Spinal Cord InjuriesNCT04972773
Spinal Cord Injury Mental Health Functional Outcomes Improved by Mindfulness
A study testing Mindfulness meditation (MM) in people with Spinal Cord Injuries and Mindfulness Meditation, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Mindfulness Meditation, Mental Health Wellness 1
- What is being tested?
- Mindfulness meditation (MM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2021to 27 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- legal adults (age > 17)
- in- or out-patients of all diagnoses in the SCI Rehabilitation Program at Providence Care Hospital or with SCI Ontario (ie. have SCI)
- own a smartphone on which they are willing to download the MM app(/s)
- have hand function or can provide a caregiver themselves to assist them with filling out 1 hour of questionnaires at three different time points in the study (0 weeks, 8 weeks, and 12 weeks)
- ability to consent themselves to research
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
SCI can pose significant limitations on a patient, with paralyzed patients requiring assisted living for activities of daily living like eating, dressing, hygiene, bathing, toileting, transferring and walking, any improvement in rehabilitation is important. Lack of independence and chronic pain contributes to a higher rate of mental health problems (48.5%) and clinical stress (25%) in these patients. Stress-targeted therapies like MM are correlated to better QOL, mental health, and moderately to physical health in other therapeutic populations. It is essential to translate these MM results on the functional outcomes of mental health to SCI patients. Effective early rehabilitation is essential to minimize muscle, bone, and flexibility loss and better stress management and pain control are key to getting into early rehabilitation. The stress and pain control MM could offer would benefit not only recovery but also health. New methods for pain management are essential because most current pain drugs are or become ineffective in up to half of patients or have strong side effects and/or societal burdens like opioids. Effective non-medication management of pain like MM could reduce opioid prescriptions and lessen the strain of addiction on society. This study aims not only to address the efficacy of MM on traditional outcome measures but also to examine the effect on functional outcomes, making it more clinically applicable.
In balancing limited resources like healthcare expenditure and healthcare professionals' time, MM mobile applications are one solution that promises accessible, cost-effective, and time-effective treatments, giving patients' autonomy and flexibility to incorporate mindfulness into their rehabilitation. MM present a promising, novel advancement to rehabilitation, stress control, and functional outcomes of mental health, that needs more research to apply in SCI patient groups through mobile app modalities.
Patients:
A participant will be eligible if they are an English-speaking adult in- or out-patient of all diagnoses in the SCI Rehabilitation Program at Providence Care Hospital or with SCI Ontario and own a smartphone on which they are willing to download a MM app. Sample size calculation identifies that 112 total participants are required to give 80% statistical power at a two-sided alpha of 0.05 for significance based on previous stress reduction effect size in SCI patients (n=56, 2 groups, N=112). Participants will be enrolled for 12 weeks, 8 of which will be the treatment weeks and 4 of which will be the follow-up weeks.
Treatment:
Computer-based randomization (https://www.randomizer.org/) will assign half of the participants to a MM intervention group (in addition to 'standard therapy') and half of the participants to the 'standard therapy' control group. Randomization will be stratified by in-/out-patient as the in-patients receive some MM as a part of 'standard therapy', while the out-patients do not. The goal of randomization and adding MM as a treatment is to ensure a distribution of doses of MM for analysis. Analysis of the data for a dose-dependent response will combat inherent contamination in the control group as a small amount of MM is a part of standard therapy for in-patients.
'Standard therapy' control group: 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.
Intervention group: Participants randomized to the intervention group, in addition to receiving 'standard therapy', will be asked to practice MM using a MM app for at least 10 minutes per day from weeks 0 to 8. 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.
Measurements:
Demographic data (age, injury type, mental health history, medication use, and therapy/counselling history) and current and a 1-year history of mindfulness practices, including use of MM apps, yoga, group MM, CBT, and MM technique use like body scan will be collected at baseline (0 weeks).
Both groups (intervention and control) will receive a survey each week asking them to report their MM practice total time for the week as a way of monitoring their MM dose.
