CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Mindfulness meditation (MM)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04972773
NCT04972773N/ACompleted

Spinal Cord Injury Mental Health Functional Outcomes Improved by Mindfulness

Queen's University·interventional·Posted Jul 22, 2021·Updated Mar 29, 2023

In Brief

A clinical study evaluating Mindfulness meditation (MM) for Spinal Cord Injuries and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 22, 2021
Enrollment StartOct 4, 2021
Primary CompletionMar 27, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.9 years ago

Interventions

Mindfulness meditation (MM)behavioral

Towards this additional MM practice, participants will be able to use any combination of the MM apps: "Insight timer", which focuses on community/group-like therapy, "Healthy minds", which focuses on resilience that is essential in disability adjustment, and "Smiling mind", that reminds patients of their family/support structures. These three options were chosen for delivering free MM with different focuses that would cater to the variety of SCI patients needs. Participants will be alerted if they are not achieving 30 minutes of additional MM per week. This will guarantee that the treatment group have a higher time spent on MM for dose-response analysis. Participants will receive a reminder email (see attached) on the Sunday evening of a week with \<30 minutes of additional MM encouraging them to use their mindfulness app.