Clinical trial NCT04184037: iMeditate at Home for Older Adults With Mild Cognitive Impairment and Caregivers
Official title: A Pilot Randomized Controlled Trial of an At-home Mindfulness Meditation Intervention in Older Adults With Mild Cognitive Impairment and in Family Caregivers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mild Cognitive Impairment
Caregivers
Keywords: Mindfulness meditation
stress reduction
mobile application
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: Center for Aging and Brain Health Innovation
name: InteraXon, Inc.
First posted: 2019-12-03
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot randomised, controlled trial conducted in two study populations: older adults diagnosed with mild cognitive impairment (MCI) and family caregivers of individuals diagnosed with any neurodegenerative disease or MCI. Dyads of participants (older adult with MCI and their caregiver) may also be enrolled. Participants are randomly allocated to a mindfulness meditation with neurofeedback (NFB) or mindfulness meditation without neurofeedback (no-NFB).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Individuals diagnosed with mild cognitive impairment (MCI) are at a high risk of developing dementia and are an important target population for interventions that may reduce the risk of cognitive decline. A diagnosis of MCI or dementia also has an important impact on caregivers, who show increased levels of stress, anxiety, and depression. Mindfulness meditation is a promising behavioural intervention that may have important benefits both for older adults with MCI and for caregivers. Previous research suggests that meditation may improve psychological wellbeing, reduce stress, and even improve cognitive function. Technology-based mindfulness meditation platforms may be a much-needed solution for promoting the adoption of mindfulness in these populations.

The current study is a pilot randomized control trial of a mindfulness meditation intervention delivered via the Muse platform in two study populations: a) older adults diagnosed with MCI, and b) family caregivers of persons with MCI or neurodegenerative disorders. Muse is a mobile application for meditation that provides real-time feedback about the user's state of mindfulness during meditation via a headband containing electroencephalographic sensors (EEG) that the user wears while meditating. It is thought that this neurofeedback can promote learning and lead to faster improvements in meditation ability and, consequently, greater benefits from meditation practice.

This aim of this pilot study is to establish the acceptability of the Muse platform as an intervention in the two study populations, to determine the feasibility of the randomized control trial designed to evaluate the effectiveness of a 6 week intervention with the Muse platform, and to evaluate the effect of neurofeedback on meditation. Participants will be randomly allocated to meditation with neurofeedback (NFB) or meditation without neurofeedback (no-NFB) and will complete daily meditation sessions for 6 weeks. An assessment visit before and after the intervention will evaluate participants' psychological well-being using questionnaires; their visual working memory, attention, and visual perception using behavioural tests; and their mindfulness ability using questionnaires and a behavioural measure. EEG will also be recorded using the Muse headband to examine changes in electrophysiological markers during cognitive tests and at rest.

Detailed description: The Primary objectives of the main study are:

1. To determine if mindfulness meditation with auditory neurofeedback (NFB) leads to greater improvements in mindfulness relative to a mindfulness meditation without neurofeedback (no-NFB).
2. To determine if a mindfulness meditation intervention with neurofeedback leads to greater improvements in psychological well-being, with perceived stress levels as the primary outcome measure, in the two study populations, relative to a mindfulness meditation program without neurofeedback .

Secondary objectives of the main study are to determine if the NFB intervention leads to greater improvements in 1) other measures of psychological wellbeing and 2 ) behavioural and EEG markers of perceptual and cognitive function, relative to the no-NFB arm, in the two study populations (individuals with MCI; caregivers)

Feasibility and acceptability objectives of the pilot study

1. To evaluate the acceptability of the intervention for older adults with MCI and family caregivers of persons with MCI or neurodegenerative disorders, and to examine whether the acceptability of the intervention is associated with the individual's technological abilities.
2. To estimate the recruitment rate of older adults with MCI and family caregivers separately, as well as dyads of older adults with MCI and their caregivers.
3. To determine the rate of adherence to the intervention schedule (durations per session and number of sessions), and the rate of completion of assessment visits and weekly questionnaires
4. To determine the extent of technical expertise and time resources required of the experimenters to provide technical support to participants in each group
5. To determine the feasibility of blinding experimenters to the intervention arm and of blinding Muse-control participants to the neurofeedback group, given that information about the Muse app is easily available online.
6. To obtain preliminary estimates of the effects of Muse and Muse-control interventions on the psychological well-being, and perceptual and cognitive measures, and the standard deviations of these measures.

Procedures:

Briefly, participants will be enrolled on a continuous basis. After an initial pre-screening phone call or email, interested and eligible participants will come for a consenting and screening visit, which will include a clinical interview to screen for mental-health exclusion criteria, as well as exclusion related to prior use of the Muse device. All those eligible to proceed will return for a baseline assessment visit (Visit 2) where they will complete a series of computer-based task assessments and self-report questionnaires. At the end of the assessments, participants will be introduced to the research assistant responsible for the intervention (training RA). The training RA will train the participant on how to use the Muse headband and app associated with their training condition, as well as give instructions on the required training regimen. The next six weeks will consist of the training period. The training RA will contact participants by phone or email once a week to monitor for any issues. Following the training period, all participants will come back for Visit 3 to repeat the same assessments as were completed at baseline (Visit 2) with the experimenter RAs. All participants will be fully debriefed by the training RA during Visit 3 as to which version of the app they trained with and what the differences are between the two apps.

