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The Maintaining Musculoskeletal Health Study (MAmMOTH)

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ClinicalTrials.gov Identifier: NCT02668003
Recruitment Status : Completed
First Posted : January 29, 2016
Results First Posted : August 10, 2021
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:
It is known from many studies that when patients have developed chronic widespread pain (CWP) or fibromyalgia that managing such symptoms is extremely challenging for both doctors and patients. The investigators have shown in a recently completed study funded by Arthritis Research UK that a course of Cognitive Behaviour Therapy delivered by telephone (tCBT) or an exercise regime can substantially improve the chances of the symptoms improving. The investigators now plan to offer this therapy to patients who are at a high risk of developing CWP (but who have not developed it yet) to see whether its onset can be prevented.

Condition or disease Intervention/treatment Phase
Widespread Chronic Pain Behavioral: Cognitive Behavioural Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1002 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The MAintaining MusculOskeleTal Health (MAmMOTH) Study
Study Start Date : May 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Cognitive Behavioural Therapy
Brief Cognitive Behavioural Therapy delivered by telephone
Behavioral: Cognitive Behavioural Therapy
The CBT intervention, delivered by telephone, will consist of an initial assessment, 6 weekly sessions, and then booster sessions at 3 and 6 months. The intervention will be delivered by trained and accredited therapists. Participants will be supported by a self-management CBT manual. 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, 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.
Other Name: Telephone-delivered Cognitive Behavioural Therapy

No Intervention: Treatment as usual
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. Participants in this group will receive 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.



Primary Outcome Measures :
  1. Development of Chronic Widespread Pain Assessed by Questionnaire [ Time Frame: 12 months after treatment start ]
    The development of new chronic widespread pain, as defined by ACR 1990 criteria for fibromyalgia and assessed by questionnaire, at follow-up will be compared between participants in the two treatment arms. A participant was counted as having chronic widespread pain if they said they had pain in the last month that had lasted a day or more, indicated on a paper manikin that the pain that was on both the left and right hand sides, and above and below the waist, and in the axial skeleton, and answered that they had this pain for more than 3 months. If they did not have pain that was that above and below the waist and on the left and right hand sides, and in the axial skeleton, or they did not say they had the pain for more than 3 months, then they did not have chronic widespread pain.


Secondary Outcome Measures :
  1. Pain Assessed by Questionnaire [ Time Frame: 3 months after treatment start ]
    Assessed by follow-up questionnaire. Participants were asked if they had pain in the last month that had lasted a day or more and could answer 'yes' or 'no.

  2. Pain Assessed by Questionnaire [ Time Frame: 12 months after treatment start ]
    Assessed by follow-up questionnaire. Participants were asked if they had pain in the last month that lasted a day or more, and could answer 'yes' or 'no'.

  3. Pain Assessed by Questionnaire [ Time Frame: 24 months after treatment start ]
    Assessed by follow-up questionnaire. Participants were asked if they had pain in the last month that lasted a day or more, and could answer 'yes' or 'no'.

  4. Illness Behaviour Assessed by Illness Behaviour Scale [ Time Frame: 3 months after treatment start ]
    Illness Behaviour Scale, which is comprised of the 'Treatment experiences' and 'Effects of symptoms' sub-scales of the Illness Attitudes Scales. The range of scores is from 0 (best) to 24 (worst).

  5. Illness Behaviour Assessed by Illness Behaviour Scale [ Time Frame: 12 months after treatment start ]
    Illness Behaviour Scale, which is comprised of the 'Treatment experiences' and 'Effects of symptoms' sub-scales of the Illness Attitudes Scales. The range of scores is from 0 (best) to 24 (worst).

  6. Illness Behaviour Assessed by Illness Behaviour Scale [ Time Frame: 24 months after treatment start ]
    Illness Behaviour Scale, which is comprised of the 'Treatment experiences' and 'Effects of symptoms' sub-scales of the Illness Attitudes Scales. The range of scores is from 0 (best) to 24 (worst).

