Mindfulness-based stress reduction for community-dwelling older adults with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) in primary care: a mixed-methods feasibility randomized control trial

It is estimated that one-third of community-dwelling older adults will experience cognitive complaints [1]. Experiences of cognitive decline vary, including for individuals with the earliest signs of memory complaint defined as subjective cognitive decline (SCD), a self-reported subtle decline in cognitive performance, without objective impairment on cognitive assessment [2]. The next stage of cognitive dysfunction [3] is mild cognitive impairment (MCI), which is defined as having an impairment in one or more of the cognitive domains relative to appropriate normative data for that individual [4]. The prevalence of MCI is between 15 and 20% in older adults aged ≥ 60 years, and the rate of MCI progressing to dementia, a more severe cognitive impairment, is between 8 to 15% per year [5].

As cognitive performance declines, older adults with SCD or MCI report inefficiency with day-to-day functioning, particularly complex instrumental activities of daily living, such as financial management and shopping [6]. Such individuals may take longer to complete complex tasks and make more errors than in the past [4, 7], while basic activities of daily living such as bathing, dressing and feeding are all intact [8]. This subtle functional decline may result in a general sense of dissatisfaction and discontentment experienced by older adults with respect to their overall functional performance [9]. Furthermore, the emotional aspect of living with SCD or receiving an MCI diagnosis can negatively impact an individual’s emotional health and well-being [10]. As such, it may raise fears of dependency on others, and activity limitation [11], which may result in depressive mood and increased anxiety [10, 12, 13].

The efficacy of pharmacological management to improve concomitant anxiety disorders and depression among older adults living with cognitive impairment is questionable [14‐18]. Researchers have found that pharmacological interventions are over-prescribed in older adults, despite the potential risk of drug-induced side effects [17], drug complications [19], and falls [20].

Clinical guidelines for the management of cognitive impairment in primary care prioritize non-pharmacological interventions, which are appropriate to patients’ cognitive and physical capabilities [21]. Therefore, identifying effective non-pharmacological interventions to mitigate psychosocial factors, such as anxiety and low mood, and supporting functional performance with those living with SCD or MCI is warranted [17, 18]. The expanding focus of interventional research in primary care is to evaluate management strategies to reduce symptoms before further irreversible dysfunction has occurred for older adults at risk of developing AD. Ideally, reducing the incidence and prevalence of AD [22] would be crucial.

Primary care teams are gaining increased attention in Canada as potentially being a significant way to help address the complexities of the changing Canadian demographics, including an aging population and an increase in chronic physical and mental health conditions. It has been noted that a holistic approach to care that addresses the well-being and mental health of older adults is imperative [14]. Primary care teams can offer this broader lens through the use of mindfulness-based stress reduction (MBSR), a 9-Week program that was first introduced in 1979 by Jon Kabat-Zinn [23]. MBSR is used to treat a variety of clinical psychiatric diagnoses (e.g. depression, anxiety, perceived stress) [24‐26] and to help cope with other clinical illnesses (e.g. HIV, diabetes, cancer) [27‐29]. MBSR is widely taught in hospitals, community centres, universities, schools and in private practice. Since its inception, MBSR has demonstrated considerable positive mental health outcomes for the general adult population [30, 31]. More recently, small proof-of-concept and pilot studies have found MBSR to be feasible with older adults with early cognitive deficits such as SCD and MCI [32‐34]. Furthermore, there is mounting evidence that mindfulness-based interventions such as MBSR can help community-dwelling older adults living with cognitive dysfunction to self-manage anxiety, depressive symptoms, as well as perceived stress in the context of SCD or MCI, which in turn may support their emotional health and well-being [35‐37].

Primary care providers on Family Health Teams (FHTs) are usually the first point of contact when older adults experience cognitive problems such as SCD or MCI [38]. There is an increasing emphasis on these interprofessional primary care teams to support and address the healthcare needs of the aging population. However, there has been limited research examining the benefits of an MBSR program with older adults living with cognitive complaints, and no studies have examined the use of MBSR in an interprofessional primary care setting with this population. Drawing on the expertise and understanding of cognitive problems and their impact on daily functioning, occupational therapists working on primary care teams are well-positioned to address the functional and psychosocial needs of community-dwelling older adults living with SCD or MCI. However, there is currently scant information on the types of health services provided by occupational therapists to older adults with SCD or MCI in primary care settings.

