None listed
Conditions
Brief summary
As many as 1 in 4 Australians experience chronic pain. There is a critical need for the development and evaluation of fast-acting non-pharmaceutical treatments that have the capacity to target the multidimensional nature of chronic pain. This study will compare the effects and mechanisms of mindfulness meditation against placebo and no-treatment control groups. Results will ultimately lead to targeted interventions that more effectively engage cognitive mechanisms associated with pain attenuation.
Interventions
Six, 20-minute guided-audio-delivered mindfulness meditation training sessions (over a 7-10 day period) of either:
(1) mindfulness meditation – “focussed attention” mindfulness meditation technique taught as means to reduce pain intensity and unpleasantness.
or
(2) sham (placebo) mindfulness meditation – all features of the training sessions match the real mindfulness meditation intervention but lack the proposed “active ingredient” of the training (the practice does not provide an anchor fo
Six, 20-minute guided-audio-delivered mindfulness meditation training sessions (over a 7-10 day period) of either: (1) mindfulness meditation – “focussed attention” mindfulness meditation technique taught as means to reduce pain intensity and unpleasantness. or (2) sham (placebo) mindfulness meditation – all features of the training sessions match the real mindfulness meditation intervention but lack the proposed “active ingredient” of the training (the practice does not provide an anchor for attention or instructions on how to relate mindfully to present moment experience). Delivered as a means to elicit placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness. or (3) natural history control group – this group completes no training. They listen to a podcast about meditation and society (abridged to 20-minutes) at baseline (This American Life - Psychic Buddha; https://www.thisamericanlife.org/212/the-other-man/act-one-0) and post-test (ABC Radio National - Who Owns Mindfulness?; http://www.abc.net.au/radionational/programs/earshot/who-owns-mindfulness/9024864) to maintain experimenter blinding only. So as not to manipulate participant expectancy, these podcasts do not discuss any benefits of mindfulness. Each participant receives 2 training sessions in-lab at baseline and post-test, and is asked to complete 4 training sessions at home in between experimental sessions. Home guided-audio training is delivered via online survey software and adherence is monitored. All guided-training sessions are delivered by a qualified mindfulness instructor with 4+ years’ experience.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(1) at least 18 years of age; (2) pain-free (defined as 3/10 or lower on NRS); (3) not currently taking analgesic or psychotropic medications; (4) be able to read, speak and understand English; and (5) be able to attend two experimental sessions over 2 consecutive weeks and four sessions of home-practice.
Exclusion criteria
(1) currently taking analgesic or psychotropic medications; (2) current pain higher than 3/10 on NRS; (3) pregnant or breastfeeding; (4) current mindfulness or meditation practice (average >20 min/week in last six months); (5) previously completed a mindfulness course (e.g. MBSR, Vipassana); and (6) practicing a meditation-based religion (e.g. Hinduism, Buddhism, contemplative Christianity);
Outcome results
None listed