Additionally, both groups will be assessed using Qualtrics at baseline, post-intervention (8 weeks), and at follow-up (12 weeks) for the outcome measures of:
- Mindfulness via the 39-item Five Facet Mindfulness Questionnaire (FFMQ)
- Anxiety and depression via the 14-item Hospital Anxiety and Depression Scale (HADS), validated in SCI
- Functional outcomes of mental health, including:
- Stress via the 10-item Perceived Stress Scale survey
- Quality of life (QOL) via the 26-item WHO QOL-BREF measuring physical health, psychological health, social relationships, and health of the patient's environment, validated in SCI
- Quality of Sleep via the Pittsburgh Sleep Quality Index (PSQI)
- Pain via the Global Pain Scale and its outcomes via the validated 13-item Pain catastrophizing scale
- Depression outcomes via the validated Clinical Global Impression - Clinical Improvement tool, as recommended for quantifying the mental health outcomes Finally, in only the intervention group, feasibility will be measured via adherence (in minutes/week) to the prescribed 10 min/day of MM for 8 weeks and acceptability will be measured via a Likert-scale (1-5) satisfaction survey delivered in week 8.
Statistical analysis:
All statistical analyses will be performed in GraphPad Prism 7 (GraphPad Software Inc., CA, USA). First, all data will be examined for distribution normality and outliers to ensure that statistical tests hold validity.
Group data (n=56) will be normalized to baseline and then averaged for comparison. The analysis will compare the Likert scale-based outcomes of mindfulness, anxiety and depression, stress, QOL, quality of sleep, pain, and depression outcomes between the intervention (high dose) and control (low dose) group at the three time points (2x3 analysis). Statistical significance will be tested using a two-way sample t-test in all experiments, where a P-value of =0.05 will be considered statistically significant between groups. The Bonferroni method to correct for multiple comparisons with a Bonferonni a=0.016 for within-group comparison will be used. The Cohen d effect size will be reported. To analyze the dose-dependent effects of MM, MM time will be treated as a continuous variable. General linear models can be used to compare functional outcomes of mental health based on MM dose at the post-intervention (8 week) measurement. A linear mixed-model will test the sustained mean difference between groups and time with group×time as an interaction factor at follow-up (12 week).
Feasibility will be assessed by calculating adherence to the treatment protocol as a percentage of participants and as a percentage of individual's time spent doing MM based on weekly self-reports by participants of their MM activities. Acceptability will be calculated by averaging responses to the satisfaction survey (rating 1-5) for those assigned to the MM intervention group.
Data presentation:
Data will be graphed as mean±sem of each outcome measure vs time engaged with MM, with the control group naturally being at a deficit to the intervention group to illustrate any dose-dependent effects of MM.
The primary aims of this research are:
- Beyond the negative effect of stress on mental health, mental health negatively affects physical health via poor sleep, less exercise, and unhealthy eating. Yet, little research exists on mental health functional outcomes and it remains controversial. Despite the importance of QOL, metanalysis found this was not an outcome in most studies and only 5% of studies look at functional outcomes of mental health. This research aims to measure functional outcomes of mental health by measuring QOL, stress, pain, depression/anxiety, and depression disability.
The secondary aims of this research are:
- Most studies use heterogenous injury type and severity, preventing meaningful statistical comparison. While evidence exists for CLBP, no evidence yet exists for MM effects in SCI. This research will isolate SCI patients to understand the effects of MM.
- Research focuses on programs like mindfulness-based stress reduction (MBSR), an 8-week group MM program. Although effective, these formalized programs are less feasible during social distancing, cost more time and money, and cannot serve outpatients. This research will focus on a modality of MM that is convenient, cost-effective, and accessible, but has precedent in the literature - mobile MM apps, including "Insight timer", "Healthy minds", and "Smiling mind". Mobile health apps offer remote care, user autonomy, and longer treatment. However, these apps require independent testing for efficacy and feasibility. This study hopes to make MM more accessible by assessing the outcomes of MM app use.
- Being tested
- Mindfulness meditation (MM)
- Keywords
- Spinal Cord Injuries, Mindfulness meditation, Mental Health outcomes, Quality of life
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation (MM)Behavioural
Also called Consumer app-based meditation, Insight timer, Healthy minds, Smiling mind
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.