This study’s primary objective was to evaluate the feasibility of an occupational therapist-led MBSR program, for community-dwelling older adults living with SCD or MCI, in primary care. The secondary objective was to evaluate the acceptability of using technology (e.g., computer tablets and App Insight Timer®) as a tool for program delivery and home practice.

There were five participants in the MBSR group that met the MCI inclusion eligibility for our study. For MCI confirmation, two participants in the MBSR group met the criteria for MCI of: (i) MoCA score of ≤23; and (ii) an MCI label by their primary care physician in their EMR. Conversely, another three participants in the MBSR group had a MoCA score of ≤23 but lacked the MCI label in their EMR, in which case Petersen et al.’s MCI criteria was used to assess the participants’ cognitive complaints for MCI to meet the study’s eligibility.

Participants’ characteristics are summarized in Table 3. Control and intervention groups were similar and had no clinically relevant differences.

In this convergent mixed-methods, single-blind, pilot RCT we demonstrated that a 9-week occupational therapy-led MBSR program was feasible for practice among community-dwelling, older adult primary care patients living with SCD or MCI. However, based on the lower-than-expected rates of recruitment, retention, and adherence, our study as designed did not meet the feasibility bench marks that were set. However, with minor modifications to the design, including changing how participants who drop-out are analyzed, extending recruitment, adding multiple sites, this intervention would be well suited to further study using a full-scale RCT.

Following our research protocol, we used last observation carried forward (LOCF) method to manage drop-outs. As such, since three participants withdrew early from the study for reasons unrelated to the MBSR program, the retention rate was below our specified 75–80% benchmark because a small number of drop-outs impacted our results based on the LOCF approach used in our protocol. Excluding participants who withdrew, the study’s retention rate would have been higher. Similarly, the study had low adherence and true adherence rates but, excluding participants who withdrew early, the true adherence rate would have been moderate, compared to other mindfulness adherence studies [50]. Additionally, participants who remained in the intervention group to its entirety remained committed despite the substantial time commitment. Lastly, although our study’s feasibility outcomes were lower than expected, a high number of participants completed the entire MBSR program, and we had a high follow-up rate in an FHT. Based on our findings, it is recommended that a future trial may consider using an alternative LOCF method, as we noted that drop-outs significantly impacted our rates of retention and adherence. Second, the recruitment period (4.5 months) should be longer or the MBSR program offered at multiple primary care sites to obtain a larger sample size.

As the study proceeded, we made two changes to the original study protocol. The first change was to modify the inclusion criteria to clarify how MCI was determined. An MCI diagnosis in the EMR would meet the study’s eligibility, but in cases where there was no MCI confirmation in the EMR, but a participant’s MoCA score was ≤23, we used Petersen et al.’s (2014) MCI criteria for eligibility [4]. Second, we changed the retention rate, from completing 6 ≥ of the 9 sessions to 6 ≥ of the 10 sessions to capture the orientation session, resulting in a moderate retention rate of 64.3% (9/14), although it was below our specified 75–80% benchmark. If the orientation session was excluded as per our original study protocol, it would have been a lower retention rate of 50% (7/14 attended ≥6 of the 9 sessions). The decision to include the orientation session in our retention rate was because it was similar in structure to the other weekly sessions (provided in a three-hour group format). In contrast, other MBSR studies conducted a one-hour orientation session individually and right after the randomization process or did not provide a description of their orientation session [51, 52].

Our findings are consistent with the growing body of literature on the benefits of mindfulness-based interventions in primary care [53]. However, we only achieved 90% of our targeted 30 plus participants. To achieve our recruitment target, the recruitment period would need to be extended from 4.5 months to at least six months or to include multiple primary care sites to achieve a larger sample size and the recruitment rate.

