Clinical trial NCT04972773: Spinal Cord Injury Mental Health Functional Outcomes Improved by Mindfulness
Official title: Spinal Cord Injury Mental Health Functional Outcomes Improved by Mindfulness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Mindfulness Meditation
Mental Health Wellness 1
Keywords: Spinal Cord Injuries
Mindfulness meditation
Mental Health outcomes
Quality of life
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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:

1) 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:

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in Mindfulness during treatment phase assessed via the 39-item Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Weeks 0-8 (treatment [or control])
measure: Change in Anxiety and depression during treatment phase assessed via the 14-item Hospital Anxiety and Depression Scale (HADS)
timeFrame: Weeks 0-8 (treatment [or control])
measure: Change in Stress during treatment phase assessed via the 10-item Perceived Stress Scale survey
timeFrame: Weeks 0-8 (treatment [or control])
measure: Change in Quality of life during treatment phase assessed via the 26-item World Health Organization (WHO) Quality of life (QOL)-Abbreviated (BREF)
timeFrame: Weeks 0-8 (treatment [or control])
measure: Change in Quality of Sleep during treatment phase assessed via the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Weeks 0-8 (treatment [or control])
measure: Change in Pain during treatment phase assessed via the validated Global Pain Scale
timeFrame: Weeks 0-8 (treatment [or control])
measure: Change in Pain Catastrophizing during treatment phase assessed via the validated 13-item Pain catastrophizing scale
timeFrame: Weeks 0-8 (treatment [or control])
measure: Change in Clinical Improvement of Depression during treatment phase assessed via the validated Clinical Global Impression - Clinical Improvement tool
timeFrame: Weeks 0-8 (treatment [or control])
measure: Change in Mindfulness during follow-up phase assessed via the 39-item Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Weeks 8-12 (follow-up)
measure: Change in Anxiety and depression during follow-up phase assessed via the 14-item Hospital Anxiety and Depression Scale (HADS)
timeFrame: Weeks 8-12 (follow-up)
measure: Change in Stress during follow-up phase assessed via the 10-item Perceived Stress Scale survey
timeFrame: Weeks 8-12 (follow-up)
measure: Change in Quality of life during follow-up phase assessed via the 26-item World Health Organization (WHO) Quality of life (QOL)-Abbreviated (BREF)
timeFrame: Weeks 8-12 (follow-up)
measure: Change in Quality of Sleep during follow-up phase assessed via the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Weeks 8-12 (follow-up)
measure: Change in Pain during follow-up phase assessed via the validated Global Pain Scale
timeFrame: Weeks 8-12 (follow-up)
measure: Change in Pain Catastrophizing during follow-up phase assessed via the validated 13-item Pain catastrophizing scale
timeFrame: Weeks 8-12 (follow-up)
measure: Change in Clinical Improvement of Depression during follow-up phase assessed via the validated Clinical Global Impression - Clinical Improvement tool
timeFrame: Weeks 8-12 (follow-up)
Secondary outcomes:
measure: Average Adherence as a marker of how feasibly a patient can complete the mindfulness dose requested by the protocol
timeFrame: Weekly for 8 weeks
measure: Self-reported Likert-scale rating of satisfaction with the mindfulness meditation practice as a measure of acceptability
timeFrame: Week 8
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Providence Care Hospital
state: Ont
Study officials:
affiliation: Queen's University
name: Karen Smith, MD
role: PRINCIPAL_INVESTIGATOR
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