Spinal Cord Injury Mental Health Functional Outcomes Improved by Mindfulness

NCT04972773 | Completed

• 1 other identifier: RMED-087-21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Mindfulness Meditation; Mental Health Wellness 1

Keywords

Spinal Cord Injuries; Mindfulness meditation; Mental Health outcomes; Quality of life

Outcome Measures

Primary Outcomes (16)

• 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

  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)

  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

  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

  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

  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

  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

  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

  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

  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)

  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

  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

  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

  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

  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

  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

  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

  Weekly for 8 weeks

• Self-reported Likert-scale rating of satisfaction with the mindfulness meditation practice as a measure of acceptability

  Week 8

Study Arms (2)

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.

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.

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.

Also known as: Consumer app-based meditation, Insight timer, Healthy minds, Smiling mind

MM + standard-therapy intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Providence Care Hospital

Kingston, Ontario, K7L 4X3, Canada

Location

Related Publications (11)

• 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.

  PMID: 18330773 BACKGROUND

• Maldonado 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.

  PMID: 24782818 BACKGROUND

• Tran 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.

  PMID: 27163453 BACKGROUND

• Pillastrini 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.

  PMID: 17453011 BACKGROUND

• Krupa 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.

  PMID: 19136347 BACKGROUND

• Brown 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.

  PMID: 12703651 BACKGROUND

• Khoury 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.

  PMID: 23796855 BACKGROUND

• Goldberg 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.

  PMID: 29126747 BACKGROUND

• Hearn 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.

  PMID: 31964353 BACKGROUND

• Huberty 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.

  PMID: 31237569 BACKGROUND

• Hearn 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.

  PMID: 29581519 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karen Smith, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 22, 2021
• Study Start: October 4, 2021
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)