The MAintaining MusculOskeleTal Health (MAmMOTH) Study
Phase: NA
Conditions: Widespread Chronic Pain
Sponsor: University of Aberdeen

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MAmMOTH Epi027 Protocol 22 May 2020 Version 9 
 
 
1. The MAmMOTH Protocol 
Full Title: Maintaining Musculoskeletal Health Study 
Sponsor 
University of Aberdeen, King's College, Aberdeen,  AB24 
3FX 
Funder 
Arthritis Research UK  
Funding Reference Number 
20748 
Chief Investigator 
Prof. Gary J Macfarlane 
REC Number 
16/SW/0019 
Version Number and Date 
 Version 9 22nd May 2020 
 
Protocol approval 
Maintaining Musculoskeletal Health Study (MAmMOTH) 
Signatures 
Professor Gary J Macfarlane 
 
 
Chief Investigator 
Signature 
 
Date 

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MAmMOTH Epi027 Protocol 22 May 2020 Version 9 
2. Personnel 
Name 
Role 
Institution 
email 
Prof Gary Macfarlane 
Chief Investigator 
University of Aberdeen 
g.j.macfarlane@abdn.ac.uk  
Prof Paul McNamee 
Investigator 
University of Aberdeen 
p.mcnamee@abdn.ac.uk 
Prof Karina Lovell 
Investigator 
University of Manchester 
karina.lovell@manchester.ac.uk 
Prof Philip Keeley 
Investigator 
University of Huddersfield 
p.n.keeley@hud.ac.uk 
Prof Phil Hannaford 
Investigator 
University of Aberdeen 
p.hannaford@abdn.ac.uk 
Dr Gordon Prescott 
Investigator (Statistician) 
University of Aberdeen 
gordon.prescott@abdn.ac.uk 
Dr Majid Artus 
Investigator 
Keele University 
m.artus@keele.ac.uk 
Dr Gareth Jones 
Investigator 
University of Aberdeen 
gareth.jones@abdn.ac.uk 
Dr John McBeth 
Investigator 
University of Manchester 
j.mcbeth@manchester.ac.uk 
Dr Neil Basu 
Investigator 
University of Aberdeen 
neilbasu@abdn.ac.uk 
Kathy Longley 
Patient Representative 
 
kathy_longley@blueyonder.co.uk 
Dr Alison Hinds 
Collaborator 
University of Dundee 
a.hinds@dundee.ac.uk 
Marcus Beasley 
Trial Manager 
University of Aberdeen 
m.beasley@abdn.ac.uk 
Prof John Norrie 
CTU Representative 
University of Aberdeen 
j.norrie@abdn.ac.uk 

