Low Back PainPhase 1/2NCT02478307

Coping Skills Training for Living With Chronic Low Back Pain

A Phase 1/2 study testing Cognitive Therapy, Mindfulness Meditation and Mindfulness-Based Cognitive Therapy in people with Low Back Pain, run by The University of Queensland at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
What is being tested?: Cognitive Therapy, Mindfulness Meditation and Mindfulness-Based Cognitive Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteAustralia
Study dates: May 2015to 30 Jun 2018
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

The University of Queensland
Brisbane, Queensland, 4072

Other trials in Australia

About this study

Official title: Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain

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.

Read the detailed description

Up to 80% of Australians experience back pain and 10% have significant disability as a result. This translates into substantial economic cost with far reaching psychological, emotional and social implications. Unfortunately, the treatment options for chronic low back pain (CLBP) are limited and typical medical/pharmacological approaches entail potentially serious side-effects (e.g., opioid addiction). There is a critical need for the development and evaluation of innovative interventions that have the capacity to target the multidimensional nature of CLBP.

Research indicates that psychosocial interventions for CLBP are viable treatment approaches that entail few (if any) deleterious side effects and can have benefit beyond pain reduction. Cognitive Therapy (CT) and Mindfulness Meditation (MM) have both been found to be feasible and effective for CLBP. A promising recently developed treatment that combines aspects of CT and MM is Mindfulness-Based Cognitive Therapy (MBCT). MBCT has been successfully applied to problems such as depression and headache; however, this approach has not been investigated for CLBP.

Thus, the current study is a randomised controlled trial (RCT) designed to examine the effects and mechanisms (i.e., how and for whom do these treatments work) of CT, MM, and MBCT for CLBP. Brain state data (electroencephalogram (EEG)) as well as self-report data will be examined to investigate the potential unique and shared mechanisms underlying treatment effects. Furthering the field's understanding of these treatments and their mechanisms will lead to the development of streamlined interventions designed to efficiently maximise benefit for individuals with CLBP, and that optimise relief from suffering.

Conditions: Low Back Pain
Being tested: Cognitive Therapy, Mindfulness Meditation, Mindfulness-Based Cognitive Therapy
Keywords: chronic low back pain, mindfulness meditation, cognitive therapy, mindfulness-based cognitive therapy, efficacy, mechanisms, coping
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive TherapyOther
Mindfulness MeditationOther
Mindfulness-Based Cognitive TherapyOther

Study groups in NCT02478307
Study group	Role	What they receive
Cognitive Therapy	Active comparator	Eight, 2-hours sessions of group delivered cognitive therapy. Receives: Other: Cognitive Therapy
Mindfulness Meditation	Active comparator	Eight, 2-hours sessions of group delivered mindfulness meditation. Receives: Other: Mindfulness Meditation
Mindfulness-Based Cognitive Therapy	Active comparator	Eight, 2-hours sessions of group delivered mindfulness-based cognitive therapy Receives: Other: Mindfulness-Based Cognitive Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain interference PROMIS scale
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain interference is assessed via the PROMIS scale
Measured: pre to post-treatment (at least 8 weeks)

Secondary outcomes (8)

Pain intensity assessed via the numerical rating scale (NRS)
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)
Measured: pre to post-treatment (at least 8 weeks)
Pain catastrophizing assessed via the Pain Catastrophizing Scale
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
Measured: pre to post-treatment (at least 8 weeks)
Mindfulness assessed via the FFMQ
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in mindfulness is assessed via the FFMQ
Measured: pre to post-treatment (at least 8 weeks)
Pain acceptance assessed via the CPAQ
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain acceptance is assessed via the CPAQ
Measured: pre to post-treatment (at least 8 weeks)
Psychological functioning PROMIS scale
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in psychological functioning is assessed via the PROMIS scale
Measured: pre to post-treatment (at least 8 weeks)
Emotional functioning PROMIS scale
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in emotional functioning is assessed via the PROMIS scale
Measured: pre to post-treatment (at least 8 weeks)
Physical functioning PROMIS scale
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in physical functioning is assessed via the PROMIS scale
Measured: pre to post-treatment (at least 8 weeks)
Delta, theta, alpha, beta, and gamma bands assessed via EEG
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in brain state data is assessed via EEG
Measured: pre to post-treatment (at least 8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201530 Jun 2018

First posted23 Jun 2015 (estimated)
Study startMay 2015
Primary completion30 Jun 2018
Study completion30 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02478307
Sponsor's protocol ID: UQueensland
Status last verified: May 2019
First submitted: 9 Jun 2015
Last updated: 20 May 2019
Results posted: No
Data monitoring committee: Yes

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.
PubMed 30920244

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain
ClinicalTrials.gov ID: NCT02478307
Acronym / sponsor ID: UQueensland
Conditions: Low Back Pain
Keywords: chronic low back pain, mindfulness meditation, cognitive therapy, mindfulness-based cognitive therapy, efficacy, mechanisms, coping
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: The University of QueenslandUniversity, hospital or other
Collaborators: University of Washington, University of Alabama at Birmingham, Rush University Medical Center
Study start: May 2015
Primary completion: 30 Jun 2018 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 23 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Cognitive Therapy	Active comparator	Other: Cognitive TherapyEight, 2-hours sessions of group delivered cognitive therapy.
Mindfulness Meditation	Active comparator	Other: Mindfulness MeditationEight, 2-hours sessions of group delivered mindfulness meditation.
Mindfulness-Based Cognitive Therapy	Active comparator	Other: Mindfulness-Based Cognitive TherapyEight, 2-hours sessions of group delivered mindfulness-based cognitive therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

≥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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive Therapy	Other	Cognitive Therapy
Mindfulness Meditation	Other	Mindfulness Meditation
Mindfulness-Based Cognitive Therapy	Other	Mindfulness-Based Cognitive Therapy

Primary outcome

Pain interference PROMIS scale
Time frame: pre to post-treatment (at least 8 weeks)
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain interference is assessed via the PROMIS scale

8 secondary outcomes

Pain intensity assessed via the numerical rating scale (NRS)
Time frame: pre to post-treatment (at least 8 weeks)
Pain catastrophizing assessed via the Pain Catastrophizing Scale
Time frame: pre to post-treatment (at least 8 weeks)
Mindfulness assessed via the FFMQ
Time frame: pre to post-treatment (at least 8 weeks)
Pain acceptance assessed via the CPAQ
Time frame: pre to post-treatment (at least 8 weeks)
Psychological functioning PROMIS scale
Time frame: pre to post-treatment (at least 8 weeks)
Emotional functioning PROMIS scale
Time frame: pre to post-treatment (at least 8 weeks)
Physical functioning PROMIS scale
Time frame: pre to post-treatment (at least 8 weeks)
Delta, theta, alpha, beta, and gamma bands assessed via EEG
Time frame: pre to post-treatment (at least 8 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
Derived from this study: PubMed 30920244Day 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.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa Day, MA(Clin), PhD principal investigator

The University of Queensland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cognitive Therapy, Mindfulness Meditation and Mindfulness-Based Cognitive Therapy in people with Low Back Pain, run by The University of Queensland at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain interference PROMIS scale (time frame: pre to post-treatment (at least 8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02478307, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.