| Study group | Role | What they receive |
|---|---|---|
| MM + standard-therapy intervention group | Experimental | 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. Receives: Behavioral: Mindfulness meditation (MM) |
| Standard-therapy control group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mindfulness during treatment phase assessed via the 39-item Five Facet Mindfulness Questionnaire (FFMQ)
With 5 categories: 1) Observe, 2) Describe, 3) Act with Awareness, 4) Non-judge, each of which is on a scale of 8-40 where greater is more mindful and 5) Non-react, which is on a scale of 7-35 where greater is more mindful
Measured: Weeks 0-8 (treatment [or control])
Change in Anxiety and depression during treatment phase assessed via the 14-item Hospital Anxiety and Depression Scale (HADS)
With two categories: 1) Depression, 2) Anxiety, each of which can range from 0-21, where an increased score is more deviation from neurotypical (depressed or anxious)
Measured: Weeks 0-8 (treatment [or control])
Change in Stress during treatment phase assessed via the 10-item Perceived Stress Scale survey
With a range of 0-40 with higher scores being more stress
Measured: Weeks 0-8 (treatment [or control])
Change in Quality of life during treatment phase assessed via the 26-item World Health Organization (WHO) Quality of life (QOL)-Abbreviated (BREF)
Measuring physical health, psychological health, social relationships, and health of the patient's environment, validated in SCI patients, averaged responses (as oppose to summed) ranging from 1 - 5, where 5 is a higher quality of life
Measured: Weeks 0-8 (treatment [or control])
Change in Quality of Sleep during treatment phase assessed via the Pittsburgh Sleep Quality Index (PSQI)
With a range of 0-21 points, where higher scores indicate more sleep disturbances
Measured: Weeks 0-8 (treatment [or control])
Change in Pain during treatment phase assessed via the validated Global Pain Scale
With a range of 0-100, where 100 is greater global (physical, emotional, functional, and clinical) pain
Measured: Weeks 0-8 (treatment [or control])
Change in Pain Catastrophizing during treatment phase assessed via the validated 13-item Pain catastrophizing scale
With a range of 0 - 52, where higher values indicate more catastrophizing about pain
Measured: Weeks 0-8 (treatment [or control])
Change in Clinical Improvement of Depression during treatment phase assessed via the validated Clinical Global Impression - Clinical Improvement tool
Which has items: 1) Severity of illness, range 1 - 7, with greater being more severe. 2) Global improvement, range 1 - 7, with greater being more worsening and lesser being more improvement. 3) Efficacy, range 0.25 - 4 based on the multiplication of the two answers - for therapeutic effect, the response: "Marked improvement" = 2, "Moderate improvement" = 1.5, "Minimal improvement" = 1, or "Worse" = 0.5; the while response: "No side effects" multiples the result by 2, "Side effects which don't interfere with functioning" multiplies the result by 1, "Side effects which significantly interfere with patient's functioning" multiples the result by 0.66X, and "side effects worse than the benefits" multiples the result by 0.5. Lower scores indicate worse clinical outcome (no effect or too many side effects), higher scores mean better outcome (effects and few side effects), with 1 being the cut-off for clinical recommendation
Measured: Weeks 0-8 (treatment [or control])
Change in Mindfulness during follow-up phase assessed via the 39-item Five Facet Mindfulness Questionnaire (FFMQ)
With 5 categories: 1) Observe, 2) Describe, 3) Act with Awareness, 4) Non-judge, each of which is on a scale of 8-40 where greater is more mindful and 5) Non-react, which is on a scale of 7-35 where greater is more mindful
Measured: Weeks 8-12 (follow-up)
Change in Anxiety and depression during follow-up phase assessed via the 14-item Hospital Anxiety and Depression Scale (HADS)
With two categories: 1) Depression, 2) Anxiety, each of which can range from 0-21, where an increased score is more deviation from neurotypical (depressed or anxious)
Measured: Weeks 8-12 (follow-up)
Change in Stress during follow-up phase assessed via the 10-item Perceived Stress Scale survey
With a range of 0-40 with higher scores being more stress
Measured: Weeks 8-12 (follow-up)
Change in Quality of life during follow-up phase assessed via the 26-item World Health Organization (WHO) Quality of life (QOL)-Abbreviated (BREF)
Measuring physical health, psychological health, social relationships, and health of the patient's environment, validated in SCI patients, averaged responses (as oppose to summed) ranging from 1 - 5, where 5 is a higher quality of life
Measured: Weeks 8-12 (follow-up)
Change in Quality of Sleep during follow-up phase assessed via the Pittsburgh Sleep Quality Index (PSQI)