Our study also supports other recent RCT findings that MBSR is feasible for practice and is an optimal early intervention for the SCD population [33, 54, 55]. Our analysis also demonstrated that using technology such as computer tablets for program delivery was feasible and highly acceptable to our participants living with cognitive complaints. Based on our results, embedding the use of this technology in a primary care setting such as an FHT would be viable. As the numbers of community-dwelling older adults with SCD or MCI increase in the coming years, strategies that support their functional and psychosocial needs, especially from a non-pharmacological perspective, are critical. There is currently limited information on the types of healthcare services provided to older adults with SCD or MCI in interprofessional primary care settings. For example, a national survey by Donnelly et al. (2016) has shown that 57% of occupational therapists’ caseload in primary care involves providing support to older adults. Health promotion and prevention-related activities (75%) followed by group-based interventions (14%) were the most frequently described interventions in this setting [56], and this aligns well with our study noting the benefits of such an occupational therapy-led MBSR group. A study by Mirza et al. (2020) determined that an occupational therapy group-based intervention in primary care was feasible, acceptable and highly satisfying to older adults living with chronic conditions [57] which further supports our findings. These findings are consistent with many other studies showing that an occupational therapist-led MBSR is feasible for practice among participants with MCI or mild dementia [58], as demonstrated by the qualitative data of the focus group and noting low attrition; high completion; and a 100% follow-up. Further, excluding those three participants who withdrew, the results demonstrate moderate true adherence rates along with high retention rates.

Our qualitative investigation found that MBSR program supports individuals with cognitive complaints such as SCD or MCI through a broad range of positive effects, such as mental health benefits of group process including “social support” and “feeling safe.” These findings were consistent with a mixed-methods study by Berk et al. (2018), which found similar themes in a group process among middle-aged and older adults with memory complaints while attending an MBSR program [59]. Other studies have noted a reduction in worrying about memory complaints [59] and increased memory self-efficacy following MBSR [33]. Also, our study participants gained more insights into how to manage their everyday lives. Perhaps future, more extensive trials may consider evaluating the impact of incorporating MBSR programs within this population’s everyday life participation. Consistent with the literature, there were no noted adverse events [60, 61].

Embedding MBSR in a primary care setting may effectively meet the complex and unique needs of this population by supporting and managing their health care needs, including psychosocial support. The unique feature of collaborative practice in primary care is communication between providers. With this collaborative practice, it is developing a partnership between interprofessional primary care providers and patients to negotiate and navigate their health care needs. This results in patients establishing a more personal connection with interprofessional primary care providers on the team. Feelings of trust and safety are pre-established elements that can be leveraged for adopting such a program in an interprofessional primary care setting.

Participants with SCD or MCI were open and receptive to and were capable of learning how to use computer tablets. This receptiveness was demonstrated in Wahbeh et al.’s study (2016), where they found a high recruitment rate (75%) and acceptability of an internet-based mindfulness meditation intervention for cognition and mood among older adults. However, Wahbeh’s et al. (2016) study contradicts ours slightly; they stated that it was too difficult for older adults to use iPads or iPod touch and they had to be switched over to participants’ desktop and laptop computers if they owned them. The Wahbeh et al. (2016) study is 6 years old (and the data is potentially older) which could explain the discrepancies as older adults are becoming more and more proficient with using technology. Wahbeh et al. (2016) also recommended that older adults need some basic knowledge of computers and how they work and to have their own computers to access online programs. Only 38% (3/8) of our study participants who used the tablets had minor issues accessing the App or Wi-Fi access. However, once support was provided, they independently used the tablets thereafter. Providing technological support in the initial phase of the study was crucial. The literature supports the importance of providing assistance with technology and that technology-based instructions require a high structure environment along with ensuring helpful resources are readily available [62] to ensure successful use of technology. It could be argued that participants who had Wi-Fi in their homes or who own smartphones were more receptive to and comfortable with using technology as demonstrated by eight out of 10 or 80% of participants choosing tablets. The provision of access to Wi-Fi in our study for tablet use provided valuable insight into the acceptability of technology for MBSR program delivery and data collection. However, we found that being flexible and inclusive of participants’ comfort levels by also offering a CD option for home practice is an important factor to ensure that participants fully participate in the MBSR program. Technology-based mindfulness programs are on the horizon for older adults. Choo et al. (2018) reported on the potential use of a smartphone App to deliver mindfulness interventions to older Asian adults at risk for suicide [63]. In another study, Ungar et al. (2019) used an online mindfulness program that was greatly beneficial to lonely older adults [64]. The literature exemplifies a growing use of technology to support older adults to “age-in-place.” The qualitative data from our focus group and interviews with the occupational therapists, validates embedding technology in an interprofessional primary care setting. Future studies could explore the use of technology in primary care program delivery and research.

