Examining the Effect of an 8-Week Mindfulness Training Program on Caregiver Burden and Occupational Balance, and on Functional Capacity in People with Alzheimer’s Disease: A Randomized Controlled Trial
Auteurs:
Daniel Prieto-Botella, Paula Peral-Gómez, Daniel Mendialdua-Canales, Paula Fernández-Pires, Gemma Benavides-Gil, Verónica Company-Devesa, Fermín Martínez-Zaragoza, José-Ángel Pastor-Zaplana, Carmen Lillo-Navarro, Cristina Espinosa-Sempere, Philippe Goldin, Alicia Sánchez-Pérez
The purpose of the present study was to examine the effect of an 8-week Mindfulness-Based Health Care (MBHC) Program on informal caregiver (CG) burden and occupational balance, as well as on the functional capacity of people with Alzheimer’s disease cared for.
Method
In this randomized controlled trial, 66 CGs were allocated to an MBHC (n = 33) and a treatment as usual (n = 33) group. Data collection included the Zarit Burden Interview, the Occupational Balance Questionnaire, and the Disability Assessment for Dementia. CGs were evaluated at baseline, post-intervention, and 3-month follow-up. A total of 50 (75.6%) and 30 (45.5%) CGs completed the post-intervention and the 3-month follow-up assessments, respectively. Linear regression and generalized linear mixed models were performed to explore the intervention effects.
Results
In comparison to treatment as usual, the MBHC intervention was associated with a significant decrease in CG burden post-intervention (β = − 7.04; 95% CI: − 13.19, − 0.88; p = 0.026). Furthermore, MBHC intervention was associated with a significant increase in CGs’ occupational balance right after intervention (β = 6.54; 95% CI: 1.85, 11.22; p = 0.007). However, these positive effects were not statistically significant at the 3-month follow-up. Finally, the functional capacity of the people with Alzheimer’s disease showed non-relevant changes or differences between groups.
Conclusions
This randomized controlled trial showed that an MBHC could have a positive impact in reducing CG burden and improving their occupational balance. These results highlight the viability of implementing an MBHC as a cost-effective, community-based care intervention aimed at improving mental well-being in CGs of individuals with Alzheimer’s disease.
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Globally, 55 million people are currently affected by Alzheimer’s disease (AD), accounting for approximately 60–70% of dementia cases worldwide (World Health Organization, 2023). In fact, due to the increment of the aging population, the number of people impacted by this condition is estimated to increase to 139 million by 2050, revealing a potential public health problem (World Health Organization, 2020, 2022). This concern can be underscored by observing the clinical manifestations of AD. AD is characterized by psychological and behavioral alterations, in addition to a gradual decline in cognitive abilities (Arvanitakis et al., 2019; Chen et al., 2021). These changes result in a severe and progressive decline in the individual’s ability to perform activities of daily living, leading to heightened dependence (Altieri et al., 2021; Becker et al., 2021). Consequently, a substantial portion of those people diagnosed with AD heavily rely on the assistance of either formal (professional caregivers) or, more commonly, informal (relatives) caregivers (Vu et al., 2022).
Informal caregivers (CGs) play an important role in the care, treatment, and rehabilitation of people with AD, absorbing up to 70% of the total hours of care occupations (Wimo et al., 2018). However, due to the progressive dependency led by AD and its associated behavioral and psychological symptoms, CGs are exposed to a high physical and mental burden (del-Pino-Casado et al., 2018, 2019). For instance, in comparison to the general population, CGs of people with dementia are more prone to developing anxiety, depression, and burden. Additionally, CGs usually face most care costs, which can lead to financial stress, exacerbating their mental burden (del-Pino-Casado et al., 2018, 2019).
Other areas that tend to be especially altered in the CGs are related to their occupational functioning since important changes are generated in their roles, habits, and daily routines due to the demands involved in caring for their family member with AD (Fujihara et al., 2019; Gómez-Trinidad et al., 2021). If occupational balance is understood as the individual’s perception of having an adequate quantity and variety of occupations in daily life, the experience of an adequate balance between meaningful activities, or the satisfaction with occupations in different areas, studies show that CGs of people with AD often experience a significant occupational imbalance (del-Pino-Casado et al., 2018, 2019; Röschel et al., 2021, 2022; Wagman et al., 2012). Caring for a loved one with AD implies a great responsibility for the CGs, and, as dementia progresses, the CGs experience an occupational transition, in the sense that they leave previous meaningful occupations behind (family, job, career, leisure time, friends, sports, rest, etc.) and put their role as caregivers first (Groezinger et al., 2023; Persson & Zingmark, 2006; Yong et al., 2020).
Given the importance of mental health in CGs as they perform their caregiving roles, several psychosocial interventions have gained attention in recent years (Wiegelmann et al., 2021). Among these, mindfulness-based interventions (MBIs) have emerged as a promising approach for training skills to alleviate CGs’ burden and strengthen their mental well-being (Han, 2022).
