Cognitive Behavioral Therapy Trial in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive behavioral therapy; Waiting list
Intervention type(s): Behavioral; Other
Intervention description(s): The treatment, adopted to reduce hostility and stress behavior, was given during group sessions once a week during six months with two follow-up occasions during the next six months; The group served as referents during the trial and received no intervention other than measurements at the same points in time as the intervention group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibromyalgia; cognitive behavioral therapy; women; pain; stress; type A behavior