2

assumptions and have different emphases. OBT focuses on the modification of reinforcement contingencies that maintain pain behaviours and on changing pain-related behaviours, whereas CBT emphasises the role of maladaptive beliefs and expectations of patients (that is, cognitive variables in the maintenance and exacerbation of symptoms and disability) and thus aims primarily to alter the attitude of the patients toward the pain and self-management. Turk and colleagues have demonstrated that patients diagnosed with FMS are heterogeneous [13], characterised by several patterns based on how they respond to their symptoms. They suggested that different treatments that are matched to specific psychosocial and behavioural features may be required. The aims of the present study were (a) to examine the effectiveness of CBT and OBT in comparison with an attention-placebo (AP) group and (b) to compare the relative effectiveness of OBT and CBT with each other. Specific hypotheses 1. CBT and OBT will produce significant improvements in pain, physical functioning, and emotional distress in patients with FMS. 2. CBT and OBT will produce significantly greater improvements in pain, physical functioning, and emotional distress than the AP treatment. 3. CBT will produce significantly greater effects than the OBT and AP groups on coping and catastrophising responses. 4. OBT will produce significantly greater reductions in pain behaviours, physical disability, and physician visits than the CBT or AP treatments. A sample of 125 consecutive married female patients with FMS was recruited from 10 outpatient rheumatological clinics. The groups were comparable with respect to demographic and FMS-specific variables (for example, number of TPs and severity of TP pain All patients signed informed consent and were randomly assigned to OBT, CBT, or AP treatment. The study was approved by the local ethics committee. The administering of the three types of treatment was counterbalanced in order to control for time of year and time of entry into the clinical trial. provides an overview of the patient flow in the study based on the CONSORT guidelines All patients received a general medical and a rheumatological assessment (see below). The inclusion criteria consisted of (a) meeting ACR (American College of Rheumatology) criteria of FMS [1], (b) pain for a period of at least 6 months, (c) married, (d) willingness of the spouse to participate, and (e) ability to complete the questionnaires and understand the treatment components. The exclusion criteria consisted of inflammatory rheumatologic diseases and any concurrent major disease such as cancer, diabetes, or kidney failure. The physical assessment included blood chemistry analysis, neurological examination, and evaluation of TPs. The number of positive TPs and pain intensity of TPs, rated on a numeric scale from 0 (no pain) to 10 (worst pain possible), were assessed using the Manual Tender Point Survey [23], and responses were calculated by summing the patients' responses to palpation of the 18 TPs. Psychometric assessment Three self-report measures that had been used in previous studies of FMS (for example, [6, 8, 21]) were included. These consisted of the following:The Fibromyalgia Impact Questionnaire (FIQ) [24, 25] is a 19-item self-report questionnaire measuring physical impairment, fatigue, stiffness, and functional activities, including sleep. The FIQ has good psychometric properties (for example, [26]).The West Haven-Yale Multidimensional Pain Inventory (MPI) [27, 28] is a 60-item questionnaire assessing pain intensityinterference of pain, life control, affective distress, social support, significant-other responses, and general activity levels. The MPI has been widely used with diverse chronic pain samples, including FMS [28–30], and has been demonstrated to have good psychometric properties [28–30]. Cognitive variables were assessed using the 32-item Pain-Related Self-Statements Scale (PRSS) [31] with the subscales 'active coping' (for example, 'I can handle my pain') and 'catastrophising' (for example, 'I am a hopeless case') shown to have excellent psychometric properties [31]. In addition to performing the

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20