Trial Outcomes & Findings for The Maintaining Musculoskeletal Health Study (NCT NCT02668003)
NCT ID: NCT02668003
Last Updated: 2021-08-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1002 participants
Primary outcome timeframe
12 months after treatment start
Results posted on
2021-08-10
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioural Therapy
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
501
|
501
|
|
Overall Study
COMPLETED
|
500
|
496
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There was 1 post-randomisation exclusion in the Cognitive Behavioural Therapy group and 5 post-randomisation exclusions in the Treatment as usual group.
Baseline characteristics by cohort
| Measure |
Cognitive Behavioural Therapy
n=501 Participants
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.
|
Treatment as Usual
n=501 Participants
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
n=1002 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 years
n=500 Participants • There was 1 post-randomisation exclusion in the Cognitive Behavioural Therapy group and 5 post-randomisation exclusions in the Treatment as usual group.
|
59.5 years
n=496 Participants • There was 1 post-randomisation exclusion in the Cognitive Behavioural Therapy group and 5 post-randomisation exclusions in the Treatment as usual group.
|
59.3 years
n=996 Participants • 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
Female
|
209 Participants
n=500 Participants • There was 1 post-randomisation exclusion in the Cognitive Behavioural Therapy group and 5 post-randomisation exclusions in the Treatment as usual group.
|
204 Participants
n=496 Participants • There was 1 post-randomisation exclusion in the Cognitive Behavioural Therapy group and 5 post-randomisation exclusions in the Treatment as usual group.
|
413 Participants
n=996 Participants • 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
Male
|
291 Participants
n=500 Participants • There was 1 post-randomisation exclusion in the Cognitive Behavioural Therapy group and 5 post-randomisation exclusions in the Treatment as usual group.
|
292 Participants
n=496 Participants • There was 1 post-randomisation exclusion in the Cognitive Behavioural Therapy group and 5 post-randomisation exclusions in the Treatment as usual group.
|
583 Participants
n=996 Participants • 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
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 months after treatment startThe 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.
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=384 Participants
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.
|
Treatment as Usual
n=441 Participants
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.
|
|---|---|---|
|
Development of Chronic Widespread Pain Assessed by Questionnaire
|
69 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: 3 months after treatment startAssessed 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.
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=380 Participants
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.
|
Treatment as Usual
n=443 Participants
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.
|
|---|---|---|
|
Pain Assessed by Questionnaire
|
308 Participants
|
384 Participants
|
SECONDARY outcome
Timeframe: 12 months after treatment startAssessed 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'.
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=384 Participants
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.
|
Treatment as Usual
n=441 Participants
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.
|
|---|---|---|
|
Pain Assessed by Questionnaire
|
305 Participants
|
373 Participants
|
SECONDARY outcome
Timeframe: 24 months after treatment startAssessed 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'.
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=400 Participants
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.
|
Treatment as Usual
n=453 Participants
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.
|
|---|---|---|
|
Pain Assessed by Questionnaire
|
305 Participants
|
376 Participants
|
SECONDARY outcome
Timeframe: 3 months after treatment startIllness 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).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=379 Participants
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.
|
Treatment as Usual
n=441 Participants
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.
|
|---|---|---|
|
Illness Behaviour Assessed by Illness Behaviour Scale
|
8.96 score on a scale
Standard Deviation 3.99
|
9.21 score on a scale
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: 12 months after treatment startIllness 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).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=373 Participants
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.
|
Treatment as Usual
n=431 Participants
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.
|
|---|---|---|
|
Illness Behaviour Assessed by Illness Behaviour Scale
|
8.21 score on a scale
Standard Deviation 4.04
|
8.96 score on a scale
Standard Deviation 4.19
|
SECONDARY outcome
Timeframe: 24 months after treatment startIllness 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).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=310 Participants
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.
|
Treatment as Usual
n=377 Participants
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.
|
|---|---|---|
|
Illness Behaviour Assessed by Illness Behaviour Scale
|
7.75 score on a scale
Standard Deviation 4.14
|
8.95 score on a scale
Standard Deviation 4.18
|
SECONDARY outcome
Timeframe: 3 months after treatment startSomatic Symptoms Scale, which measures the presence or absence of 5 somatic symptoms, with a range of 0 (best) to 5 (worst) somatic symptoms.
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=379 Participants
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.
|
Treatment as Usual
n=442 Participants
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.
|
|---|---|---|
|
Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
0
|
224 Participants
|
239 Participants
|
|
Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
1
|
96 Participants
|
127 Participants
|
|
Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
2-5
|
59 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: 12 months after treatment startSomatic Symptoms Scale, which measures the presence or absence of 5 somatic symptoms, with a range of 0 (best) to 5 (worst) somatic symptoms.
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=372 Participants
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.
|
Treatment as Usual
n=432 Participants
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.
|
|---|---|---|
|
Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
0
|
210 Participants
|
228 Participants
|
|
Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
1
|
103 Participants
|
123 Participants
|
|
Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
2-5
|
59 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: 24 months after treatment startSomatic Symptoms Scale, which measures the presence or absence of 5 somatic symptoms, with a range of 0 (best) to 5 (worst) somatic symptoms.