Sample size justification for the pilot study

A minimum of 12 participants per group and condition is required to provide feasibility and acceptability information. However, to obtain reliable estimates of the variability of each outcome measure, our target sample size is 20 participants per condition (i.e., 40 MCI participants in total and 40 caregivers in total). The actual sample size for the pilot study will be limited by the timeline of the project and the combination of recruitment and retention rates.

Recruitment:

Caregivers will be recruited through advertisements on the Baycrest campus or at institutions that provide services for caregivers. Older adults with MCI will be recruited at Baycrest through advertisements and by contacting eligible participants through the Baycrest Client Registry.

Eligibility criteria: Inclusion Criteria (Older adults with MCI):

* Diagnosis of mild cognitive impairment, any type, by a physician at the Baycrest Sam \& Ida Ross Memory Clinic
* Confirmation of the absence of progression to dementia within 90 days of study start by a physician or by the study staff
* Aged 55 years to 90 years

Inclusion Criteria (Caregivers):

* Identify as a caregiver of a family member or friend living with mild cognitive impairment (MCI) or any neurodegenerative disease
* Not be financially compensated for their caregiving work
* Aged 20 years to 90 years
* Passes the Telephone Interview for Cognitive Status and Montreal Cognitive Assessment \> 23

Exclusion Criteria:

* History of neurological disorders (e.g., malignant brain tumour, multiple sclerosis, Down's syndrome or any other developmental disorders, epilepsy, seizures, Parkinson's, any dementia or neurodegenerative disorder except for MCI), and history of MCI for the caregiver group
* Stroke or history of transient ischemic attack (TIA)
* History of traumatic brain injury (TBI) with loss of consciousness lasting longer than 30 minutes
* Active cancer, history of chemotherapy, or history of radiation to the head
* History of psychiatric conditions including:

  * Diagnosis of major depressive disorder, generalized anxiety disorder, or other psychiatric diagnosis within 90 days of study entry, or
  * Lifetime history of psychosis, bipolar disorder, obsessive compulsive disorder, schizophrenia, or post-traumatic stress disorder
  * History of substance use within the past year
* Serious medical disease that would/could lead to death over the next 2-3 years (e.g. cardiac/renal/liver disease, or cancer) with poor prognosis
* Presence of visual impairment (binocular vision worse than Snellen acuity 20/40)
* Hearing loss that prevents the individual to hear sounds in the Muse app even with a hearing aid (if applicable), or incompatibility of their hearing aid with the Muse headband and inability to hear the Muse app sounds without the hearing aid
* Started taking psychotropic medication (anti-anxiety, anti-psychotics) or cognitive enhancers (memantine, acetylcholinesterase inhibitors) less than 3 months prior to randomization, or has had a change in dosages of any acetylcholinesterase inhibitors or cognitive enhancers within 6 weeks of randomization, or has had any changes in all types of medications or dosages within 4 weeks of randomization.
* Already engages in active meditation practice
* Is enrolled or recently completed (within 30 days) another intervention study or clinical trial
* Unable to understand, read, and speak English

Primary outcomes:
measure: Change in the Perceived Stress Scale (PSS-10) score
timeFrame: Baseline (Visit 2/Week 1) to Post-Intervention (Visit 3/Week 7).
measure: Recruitment rate
timeFrame: Study recruitment period, approximately 3 months
measure: Total number of meditation sessions
timeFrame: Intervention period (6 weeks)
Secondary outcomes:
measure: Change in breath counting accuracy
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in the Mindfulness Attention and Awareness Scale (MAAS) score
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in the Perceived Stress Scale (PSS-10) score
timeFrame: Baseline (Visit 2/Week 1) to During Intervention (Week 3)
measure: Change in the Beck Depression Inventory (BDI-II) score
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in the Brief Symptom Inventory (BSI) score
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in the Warwick Edinburgh Mental Well-being Scale (WEMWBS) score
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in the quality of life (WHO-Quality of Life BREF) score
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in the Sleep Disturbance score
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in the Multifactorial Memory Questionnaire (MMQ)-Ability scale score
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in the Multifactorial Memory Questionnaire (MMQ)-Satisfaction scale score
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in the Conor-Davidson Resilience Scale (CD-RISC) score
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: 10-item Burden Scale for Family Caregivers (BSFC-s)
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Average hours of technical support per person
timeFrame: Intervention period (6 weeks)
measure: Change in visual working memory
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in visual attention
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in event-related potentials in the auditory oddball task
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Toronto Mindfulness Scale (TMS)
timeFrame: Intervention period (6 weeks)
measure: Change in the Credibility/Expectancy Questionnaire Score
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Retention rate
timeFrame: Post-intervention visit (Visit 3/Week 7)
measure: Mean duration of meditation sessions
timeFrame: Intervention period (6 weeks)
measure: Study acceptability score
timeFrame: Post-intervention visit (Visit 3, Week 7)
measure: Change in EEG features during meditation
timeFrame: Intervention period (6 weeks)
measure: Change in resting state EEG features with eyes open
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in resting state EEG features with eyes closed
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
Other outcomes:
measure: Change in far visual acuity
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
measure: Change in visual contrast sensitivity
timeFrame: Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)
Locations:
city: Toronto
country: Canada
facility: Baycrest
state: Ontario
Study officials:
affiliation: Baycrest
name: Allison B Sekuler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baycrest
name: Morris Freedman, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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