  7. Somatic Symptom Reporting Assessed by Somatic Symptoms Scale [ Time Frame: 3 months after treatment start ]
    Somatic Symptoms Scale, which measures the presence or absence of 5 somatic symptoms, with a range of 0 (best) to 5 (worst) somatic symptoms.

  8. Somatic Symptom Reporting Assessed by Somatic Symptoms Scale [ Time Frame: 12 months after treatment start ]
    Somatic Symptoms Scale, which measures the presence or absence of 5 somatic symptoms, with a range of 0 (best) to 5 (worst) somatic symptoms.

  9. Somatic Symptom Reporting Assessed by Somatic Symptoms Scale [ Time Frame: 24 months after treatment start ]
    Somatic Symptoms Scale, which measures the presence or absence of 5 somatic symptoms, with a range of 0 (best) to 5 (worst) somatic symptoms.

  10. Sleep Problems Assessed by Sleep Problem Scale [ Time Frame: 3 months after treatment start ]
    Sleep Problem Scale

  11. Sleep Problems Assessed by Sleep Problem Scale [ Time Frame: 12 months after treatment start ]
    Sleep Problem Scale, with a range of 0 (best) to 20 (worst).

  12. Sleep Problems Assessed by Sleep Problem Scale [ Time Frame: 24 months after treatment start ]
    Sleep Problem Scale, with a range of 0 (best) to 20 (worst).

  13. EQ-5D [ Time Frame: 3 months after treatment start ]
    The EQ-5D is a standardised measure of health-related quality of life, with a range of values from 0 (worst) to 1 (best).

  14. EQ-5D [ Time Frame: 12 months after treatment start ]
    The EQ-5D is a standardised measure of health-related quality of life, with a range of values from 0 (worst) to 1 (best).

  15. EQ-5D [ Time Frame: 24 months after treatment start ]
    The EQ-5D is a standardised measure of health-related quality of life, with a range of values from 0 (worst) to 1 (best).

  16. Wellbeing [ Time Frame: 3 months after treatment start ]
    ICECAP-A (ICEpop CAPability measure for Adults) is a self-report measure of capability wellbeing for adults, with a range of scores from -0.001 (worst) to 1 (best).

  17. Wellbeing [ Time Frame: 12 months after treatment start ]
    ICECAP-A (ICEpop CAPability measure for Adults) is a self-report measure of capability wellbeing for adults, with a range of scores from -0.001 (worst) to 1 (best).

  18. Wellbeing [ Time Frame: 24 months after treatment start ]
    ICECAP-A (ICEpop CAPability measure for Adults) is a self-report measure of capability wellbeing for adults, with a range of scores from -0.001 (worst) to 1 (best).

  19. Psychological Distress Assessed by GHQ-12 [ Time Frame: 3 months after treatment start ]
    GHQ-12 (12-item General Health Questionnaire) has a range of 0 (best) to 12 (worst).

  20. Psychological Distress Assessed by GHQ-12 [ Time Frame: 12 months after treatment start ]
    GHQ-12 (12-item General Health Questionnaire) has a range of 0 (best) to 12 (worst).

  21. Psychological Distress Assessed by GHQ-12 [ Time Frame: 24 months after treatment start ]
    GHQ-12 (12-item General Health Questionnaire) has a range of 0 (best) to 12 (worst).

  22. Patient Global Impression of Change Assessed by 7-item Scale [ Time Frame: 3 months after treatment start ]
    7-item scale from "very much worse" to "very much better"

  23. Patient Global Impression of Change Assessed by 7-item Scale [ Time Frame: 12 months after treatment start ]
    7-item scale from "very much worse" to "very much better"

  24. Patient Global Impression of Change Assessed by 7-item Scale [ Time Frame: 24 months after treatment start ]
    7-item scale from "very much worse" to "very much better"

  25. Fatigue Assessed by Chalder Fatigue Scale [ Time Frame: 3 months after treatment start ]
    Chalder Fatigue Scale has a range of 0 (best) to 33 (worst).