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=310 Participants
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.
|
Treatment as Usual
n=377 Participants
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.
|
|---|---|---|
|
Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
0
|
184 Participants
|
219 Participants
|
|
Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
1
|
82 Participants
|
90 Participants
|
|
Somatic Symptom Reporting Assessed by Somatic Symptoms Scale
2-5
|
44 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 3 months after treatment startSleep Problem Scale
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=377 Participants
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.
|
Treatment as Usual
n=439 Participants
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.
|
|---|---|---|
|
Sleep Problems Assessed by Sleep Problem Scale
|
8.54 score on a scale
Standard Deviation 4.99
|
9.16 score on a scale
Standard Deviation 5.08
|
SECONDARY outcome
Timeframe: 12 months after treatment startSleep Problem Scale, with a range of 0 (best) to 20 (worst).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=373 Participants
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.
|
Treatment as Usual
n=432 Participants
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.
|
|---|---|---|
|
Sleep Problems Assessed by Sleep Problem Scale
|
8.20 score on a scale
Standard Deviation 4.89
|
9.20 score on a scale
Standard Deviation 5.16
|
SECONDARY outcome
Timeframe: 24 months after treatment startSleep Problem Scale, with a range of 0 (best) to 20 (worst).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=309 Participants
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.
|
Treatment as Usual
n=376 Participants
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.
|
|---|---|---|
|
Sleep Problems Assessed by Sleep Problem Scale
|
8.45 score on a scale
Standard Deviation 5.3
|
9.06 score on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 3 months after treatment startThe EQ-5D is a standardised measure of health-related quality of life, with a range of values from 0 (worst) to 1 (best).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=379 Participants
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.
|
Treatment as Usual
n=442 Participants
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.
|
|---|---|---|
|
EQ-5D
|
0.74 score on a scale
Interval 0.67 to 0.84
|
0.74 score on a scale
Interval 0.65 to 0.84
|
SECONDARY outcome
Timeframe: 12 months after treatment startThe EQ-5D is a standardised measure of health-related quality of life, with a range of values from 0 (worst) to 1 (best).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=371 Participants
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.
|
Treatment as Usual
n=435 Participants
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.
|
|---|---|---|
|
EQ-5D
|
0.74 score on a scale
Interval 0.66 to 0.84
|
0.74 score on a scale
Interval 0.65 to 0.82
|
SECONDARY outcome
Timeframe: 24 months after treatment startThe EQ-5D is a standardised measure of health-related quality of life, with a range of values from 0 (worst) to 1 (best).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=313 Participants
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.
|
Treatment as Usual
n=386 Participants
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.
|
|---|---|---|
|
EQ-5D
|
0.74 score on a scale
Interval 0.68 to 0.84
|
0.74 score on a scale
Interval 0.65 to 0.84
|
SECONDARY outcome
Timeframe: 3 months after treatment startICECAP-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).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=378 Participants
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.
|
Treatment as Usual
n=440 Participants
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.
|
|---|---|---|
|
Wellbeing
|
0.89 score on a scale
Interval 0.8 to 0.95
|
0.89 score on a scale
Interval 0.78 to 0.95
|
SECONDARY outcome
Timeframe: 12 months after treatment startICECAP-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).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=368 Participants
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.
|
Treatment as Usual
n=429 Participants
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.
|
|---|---|---|
|
Wellbeing
|
0.91 score on a scale
Interval 0.82 to 0.97
|
0.89 score on a scale
Interval 0.78 to 0.95
|
SECONDARY outcome
Timeframe: 24 months after treatment startICECAP-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).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=311 Participants
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.
|
Treatment as Usual
n=386 Participants
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.
|
|---|---|---|
|
Wellbeing
|
0.91 score on a scale
Interval 0.8 to 0.96
|
0.89 score on a scale
Interval 0.79 to 0.95
|
SECONDARY outcome
Timeframe: 3 months after treatment startGHQ-12 (12-item General Health Questionnaire) has a range of 0 (best) to 12 (worst).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=374 Participants
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.
|
Treatment as Usual
n=439 Participants
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.
|
|---|---|---|
|
Psychological Distress Assessed by GHQ-12
0
|
224 Participants
|
207 Participants
|
|
Psychological Distress Assessed by GHQ-12
1
|
50 Participants
|
63 Participants
|
|
Psychological Distress Assessed by GHQ-12
2-5
|
65 Participants
|
96 Participants
|
|
Psychological Distress Assessed by GHQ-12
6-12
|
35 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: 12 months after treatment startGHQ-12 (12-item General Health Questionnaire) has a range of 0 (best) to 12 (worst).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=369 Participants
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.
|
Treatment as Usual
n=432 Participants
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.
