Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Maintaining Musculoskeletal Health Study (MAmMOTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Widespread Chronic Pain
Intervention Behavioral: Cognitive Behavioural Therapy
Enrollment 1002
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Period Title: Overall Study
Started 501 501
Completed 500 496
Not Completed 1 5
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual Total
Hide Arm/Group Description

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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. Total of all reporting groups
Overall Number of Baseline Participants 501 501 1002
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 500 participants 496 participants 996 participants
58.8
(47.7 to 68.7)
59.5
(47.9 to 68.9)
59.3
(47.9 to 68.8)
[1]
Measure Analysis Population Description: There was 1 post-randomisation exclusion in the Cognitive Behavioural Therapy group and 5 post-randomisation exclusions in the Treatment as usual group.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 496 participants 996 participants
Female
209
  41.8%
204
  41.1%
413
  41.5%
Male
291
  58.2%
292
  58.9%
583
  58.5%
[1]
Measure Analysis Population Description: There was 1 post-randomisation exclusion in the Cognitive Behavioural Therapy group and 5 post-randomisation exclusions in the Treatment as usual group.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Development of Chronic Widespread Pain Assessed by Questionnaire
Hide Description 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.
Time Frame 12 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 384 441
Measure Type: Count of Participants
Unit of Measure: Participants
69
  18.0%
77
  17.5%
2.Secondary Outcome
Title Pain Assessed by Questionnaire
Hide Description 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.
Time Frame 3 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 380 443
Measure Type: Count of Participants
Unit of Measure: Participants
308
  81.1%
384
  86.7%
3.Secondary Outcome
Title Pain Assessed by Questionnaire
Hide Description 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'.
Time Frame 12 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 384 441
Measure Type: Count of Participants
Unit of Measure: Participants
305
  79.4%
373
  84.6%
4.Secondary Outcome
Title Pain Assessed by Questionnaire
Hide Description 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'.
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 400 453
Measure Type: Count of Participants
Unit of Measure: Participants
305
  76.3%
376
  83.0%
5.Secondary Outcome
Title Illness Behaviour Assessed by Illness Behaviour Scale
Hide Description 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).
Time Frame 3 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 379 441
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.96  (3.99) 9.21  (3.86)
6.Secondary Outcome
Title Illness Behaviour Assessed by Illness Behaviour Scale
Hide Description 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).
Time Frame 12 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 373 431
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.21  (4.04) 8.96  (4.19)
7.Secondary Outcome
Title Illness Behaviour Assessed by Illness Behaviour Scale
Hide Description 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).
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 310 377
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.75  (4.14) 8.95  (4.18)
8.Secondary Outcome
Title Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
Hide Description Somatic Symptoms Scale, which measures the presence or absence of 5 somatic symptoms, with a range of 0 (best) to 5 (worst) somatic symptoms.
Time Frame 3 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 379 442
Measure Type: Count of Participants
Unit of Measure: Participants
0
224
  59.1%
239
  54.1%
1
96
  25.3%
127
  28.7%
2-5
59
  15.6%
76
  17.2%
9.Secondary Outcome
Title Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
Hide Description Somatic Symptoms Scale, which measures the presence or absence of 5 somatic symptoms, with a range of 0 (best) to 5 (worst) somatic symptoms.
Time Frame 12 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 372 432
Measure Type: Count of Participants
Unit of Measure: Participants
0
210
  56.5%
228
  52.8%
1
103
  27.7%
123
  28.5%
2-5
59
  15.9%
81
  18.8%
10.Secondary Outcome
Title Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
Hide Description Somatic Symptoms Scale, which measures the presence or absence of 5 somatic symptoms, with a range of 0 (best) to 5 (worst) somatic symptoms.