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MAmMOTH Epi027 Protocol 22 May 2020 Version 9 
3. Background 
Chronic widespread pain (CWP), the cardinal feature of fibromyalgia, is associated with lost work 
productivity, psychological ill health, and poor quality of life. It is one of the most common reasons for 
referral to a rheumatologist (1). 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 (including pain and non–pain-related 
medication, physician consultations, tests and procedures, and emergency department visits) 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). Current guidelines recommend 
pharmacological, physical, and psychological therapies although the importance attributed to individual 
therapies is inconsistent (4). There is good evidence for musculoskeletal pain conditions generally that 
the longer the duration of symptoms, the less likely that symptoms are to improve (5, 6), including with 
specific interventions (7, 8). This is particularly so for CWP which, once developed, is challenging to 
manage and effect improvement.  
A systematic review and meta-analysis of randomised controlled trials (RCT) of Cognitive Behaviour 
Therapy (CBT) for patients with fibromyalgia concluded that CBT improves coping with pain, reduces 
depressed mood and healthcare-seeking behaviour in such patients (9). The delivery of CBT by 
telephone has been shown to be effective, acceptable and accessible (10). The MUSICIAN study, which 
we have recently concluded, tested telephone delivered CBT (tCBT) and/or exercise for patients with 
chronic widespread pain consulting to their GP (using a 2 x 2 factorial design). Three months after the 
end of therapy, both interventions resulted in significantly better primary outcome measures (patient 
global health) than treatment as usual (tCBT 33% of participants with positive outcome, exercise 24%, 
treatment as usual 8%), but there was no significant additional benefit of receiving both interventions 
(combined 37%). Recent analyses have demonstrated these benefits are maintained 2 years after the 
end of therapy (11): tCBT 35% with positive outcome, exercise 29%, combined 31%, treatment as usual 
13%. We have conducted a comprehensive literature review with the aim of identifying randomised 
trials which had the aim of preventing the onset either of CWP or fibromyalgia. This review did not 
identify any such published trials. Further, a search of 11 international clinical trials registers/databases 
(including US, UK, Europe, Australia/New Zealand, Japan), undertaken in Autumn 2013 did not identify 
any ongoing trial with the aim of preventing the onset of CWP (or fibromyalgia). 
There are several reasons why it may be desirable to try to prevent CWP onset, namely that the majority 
of CWP patients do not have important symptom improvement with current management (even within 
trials). Prediction models from epidemiological studies have been developed to identify “high risk” 
patients, which makes such an approach feasible. Research using the General Practice Research 
Database (GPRD) has demonstrated that prior to receiving a diagnosis of fibromyalgia in primary care, 
persons have a long-term prior history of consultation with symptoms (12). Although this will be the first 
prevention trial in this area, the concept of prevention using CBT has been addressed in 
musculoskeletal disorders with respect to intervention in neck pain and low back pain before people 
become patients (13) and in mental disorders (14). 

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We have conducted prospective epidemiological studies which have demonstrated that it is possible to 
identify “high risk” groups. In the first study, a high risk group for CWP onset was identified on the basis 
of two factors: somatic awareness (using the Somatic Symptom Scale) and illness behaviour (using the 
Illness Behaviour Score) (15). This was replicated in a second study conducted by the applicants (16). 
These “aetiological models” excluded pain and therefore we have re-analysed data from the latter study 
(also considering pain status) to identify the best predictors of onset and which results in a model more 
suitable for use in prevention studies. The resulting “at risk model” requires regional pain and two of the 
following: maladaptive behavioural response to illness (Illness Behaviour score > 4), a high number of 
somatic symptoms (Somatic Symptom Score > 2) and sleep disturbance (Sleep Problem Scale Score 
> 4). In the second "validation" study, from a population of 2,374 persons without CWP, 653 satisfied 
the definition of “high risk of CWP” of whom 139 had developed CWP twelve months later (that is a 
Positive Predictive value of 21.3%). Amongst persons not deemed to be at high risk (n=1721), 77 
developed CWP which is a Negative Predictive Value of 95.5%. 
An Arthritis Research UK report on fibromyalgia/CWP, based on a think-tank held in July 2012, identified 
prevention as a research priority. We have previously shown short and long-term effectiveness of tCBT 
for CWP (compared to usual care), in an Arthritis Research UK funded study (11, 17). Specifically this 
demonstrated sustained improvement in patient global assessment of change, reduced psychological 
distress, fear of movement and reliance on passive coping styles. Secondly we have developed and 
refined statistical models which identify persons at high risk for the future development of CWP. We 
therefore now propose a study to test whether tCBT can reduce the risk of CWP onset amongst those 
at high risk. 
4. Objectives 
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 (tCBT) reduces 
the onset of CWP. 
We will further determine the cost-effectiveness of such a preventative intervention. 
5. Research Sites 
Three health boards in Scotland will be research sites for the study. The three health boards are NHS 
Grampian, NHS Highland, and NHS Greater Glasgow and Clyde. We will require the involvement of 7 
or 8 equivalent general practices. 
6. Methods 
6.1 Study design 
The study will be a two-arm randomised controlled trial testing a course of tCBT against usual care. 