With a range of 0-21 points, where higher scores indicate more sleep disturbances
Measured: Weeks 8-12 (follow-up)
Change in Pain during follow-up phase assessed via the validated Global Pain Scale
With a range of 0-100, where 100 is greater global (physical, emotional, functional, and clinical) pain
Measured: Weeks 8-12 (follow-up)
Change in Pain Catastrophizing during follow-up phase assessed via the validated 13-item Pain catastrophizing scale
With a range of 0 - 52, where higher values indicate more catastrophizing about pain
Measured: Weeks 8-12 (follow-up)
Change in Clinical Improvement of Depression during follow-up phase assessed via the validated Clinical Global Impression - Clinical Improvement tool
Which has items: 1) Severity of illness, range 1 - 7, with greater being more severe. 2) Global improvement, range 1 - 7, with greater being more worsening and lesser being more improvement. 3) Efficacy, range 0.25 - 4 based on the multiplication of the two answers - for therapeutic effect, the response: "Marked improvement" = 2, "Moderate improvement" = 1.5, "Minimal improvement" = 1, or "Worse" = 0.5; the while response: "No side effects" multiples the result by 2, "Side effects which don't interfere with functioning" multiplies the result by 1, "Side effects which significantly interfere with patient's functioning" multiples the result by 0.66X, and "side effects worse than the benefits" multiples the result by 0.5. Lower scores indicate worse clinical outcome (no effect or too many side effects), higher scores mean better outcome (effects and few side effects), with 1 being the cut-off for clinical recommendation
Measured: Weeks 8-12 (follow-up)
Secondary outcomes (2)
Average Adherence as a marker of how feasibly a patient can complete the mindfulness dose requested by the protocol
Measuring adherence (in minutes/week) as = actual time doing mindfulness / the prescribed total (70 mins/week, since 10 min/day of MM), reported as a percentage which can range from 0%-above 100%, where higher values indicate greater adherence and thus suggest greater feasibility. Results will be averaged over the 8 weeks.
Measured: Weekly for 8 weeks
Self-reported Likert-scale rating of satisfaction with the mindfulness meditation practice as a measure of acceptability
Assessed via a Likert-scale ranging from 1-5 on a satisfaction survey, where a higher value indicates greater satisfaction
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start4 Oct 2021
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment: Computer-based randomization (https://www.randomizer.org/) will assign half of the participants taken in on a rolling basis to a MM intervention group (in addition to standard-therapy) and half of the participants to the standard-therapy control group which run in parallel.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Smith, Queen's University
- Investigators
- Karen Smith, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972773
- Sponsor's protocol ID
- RMED-087-21
- Status last verified
- Mar 2023
- First submitted
- 30 Jun 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Migliorini C, Tonge B, Taleporos G. Spinal cord injury and mental health. Aust N Z J Psychiatry. 2008 Apr;42(4):309-14. doi: 10.1080/00048670801886080.
PubMed 18330773Maldonado Bouchard S, Hook MA. Psychological stress as a modulator of functional recovery following spinal cord injury. Front Neurol. 2014 Apr 9;5:44. doi: 10.3389/fneur.2014.00044. eCollection 2014.
PubMed 24782818Tran J, Dorstyn DS, Burke AL. Psychosocial aspects of spinal cord injury pain: a meta-analysis. Spinal Cord. 2016 Sep;54(9):640-8. doi: 10.1038/sc.2016.66. Epub 2016 May 10.
PubMed 27163453Pillastrini P, Mugnai R, Bonfiglioli R, Curti S, Mattioli S, Maioli MG, Bazzocchi G, Menarini M, Vannini R, Violante FS. Evaluation of an occupational therapy program for patients with spinal cord injury. Spinal Cord. 2008 Jan;46(1):78-81. doi: 10.1038/sj.sc.3102072. Epub 2007 Apr 24.
PubMed 17453011Krupa T, Fossey E, Anthony WA, Brown C, Pitts DB. Doing daily life: how occupational therapy can inform psychiatric rehabilitation practice. Psychiatr Rehabil J. 2009 Winter;32(3):155-61. doi: 10.2975/32.3.2009.155.161.
PubMed 19136347Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.
PubMed 23796855Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Wampold BE, Kearney DJ, Simpson TL. Mindfulness-based interventions for psychiatric disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2018 Feb;59:52-60. doi: 10.1016/j.cpr.2017.10.011. Epub 2017 Nov 8.
PubMed 29126747Hearn JH, Cross A. Mindfulness for pain, depression, anxiety, and quality of life in people with spinal cord injury: a systematic review. BMC Neurol. 2020 Jan 21;20(1):32. doi: 10.1186/s12883-020-1619-5.