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 310 377
Measure Type: Count of Participants
Unit of Measure: Participants
0
184
  59.4%
219
  58.1%
1
82
  26.5%
90
  23.9%
2-5
44
  14.2%
68
  18.0%
11.Secondary Outcome
Title Sleep Problems Assessed by Sleep Problem Scale
Hide Description Sleep Problem Scale
Time Frame 3 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 377 439
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.54  (4.99) 9.16  (5.08)
12.Secondary Outcome
Title Sleep Problems Assessed by Sleep Problem Scale
Hide Description Sleep Problem Scale, with a range of 0 (best) to 20 (worst).
Time Frame 12 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 373 432
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.20  (4.89) 9.20  (5.16)
13.Secondary Outcome
Title Sleep Problems Assessed by Sleep Problem Scale
Hide Description Sleep Problem Scale, with a range of 0 (best) to 20 (worst).
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 309 376
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.45  (5.3) 9.06  (5.0)
14.Secondary Outcome
Title EQ-5D
Hide Description The EQ-5D is a standardised measure of health-related quality of life, with a range of values from 0 (worst) to 1 (best).
Time Frame 3 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 379 442
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0.74
(0.67 to 0.84)
0.74
(0.65 to 0.84)
15.Secondary Outcome
Title EQ-5D
Hide Description The EQ-5D is a standardised measure of health-related quality of life, with a range of values from 0 (worst) to 1 (best).
Time Frame 12 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 371 435
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0.74
(0.66 to 0.84)
0.74
(0.65 to 0.82)
16.Secondary Outcome
Title EQ-5D
Hide Description The EQ-5D is a standardised measure of health-related quality of life, with a range of values from 0 (worst) to 1 (best).
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 313 386
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0.74
(0.68 to 0.84)
0.74
(0.65 to 0.84)
17.Secondary Outcome
Title Wellbeing
Hide Description 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).
Time Frame 3 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 378 440
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0.89
(0.80 to 0.95)
0.89
(0.78 to 0.95)
18.Secondary Outcome
Title Wellbeing
Hide Description 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).
Time Frame 12 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 368 429
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0.91
(0.82 to 0.97)
0.89
(0.78 to 0.95)
19.Secondary Outcome
Title Wellbeing
Hide Description 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).
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 311 386
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0.91
(0.80 to 0.96)
0.89
(0.79 to 0.95)
20.Secondary Outcome
Title Psychological Distress Assessed by GHQ-12
Hide Description GHQ-12 (12-item General Health Questionnaire) has a range of 0 (best) to 12 (worst).
Time Frame 3 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 374 439
Measure Type: Count of Participants
Unit of Measure: Participants
0
224
  59.9%
207
  47.2%
1
50
  13.4%
63
  14.4%
2-5
65
  17.4%
96
  21.9%
6-12
35
   9.4%
73
  16.6%
21.Secondary Outcome
Title Psychological Distress Assessed by GHQ-12
Hide Description GHQ-12 (12-item General Health Questionnaire) has a range of 0 (best) to 12 (worst).
Time Frame 12 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 369 432
Measure Type: Count of Participants
Unit of Measure: Participants
0
201
  54.5%
202
  46.8%
1
59
  16.0%
54
  12.5%
2-5
68
  18.4%
113
  26.2%
6-12
41
  11.1%
63
  14.6%
22.Secondary Outcome
Title Psychological Distress Assessed by GHQ-12
Hide Description GHQ-12 (12-item General Health Questionnaire) has a range of 0 (best) to 12 (worst).
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 310 376
Measure Type: Count of Participants
Unit of Measure: Participants
0
168
  54.2%
178
  47.3%
1
36
  11.6%
42
  11.2%
2-5
67
  21.6%
91
  24.2%
6-12
39
  12.6%
65
  17.3%
23.Secondary Outcome
Title Patient Global Impression of Change Assessed by 7-item Scale
Hide Description 7-item scale from "very much worse" to "very much better"
Time Frame 3 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 378 442
Measure Type: Count of Participants
Unit of Measure: Participants
Very much better
14
   3.7%
15
   3.4%
Much better
76
  20.1%
48
  10.9%
A little better
132
  34.9%