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6.2 Timeline Flowchart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Telephone-delivered 
Cognitive Behavioural 
Therapy group 
Treatment as usual 
group 
3 month Follow-up 
questionnaire 
3 Month Follow-up 
questionnaire 
Recruitment to trial and randomisation by 
phone call 
Invitation letters sent to those returning 
screening questionnaires and consenting 
to take part and at high-risk 
Screening questionnaires sent to patients 
at GP practices 
24 month Follow-up 
questionnaire 
12 month Follow-up 
questionnaire 
12 month Follow-up 
questionnaire 
24 month Follow-up 
questionnaire 

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6.3 Recruitment 
We will mail a randomly selected sample of adults aged 25 years and over registered with participating 
general practices in the study areas.  
The Scottish Primary Care Research Network (SPCRN) will be involved in recruitment of patients to 
this study from primary care. SPCRN staff provide GP practices with an expert service to undertake 
searches of their electronic databases to identify a random sample of potentially eligible patients and 
prepare the ethically approved letters to be sent out. SPCRN staff work on behalf of the healthcare 
team under practice staff supervision. Each member of SPCRN staff must have a current NHS 
substantive or honorary contract in order to carry out these activities. Searches are undertaken at each 
GP practice before the screening survey questionnaires are sent out by Health Informatics Centre 
Services in Dundee on behalf of the practice. Patients will return completed survey questionnaires to 
the research team at the University of Aberdeen where they will be assessed by the research team for 
eligibility and sent invitation letters if eligible. 
The “screening questionnaire” will determine whether a) they meet the study eligibility criteria and b) 
they would be willing to be contacted again regarding a treatment trial for “musculoskeletal health”. The 
questionnaire will include: 
• 
Pain assessed by specific questions on the experience of pain, consultation and body manikins 
(which will provide site and also allow us to exclude those who already have chronic widespread 
pain). 
• 
Illness Behaviour Scale (18) 
• 
Somatic Symptoms Scale (excluding pain items) (19) 
• 
Sleep Problem Scale (20) 
• 
Quality of Life and Wellbeing (EQ-5D-5L (21); ICECAP (22)) 
• 
General Health Questionnaire (23) 
• 
Chalder Fatigue Scale (24) 
The inclusion criteria are: 
• 
A ‘high-risk’ profile for developing CWP as identified on the screening survey, i.e.: 
o 
Have pain for which they have sought consultation to primary care in the last 6 months, or 
have pain and report consulting a doctor frequently 
o 
Any 2 of the following: 
▪ 
Illness Behaviour Score > 4 
▪ 
Somatic Symptom Score > 2 
▪ 
Sleep Problem Score >= 4 
• 
Access to a landline telephone or mobile telephone 

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• 
Ability to understand English sufficiently to participate in the intervention 
• 
Ability to give informed consent 
• 
Aged 25 years or over 
Exclusion criteria: 
• 
Meeting American College of Rheumatology definition of CWP in the 1990 criteria for 
fibromyalgia (as assessed by the screening questionnaire) (23) 
• 
Medical conditions which would make the proposed intervention unsuitable (e.g. cognitive 
ability) 
A list of eligible patients will be provided to the general practitioner in advance, with the option of 
indicating any as unsuitable for the study. Patients would then 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. 
6.4 Consent 
Included in the mailing to eligible patients will be an information sheet, consent form, best-time-to-call 
slip, and 4-item Pain Treatment Beliefs Questionnaire (24). Once a patient has returned a signed 
consent form and best-time-to-call slip, a member of the research team will phone them. The researcher 
will read out from a script giving information about the study, and the patient will have the opportunity 
then to ask questions about the study. If the patient consents to participate they will be recruited to the 
study and randomised to one of the arms of the trial. (It is only at this point that the participant is 
considered to have given informed consent). 
6.5 Randomisation 
After consent has been given to participate in the study the researcher will contact the Trial 
randomisation centre at the Centre for Healthcare Randomised Trials (CHaRT) at the University of 
Aberdeen, using the internet or by telephone. This service is available 24 hours a day. Using a computer 
randomisation program, subjects will be randomly allocated into one of the two treatment groups, 
stratified in blocks by one predictor of outcome i.e. the number of non-pain “high-risk” factors they report 
(2 or 3) since this is related to the risk of CWP onset, and GP Practice. Subjects will be notified of the 
outcome of allocation during the consent/randomisation phone-call. If allocated to the active 
intervention, the participant will receive a phone call from a therapist within 3 working days to arrange 
an initial appointment. We will confirm the allocation to treatment arm in a letter to the participant. 
6.6 Follow Up 
Follow-up questionnaires will be mailed to participants at 3, 12 and 24 months after the treatment start 
date (for participants in the active treatment group) or dummy treatment start date (for those in usual 
care). Instruments included in the follow-up questionnaires will be the same as in the screening survey 
questionnaire. Additionally, follow-up questionnaires will include the Patient Global Impression of 
Change (7-item scale from “very much worse” to “very much better”), questions on health care usage, 

