previous treatments (i.e., “no benefit,” “some
benefit”). the region or losing interest in continuing the study over the
Statistical analyses. Baseline comparability. To insure that the demographic 12 month followup period. There were no differences of
and illness characteristics associated with each group were comparable, com- demographic characteristics or pretreatment assessment mea-
parisons of these variables were completed at the close of subject recruitment. sures between subjects completing the study and dropouts.
Continuous variables were compared via t tests and categorical variables were
Primary outcome (physical functioning). Twenty-five percent
compared by chi-square analysis.
of the patients receiving CBT realized a clinically meaningful
Analysis of primary outcome measure. The primary study endpoint was the
proportion of patients who improved their PCS by more than 6.5 points at one and sustained improvement in physical functional status. The
year relative to baseline. Odds ratios evaluated by chi-square were used to number of patients realizing this level of change was signifi-
detect significant differences in the proportion of patients showing improve- cantly greater than the standard care control group, in which
ment between the 2 groups. only 11.6% realized the same degree of improvement during
Exploratory post-hoc analyses dismantled the PCS score into its scale
the same time period. These conditional percentages translate
score components and used paired t tests (with appropriate Bonferroni cor-
rection to the alpha level) to identify which functional domains accounted for into an odds ratio of 2.9 (chi-square = 5.30, p < 0.05), sug-
treatment successes and treatment failures in each group (CBT vs control). gesting that this level of improvement was nearly 3 times
Analysis of secondary outcome measures. Secondary outcomes (i.e., sensory more likely to occur in the CBT condition than in standard
and affective pain) were treated in an identical manner as the primary out- care (Figure 1).
come measure using the dichotomous cutoff values for “success” and “fail-
An exploratory attempt was made to determine which ele-
ure” associated with each respective measure.
ments of the PCS score differentiated the treatment successes
Adherence to treatment. Treatment adherence was measured in 2 ways. The
first was a simple tally of the number of sessions attended (out of 6) by each from the treatment failures. Paired t test comparisons using a
participant. The second was a measure of adherence to the CBT skills given Bonferroni correction to alpha (alpha = 0.05/8 = 0.006) were
as homework assignments. Individual adherence ratings (i.e., goal attainment) performed on the subscales of the SF-36 for the successes and
by skill and by month were used to assess the pattern of goal attainment over for the failures in each arm of the study between baseline and
the 12 month period. This measure of adherence pattern (i.e., never meeting
goals, sometimes meeting goals, always meeting goals) was used to analyze
the relationship between adherence and outcomes in physical functional sta-
tus using chi-square tests.

RESULTS
Sample selection and patient characteristics. Consecutive
clinic patients who met the study criteria were recruited over
a 24 month period. This resulted in the study sample (n = 145)
of 130 women and 15 men with an average age of 47.7 years
(SD 11.4). The majority of subjects were white (not of
Hispanic origin — 88%), the remainder of the sample being
black (not of Hispanic origin — 9%), Hispanic (2%), and
Asian American (1%). The average education level of the
sample was 16 years or the equivalent of a college education,
and 60% of the sample were married. Compensation was pre-
sent or pending in 28% of the sample. The average reported
duration of FM in the sample was 8.6 years (range 6
months–40 years) and the average severity of illness rating on Figure 1. Improvement in physical functioning: brief CBT vs standard care
the DUSOI was 54.8 (SD 15.2) (e.g., 100 being poorest over 12 months. N = 122, OR 2.9, p < 0.05.

