NCT02478307

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_1 low-back-pain

Timeline
Completed

Started May 2015

Longer than P75 for phase_1 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

3.2 years

First QC Date

June 9, 2015

Last Update Submit

May 16, 2019

Conditions

Low Back Pain

Keywords

chronic low back painmindfulness meditationcognitive therapymindfulness-based cognitive therapyefficacymechanismscoping

Outcome Measures

Primary Outcomes (1)

  • 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

    pre to post-treatment (at least 8 weeks)

Secondary Outcomes (8)

  • Pain intensity assessed via the numerical rating scale (NRS)

    pre to post-treatment (at least 8 weeks)

  • Pain catastrophizing assessed via the Pain Catastrophizing Scale

    pre to post-treatment (at least 8 weeks)

  • Mindfulness assessed via the FFMQ

    pre to post-treatment (at least 8 weeks)

  • Pain acceptance assessed via the CPAQ

    pre to post-treatment (at least 8 weeks)

  • Psychological functioning PROMIS scale

    pre to post-treatment (at least 8 weeks)

  • +3 more secondary outcomes

Study Arms (3)

Cognitive Therapy

ACTIVE COMPARATOR

Eight, 2-hours sessions of group delivered cognitive therapy.

Other: Cognitive Therapy

Mindfulness Meditation

ACTIVE COMPARATOR

Eight, 2-hours sessions of group delivered mindfulness meditation.

Other: Mindfulness Meditation

Mindfulness-Based Cognitive Therapy

ACTIVE COMPARATOR

Eight, 2-hours sessions of group delivered mindfulness-based cognitive therapy

Other: Mindfulness-Based Cognitive Therapy

Interventions

Cognitive TherapyOTHER
Cognitive Therapy
Mindfulness MeditationOTHER
Mindfulness Meditation
Mindfulness-Based Cognitive TherapyOTHER
Mindfulness-Based Cognitive Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Queensland

Brisbane, Queensland, 4072, Australia

Location

Related Publications (1)

  • 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.

    PMID: 30920244DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Cognitive Behavioral TherapyMindfulnessMindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Melissa Day, MA(Clin), PhD

    The University of Queensland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
NHMRC Early Career Fellow

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 23, 2015

Study Start

May 1, 2015

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

AU(1)