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and the Pain Treatment Beliefs Questionnaire (24). At 3-month and 12-month follow-up time-points, 
participants who do not return a questionnaire will receive a reminder telephone call, and those 
uncontactable by telephone will be sent a shortened one-sheet version of the follow-up questionnaire. 
At the 24-months follow-up time-point, participants who do not return a questionnaire will be telephoned 
and asked some questions over the phone (date of birth, Patient Global Impression of Change, and 
whether they have pain at specific sites and for how long), and those uncontactable by telephone will 
be sent the shortened one-sheet version of the questionnaire. 
Cohort Follow-up 
In order examine the effects of selection bias and the effects of being randomised into a trial a cohort 
of participants who were eligible and gave consent to be contacted for future health surveys but either 
did not consent to an invitation letter, or were invited but not recruited to the trial will also be followed-
up to collect main outcome data. 
A questionnaire will be sent 66 weeks after the date of completion of the screening survey questionnaire 
(to match the average length of time between screening survey completion and 12-month follow-up for 
trial participants) to those matching the following criteria: 
• 
A ‘high-risk’ profile for developing CWP as identified on the screening survey, i.e.: 
o 
Have pain for which they have sought consultation to primary care in the last 6 months, 
or have pain and report consulting a doctor frequently 
o 
Any 2 of the following: 
• 
Illness Behaviour Score > 4 
• 
Somatic Symptom Score > 2 
• 
Sleep Problem Score >= 4 
• 
Gave consent to be contacted for future health surveys 
• 
Were not recruited to the MAmMOTH trial 
• 
Provided name and address details 
The questionnaire will collect the following information: 
• 
Demographic information (age, gender, employment status)  
• 
Self-reported change in overall health 
• 
Pain assessed by manikin, and chronicity 
• 
The Sleep Problem Scale 
• 
Illness Behaviours Scale 
• 
Somatic Symptoms Scale 
The questionnaire will be sent with a covering letter, and reminders will be sent to the same schedule 
as in the main trial. 
6.7 Acceptability sub-study 
Participants assigned to the CBT group who complete their treatment, will be invited to participate in an 
acceptability sub-study. The purpose of the sub-study is to explore participants’ experience of treatment 

