Abstract
BackgroundCognitive behavioural therapy (CBT) has been shown to improve outcomes for patients with fibromyalgia, and its cardinal feature chronic widespread pain (CWP). Prediction models have now been developed which identify groups who are at high-risk of developing CWP. It would be beneficial to be able to prevent the development of CWP in these people because of the high cost of symptoms and because once established they are difficult to manage. We will test the hypothesis that among patients who are identified as at high-risk, a short course of telephone-delivered CBT (tCBT) reduces the onset of CWP. We will further determine the cost-effectiveness of such a preventative intervention.MethodsThe study will be a two-arm randomised trial testing a course of tCBT against usual care for prevention of CWP. Eligible participants will be identified from a screening questionnaire sent to patients registered at general practices within three Scottish health boards. Those returning questionnaires indicating they have visited their doctor for regional pain in the last 6 months, and who have two of, sleep problems, maladaptive behaviour response to illness, or high number of somatic symptoms, will be invited to participate. After giving consent, participants will be randomly allocated to either tCBT or usual care. We aim to recruit 473 participants to each treatment arm. Participants in the tCBT group will have an initial assessment with a CBT therapist by telephone, then 6 weekly sessions, and booster sessions 3 and 6 months after treatment start. Those in the usual care group will receive no additional intervention. Follow-up questionnaires measuring the same items as the screening survey questionnaire will be sent 3, 12 and 24 months after start of treatment. The main outcome will be CWP at the 12 month questionnaire.DiscussionThis will be the first trial of an intervention aimed at preventing fibromyalgia or CWP. The results of the study will help to inform future treatments for the prevention of chronic pain, and aetiological models of its development.Trial registrationClinicalTrials.gov ID: NCT02668003URL: Please check that the following URLs are working. If not, please provide alternatives: NCT02668003Alternative is: https://www.clinicaltrials.gov/ct2/show/NCT02668003>. Date registered: 28-Jan-2016.
Highlights
Cognitive behavioural therapy (CBT) has been shown to improve outcomes for patients with fibromyalgia, and its cardinal feature chronic widespread pain (CWP)
The cost of CWP is high in terms of both individual, societal and health costs: for example, in the United States, mean per-patient costs in the 6 months following a new diagnosis of fibromyalgia have been reported as $3481, comparable to patients with rheumatoid arthritis [2] but resulting in worse quality of life [3]
We will test the hypothesis that among patients who report regional pain for which they have already sought a consultation in primary care, and who are identified as high risk of developing chronic widespread pain, a short course of telephone-delivered Cognitive Behaviour Therapy reduces the onset of CWP
Summary
Study design The study will be a two-arm randomised controlled trial testing a course of tCBT against usual care among patients identified at high-risk developing CWP (Fig. 1). Patients would be sent information about the study and subsequently contacted by a member of the research team by telephone and, if appropriate, consented and recruited into the trial. We further assume, based on prior data, that 75 % of persons allocated to the tCBT arm will be adherent to the intervention, and that 80 % of all subjects will return the follow-up questionnaires to assess outcome. A previous trial of a cognitive-behavioural intervention to prevent chronic pain found that 36 % of patients identified as eligible were recruited to the study [13]. If 80 % of eligible patients agreed to be contacted about taking part, this equates to 45 % of those eligible and willing to consider taking part being randomised - higher numbers for a clinical trial of CWP reflect the fact that this is a prevention trial rather than a treatment trial and may be less attractive to potential participants. The sponsor does not provide study participants with indemnity in relation to participation in the study but has insurance for legal liability as described above
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