|
|---|---|---|
|
Psychological Distress Assessed by GHQ-12
0
|
201 Participants
|
202 Participants
|
|
Psychological Distress Assessed by GHQ-12
1
|
59 Participants
|
54 Participants
|
|
Psychological Distress Assessed by GHQ-12
2-5
|
68 Participants
|
113 Participants
|
|
Psychological Distress Assessed by GHQ-12
6-12
|
41 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 24 months after treatment startGHQ-12 (12-item General Health Questionnaire) has a range of 0 (best) to 12 (worst).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=310 Participants
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.
|
Treatment as Usual
n=376 Participants
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.
|
|---|---|---|
|
Psychological Distress Assessed by GHQ-12
0
|
168 Participants
|
178 Participants
|
|
Psychological Distress Assessed by GHQ-12
1
|
36 Participants
|
42 Participants
|
|
Psychological Distress Assessed by GHQ-12
2-5
|
67 Participants
|
91 Participants
|
|
Psychological Distress Assessed by GHQ-12
6-12
|
39 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 3 months after treatment start7-item scale from "very much worse" to "very much better"
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=378 Participants
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.
|
Treatment as Usual
n=442 Participants
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.
|
|---|---|---|
|
Patient Global Impression of Change Assessed by 7-item Scale
Very much better
|
14 Participants
|
15 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
Much better
|
76 Participants
|
48 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
A little better
|
132 Participants
|
91 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
No change
|
100 Participants
|
165 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
A little worse
|
45 Participants
|
98 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
Much worse
|
11 Participants
|
23 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
Very much worse
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 months after treatment start7-item scale from "very much worse" to "very much better"
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=371 Participants
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.
|
Treatment as Usual
n=429 Participants
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.
|
|---|---|---|
|
Patient Global Impression of Change Assessed by 7-item Scale
Very much better
|
24 Participants
|
15 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
Much better
|
88 Participants
|
59 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
A little better
|
90 Participants
|
84 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
No change
|
83 Participants
|
126 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
A little worse
|
65 Participants
|
119 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
Much worse
|
18 Participants
|
23 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
Very much worse
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 months after treatment start7-item scale from "very much worse" to "very much better"
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=378 Participants
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.
|
Treatment as Usual
n=442 Participants
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.
|
|---|---|---|
|
Patient Global Impression of Change Assessed by 7-item Scale
Very much better
|
14 Participants
|
15 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
Much better
|
76 Participants
|
48 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
A little better
|
132 Participants
|
91 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
No change
|
100 Participants
|
165 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
A little worse
|
45 Participants
|
98 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
Much worse
|
11 Participants
|
23 Participants
|
|
Patient Global Impression of Change Assessed by 7-item Scale
Very much worse
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 months after treatment startChalder Fatigue Scale has a range of 0 (best) to 33 (worst).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=372 Participants
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.
|
Treatment as Usual
n=440 Participants
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.
|
|---|---|---|
|
Fatigue Assessed by Chalder Fatigue Scale
|
12.2 score on a scale
Standard Deviation 4.2
|
13.6 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 12 months after treatment startChalder Fatigue Scale has a range of 0 (best) to 33 (worst).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=370 Participants
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.
|
Treatment as Usual
n=433 Participants
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.
|
|---|---|---|
|
Fatigue Assessed by Chalder Fatigue Scale
|
12.6 score on a scale
Standard Deviation 4.5
|
13.6 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 24 months after treatment startChalder Fatigue Scale has a range of 0 (best) to 33 (worst).
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=309 Participants
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.
|
Treatment as Usual
n=377 Participants
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.
|
|---|---|---|
|
Fatigue Assessed by Chalder Fatigue Scale
|
13.0 score on a scale
Standard Deviation 4.3
|
13.9 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 24 months after treatment startHealth 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.
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=277 Participants
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.
|
Treatment as Usual
n=343 Participants
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.
|
|---|---|---|
|
Health Care Usage Assessed by Questionnaire
|
3094.68 £
Interval 1775.65 to 9074.15
|
3052.38 £
Interval 1735.77 to 8567.24
|
SECONDARY outcome
Timeframe: 3 months after treatment startThe 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.
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=380 Participants
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.
|
Treatment as Usual
n=443 Participants
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.
|
|---|---|---|
|
Development of Chronic Widespread Pain Assessed by Questionnaire
|
68 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: 24 months after treatment startThe 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.
Outcome measures
| Measure |
Cognitive Behavioural Therapy
n=400 Participants
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.
|
Treatment as Usual
n=453 Participants
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.
|
|---|---|---|
|
Development of Chronic Widespread Pain Assessed by Questionnaire
|
78 Participants
|
101 Participants
|
Adverse Events
Cognitive Behavioural Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive Behavioural Therapy
n=501 participants at risk
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.
|
Treatment as Usual
n=501 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Participant expressing thoughts that might be considered suicidal to therapist or on questionnaire
|
0.40%
2/501 • 2 years
|
0.00%
0/501 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.20%
1/501 • 2 years
|
0.00%
0/501 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place