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with a view to understanding influences on acceptability of the intervention. Interviews will be conducted 
by telephone. The protocol for this sub-study will be a separate document. 
6.8 Newsletter Sub-study 
Before participants reach the 24-month questionnaire timepoint, half will be randomly assigned to 
receive a participant newsletter. The purpose of this is to examine the effect of receiving such a 
newsletter on follow-up rates. The newsletter will contain an update on the progress of the study (e.g. 
recruitment numbers, follow-up timeline, participating regions) with a stress on the importance of 
participation in studies. 
6.9 CONTAIN Sub-study 
Trial participants who have not withdrawn from receiving further follow-up questionnaires and who have 
not been marked as deceased, will be invited to participate in a sub-study looking at the effects of the 
COVID-19 pandemic and the associated ‘lockdown’ measures on their health and healthcare needs. 
The protocol for this study, the CONTAIN Study, and participant documents are an appendix to the 
main MAmMOTH Study protocol. 
7. Treatment Protocol 
The CBT intervention, delivered by telephone, will consist of an initial assessment (45-60 minutes), 6 
weekly sessions (each 30-45 minutes) over six weeks, and then booster sessions at 3 and 6 months. 
The intervention will be delivered by therapists trained for the study and accredited by the British 
Association for Behaviour and Cognitive Psychotherapies (BABCP). Participants will be supported by 
a self-management CBT manual refined from the manual we developed for the MUSICIAN study where 
it was successfully used with demonstrable patient benefit. 
There will be a patient-centred assessment by the therapist for problem identification, risk assessment 
and development of a shared formulation of the current health problem. The sessions will involve 
education about musculoskeletal pain (all persons will have recently consulted to primary care with 
regional pain), somatic symptoms and specific CBT techniques such as pacing of activity, behavioural 
activation, diary keeping, identifying and challenging negative and unhelpful thinking patterns and the 
development of a longer term management plan. Participants' self-management manuals will include 
agreed collaborative goals for the therapist and patient to work towards, diaries, some example patient 
stories and some exercises to complete after specific sessions. Participants and therapists will be asked 
to complete the 5-item Agnew Relationship Measure after the sixth of the weekly sessions (25). 
Therapists delivering the intervention will receive a 2 day training programme conducted by two of the 
investigators, KL and JM. Therapists will also be asked to complete the Pain Treatment Beliefs 
Questionnaire (24). Therapists will be supervised two weekly throughout the trial period. Patient 
adherence will be examined through collecting data on number of telephone consultations conducted 
and evaluation of the use of CBT techniques through exercises contained in the manual. 
The group allocated to usual care will receive no additional intervention – this will reflect the fact there 
is no specific intervention provided to patients currently for the prevention of CWP. They will receive 

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usual care and there will be no restriction on what this can involve. CBT is not readily available within 
the NHS and is generally restricted to persons who have developed specific conditions rather than 
persons at risk of those conditions. We will however monitor care received, outwith the trial, in all 
participating subjects, and health care usage will be recorded in follow-up. 
8. Patient Safety 
There are unlikely to be major safety issues in terms of delivery of the CBT. However, if the therapists 
delivering CBT have any concerns, one of the investigators will be available to assess these. There will 
be a standard template for reporting concerns and recording of any action recommended. This will be 
overseen by the investigator, KL. 
9. Withdrawal 
Participants will have the option to withdraw from the treatment or the study at any time. Those 
withdrawing from the treatment will continue to be sent follow-up questionnaires unless they specifically 
request not to receive them. Failure of any participant to complete a follow-up questionnaire at any 
particular time-point will not be counted as a withdrawal unless the participant requests not to receive 
any further follow-ups.   
10. Statistical Issues 
Sample Size 
Our previous longitudinal study of onset of CWP (and subsequent replication) has suggested that 21% 
of "high risk" persons identified will develop CWP over the course of the next twelve months. Our 
previous data is based on persons with pain and at least 2 out of 3 other "risk factors". There are no 
published studies of prevention of CWP on which to base our measure of effect. However in the 
MUSICIAN study some subjects, although reporting CWP at the screening survey, no longer had CWP 
at the enrolment interview. They were however still eligible to take part, provided they had regional pain. 
Therefore those subjects with regional pain provide a sub-population on which to base the likely effects 
of the tCBT. Amongst such subjects, those who received tCBT had a reduced odds of having CWP at 
the end of the study OR 0.5 95% CI (0.2-1.4) compared to those in usual care. 
Thus the study is powered on the ability of the current study to reduce the onset of CWP from 21% to 
12%, with 90% power and a 5% significance level. 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. 
Accordingly we require 473 subjects per arm that is a total of 946 subjects recruited. In MUSICIAN 
exactly 50% of those found eligible and willing to consider taking part ultimately were randomised. A 
previous trial of a cognitive-behavioural intervention to prevent chronic pain found that 36% of patients 
identified as eligible ended up being recruited to the study (13). If 84% of eligible patients agreed to be 
contacted about taking part, this equates to 43% 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. Thus we aim to find 