A recent systematic review and meta-analysis of 43 interventional mindfulness studies by Parsons et al. (2017) found that average home practice was 180 minutes (SD = 43) a week (e.g., 30 minutes per day, six days a week) among participants (general adults). In our study, based on the direct measure (i.e., tablets), participants practiced for 96.4 minutes/week (SD = 61.1) at home (e.g., 16 minutes per day on average). However, based on the subjective self-report measure (i.e., home practice diary), participants practiced for 131.6 mins (SD = 68.8) a week for 13 weeks (e.g., 22 min per day, 6 days per week on average) outside of class time. This demonstrates approximately 6 minutes or about 27% inflation in subjective self-report (i.e., home practice diaries). This study is consistent with the literature reporting a discrepancy between direct versus subjective self-reported measures [65]. Nevertheless, since there only appears to be a 6-minute discrepancy, it could be argued that participants in our study were acceptable accuracy with their self-reporting. In a study by Wahbeh et al. (2016), iPad/iPod was used, but participants were not asked to report their analysis of home practice frequency and duration of practice per day for their mindfulness-based internet intervention. Thus, to the author’s knowledge, this is the first study to describe the use of direct measures using tablets to collect formal home practice versus subjective self-report measures (i.e., home practice dairy) in an MBSR program. Secondly, to our knowledge, there is no home practice data in the literature of older adults living with cognitive complaints for comparison at present.

Direct measure (i.e., tablet) does come with limitations and consideration of using subjective self-reporting may be worthwhile to include in the overall evaluation of home practice data. The adherence rate of completing formal home meditation practice on tablets was 40% (4/10), as opposed to the higher true adherence rate which was 50% that also captured informal homework practices or behavioural change. Informal practices such as deliberately adopting attention to everyday activities and noticing the experience (e.g., walking, eating, washing dishes, etc.) are important. The lower adherence rate was accounted for by situations when participants could not capture home practice data. For example, one participant did not have Wi-Fi access when she was at her cottage, while other participants travelled during the summer months without their tablets for fear of damaging or losing them. Self-reported home practice dairy sheets were, therefore, necessary to determine the true adherence rate. The true adherence rate is essential since attending weekly MBSR sessions alone is insufficient. Excluding participants that withdrew, the higher true adherence rate positively reflects participants’ high level of engagement and adherence to the MBSR program, and it also validates their overall practice quality [66]. Parsons et al. (2017) reported that participants’ level of engagement with home practice is essential, and there was a statistically significant association between participants’ home practice and the impact on health outcomes [67].

Some minor barriers in this tablet-based practice included lack of reliable or general Wi-Fi access, which was similarly noted by Schepens et al. (2018), where unreliable Wi-Fi made it difficult at times in carrying out the intervention [68]. Only two participants in the intervention group did not have home Wi-Fi and needed CDs for their home practice. However, one participant with Wi-Fi access preferred using CDs rather than tablet for formal home practice. Those participants who used tablets required help during the first few sessions, but thereafter, all could conduct their home practices independently. Research on technology acceptance by community-dwelling older adults has emerged. Our study showed that older adults living with SCD or MCI are highly receptive to learning how to use technology, and future group intervention programs in interprofessional primary care settings may also incorporate tablet use.

Based on our lower than expected rates of recruitment, retention, and adherence we found that our study did not meet the feasibility benchmarks as proposed in the current research design. However, this study highlighted that MBSR is feasible for practice, in an older adult population with early cognitive impairment in an interprofessional primary care setting. A future RCT is recommended with changes to the design to account for the findings of this study. A future trial may consider using an alternative LOCF method, we noted that drop-outs significantly impacted our rates of retention and adherence. Second, the recruitment period should extend beyond 4.5 months or the program offered at multiple primary care sites to achieve a larger sample size and the desired recruitment rate.

Our participants reported on their satisfaction and perceived benefits from the qualitative data and there is much promise for this intervention as it is well aligned with the philosophies of primary care and team-based models. The study’s findings uphold the acceptability and portability of technology and illustrate those persons with SCD or MCI are receptive to learning and using computer tablets. Thus, future group MBSR programs in primary care may adopt technology use with this population. This study adds to the sparse literature on types of health care delivery in an interprofessional primary care setting and the vital contribution of occupational therapy to better support individuals with complex health conditions compared with physician care alone. This study will inform future research for evidence-based, occupational therapy-focused interventions on how best to deliver care to older adults with cognitive complaints such as SCD or MCI in an interprofessional primary care setting.