Cognitive behaviour therapy in women with fibromyalgia: A randomized clinical trial.

Background and aims Stress has been pointed out as an important influential factor in the development and maintaining of the fibromyalgia syndrome (FMS) . Since stress may worsen the pain experience, the development of individual strategies for coping with stress is essential to reduce the impact of FMS on daily life. The aim of the study was to investigate whether a group based stress management cognitive behaviour therapy (CBT) programme could influence self-reported stress, wellbeing and life control, as well as self-reported pain behaviour in female FMS patients. Methods 48 female FMS patient were randomized into a cognitive behaviour therapy treatment group (n = 24) and a waitlist control group (n = 24) . When the 6 months waitlist period was over the control group received the same CBT programme. This allowed two analytical approaches, one based on the randomized controlled trial design and one based on a before-and-after design to improve the statistical power of the study. Four psychometric instruments were used: The West Haven-Yale Multidimensional Pain Inventory (three parts, MPI-1 to MPI-3), the Maastricht Questionnaire, the Everyday Life Stress, and the Montgomery-Åsberg Depression rating scale - self-reported. Primary outcome was the MPI-1 dimension 'life control', secondary outcomes were the MPI-1 dimensions 'interference', 'affective distress' and 'support from spouses or significant others', the various MPI-2 dimensions, the 'general activity level' in the MPI-3 dimension, and 'vital exhaustion', 'stress behaviour', and 'depression'. The only tertiary outcome was the MPI-1 dimension 'pain severity'. Results In the RCT design the West Haven-Yale Multidimensional Pain Inventory dimensions 'life control', 'interference from pain', 'affective distress', 'support from spouses or significant others', and 'distracting responses' and ratings for depression improved in the treatment group as compared with the control group. In the before-and after design these improvements were maintained and enhanced during 1-year follow-up, and so was the 'vital exhaustion' and 'stress behaviour'. 'Pain severity' was rated higher after the intervention. Conclusions Cognitive behaviour therapy improved the life control in a female population with FMS. Coping behaviour in response to chronic pain was improved at the same time and in spite of higher subjective ratings of pain. Positive effects were seen on depression, vital exhaustion and stress behaviour. The effects of therapy were maintained and enhanced during the follow up period. It appears that women with FMS after the CBT treatment, according to this protocol obtained tools leading to better acceptance of their disorder. Implications FMS is a disorder with great therapeutic challenges. Total abolishment of pain symptoms is extremely difficult or impossible to achieve. Thus, the development of individual strategies for coping with pain is essential to reduce its impact on daily life. Since stress may worsen the pain experience, coping with stress might be a promising route to accomplishing that goal. In evaluations of interventions for pain it is important to monitor the effect on behaviour responses to pain and not only ratings of pain itself.