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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: 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. TRIAL REGISTRATION: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.

SUBMITTER: Macfarlane GJ

PROVIDER: S-EPMC4845348 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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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.

Macfarlane Gary J GJ Beasley Marcus M Prescott Gordon G McNamee Paul P Keeley Philip P Artus Majid M McBeth John J Hannaford Philip P Jones Gareth T GT Basu Neil N Norrie John J Lovell Karina K

BMC musculoskeletal disorders 20160426

<h4>Background</h4>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 ...[more]

PMID: 27113442

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Project description:This systematic review and meta-analysis aimed to examine the effects of physical exercise cum cognitive-behavioural therapy (CBT) on alleviating pain intensity, functional disabilities, and mood/mental symptoms in those suffering with chronic musculoskeletal pain. MEDLINE, EMBASE, PubMEd, PsycINFO and CINAHL were searched to identify relevant randomised controlled trials from inception to 31 December 2018. The inclusion criteria were: (a) adults ?18 years old with chronic musculoskeletal pain ?3 months, (b) randomised controlled design, (c) a treatment arm consisting of physical intervention and CBT combined, (d) the comparison arm being waitlist, usual care or other non-pharmacological interventions such as physical exercise or CBT alone, and (e) outcomes including pain intensity, pain-related functional disabilities (primary outcomes), or mood/mental symptoms (secondary outcome). The exclusion criteria were: (a) the presence of comorbid mental illnesses other than depression and anxiety and (b) non-English publication. The search resulted in 1696 records and 18 articles were selected for review. Results varied greatly across studies, with most studies reporting null or small effects but a few studies reporting very large effects up to 2-year follow-up. Pooled effect sizes (Hedges' g) were ~1.00 for pain intensity and functional disability, but no effect was found for mood/mental symptoms. The effects were mainly driven by several studies reporting unusually large differences between the exercise cum CBT intervention and exercise alone. When these outliers were removed, the effect on pain intensity disappeared at post-intervention while a weak effect (g = 0.21) favouring the combined intervention remained at follow-up assessment. More consistent effects were observed for functional disability, though the effects were small (g = 0.26 and 0.37 at post-intervention and follow-up respectively). More importantly, the value of adding CBT to exercise interventions is questionable, as consistent benefits were not seen. The clinical implications and directions for future research are discussed.

Project description:BackgroundTelephone cognitive behavioural therapy (tCBT) is an acceptable and effective treatment for patients with chronic widespread pain (CWP). Preventing the onset of CWP offers considerable benefits to the individual and society and the MAmMOTH study is the first aimed at CWP prevention. The study is a two-arm randomised trial testing a course of tCBT against usual care for prevention of CWP. This nested qualitative study explores patients' treatment experiences, with a view to understanding their potential influences on acceptability of the intervention.MethodsThe MAmMOTH Study recruited 1002 participants, half of whom were randomised to receive tCBT. Participants were eligible for invitation to the trial if they had pain for which they had consulted their GP, or had pain and visited a doctor frequently, and had 2 of 3 risk factors for development of CWP. Participants randomised to tCBT who had completed treatment were eligible for invitation to qualitative interviews for this study. Individual qualitative interviews were conducted with a sub-sample (n = 33) of patients at high risk of developing CWP who had been allocated to the intervention arm. Semi-structured telephone interviews explored treatment experiences and intervention acceptability. Data was analysed using Framework analysis.ResultsParticipants presented with a range of musculoskeletal and auto-immune conditions and almost half described their pain as 'chronic' on study entry. Many participants perceived the trial intervention to be aimed at treatment of pain rather than prevention of pain. Initial expectations prior to treatment varied, with scepticism more likely for those who had little prior knowledge of CBT approaches. All participants provided positive feedback post intervention particularly in relation to the modality, therapist experience and skills and the intervention. The majority of participants described positive changes in either their subjective level of pain or pain-management post-intervention and some attributed the positive change directly to the intervention as a result of empowerment, increased self-management and cognitive restructuring.ConclusionsThis study extends our understanding of the acceptability and suitability of preventative interventions for chronic widespread pain and provides further evidence for the acceptability of tCBT.Trial registrationClinical Trials.gov NCT02668003 (registered 29th January, 2016).

