Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000714583
Ethics application status
Approved
Date submitted
10/06/2015
Date registered
10/07/2015
Date last updated
17/05/2019
Date data sharing statement initially provided
17/05/2019
Date results information initially provided
17/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Coping Skills Training for Living With Chronic Low Back Pain
Scientific title
Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain
Secondary ID [1] 286890 0
Nil Known
Universal Trial Number (UTN)
Nil known
Trial acronym
Nil known
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 295295 0
Condition category
Condition code
Musculoskeletal 295555 295555 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 295556 295556 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eight, group delivered 2 hours sessions (1 per week) of either:

(1) mindfulness meditation - various mindfulness meditation techniques are taught as means to reduce stress and improve coping and management of pain.

or

(2) cognitive therapy - exercises such as cognitive restructuring are taught to change unhelpful ways of thinking and responding to pain to improve pain management.

or

(3) mindfulness-based cognitive therapy - both mindfulness meditation and cognitive coping techniques are taught to improve adaptive pain coping and management.

Each participant receives all 8 sessions for one of the above three interventions only. Between session practice is encouraged and recorded via participant self-report. All interventions are group delivered by a clinical psychologist.
Intervention code [1] 292068 0
Treatment: Other
Comparator / control treatment
mindfulness meditation, cognitive therapy, or mindfulness-based cognitive therapy; no control group included
Control group
Active

Outcomes
Primary outcome [1] 295273 0
Pain Interference, assessed via the PROMIS pain interference scale
Timepoint [1] 295273 0
Pre to post-treatment, i.e., baseline and after 8 weeks of treatment
Secondary outcome [1] 315249 0
Pain intensity, assessed via a numerical rating scale
Timepoint [1] 315249 0
Pre to post-treatment, i.e., baseline and after 8 weeks of treatment
Secondary outcome [2] 315250 0
Psychological functioning, assessed via the PROMIS scale
Timepoint [2] 315250 0
Pre to post-treatment, i.e., baseline and after 8 weeks of treatment
Secondary outcome [3] 315377 0
Emotional functioning, assessed via the PROMIS scale
Timepoint [3] 315377 0
Pre to post-treatment, i.e., baseline and after 8 weeks of treatment
Secondary outcome [4] 315378 0
Physical functioning, assessed via the PROMIS scale
Timepoint [4] 315378 0
Pre to post-treatment, i.e., baseline and after 8 weeks of treatment
Secondary outcome [5] 315379 0
Pain catastrophizing, assessed via the Pain Catastrophizing Scale
Timepoint [5] 315379 0
Pre to post-treatment, i.e., baseline and after 8 weeks of treatment
Secondary outcome [6] 315380 0
Mindfulness, assessed via the FFMQ
Timepoint [6] 315380 0
Pre to post-treatment, i.e., baseline and after 8 weeks of treatment
Secondary outcome [7] 315381 0
Pain acceptance, assessed via the CPAQ
Timepoint [7] 315381 0
Pre to post-treatment, i.e., baseline and after 8 weeks of treatment

Eligibility
Key inclusion criteria
(1) at least 18 years of age; (2) chronic pain of the low back (at least 3 months) that is the primary source of reported pain; (3) average pain intensity of at least 4 on a 10-point scale; (4) if currently taking analgesic or psychotropic medications, they must have been stabilised for at least 4 weeks prior to this study; (5) be able to read, speak and understand English; and (6) be able to attend a weekly 2-hour therapy session for 8 concurrent weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) cognitive impairment, uncontrolled psychotic symptoms or current elevated suicidal ideation as this may interfere with group-delivered therapy (as evidenced by the 6-item screener); (2) chronic pain due to malignancy; (3) history of a medical condition that could produce an abnormal EEG and interfere with the tests of the effects of treatment on EEG (e.g., epilepsy, history of traumatic brain injury); and (4) currently receiving other psychosocial pain treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2016
Actual
20/01/2016
Date of last participant enrolment
Anticipated
10/01/2018
Actual
16/10/2017
Date of last data collection
Anticipated
30/06/2018
Actual
30/06/2018
Sample size
Target
63
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291443 0
Government body
Name [1] 291443 0
National Health and Medical Research Council
Country [1] 291443 0
Australia
Primary sponsor type
Individual
Name
Dr Melissa Day
Address
330 McElwain Building
School of Psychology
The University of Queensland
Brisbane, QLD, 4072
Country
Australia
Secondary sponsor category [1] 290118 0
None
Name [1] 290118 0
Nil known
Address [1] 290118 0
Nil known
Country [1] 290118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292994 0
Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [1] 292994 0
Cumbrae-Stewart Building
The University of Queensland
Brisbane, QLD 4072
Ethics committee country [1] 292994 0
Australia
Date submitted for ethics approval [1] 292994 0
Approval date [1] 292994 0
11/05/2015
Ethics approval number [1] 292994 0
2015000568
Ethics committee name [2] 295330 0
Metro South Hospital and Health Service Human Research Ethics Committee
Ethics committee address [2] 295330 0
Centres for Health Research
Princess Alexandra Hospital
Metro South Hospital and Health Service
37 Kent St
Woolloongabba, QLD 4102
Ethics committee country [2] 295330 0
Australia
Date submitted for ethics approval [2] 295330 0
01/09/2015
Approval date [2] 295330 0
15/12/2015
Ethics approval number [2] 295330 0
HREC/15/QPAH/579-SSA/15/QPAH/580

Summary
Brief summary
Up to 80% of Australians experience back pain and 10% have significant disability as a result. There is a critical need for the development and evaluation of innovative treatments that have the capacity to target the multidimensional nature of chronic low back pain. This study will compare the effects and mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for chronic low back pain. Results will ultimately lead to streamlined interventions designed to efficiently maximise benefit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57998 0
Dr Melissa Day
Address 57998 0
330 McElwain Building
School of Psychology
The University of Queensland
Brisbane, QLD 4072
Country 57998 0
Australia
Phone 57998 0
+61 7 3365 6421
Fax 57998 0
Email 57998 0
[email protected]
Contact person for public queries
Name 57999 0
Dr Melissa Day
Address 57999 0
330 McElwain Building
School of Psychology
The University of Queensland
Brisbane, QLD 4072
Country 57999 0
Australia
Phone 57999 0
+61 7 3365 6421
Fax 57999 0
Email 57999 0
[email protected]
Contact person for scientific queries
Name 58000 0
Dr Melissa Day
Address 58000 0
330 McElwain Building
School of Psychology
The University of Queensland
Brisbane, QLD 4072
Country 58000 0
Australia
Phone 58000 0
+61 7 3365 6421
Fax 58000 0
Email 58000 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical restrictions.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Day, M.A., Ward, L.C., Ehde, D.M., Thorn, B.E., Bu... [More Details]
Study results articleYes Day, M.A., Matthews, N. Newman, A., Mattingley, J.... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseChange in Brain Oscillations as a Mechanism of Mindfulness-Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain.2021https://dx.doi.org/10.1093/pm/pnab049
EmbaseAn evaluation of the behavioral inhibition and behavioral activation system (BIS-BAS) model of pain.2019https://dx.doi.org/10.1037/rep0000274
EmbaseMechanisms of mindfulness meditation, cognitive therapy, and mindfulness-based cognitive therapy for chronic low back pain.2020https://dx.doi.org/10.1097/AJP.0000000000000862
N.B. These documents automatically identified may not have been verified by the study sponsor.