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

Gary J. Macfarlane, Marcus Beasley (Corresponding Author), Gordon Prescott, Paul McNamee, Philip Keeley, Majid Artus, John McBeth, Philip Hannaford, Gareth T. Jones, Neil Basu, John Norrie, Karina Lovell

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Abstract

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.

Discussion
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.
Original languageEnglish
Article number179
Pages (from-to)1-8
Number of pages8
JournalBMC Musculoskeletal Disorders
Volume17
DOIs
Publication statusPublished - 26 Apr 2016

Fingerprint

Cognitive Therapy
Chronic Pain
Telephone
Health
Fibromyalgia
Therapeutics
General Practice
Cost-Benefit Analysis
Sleep
Surveys and Questionnaires
Costs and Cost Analysis
Pain

Keywords

  • chronic widespread pain
  • fibromyalgia
  • prevention
  • randomised trial
  • treatment as usual
  • usual care
  • chronic pain
  • CBT
  • health economics
  • cost-effectiveness

Cite this

@article{5e4a2524d11941d2a4bf00842bd7da00,
title = "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",
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.",
keywords = "chronic widespread pain, fibromyalgia, prevention, randomised trial, treatment as usual, usual care, chronic pain, CBT, health economics, cost-effectiveness",
author = "Macfarlane, {Gary J.} and Marcus Beasley and Gordon Prescott and Paul McNamee and Philip Keeley and Majid Artus and John McBeth and Philip Hannaford and Jones, {Gareth T.} and Neil Basu and John Norrie and Karina Lovell",
note = "Acknowledgements The authors would like to thank Kathy Longley, patient representative from Arthritis Research UK, for help with designing the study. Funding The research is funded by the Arthritis Research UK Grant no. 20748. Arthritis Research UK had no input into the design of the study, collection, interpretation of data nor writing of the manuscript.",
year = "2016",
month = "4",
day = "26",
doi = "10.1186/s12891-016-1037-4",
language = "English",
volume = "17",
pages = "1--8",
journal = "BMC Musculoskeletal Disorders",
issn = "1471-2474",
publisher = "BMC",

}

TY - JOUR

T1 - The Maintaining Musculoskeletal Health (MAmMOTH) Study

T2 - Protocol for a randomised trial of cognitive behavioural therapy versus usual care for the prevention of chronic widespread pain

AU - Macfarlane, Gary J.

AU - Beasley, Marcus

AU - Prescott, Gordon

AU - McNamee, Paul

AU - Keeley, Philip

AU - Artus, Majid

AU - McBeth, John

AU - Hannaford, Philip

AU - Jones, Gareth T.

AU - Basu, Neil

AU - Norrie, John

AU - Lovell, Karina

N1 - Acknowledgements The authors would like to thank Kathy Longley, patient representative from Arthritis Research UK, for help with designing the study. Funding The research is funded by the Arthritis Research UK Grant no. 20748. Arthritis Research UK had no input into the design of the study, collection, interpretation of data nor writing of the manuscript.

PY - 2016/4/26

Y1 - 2016/4/26

N2 - 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.

AB - 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.

KW - chronic widespread pain

KW - fibromyalgia

KW - prevention

KW - randomised trial

KW - treatment as usual

KW - usual care

KW - chronic pain

KW - CBT

KW - health economics

KW - cost-effectiveness

U2 - 10.1186/s12891-016-1037-4

DO - 10.1186/s12891-016-1037-4

M3 - Article

VL - 17

SP - 1

EP - 8

JO - BMC Musculoskeletal Disorders

JF - BMC Musculoskeletal Disorders

SN - 1471-2474

M1 - 179

ER -