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a total of 2,200 subjects who are eligible and willing to consider taking part. Assuming a participation 
rate to the survey of 24%, that 18% people will be "at risk", and that 84% of people who return a 
questionnaire agree to consider taking part, we require to survey 60,625 persons. 
Statistical analysis 
A pre-defined statistical analysis plan will be developed and signed off by the trial steering committee 
before undertaking any data analysis. Comparison between arms will be on an intention-to-treat basis 
(main analysis) with a per protocol sensitivity analysis. 
Characteristics of the study participants in the two treatment arms will be described using simple 
summary statistics. Descriptive statistics will include mean and standard deviation for normally 
distributed continuous data, median and inter-quartile range for skewed continuous data and count and 
percentage for categorical data. No formal statistical comparisons will be made between baseline 
characteristics. Primary and secondary outcomes will be described at the three follow-up times: 3, 12 
and 24 months, using appropriate summary statistics. The primary outcome is the between arm 
difference in the proportions of people developing CWP from baseline to follow-up. This comparison 
will be made using simple chi-squared tests at each follow-up time. Appropriate adjustment will be made 
for the stratification factor used in the randomisation (the number of non-pain “high-risk” factors that a 
participant reports at baseline) using multiple logistic regression. 
Comparisons with appropriate hypothesis tests will be used for the secondary outcomes, pain, illness 
behaviour, somatic symptom reporting, sleep problems, quality of life and wellbeing, psychological 
distress, patient global impression of change measure and fatigue. Appropriate adjustment will be made 
for the stratification factor. Given the multiple secondary outcomes, the p-value used to denote statistical 
significance will reflect the multiple comparisons.  
Mixed models analyses with an appropriate error structure will take into account the repeated 
assessment of the outcome data for the same patient across the three follow-up times. As part of 
sensitivity analyses, multiple imputation methods will be used, where appropriate, to address issues of 
missing data. However, these methods will not be applied if the use of imputation is contrary to specified 
rules for the relevant validated measurement scale. 
11. Study Management and conduct 
11.1 Trial Steering Committee 
A trial steering committee (TSC) will be established and comprise an independent chair who has 
expertise in both trials and CWP and two other independent members including a user representative 
who has had lived experience of CWP and a clinician working with people with CWP. 
11.2 Inspection of Records 
Investigators and institutions involved in the study will permit study related monitoring and audits on 
behalf of the sponsor and REC. In the event of an audit or monitoring, the Investigator agrees to allow 
the representatives of the sponsor direct access to all study records and source documentation, and 
participant consent will be obtained for this. 

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11.3 Confidentiality 
All evaluation forms, reports, and other records will be identified in a manner designed to maintain 
participant confidentiality.  All records will be kept in a secure storage area with limited access.   
11.4 Data Protection 
All Investigators and study site staff involved with this study will comply with the requirements of the 
Data Protection Act 1998 with regard to the collection, storage, processing and disclosure of personal 
information and will uphold the Act’s core principles. Computers used to collate the data will have limited 
access measures via user names and passwords. Published results will not contain any personal data 
that could allow identification of individual participants. 
11.5 Study Record Retention 
All study documentation will be kept for a minimum of 5 years from the protocol defined end of study 
point. When the minimum retention period has elapsed, study documentation will not be destroyed 
without permission from the sponsor. 
11.6 End of Study 
The end of study is defined as data collection at 2 years from the last participant’s date of beginning 
treatment or dummy treatment start date. 
11.7 Reporting, Publication and Notification of Result 
Ownership of the data arising from this study resides with the University of Aberdeen. On completion 
of the study, the study data will be analysed and tabulated, and a clinical study report will be prepared 
in accordance with ICH guidelines.  
The clinical study report will be used for publication and presentation at scientific meetings. Investigators 
have the right to publish orally or in writing the results of the study. 
11.8 Insurance and Indemnity 
The University of Aberdeen is sponsoring the study. 
Insurance: 
• 
The University of Aberdeen will obtain and hold a policy of Public Liability Insurance of legal 
liabilities arising from the study. 
• 
Where the study involves University of Aberdeen staff undertaking clinical research of NHS 
patients, such staff will hold honorary contracts with Grampian Health Board with means they 
will have cover under Grampian’s membership of CNORIS scheme. 
Indemnity: 
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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