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.
BACKGROUND
Cognitive 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.


METHODS
The 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.


CONCLUSIONS
This 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.


BACKGROUND
ClinicalTrials.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.
Epidemiology Group, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.|Aberdeen Centre for Arthritis and Musculoskeletal Health, University of Aberdeen, Aberdeen, UK.
Gary J
GJ
Macfarlane
Epidemiology Group, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK. m.beasley@abdn.ac.uk.|Aberdeen Centre for Arthritis and Musculoskeletal Health, University of Aberdeen, Aberdeen, UK. m.beasley@abdn.ac.uk.
Marcus
M
Beasley
Medical Statistics Team, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Gordon
G
Prescott
Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Paul
P
McNamee
Department of Health Sciences, University of Huddersfield, Huddersfield, UK.
Philip
P
Keeley
Arthritis Research UK Primary Care Centre, Primary Care Sciences, Keele University, Keele, UK.
Majid
M
Artus
Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK.
John
J
McBeth
Centre of Academic Primary Care, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Philip
P
Hannaford
Epidemiology Group, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.|Aberdeen Centre for Arthritis and Musculoskeletal Health, University of Aberdeen, Aberdeen, UK.
Gareth T
GT
Jones
Epidemiology Group, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.|Aberdeen Centre for Arthritis and Musculoskeletal Health, University of Aberdeen, Aberdeen, UK.
Neil
N
Basu
Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
John
J
Norrie
School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
Karina
K
Lovell
D059350:Chronic Pain / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D005260:Female; D005356:Fibromyalgia / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009140:Musculoskeletal Diseases / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D010147:Pain Measurement / Q000379:methods; D012606:Scotland / Q000453:epidemiology
CBT; Chronic pain; Chronic widespread pain; Cost-effectiveness; Fibromyalgia; Health economics; Prevention; Randomised trial; Treatment as usual; Usual care