  26. Fatigue Assessed by Chalder Fatigue Scale [ Time Frame: 12 months after treatment start ]
    Chalder Fatigue Scale has a range of 0 (best) to 33 (worst).

  27. Fatigue Assessed by Chalder Fatigue Scale [ Time Frame: 24 months after treatment start ]
    Chalder Fatigue Scale has a range of 0 (best) to 33 (worst).

  28. Health Care Usage Assessed by Questionnaire [ Time Frame: 24 months after treatment start ]
    Health care usage will be assessed by questionnaire at 3 months, 12 months and 24 months after treatment start to determine the cost-effectiveness of the intervention. Only the cost of health care usage for the 24 month period after treatment start was calculated using this data.

  29. Development of Chronic Widespread Pain Assessed by Questionnaire [ Time Frame: 3 months after treatment start ]
    The development of new chronic widespread pain, as defined by ACR 1990 criteria for fibromyalgia and assessed by questionnaire, at follow-up will be compared between participants in the two treatment arms. A participant was counted as having chronic widespread pain if they said they had pain in the last month that had lasted a day or more, indicated on a paper manikin that the pain that was on both the left and right hand sides, and above and below the waist, and in the axial skeleton, and answered that they had this pain for more than 3 months. If they did not have pain that was that above and below the waist and on the left and right hand sides, and in the axial skeleton, or they did not say they had the pain for more than 3 months, then they did not have chronic widespread pain.

  30. Development of Chronic Widespread Pain Assessed by Questionnaire [ Time Frame: 24 months after treatment start ]
    The development of new chronic widespread pain, as defined by ACR 1990 criteria for fibromyalgia and assessed by questionnaire, at follow-up will be compared between participants in the two treatment arms. A participant was counted as having chronic widespread pain if they said they had pain in the last month that had lasted a day or more, indicated on a paper manikin that the pain that was on both the left and right hand sides, and above and below the waist, and in the axial skeleton, and answered that they had this pain for more than 3 months. If they did not have pain that was that above and below the waist and on the left and right hand sides, and in the axial skeleton, or they did not say they had the pain for more than 3 months, then they did not have chronic widespread pain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A 'high-risk' profile for developing CWP as identified on the screening survey, i.e.:

    • Have pain for which the patient has sought consultation to primary care in the last 6 months
    • Any 2 of the following: Illness Behaviour Score > 4; Somatic Symptom Score > 2; Sleep Problem Score > 4
  • Access to a land-line telephone or mobile telephone
  • 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)
  • Medical conditions which would make the proposed intervention unsuitable (e.g. cognitive ability)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668003


Locations
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United Kingdom
NHS Grampian
Aberdeen, United Kingdom
NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
NHS Highland
Inverness, United Kingdom
Sponsors and Collaborators
University of Aberdeen
Investigators
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Principal Investigator: Gary J Macfarlane, MBChB PhD MD University of Aberdeen
  Study Documents (Full-Text)

Documents provided by University of Aberdeen:
Study Protocol  [PDF] May 22, 2020
Statistical Analysis Plan  [PDF] June 19, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT02668003    
Other Study ID Numbers: 02/004/14
20748 ( Other Grant/Funding Number: Arthritis Research UK )
16/SW/0019 ( Other Identifier: National Research Ethics Service )
184303 ( Other Identifier: Integrated Research Application System )
First Posted: January 29, 2016    Key Record Dates
Results First Posted: August 10, 2021
Last Update Posted: August 10, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: After completion of the study individual participant data will be made available to other researchers on request as decided by the study data management committee.
Keywords provided by University of Aberdeen:
Prevention trial
Cognitive Behaviour Therapy
CWP
Chronic widespread pain
RCT
Fibromyalgia
Prevention
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations