Spinal Cord Injury Mental Health Functional Outcomes Improved by Mindfulness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Quality of Sleep during treatment phase assessed via the Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding will be established by having a separate collaborator randomize participants to one of the two arms and manage the notification of participants of their allocation, while the primary investigator and outcomes assessor is not informed of this randomization.
Only the researchers will be blinded to a subject's group. Because of the nature of asking the intervention group, but not the control group, to complete additional MM practice, the participants will not be blinded. Thus no provisions need to be made to break the code of the blinding protocol in an emergency. The researchers (investigator and outcomes assessors) will be unaware of participants group assignment, so as not to show preference to one group. The master code that connects participant data to a participant ID will be stored separately from the rest of the data on a USB, otherwise keeping researchers blind to the participant's group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Change in Quality of Sleep during treatment phase assessed via the Pittsburgh Sleep Quality Index (PSQI)
时间窗: Weeks 0-8 (treatment [or control])
With a range of 0-21 points, where higher scores indicate more sleep disturbances
Change in Pain Catastrophizing during treatment phase assessed via the validated 13-item Pain catastrophizing scale
时间窗: Weeks 0-8 (treatment [or control])
With a range of 0 - 52, where higher values indicate more catastrophizing about pain
Change in Mindfulness during follow-up phase assessed via the 39-item Five Facet Mindfulness Questionnaire (FFMQ)
时间窗: 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 Quality of Sleep during follow-up phase assessed via the Pittsburgh Sleep Quality Index (PSQI)
时间窗: Weeks 8-12 (follow-up)
With a range of 0-21 points, where higher scores indicate more sleep disturbances
Change in Mindfulness during treatment phase assessed via the 39-item Five Facet Mindfulness Questionnaire (FFMQ)
时间窗: 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 Quality of life during treatment phase assessed via the 26-item World Health Organization (WHO) Quality of life (QOL)-Abbreviated (BREF)
时间窗: 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 Stress during follow-up phase assessed via the 10-item Perceived Stress Scale survey
时间窗: Weeks 8-12 (follow-up)
With a range of 0-40 with higher scores being more stress
Change in Pain during follow-up phase assessed via the validated Global Pain Scale
时间窗: Weeks 8-12 (follow-up)
With a range of 0-100, where 100 is greater global (physical, emotional, functional, and clinical) pain
Change in Anxiety and depression during treatment phase assessed via the 14-item Hospital Anxiety and Depression Scale (HADS)
时间窗: 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
时间窗: Weeks 0-8 (treatment [or control])
With a range of 0-40 with higher scores being more stress
Change in Pain during treatment phase assessed via the validated Global Pain Scale
时间窗: 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 Clinical Improvement of Depression during treatment phase assessed via the validated Clinical Global Impression - Clinical Improvement tool
时间窗: 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 Anxiety and depression during follow-up phase assessed via the 14-item Hospital Anxiety and Depression Scale (HADS)
时间窗: 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 Pain Catastrophizing during follow-up phase assessed via the validated 13-item Pain catastrophizing scale
时间窗: 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
时间窗: 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
Change in Quality of life during follow-up phase assessed via the 26-item World Health Organization (WHO) Quality of life (QOL)-Abbreviated (BREF)
时间窗: 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
次要结局
- Self-reported Likert-scale rating of satisfaction with the mindfulness meditation practice as a measure of acceptability(Week 8)
- Average Adherence as a marker of how feasibly a patient can complete the mindfulness dose requested by the protocol(Weekly for 8 weeks)