PubMed 31964353Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.
PubMed 31237569Hearn JH, Finlay KA. Internet-delivered mindfulness for people with depression and chronic pain following spinal cord injury: a randomized, controlled feasibility trial. Spinal Cord. 2018 Aug;56(8):750-761. doi: 10.1038/s41393-018-0090-2. Epub 2018 Mar 26.
PubMed 29581519
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Injury Mental Health Functional Outcomes Improved by Mindfulness
- ClinicalTrials.gov ID
- NCT04972773
- Acronym / sponsor ID
- RMED-087-21
- Keywords
- Spinal Cord Injuries, Mindfulness meditation, Mental Health outcomes, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SCI can pose significant limitations on a patient, with paralyzed patients requiring assisted living for activities of daily living like eating, dressing, hygiene, bathing, toileting, transferring and walking, any improvement in rehabilitation is important. Lack of independence and chronic pain contributes to a higher rate of mental health problems (48.5%) and clinical stress (25%) in these patients. Stress-targeted therapies like MM are correlated to better QOL, mental health, and moderately to physical health in other therapeutic populations. It is essential to translate these MM results on the functional outcomes of mental health to SCI patients. Effective early rehabilitation is essential to minimize muscle, bone, and flexibility loss and better stress management and pain control are key to getting into early rehabilitation. The stress and pain control MM could offer would benefit not only recovery but also health. New methods for pain management are essential because most current pain drugs are or become ineffective in up to half of patients or have strong side effects and/or societal burdens like opioids. Effective non-medication management of pain like MM could reduce opioid prescriptions and lessen the strain of addiction on society. This study aims not only to address the efficacy of MM on traditional outcome measures but also to examine the effect on functional outcomes, making it more clinically applicable.
In balancing limited resources like healthcare expenditure and healthcare professionals' time, MM mobile applications are one solution that promises accessible, cost-effective, and time-effective treatments, giving patients' autonomy and flexibility to incorporate mindfulness into their rehabilitation. MM present a promising, novel advancement to rehabilitation, stress control, and functional outcomes of mental health, that needs more research to apply in SCI patient groups through mobile app modalities.
Patients:
A participant will be eligible if they are an English-speaking adult in- or out-patient of all diagnoses in the SCI Rehabilitation Program at Providence Care Hospital or with SCI Ontario and own a smartphone on which they are willing to download a MM app. Sample size calculation identifies that 112 total participants are required to give 80% statistical power at a two-sided alpha of 0.05 for significance based on previous stress reduction effect size in SCI patients (n=56, 2 groups, N=112). Participants will be enrolled for 12 weeks, 8 of which will be the treatment weeks and 4 of which will be the follow-up weeks.
Treatment:
Computer-based randomization (https://www.randomizer.org/) will assign half of the participants to a MM intervention group (in addition to 'standard therapy') and half of the participants to the 'standard therapy' control group. Randomization will be stratified by in-/out-patient as the in-patients receive some MM as a part of 'standard therapy', while the out-patients do not. The goal of randomization and adding MM as a treatment is to ensure a distribution of doses of MM for analysis. Analysis of the data for a dose-dependent response will combat inherent contamination in the control group as a small amount of MM is a part of standard therapy for in-patients.
'Standard therapy' control group: 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.
Intervention group: Participants randomized to the intervention group, in addition to receiving 'standard therapy', will be asked to practice MM using a MM app for at least 10 minutes per day from weeks 0 to 8. 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.
Measurements:
Demographic data (age, injury type, mental health history, medication use, and therapy/counselling history) and current and a 1-year history of mindfulness practices, including use of MM apps, yoga, group MM, CBT, and MM technique use like body scan will be collected at baseline (0 weeks).
Both groups (intervention and control) will receive a survey each week asking them to report their MM practice total time for the week as a way of monitoring their MM dose.
Additionally, both groups will be assessed using Qualtrics at baseline, post-intervention (8 weeks), and at follow-up (12 weeks) for the outcome measures of:
- Mindfulness via the 39-item Five Facet Mindfulness Questionnaire (FFMQ)
- Anxiety and depression via the 14-item Hospital Anxiety and Depression Scale (HADS), validated in SCI
- Functional outcomes of mental health, including:
- Stress via the 10-item Perceived Stress Scale survey
- Quality of life (QOL) via the 26-item WHO QOL-BREF measuring physical health, psychological health, social relationships, and health of the patient's environment, validated in SCI
- Quality of Sleep via the Pittsburgh Sleep Quality Index (PSQI)
- Pain via the Global Pain Scale and its outcomes via the validated 13-item Pain catastrophizing scale
- Depression outcomes via the validated Clinical Global Impression - Clinical Improvement tool, as recommended for quantifying the mental health outcomes Finally, in only the intervention group, feasibility will be measured via adherence (in minutes/week) to the prescribed 10 min/day of MM for 8 weeks and acceptability will be measured via a Likert-scale (1-5) satisfaction survey delivered in week 8.