Project description:BackgroundInsomnia is a prevalent sleep disorder associated with significant economic and personal burdens. Cognitive behavioural therapy for insomnia (CBTI) is considered the gold standard intervention for insomnia and its efficacy has been well demonstrated. However, the core treatment strategies of CBTI require significant behavioural change, which many individuals find challenging. As a result, although CBTI is efficacious, its effectiveness is reduced by modest levels of adherence in typical clinical settings. This is problematic as adherence is essential to attain desired treatment outcomes. Sleep is often a dyadic process, with approximately 60% of Australian adults sharing a bed. Hence, the present study aims to determine whether incorporating bed partners into treatment for insomnia increases treatment adherence and completion. The impact of adherence on symptoms of insomnia will also be examined.MethodsThis study is a mixed-effects randomised effectiveness trial of partner-assisted CBTI (PA-CBTI). It is an "effectiveness" (as opposed to "efficacy") trial, due to the focus on "real world" clinic-based clients and adherence/attrition as outcomes. Participants will include 120 clients with insomnia who are randomly assigned, in equal numbers, to PA-CBTI, traditional individual CBTI (i-CBTI), or partner-assisted sleep management therapy (PA-SMT; which serves as the control group). All interventions consist of seven weekly 1-h sessions. Treatment outcome is evaluated using clinician-rated treatment adherence, and diary-based adherence to stimulus control and sleep restriction. Clients and partners complete major assessments at pre- and post-treatment, and at 6-month follow-up. Secondary outcome variables include actigraphy, self-report measures related to sleep, comorbid psychopathology, and relationship functioning.DiscussionThis is the first randomised clinical trial to examine the impact of incorporating the bed partner in the treatment of insomnia. Results will provide new information about the role partners play in clients' insomnia presentation and treatment response, and better define the role of adherence in CBTI. This trial has the potential to optimise treatment outcomes for insomnia by improving adherence and reducing attrition. Results could have far-reaching impacts. Improvements in insomnia have been linked to improvements in mental and physical health and, given the high financial costs of insomnia, this study could have a positive economic impact.Trial registrationACTRN, ACTRN12616000586415 . Registered on 5 May 2016.

Project description:BACKGROUND:Musculoskeletal pain is globally a leading cause of physical disability. Many musculoskeletal-related pain conditions, such as low back pain, often resolve spontaneously. In some individuals, pain may recur or persist, leading to ong-term physical disability, reduced work capacity, and sickness absence. Early identification of individuals in which this may occur, is essential for preventing or reducing the risk of developing persistent musculoskeletal pain and long-term sickness absence. The aim of the trial described in this protocol is to evaluate effects of an early intervention, the PREVSAM model, on the prevention of sickness absence and development of persistent pain in at-risk patients with musculoskeletal pain. METHODS:Eligible participants are adults who seek health care for musculoskeletal pain and who are at risk of developing persistent pain, physical disability, and sickness absence. Participants may be recruited from primary care rehabilitation centres or primary care healthcare centres in Region Västra Götaland. Participants will be randomised to treatment according to the PREVSAM model (intervention group) or treatment as usual (control group). The PREVSAM model comprises an interdisciplinary, person-centred rehabilitation programme, including coordinated measures within primary health care, and may include collaboration with participants' employers. The primary outcome sickness absence is operationalised as the number and proportion of individuals who remain in full- or part-time work, the number of gross and net days of sickness absence during the intervention and follow-up period, and time to first sickness absence spell. Secondary outcomes are patient-reported short-term sickness absence, work ability, pain, self-efficacy, health-related quality of life, risk for sickness absence, anxiety and depression symptoms and physical disability at 1 and 3?months after inclusion (short-term follow-up), and at 6 and 12?months (long-term follow-up). A cost-effectiveness analysis is planned and drug consumption will be investigated. DISCUSSION:The study is expected to provide new knowledge on the effectiveness of a comprehensive rehabilitation model that incorporates early identification of patients with musculoskeletal pain at risk for development of sickness absence and persistent pain. The study findings may contribute to more effective rehabilitation processes of this large patient population, and potentially reduce sickness absence and costs. TRIAL REGISTRATION:ClinicalTrials.gov Protocol ID: NCT03913325 , Registered April 12, 2019. Version 2, 10 July 2020. Version 2 changes: Clarifications regarding trial aim and inclusion process.

Dataset Information

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.

Publications

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.

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