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coordinated individual time-contingent interval plan. In contrast to CBT, this treatment focused primarily on behavioural expressions of pain and emphasised changing inappropriate pain behaviours without directly targeting maladaptive thoughts or cognitive aspects of coping. Attention placebo The AP treatment focused on general discussions among patients in groups guided by therapists. The discussions were centered around medical and psychosocial problems of FMS (that is, stress in different areas of the patients' lives, physician-patient interaction, and use of medication). Within the groups, patients were provided with opportunities to speak about problems with coping, fatigue, pain, stress, and medication. The therapists did not initiate these topics and made no specific recommendations. The patients did not receive any specific homework. Treatment adherence Adherence to the treatment was assessed by the number of sessions attended and the completion of homework assignments in CBT and OBT Therapists Three psychologists, each with more than 15 years of experience of treatment, conducted the groups. They completed a 2-day training program together with 10 rheumatologists who served as co-therapists. Additionally, psychologists and rheumatologists met to decide which study information the patients should receive from the physician and to outline strategies for difficult situations, including problems with motivation and non-adherence. Statistical analyses The intent-to-treat principle guided the analyses such that the baseline scores (that is, 'last' observation) for those who terminated treatment prematurely were carried forward. The primary outcome measures were changes in pain intensity, physical functioning, affective distress, and health care utilisation [23, 36] at post-treatment and the 6- and 12-month follow-ups. The initial analyses of treatment effectiveness were assessed using a multivariate analysis of variance (MANOVA) for pain, function, and mood. Significant main effects and interactions were followed by post hoc analysis of variance (ANOVA) and t tests. The emphasis of CBT was on changing beliefs and expectancies, whereas the OBT was designed to change pain behaviours. To confirm the validity of the treatments, a series of 2 × 2 MANOVAs was performed. Significant effects were followed up with univariate ANOVAs and t tests. The outcome MANOVA included three variables and used a P value Bonferroni-adjusted to P < 0.02. The MANOVA on cognitive and behavioural effects included two variables and used a Bonferroni-adjusted P < 0.03. To determine whether the treatment effects were clinically significant, the effect sizes (ESs) for the combined OBT and CBT groups and the individual responses for the OBT and CBT groups were compared with the AP group and computed based on the formula: AP (meanT2–4) – CBT [or OBT] (meanT2–4)/CBT/[or OBT] (standard deviationT1) [37]. To avoid overestimation of the CBT and OBT related to the deterioration of the AP group which became apparent during data analysis, ESs were compared for the entire AP group and the subgroup of AP patients who dropped out and whose values were carried forward. This procedure compared the ESs of the OBT and CBT groups with a no-change subgroup of the AP group. The comparison of CBT and OBT with the AP group may have been distorted by the large number of dropouts in the AP group and the deterioration in many variables in the patients who remained in the group. Therefore, we computed an adjusted ES that included the baseline values of the dropouts of the AP group which were carried forward for the post-treatment analyses at the 12-month follow-up. Three patients in the OBT (6.9%), two in the CBT (4.8%), and 20 in the AP (50%) groups terminated the treatment prematurely (Figure 1). All dropouts occurred between sessions 1 and 4. The primary reason that patients gave for dropping out of the AP group was deterioration of symptoms. Patients who terminated prematurely were not significantly different from those who completed treatment in duration of symptoms, initial pain severity, or number or severity of TPs.
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