Statistical analysis:
All statistical analyses will be performed in GraphPad Prism 7 (GraphPad Software Inc., CA, USA). First, all data will be examined for distribution normality and outliers to ensure that statistical tests hold validity.
Group data (n=56) will be normalized to baseline and then averaged for comparison. The analysis will compare the Likert scale-based outcomes of mindfulness, anxiety and depression, stress, QOL, quality of sleep, pain, and depression outcomes between the intervention (high dose) and control (low dose) group at the three time points (2x3 analysis). Statistical significance will be tested using a two-way sample t-test in all experiments, where a P-value of =0.05 will be considered statistically significant between groups. The Bonferroni method to correct for multiple comparisons with a Bonferonni a=0.016 for within-group comparison will be used. The Cohen d effect size will be reported. To analyze the dose-dependent effects of MM, MM time will be treated as a continuous variable. General linear models can be used to compare functional outcomes of mental health based on MM dose at the post-intervention (8 week) measurement. A linear mixed-model will test the sustained mean difference between groups and time with group×time as an interaction factor at follow-up (12 week).
Feasibility will be assessed by calculating adherence to the treatment protocol as a percentage of participants and as a percentage of individual's time spent doing MM based on weekly self-reports by participants of their MM activities. Acceptability will be calculated by averaging responses to the satisfaction survey (rating 1-5) for those assigned to the MM intervention group.
Data presentation:
Data will be graphed as mean±sem of each outcome measure vs time engaged with MM, with the control group naturally being at a deficit to the intervention group to illustrate any dose-dependent effects of MM.
The primary aims of this research are:
- Beyond the negative effect of stress on mental health, mental health negatively affects physical health via poor sleep, less exercise, and unhealthy eating. Yet, little research exists on mental health functional outcomes and it remains controversial. Despite the importance of QOL, metanalysis found this was not an outcome in most studies and only 5% of studies look at functional outcomes of mental health. This research aims to measure functional outcomes of mental health by measuring QOL, stress, pain, depression/anxiety, and depression disability.
The secondary aims of this research are:
- Most studies use heterogenous injury type and severity, preventing meaningful statistical comparison. While evidence exists for CLBP, no evidence yet exists for MM effects in SCI. This research will isolate SCI patients to understand the effects of MM.
- Research focuses on programs like mindfulness-based stress reduction (MBSR), an 8-week group MM program. Although effective, these formalized programs are less feasible during social distancing, cost more time and money, and cannot serve outpatients. This research will focus on a modality of MM that is convenient, cost-effective, and accessible, but has precedent in the literature - mobile MM apps, including "Insight timer", "Healthy minds", and "Smiling mind". Mobile health apps offer remote care, user autonomy, and longer treatment. However, these apps require independent testing for efficacy and feasibility. This study hopes to make MM more accessible by assessing the outcomes of MM app use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment: Computer-based randomization (https://www.randomizer.org/) will assign half of the participants taken in on a rolling basis to a MM intervention group (in addition to standard-therapy) and half of the participants to the standard-therapy control group which run in parallel.
