NCT04972773

Spinal Cord Injury Mental Health Functional Outcomes Improved by Mindfulness

Completed NA Last updated 29 March 2023

What this trial tests

NA trial testing Mindfulness meditation (MM) in Spinal Cord Injuries in 10 participants. Completed in 27 March 2023.

Timeline

4 October 2021

Primary endpoint
27 March 2023

27 March 2023

Quick facts

Lead sponsor	Queen's University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	10
Start date	4 October 2021
Primary completion	27 March 2023
Estimated completion	27 March 2023
Sites	1 location across Canada

Drugs / interventions tested

• Mindfulness meditation (MM)

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Mindfulness Meditation — all drugs for Mindfulness Meditation →
• Mental Health Wellness 1 — all drugs for Mental Health Wellness 1 →

Sponsor

Queen's University

Who can join

18 and older, any sex, with Spinal Cord Injuries or Mindfulness Meditation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recovery from injury is an immune function but also involves stress. Spinal cord injury (SCI) patients are one population with a difficult recovery journey. Improvements in SCI rehabilitation could benefit patient's recovery and decrease their functional limitations. Lack of independence and chronic pain contributes to a higher rate of mental health problems (48.5%) and clinical stress (25%) in SCI patients. Depression is more common among auto-immune phenotypes and depression patients have higher pro-inflammatory cytokine profiles, suggesting stress impacts the immune system and thus opposes recovery. Mindfulness meditation (MM) is one form of stress-reduction therapy, which also decreases anxiety, depression, and pain. Little research has investigated whether this extends to functional outcomes of mental health during recovery. The investigators will look at the "functional outcomes of mental health", including stress, pain, quality of life, quality of sleep, and outcomes of depression using validated surveys. The investigators hypothesize that MM will significantly improve functional outcomes of mental health in SCI patients during their rehabilitation in a dose-dependent fashion, compared to 'standard therapy' alone control, with effects sustained 1-month post-intervention. Patients will take surveys of their mindfulness practices and mental health functional outcomes at 0 weeks (baseline), 8 weeks (post-treatment), and 12 weeks (follow-up). MM will be delivered to a randomized sample of SCI patients via one of three MM apps for 8 weeks. Linear regression will identify if patients practicing more MM have better mental health functional outcomes in a dose-dependent manner. The findings from this study will provide evidence of sustained stress-relief and mental health functional outcomes of consumer-based MM apps, which can be applied to improve SCI rehabilitation in an accessible manner.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710