iMeditate at Home for Older Adults With Mild Cognitive Impairment and Caregivers

NCT04184037 | Terminated

• 1 other identifier: REB #18-34
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Caregivers

Keywords

Mindfulness meditation; stress reduction; mobile application

Outcome Measures

Primary Outcomes (3)

• Change in the Perceived Stress Scale (PSS-10) score

  The 10-item Perceived Stress Scale is a self-administered questionnaire that measures an individual's perception of how uncontrollable, unpredictable and overloading aspects of their life are on a 5-point scale ranging from 0 (never) to 4 (very often). It has been validated in older adults, caregivers of dementia patients, and dementia patients (Deeken et al., 2018; Ezzati et al., 2014). High scores represent high levels of stress. This is the primary outcome measure in the main study.

  Baseline (Visit 2/Week 1) to Post-Intervention (Visit 3/Week 7).

• Recruitment rate

  The recruitment rate will be quantified as the number of participants recruited per month, separately for the two study population groups (MCI and caregivers). This is a primary outcome variable for the feasibility study.

  Study recruitment period, approximately 3 months

• Total number of meditation sessions

  The total number of meditation sessions lasting longer than 3 minutes will be quantified for each participant to evaluate adherence to the intervention schedule. This is a primary acceptability outcome variable for the feasibility study.

  Intervention period (6 weeks)

Secondary Outcomes (24)

• Change in breath counting accuracy

  Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)

• Change in the Mindfulness Attention and Awareness Scale (MAAS) score

  Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)

• Change in the Perceived Stress Scale (PSS-10) score

  Baseline (Visit 2/Week 1) to During Intervention (Week 3)

• Change in the Beck Depression Inventory (BDI-II) score

  Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)

• Change in the Brief Symptom Inventory (BSI) score

  Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)

Other Outcomes (2)

• Change in far visual acuity

  Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)

• Change in visual contrast sensitivity

  Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7)

Study Arms (2)

Auditory neurofeedback (NFB)

EXPERIMENTAL

Participants in this arm will meditate with the help of a custom version of the Muse app, which guides users in meditation while providing auditory neurofeedback on their state of mindfulness. Participants will wear the EEG headband and headphones when completing the meditation sessions using the app. The neurofeedback consists of changing weather sounds that are heard against a background soundscape (e.g., a beach or rainforest sound). When a user is in a focused state, the weather in the soundscape is good (e.g., it is quiet or a light breeze can be heard). When a user starts mind-wandering, the weather sounds change for the worse: it begins to rain, the wind gets louder, and there may be thunder. When the user returns to a calm state, the weather sounds quiet down again and only the background soundscape is heard. Participants are asked to pay attention to the weather sounds and to use this feedback to train their mind to remain focused on the present moment.

Behavioral: Mindfulness meditation delivered via a mobile app

No neurofeedback (no-NFB)

ACTIVE COMPARATOR

Participants in this arm will meditate using a custom version of the Muse app that is identical in all respects to the mobile app used by the NFB group, expect that the auditory neurofeedback is not active. Participants will wear the EEG headband and headphones when completing the meditation sessions using the app, but the soundscape during the sessions will only contain the background sounds (e.g., the breach or rainforest scene), without any changes to the weather.

Behavioral: Mindfulness meditation delivered via a mobile app

Interventions

Mindfulness meditation delivered via a mobile app BEHAVIORAL

This is a six-week intervention that requires completing daily meditation sessions at home using a mobile app while wearing a four-channel EEG device (Muse,RRID:SCR\_014418) and headphones. Participants are asked to increase their session duration from 5 to 15 minutes over the first 10 sessions, and continue with 15 minutes thereafter. Meditation sessions in both intervention arms consist of listening to a calm soundscape while focusing one's attention on the present moment. Prior to starting the intervention, participants are familiarized with the mobile device, EEG headband, and the study app during an onboarding session. In this session, participants listen to four different meditation exercise instructions (e.g., focusing attention on their breath, counting breaths, thinking of meditation akin to training a puppy) that offer them techniques to use during meditation.The transcript of these exercises and a basic guide on how to use the study app and headband are provided.

Also known as: Muse

Auditory neurofeedback (NFB); No neurofeedback (no-NFB)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baycrest: lead
• Center for Aging and Brain Health Innovation: collaborator
• InteraXon, Inc.: collaborator

Study Sites (1)

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

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MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Allison B Sekuler, PhD

  Baycrest

  PRINCIPAL INVESTIGATOR

• Morris Freedman, MD, FRCPC

  Baycrest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor and all individuals involved in analyzing data will be blind to the participant's study arm. Only the research assistant who will be introducing participants to their meditation app will be aware of their study arm assignment. Participants will be told that they are randomized into one of two types of meditation programs, but will not be told about the difference in the two programs and will not be told if they are in the main intervention group or the control group. That said, given the nature of auditory neurofeedback, participants in the NFB group will be aware that they are receiving neurofeedback. Participants in the no-NFB group will not be experiencing any neurofeedback and, a priori, they should not be aware that neurofeedback is missing.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sandra A Rotman Chair in Cognitive Neuroscience; Managing Director and Senior Scientist, Rotman Research Institute; Managing Director, Centre for Aging + Brain Health Innovation; Vice-President Research, Baycrest Health Sciences

Model Details: 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).

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: December 3, 2019
• Study Start: November 15, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available at the time of publication of the articles and will remain accessible indefinitely.

Locations

CA (1)