| Arm | Type | Receives |
|---|---|---|
| MM + standard-therapy intervention group | Experimental | Behavioral: Mindfulness meditation (MM)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. |
| Standard-therapy control group | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English-speaking
- legal adults (age > 17)
- in- or out-patients of all diagnoses in the SCI Rehabilitation Program at Providence Care Hospital or with SCI Ontario (ie. have SCI)
- own a smartphone on which they are willing to download the MM app(/s)
- have hand function or can provide a caregiver themselves to assist them with filling out 1 hour of questionnaires at three different time points in the study (0 weeks, 8 weeks, and 12 weeks)
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditation (MM)Also: Consumer app-based meditation, Insight timer, Healthy minds, Smiling mindTowards 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. | Behavioural | MM + standard-therapy intervention group |
Primary outcome
Change in Mindfulness during treatment phase assessed via the 39-item Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Weeks 0-8 (treatment [or control])
With 5 categories: 1) Observe, 2) Describe, 3) Act with Awareness, 4) Non-judge, each of which is on a scale of 8-40 where greater is more mindful and 5) Non-react, which is on a scale of 7-35 where greater is more mindful
Change in Anxiety and depression during treatment phase assessed via the 14-item Hospital Anxiety and Depression Scale (HADS)
Time frame: Weeks 0-8 (treatment [or control])
With two categories: 1) Depression, 2) Anxiety, each of which can range from 0-21, where an increased score is more deviation from neurotypical (depressed or anxious)
Change in Stress during treatment phase assessed via the 10-item Perceived Stress Scale survey
Time frame: Weeks 0-8 (treatment [or control])
With a range of 0-40 with higher scores being more stress
Change in Quality of life during treatment phase assessed via the 26-item World Health Organization (WHO) Quality of life (QOL)-Abbreviated (BREF)
Time frame: Weeks 0-8 (treatment [or control])
Measuring physical health, psychological health, social relationships, and health of the patient's environment, validated in SCI patients, averaged responses (as oppose to summed) ranging from 1 - 5, where 5 is a higher quality of life
Change in Quality of Sleep during treatment phase assessed via the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Weeks 0-8 (treatment [or control])
With a range of 0-21 points, where higher scores indicate more sleep disturbances
Change in Pain during treatment phase assessed via the validated Global Pain Scale
Time frame: Weeks 0-8 (treatment [or control])
With a range of 0-100, where 100 is greater global (physical, emotional, functional, and clinical) pain
Change in Pain Catastrophizing during treatment phase assessed via the validated 13-item Pain catastrophizing scale
Time frame: Weeks 0-8 (treatment [or control])
With a range of 0 - 52, where higher values indicate more catastrophizing about pain
Change in Clinical Improvement of Depression during treatment phase assessed via the validated Clinical Global Impression - Clinical Improvement tool
Time frame: Weeks 0-8 (treatment [or control])
Which has items: 1) Severity of illness, range 1 - 7, with greater being more severe. 2) Global improvement, range 1 - 7, with greater being more worsening and lesser being more improvement. 3) Efficacy, range 0.25 - 4 based on the multiplication of the two answers - for therapeutic effect, the response: "Marked improvement" = 2, "Moderate improvement" = 1.5, "Minimal improvement" = 1, or "Worse" = 0.5; the while response: "No side effects" multiples the result by 2, "Side effects which don't interfere with functioning" multiplies the result by 1, "Side effects which significantly interfere with patient's functioning" multiples the result by 0.66X, and "side effects worse than the benefits" multiples the result by 0.5. Lower scores indicate worse clinical outcome (no effect or too many side effects), higher scores mean better outcome (effects and few side effects), with 1 being the cut-off for clinical recommendation
Change in Mindfulness during follow-up phase assessed via the 39-item Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Weeks 8-12 (follow-up)
With 5 categories: 1) Observe, 2) Describe, 3) Act with Awareness, 4) Non-judge, each of which is on a scale of 8-40 where greater is more mindful and 5) Non-react, which is on a scale of 7-35 where greater is more mindful
Change in Anxiety and depression during follow-up phase assessed via the 14-item Hospital Anxiety and Depression Scale (HADS)
Time frame: Weeks 8-12 (follow-up)
With two categories: 1) Depression, 2) Anxiety, each of which can range from 0-21, where an increased score is more deviation from neurotypical (depressed or anxious)
Change in Stress during follow-up phase assessed via the 10-item Perceived Stress Scale survey
Time frame: Weeks 8-12 (follow-up)
With a range of 0-40 with higher scores being more stress
Change in Quality of life during follow-up phase assessed via the 26-item World Health Organization (WHO) Quality of life (QOL)-Abbreviated (BREF)
