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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
Scientific title
Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain
Secondary ID [1] 0 0
UQueensland
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain interference PROMIS scale
Timepoint [1] 0 0
pre to post-treatment (at least 8 weeks)
Secondary outcome [1] 0 0
Pain intensity assessed via the numerical rating scale (NRS)
Timepoint [1] 0 0
pre to post-treatment (at least 8 weeks)
Secondary outcome [2] 0 0
Pain catastrophizing assessed via the Pain Catastrophizing Scale
Timepoint [2] 0 0
pre to post-treatment (at least 8 weeks)
Secondary outcome [3] 0 0
Mindfulness assessed via the FFMQ
Timepoint [3] 0 0
pre to post-treatment (at least 8 weeks)
Secondary outcome [4] 0 0
Pain acceptance assessed via the CPAQ
Timepoint [4] 0 0
pre to post-treatment (at least 8 weeks)
Secondary outcome [5] 0 0
Psychological functioning PROMIS scale
Timepoint [5] 0 0
pre to post-treatment (at least 8 weeks)
Secondary outcome [6] 0 0
Emotional functioning PROMIS scale
Timepoint [6] 0 0
pre to post-treatment (at least 8 weeks)
Secondary outcome [7] 0 0
Physical functioning PROMIS scale
Timepoint [7] 0 0
pre to post-treatment (at least 8 weeks)
Secondary outcome [8] 0 0
Delta, theta, alpha, beta, and gamma bands assessed via EEG
Timepoint [8] 0 0
pre to post-treatment (at least 8 weeks)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2018
Sample size
Target
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Washington
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Alabama at Birmingham
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Rush University Medical Center
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/study/NCT02478307
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.
Public notes

Contacts
Principal investigator
Name 0 0
Melissa Day, MA(Clin), PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02478307