91
  20.6%
No change
100
  26.5%
165
  37.3%
A little worse
45
  11.9%
98
  22.2%
Much worse
11
   2.9%
23
   5.2%
Very much worse
0
   0.0%
2
   0.5%
24.Secondary Outcome
Title Patient Global Impression of Change Assessed by 7-item Scale
Hide Description 7-item scale from "very much worse" to "very much better"
Time Frame 12 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 371 429
Measure Type: Count of Participants
Unit of Measure: Participants
Very much better
24
   6.5%
15
   3.5%
Much better
88
  23.7%
59
  13.8%
A little better
90
  24.3%
84
  19.6%
No change
83
  22.4%
126
  29.4%
A little worse
65
  17.5%
119
  27.7%
Much worse
18
   4.9%
23
   5.4%
Very much worse
3
   0.8%
3
   0.7%
25.Secondary Outcome
Title Patient Global Impression of Change Assessed by 7-item Scale
Hide Description 7-item scale from "very much worse" to "very much better"
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 378 442
Measure Type: Count of Participants
Unit of Measure: Participants
Very much better
14
   3.7%
15
   3.4%
Much better
76
  20.1%
48
  10.9%
A little better
132
  34.9%
91
  20.6%
No change
100
  26.5%
165
  37.3%
A little worse
45
  11.9%
98
  22.2%
Much worse
11
   2.9%
23
   5.2%
Very much worse
0
   0.0%
2
   0.5%
26.Secondary Outcome
Title Fatigue Assessed by Chalder Fatigue Scale
Hide Description Chalder Fatigue Scale has a range of 0 (best) to 33 (worst).
Time Frame 3 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 372 440
Mean (Standard Deviation)
Unit of Measure: score on a scale
12.2  (4.2) 13.6  (4.2)
27.Secondary Outcome
Title Fatigue Assessed by Chalder Fatigue Scale
Hide Description Chalder Fatigue Scale has a range of 0 (best) to 33 (worst).
Time Frame 12 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 370 433
Mean (Standard Deviation)
Unit of Measure: score on a scale
12.6  (4.5) 13.6  (4.4)
28.Secondary Outcome
Title Fatigue Assessed by Chalder Fatigue Scale
Hide Description Chalder Fatigue Scale has a range of 0 (best) to 33 (worst).
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 309 377
Mean (Standard Deviation)
Unit of Measure: score on a scale
13.0  (4.3) 13.9  (4.4)
29.Secondary Outcome
Title Health Care Usage Assessed by Questionnaire
Hide Description 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.
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 277 343
Mean (95% Confidence Interval)
Unit of Measure: £
3094.68
(1775.65 to 9074.15)
3052.38
(1735.77 to 8567.24)
30.Secondary Outcome
Title Development of Chronic Widespread Pain Assessed by Questionnaire
Hide Description 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.
Time Frame 3 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 380 443
Measure Type: Count of Participants
Unit of Measure: Participants
68
  17.9%
75
  16.9%
31.Secondary Outcome
Title Development of Chronic Widespread Pain Assessed by Questionnaire
Hide Description 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.
Time Frame 24 months after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description:

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
Overall Number of Participants Analyzed 400 453
Measure Type: Count of Participants
Unit of Measure: Participants
78
  19.5%
101
  22.3%
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Behavioural Therapy Treatment as Usual
Hide Arm/Group Description

Brief Cognitive Behavioural Therapy delivered by telephone

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.

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.
All-Cause Mortality
Cognitive Behavioural Therapy Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   3/501 (0.60%)   9/501 (1.80%) 
Hide Serious Adverse Events
Cognitive Behavioural Therapy Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/501 (0.00%)   0/501 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Behavioural Therapy Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   3/501 (0.60%)   0/501 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer *  1/501 (0.20%)  /501 
Psychiatric disorders     
Participant expressing thoughts that might be considered suicidal to therapist or on questionnaire *  2/501 (0.40%)  /501 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Gary Macfarlane
Organization: University of Aberdeen
Phone: 01224 437 143
EMail: g.j.macfarlane@abdn.ac.uk
Layout table for additonal information
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 Submitted: January 20, 2016
First Posted: January 29, 2016
Results First Submitted: June 1, 2021
Results First Posted: August 10, 2021
Last Update Posted: August 10, 2021