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MM + standard-therapy intervention group for Spinal Cord Injury

N/A
Waitlist Available
Led By Karen Smith, MD
Research Sponsored by Queen's University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 8-12 (follow-up)
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Spinal Cord Injury
  • Mindfulness Meditation
  • Mental Health Wellness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 8-12 (follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 8-12 (follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Anxiety and depression during follow-up phase assessed via the 14-item Hospital Anxiety and Depression Scale (HADS)
Change in Anxiety and depression during treatment phase assessed via the 14-item Hospital Anxiety and Depression Scale (HADS)
Change in Clinical Improvement of Depression during follow-up phase assessed via the validated Clinical Global Impression - Clinical Improvement tool
+13 more
Secondary outcome measures
Average Adherence as a marker of how feasibly a patient can complete the mindfulness dose requested by the protocol
Self-reported Likert-scale rating of satisfaction with the mindfulness meditation practice as a measure of acceptability

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MM + standard-therapy intervention groupExperimental Treatment1 Intervention
In addition to receiving standard-therapy, participants will be asked to practice MM using a MM app for at least 10 minutes per day from weeks 0 to 8.
Group II: Standard-therapy control groupActive Control1 Intervention
Participants randomized to the standard-therapy control group will receive their typical in- or out-patient therapy. This is expected to include small doses of MM.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness meditation (MM)
2021
N/A
~10

Find a Location

Who is running the clinical trial?

Queen's UniversityLead Sponsor
365 Previous Clinical Trials
120,407 Total Patients Enrolled
Karen Smith, MDPrincipal InvestigatorQueen's University
3 Previous Clinical Trials
686 Total Patients Enrolled

Frequently Asked Questions

~3 spots leftby Apr 2025