Fibromyalgia Clinical Trial
Official title:
Randomized Clinical Trial of Cognitive Behavioral Therapy in Women With the Fibromyalgia Disorder
Previous studies have shown that the disorder fibromyalgia often is preceded by long-term
stress. Moreover, an association has been shown between stress, pain and co-morbidity in
these patients. Cognitive behavioral therapy (CBT) has been shown effective in reducing
stress, anxiety and pain in rheumatoid arthritis and fibromyalgia. The purpose of the
present trial was to assess whether CBT may reduce pain and other symptoms and increase
well-being and general function, affect biological markers for pain and long-term stress, to
a larger extent than treatment "as usual".
Forty eight women with verified fibromyalgia were randomly allocated to an early treatment
group or a waiting list group. The early treatment group received CBT group treatment during
six months. Measurements of outcome and potential outcome affecting variables were made at
baseline, after six months and one year after baseline. The waiting list group received the
same CBT treatment as the early treatment group after six months on the waiting list.
The design is thus a traditional "waiting list design", allowing a two parallel group
comparison during the first six months and a "before-after" analysis in both groups when the
treatment was concluded.
Long-lasting pain is a common cause for disability. In several studies 30-40% of the adult
general population suffer from pain. In this group of subjects the fibromyalgia syndrome
(FMS) is common,. This is a well defined disorder with generalized pain, well defined
tenderpoints according to the American Collage of Rheumatology (ACR) criteria, and a number
of other associated symptoms. About 5-10% of the general female population suffers from
fibromyalgia. The disorder is infrequent among men.
The etiology of the condition is unknown. However, a multi-factorial origin is postulated,
where some form of stress is a contributing factor. Also neuro-endocrine disturbances have
been observed. Cognitive behavioral therapy CBT) is an evidence based efficient treatment
method in depression and panic disorder. In open studies it has proved to be an effective
stress and pain reducer.
The purpose of the trial was to evaluate the effect of CBT in a group of female FMS patients
regarding pain, stress, and well-being (outcome). A purpose was also to study mediating
factors, such as biological markers for stress and pain, and psycho-social factors.
The study population consisted of 48 women, 27-62 years of age, living in Östhammar
municipality, central Sweden, with a verified FMS according to the 1992 ACR criteria, and no
other serious disorder. The were recruited by advertising in the local printed press and
meetings with the local rheumatology patient association.
54 subjects were screened for participation. A physical examination was performed, a medical
history was taken, blood samples and saliva specimens for biological markers regarding
metabolic status, pain and stress were taken, and a questionnaire was filled out. 48 women
fulfilled the inclusion criteria and gave informed consent to participation. A randomized
block design was used by which the women were randomly allocated to two groups, an early
treatment group and a waiting list group.
The early treatment group was subdivided into four treatment groups with six participants in
each. The CBT treatment was given by certified therapists and supervised by the chief
therapist, an experienced psychologist. Each group had the same therapist throughout the
trial. The therapy was given as group sessions once a week for 20 weeks. When the therapy
was completed the outcome variables were measured by means of questionnaire, and the same
blood and saliva specimens as at baseline were taken. During the next six months two booster
CBT sessions were performed. One year after baseline a final follow-up evaluation was made.
The waiting list group served as reference (or control) group to the early treatment group
during the first six months from baseline. No CBT therapy was given, but otherwise exactly
the same procedure was followed. When the control period was over the waiting list group got
their CBT treatment and evaluations following the same protocol as the early treatment
group.
The outcome evaluation are based on a number of questionnaire instruments, such as the
Multidimensional Pain Inventory (MPI), the Type A behavior instrument (Everyday stress), The
Maastricht Questionnaire ("Vital exhaustion"), and the self administered Montgomery Åsberg
Depression Rating Scale (MADRS-S) instrument. The blood sampling aimed at analyzing the
neuro-peptides substance P, Met-Enkephalin-Arginine-Phenylalanine (MEAP), beta-endorphin,
and neuro-peptide Y, in addition to estrogen, testosterone, prolactin and
dehydroepiandrosterone (DHEA). The saliva specimens were intended to measure diurnal
variation of cortisol. To standardize the hormonal level all evaluations were done in
ovulation phase of the menstrual cycle.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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