Time frame: Weeks 8-12 (follow-up)
Measuring physical health, psychological health, social relationships, and health of the patient's environment, validated in SCI patients, averaged responses (as oppose to summed) ranging from 1 - 5, where 5 is a higher quality of life
Change in Quality of Sleep during follow-up phase assessed via the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Weeks 8-12 (follow-up)
With a range of 0-21 points, where higher scores indicate more sleep disturbances
Change in Pain during follow-up phase assessed via the validated Global Pain Scale
Time frame: Weeks 8-12 (follow-up)
With a range of 0-100, where 100 is greater global (physical, emotional, functional, and clinical) pain
Change in Pain Catastrophizing during follow-up phase assessed via the validated 13-item Pain catastrophizing scale
Time frame: Weeks 8-12 (follow-up)
With a range of 0 - 52, where higher values indicate more catastrophizing about pain
Change in Clinical Improvement of Depression during follow-up phase assessed via the validated Clinical Global Impression - Clinical Improvement tool
Time frame: Weeks 8-12 (follow-up)
Which has items: 1) Severity of illness, range 1 - 7, with greater being more severe. 2) Global improvement, range 1 - 7, with greater being more worsening and lesser being more improvement. 3) Efficacy, range 0.25 - 4 based on the multiplication of the two answers - for therapeutic effect, the response: "Marked improvement" = 2, "Moderate improvement" = 1.5, "Minimal improvement" = 1, or "Worse" = 0.5; the while response: "No side effects" multiples the result by 2, "Side effects which don't interfere with functioning" multiplies the result by 1, "Side effects which significantly interfere with patient's functioning" multiples the result by 0.66X, and "side effects worse than the benefits" multiples the result by 0.5. Lower scores indicate worse clinical outcome (no effect or too many side effects), higher scores mean better outcome (effects and few side effects), with 1 being the cut-off for clinical recommendation
2 secondary outcomes
Average Adherence as a marker of how feasibly a patient can complete the mindfulness dose requested by the protocol
Time frame: Weekly for 8 weeks
Self-reported Likert-scale rating of satisfaction with the mindfulness meditation practice as a measure of acceptability
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 18330773Migliorini C, Tonge B, Taleporos G. Spinal cord injury and mental health. Aust N Z J Psychiatry. 2008 Apr;42(4):309-14. doi: 10.1080/00048670801886080.
- Background: PubMed 24782818Maldonado Bouchard S, Hook MA. Psychological stress as a modulator of functional recovery following spinal cord injury. Front Neurol. 2014 Apr 9;5:44. doi: 10.3389/fneur.2014.00044. eCollection 2014.
- Background: PubMed 27163453Tran J, Dorstyn DS, Burke AL. Psychosocial aspects of spinal cord injury pain: a meta-analysis. Spinal Cord. 2016 Sep;54(9):640-8. doi: 10.1038/sc.2016.66. Epub 2016 May 10.
- Background: PubMed 17453011Pillastrini P, Mugnai R, Bonfiglioli R, Curti S, Mattioli S, Maioli MG, Bazzocchi G, Menarini M, Vannini R, Violante FS. Evaluation of an occupational therapy program for patients with spinal cord injury. Spinal Cord. 2008 Jan;46(1):78-81. doi: 10.1038/sj.sc.3102072. Epub 2007 Apr 24.
- Background: PubMed 19136347Krupa T, Fossey E, Anthony WA, Brown C, Pitts DB. Doing daily life: how occupational therapy can inform psychiatric rehabilitation practice. Psychiatr Rehabil J. 2009 Winter;32(3):155-61. doi: 10.2975/32.3.2009.155.161.
- Background: PubMed 12703651Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- Background: PubMed 23796855Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.
- Background: PubMed 29126747Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Wampold BE, Kearney DJ, Simpson TL. Mindfulness-based interventions for psychiatric disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2018 Feb;59:52-60. doi: 10.1016/j.cpr.2017.10.011. Epub 2017 Nov 8.
- Background: PubMed 31964353Hearn JH, Cross A. Mindfulness for pain, depression, anxiety, and quality of life in people with spinal cord injury: a systematic review. BMC Neurol. 2020 Jan 21;20(1):32. doi: 10.1186/s12883-020-1619-5.
- Background: PubMed 31237569Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.
- Background: PubMed 29581519Hearn JH, Finlay KA. Internet-delivered mindfulness for people with depression and chronic pain following spinal cord injury: a randomized, controlled feasibility trial. Spinal Cord. 2018 Aug;56(8):750-761. doi: 10.1038/s41393-018-0090-2. Epub 2018 Mar 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Smith, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation (MM) in people with Spinal Cord Injuries and Mindfulness Meditation, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mindfulness during treatment phase assessed via the 39-item Five Facet Mindfulness Questionnaire (FFMQ) (time frame: Weeks 0-8 (treatment [or control])). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972773, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.