A clinical trial investigating if phone-delivered cognitive behavioral therapy (CBT) might prevent chronic widespread pain in people at high risk of developing fibromyalgia is soon to begin in the U.K. The trial, the first of its kind in aiming to prevent fibromyalgia, might both guide the development of future treatments and provide insights into disease mechanisms at work.
While chronic widespread pain in fibromyalgia is currently managed by medical, physical and psychological interventions, the individual importance of each approach is not clear. Like other pain conditions, chronic widespread pain in fibromyalgia is difficult to treat once it is established, and preventive approaches might be more fruitful.
There is plenty of scientific support for the use of cognitive behavioral therapy in fibromyalgia pain states, and studies show that the intervention helps patients in coping with pain and reduces depression and the need for healthcare. Earlier attempts with the delivery of therapy by phone have shown good effects, also pointing to the cost-effectiveness of the approach.
The study, described in a publication titled “The Maintaining Musculoskeletal Health (MAmMOTH) Study: Protocol for a randomised trial of cognitive behavioural therapy versus usual care for the prevention of chronic widespread pain,“ and published in the journal BMC Musculoskeletal Disorders, will compare telephone-CBT to usual care — that is, no intervention at all — reflecting the current real-life situation.
Researchers at the University of Aberdeen will recruit patients by first screening primary care databases for those potentially eligible. These individuals will be provided with a questionnaire, and those who return a completed survey and meet a number of criteria for high-risk patients will be invited to participate.
The questionnaire will explore pain, illness behavior, non-pain symptoms, sleep problems, general health, fatigue, and quality of life. To be considered for the study, individuals need to have pain for which they have sought medical care and two out of the additional requirements: sleep problems, non-pain symptoms and high illness behavior. People who already fulfill criteria for chronic widespread pain are not eligible.
CBT will consist of an initial assessment followed by six sessions delivered once weekly. Booster sessions will be held at three and six months, and follow-up will be in the form of questionnaires at three, 12, and 24 months.
The trial aims to analyze data from 946 participants, and its primary outcome will be the difference in the proportion of patients developing chronic widespread pain from study start to follow-up. Secondary outcomes will include changes in pain, illness behavior, non-pain symptoms, sleep problems, quality of life, psychological distress, fatigue, and a patient-reported assessment of overall change.