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12 month followup. Treatment failures in the control condi- disease is associated with persistent levels of abnormal func-
tion showed no significant improvements on any subscale of tioning and pain over time50. Historically, both pharmacologi-
the SF-36, but did have significant worsening of scores on cal and nonpharmacological interventions have been partially
physical role functioning, t = –4.80, p < 0.006, and on energy successful at symptom management, but have been unable to
t = –3.39, p < 0.006. In contrast, treatment failures in the CBT produce much in the way of meaningful and lasting improve-
group showed no significant worsening or improvements on ments in the functional status of patients with FM10. This study
any scale, suggesting the possibility that CBT buffered against described an intense but brief nonpharmacological interven-
worsening in this group. Treatment successes in the controls tion, cognitive behavioral therapy, that resulted in participants
were due exclusively to a significant improvement in physical being nearly 3 times more likely to achieve meaningful and
role functioning, t = 4.43, p < 0.006, whereas improvement in lasting improvements in physical functional status compared to
the CBT group was due to significant improvements in phys- controls receiving standard symptom based pharmacological
ical role functioning, t = 3.03, p < 0.006, general physical treatment. These findings are thought to be robust given the
functioning, t = 4.57, p < 0.006, and pain as assessed by the highly conservative criteria used to determine a successful case
SF-36, t = 5.88, p < 0.006. (i.e., use of the reliability of change index over a 12 month
Secondary outcomes (sensory and affective pain). The per- period in a randomized controlled clinical trial).
centage of patients reporting clinically meaningful and sus- The form of CBT used in this study appeared to influence
tained improvements on the McGill sensory and affective pain physical functional status but did not appear to affect the pri-
scales between baseline and 12 month followup did not differ mary symptom of FM (i.e., pain). Previous trials of CBT have
significantly between the CBT and control groups. reported changes in pain but have not tended to find substan-
Improvements in sensory pain were realized by 3.9% of the tial changes in functional status10. Two primary differences
CBT group and by 7.2% of the controls. Improvements in between this study and others are the length of the interven-
affective pain were realized by 9.2% of the CBT group and tion and the goal of the intervention, which was to specifical-
8.7% of controls. ly target CBT skills designed to improve physical functional
Adherence to CBT treatment. The median number of sessions status. CBT for pain management is typically offered in 8–12
attended by patients was 4 (range 2–6). For the 9 CBT skills, session blocks19,51 where multiple pain coping skills are cov-
patients were given the choice of adhering to the goals set by ered in depth and multiple pain related outcomes are assessed.
the therapist for the 12 month followup period or choosing Because of the brief duration of this intervention, and the fact
their own goals for skills usage. Given the choice, over 50% that physical function was targeted rather than pain, we were
of the participants chose to retain the goals set by the thera- not surprised that the 2 McGill scores did not change signifi-
pist. Those choosing to set their own goals were evenly split cantly for either group. This finding is also consistent with the
between raising and lowering the goal. Although underpow- well documented imperfect relationship between pain and
ered, an exploratory series of chi-square tests was used to functional status characteristic of the chronic pain litera-
examine the percentage of successes and failures using per- ture52–56.
sonally chosen goals versus therapist established goals. Our sample had a relatively high average education level
Although none of these tests were significant, the direction of (16 years). This is in contrast to most of the literature in this
the relationship favored improved outcomes for those patients area, where education is at the high school level or lower26.
who chose personally tailored goals. Thus it could be argued that the advanced education level of
Over the 12 month period, participants were evaluated our sample contributed to the patients being better able to
each month on whether they met their stated goals for using learn and take advantage of the CBT skills being taught. If this
each of the 9 CBT skills taught in the therapy. Thirty-eight were true, then expectations for this level of improvement in
percent of participants never had a month in which they met physical functional status would not generalize beyond
their stated goals. Forty-seven percent of subjects exhibited a patients with greater education. The latter argument, however,
mixed pattern of goal attainment, with goals being reached is not supported by data from our sample. In our sample, CBT
some months and not others; and 15% of participants consis- treatment successes and failures were proportionately equal
tently reached their stated goals each month over the entire across education levels [chi square (8 df) = 5.70, p > 0.10].
year. Contrary to expectations, using chi-square tests, there This study did not monitor medication usage in the 2
were no statistically significant relationships between goal groups. While it could be argued that the CBT group
attainment category and outcome status on physical function- improved more than the control group because it received
ing (i.e., successful–failure). Thus success in improving phys- more medications, several factors argue against this interpre-
ical functioning was not directly associated with level of tation. First, there is no empirically based reason to suspect
adherence. that any known medication for FM would produce this type of
functional improvement in outcome. Second, all participants
DISCUSSION were randomly assigned to groups, thus medications and
Studies of the natural history of fibromyalgia suggest that this dosages should have been roughly equal between groups.

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