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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02478307
Registration number
NCT02478307
Ethics application status
Date submitted
9/06/2015
Date registered
23/06/2015
Date last updated
20/05/2019
Titles & IDs
Public title
Coping Skills Training for Living With Chronic Low Back Pain
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Scientific title
Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain
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Secondary ID [1]
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UQueensland
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Low Back Pain
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Active comparator: Cognitive Therapy - Eight, 2-hours sessions of group delivered cognitive therapy.
Active comparator: Mindfulness Meditation - Eight, 2-hours sessions of group delivered mindfulness meditation.
Active comparator: Mindfulness-Based Cognitive Therapy - Eight, 2-hours sessions of group delivered mindfulness-based cognitive therapy
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pain interference PROMIS scale
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Assessment method [1]
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Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain interference is assessed via the PROMIS scale
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Timepoint [1]
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pre to post-treatment (at least 8 weeks)
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Secondary outcome [1]
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Pain intensity assessed via the numerical rating scale (NRS)
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Assessment method [1]
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Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain intensity is assessed via the numerical rating scale (NRS)
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Timepoint [1]
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pre to post-treatment (at least 8 weeks)
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Secondary outcome [2]
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Pain catastrophizing assessed via the Pain Catastrophizing Scale
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Assessment method [2]
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Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain catastrophizing is assessed via the Pain Catastrophizing Scale
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Timepoint [2]
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pre to post-treatment (at least 8 weeks)
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Secondary outcome [3]
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Mindfulness assessed via the FFMQ
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Assessment method [3]
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Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in mindfulness is assessed via the FFMQ
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Timepoint [3]
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pre to post-treatment (at least 8 weeks)
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Secondary outcome [4]
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Pain acceptance assessed via the CPAQ
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Assessment method [4]
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Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain acceptance is assessed via the CPAQ
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Timepoint [4]
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pre to post-treatment (at least 8 weeks)
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Secondary outcome [5]
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Psychological functioning PROMIS scale
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Assessment method [5]
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Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in psychological functioning is assessed via the PROMIS scale
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Timepoint [5]
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pre to post-treatment (at least 8 weeks)
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Secondary outcome [6]
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Emotional functioning PROMIS scale
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Assessment method [6]
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Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in emotional functioning is assessed via the PROMIS scale
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Timepoint [6]
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pre to post-treatment (at least 8 weeks)
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Secondary outcome [7]
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Physical functioning PROMIS scale
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Assessment method [7]
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Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in physical functioning is assessed via the PROMIS scale
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Timepoint [7]
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pre to post-treatment (at least 8 weeks)
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Secondary outcome [8]
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Delta, theta, alpha, beta, and gamma bands assessed via EEG
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Assessment method [8]
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Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in brain state data is assessed via EEG
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Timepoint [8]
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pre to post-treatment (at least 8 weeks)
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Eligibility
Key inclusion criteria
* =18 years of age
* Chronic pain of the low back (=3 months) that is the primary source of reported pain
* Average pain intensity of =4 on a 10-point scale
* If currently taking analgesic or psychotropic medications, they must have been stabilised for =4 weeks prior to this study
* Be able to read, speak and understand English
* Be able to attend a weekly 2-hour therapy session for 8 concurrent weeks
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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)
* Chronic pain due to malignancy
* 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)
* Currently receiving other psychosocial pain treatment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2018
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Sample size
Target
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Accrual to date
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Final
69
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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The University of Queensland - Brisbane
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Recruitment postcode(s) [1]
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4072 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Washington
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Alabama at Birmingham
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Rush University Medical Center
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02478307
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Trial related presentations / publications
Day MA, Matthews N, Newman A, Mattingley JB, Jensen MP. An evaluation of the behavioral inhibition and behavioral activation system (BIS-BAS) model of pain. Rehabil Psychol. 2019 Aug;64(3):279-287. doi: 10.1037/rep0000274. Epub 2019 Mar 28.
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Public notes
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Contacts
Principal investigator
Name
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Melissa Day, MA(Clin), PhD
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02478307
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