While there are several definitions of mindfulness, it can be defined as the capacity to focus on the present moment with interest, curiosity, and acceptance (Levit-Binnun et al., 2021). Mindfulness practices involve cultivating an attentive presence without reactivity or judgment to the experience, improving pro-social mental habits, and helping to deconstruct perceptual, cognitive, and emotional biases (Levit-Binnun et al., 2021). These practices and attitude changes have the potential to help CGs process stress more effectively and reduce the perceived burden of their caregiving responsibilities (Collins & Kishita, 2019). In fact, recent systematic reviews and meta-analyses examining MBIs in CGs of people with dementia showed medium to large effects on reducing symptoms of depression, anxiety, and stress, while also improving their quality of life after MBIs (Cheng et al., 2020; Collins & Kishita, 2019; Han, 2022). In addition, these effects tend to diminish in follow-up assessments probably due to the cessation of meditation practices (Cheng et al., 2020). However, there are few longitudinal studies of MBIs in CGs. Nevertheless, considering the potential health benefits of MBIs in this critical population, there is a clear justification for the development of prospective studies to better understand these effects (Han, 2022).
Furthermore, although there is empirical evidence of the benefits of MBIs in reducing the mental burden of CGs, no study has evaluated the effects of MBIs on the occupational balance of CGs of people with AD. For these reasons, the main objective of this study was to explore the effect of an 8-week Mindfulness-Based Health Care (MBHC) Program on burden and occupational balance of CGs of people with AD compared to treatment as usual (TAU). We also examined whether the MBHC effects on CGs influenced the functional status of individuals with AD for whom they cared.
Method
Participants
This study analyzed secondary data from the ATENEA (Mindfulness in Alzheimer’s Disease) randomized controlled trial (Sánchez-Pérez et al., 2022), conducted to explore the potential benefits of a MBI on CGs of people with AD. The ATENEA project was registered on ClinicalTrials.gov (NCT03858283), conducted under the Helsinki Declaration guidelines, and received approval from the ethics committees of Miguel Hernández University (2017.413.E.OEP; 2017.470.E.OEP), University Hospital of San Juan de Alicante (18/317), and University General Hospital of Elche (44/2019). Further information regarding the ATENEA study protocol can be found elsewhere (Sánchez-Pérez et al., 2022).
The participants in this study were adults diagnosed with mild cognitive impairment caused by AD or dementia due to probable AD according to the National Institute on Aging and Alzheimer’s Association criteria (McKhann et al., 2011). Before data collection, participants provided their written informed consent employing a document approved by the institutional review board. If the person with AD was legally incapacitated, the legal guardian signed on his/her behalf. CGs’ inclusion criteria included (i) being the primary informal family caregiver for an individual diagnosed with AD and (ii) a Mini-Mental State Examination score greater than 25 confirming normal cognition. Both CGs and the people with AD were excluded if presented (i) medical record of neurological disease (e.g., stroke, epilepsy, meningitis); (ii) alcohol or drug abuse, excluding tobacco, during the 24 months before the start of the study; (iii) systemic disease associated with cognitive impairment (e.g., hypothyroidism, liver, or kidney failure); (iv) severe psychiatric illness (e.g., major depression, schizophrenia); and/or (v) perceptual disorders regarding the visual and/or auditory systems that could limit the MBI. In addition, people with AD under medication were considered for inclusion if the dose was stable for a minimum of 3 months before being included in the study. No compensation was provided for the participants.
Participants were recruited from February 2019 to March 2020. A total of 142 CGs were contacted, of which 66 signed the informed consent and were randomized to the intervention (n = 33) and control (n = 33) groups (Fig. 1). The 75.8% of the CGs (n = 50) were assessed at Time 2 (post-intervention) and accounted for the base population in this study. During the year 2020, this study had to be halted because of the COVID-19 pandemic. Consequently, 7 CGs from the intervention group and 13 from the control group did not complete the assessment at Time 3 (3-month follow-up). As a result, a total of 30 (45.5%) CGs were completely assessed at this final, third time point.
Fig. 1
Participant selection flow diagram in the ATENEA project following the CONSORT guidelines for randomized clinical trials. Abbreviations: AD, Alzheimer’s disease; CGs, caregivers; MBHC, Mindfulness-Based Health Care; TAU, treatment as usual
×
Procedure
Participants were directly recruited from several Spanish hospitals, including the Behavioral Neurology and Dementia Unit of the Hospital San Vicente del Raspeig, the University General Hospital of Alicante, and the Neurology Service of the University Clinical Hospital of San Juan. Additionally, participants from the Elche, Muchamiel, Santa Pola, and San Juan health centers and four local associations regarding relatives of people with AD were also recruited. All these centers were located in the province of Alicante (Spain).
Firstly, CGs interested in being enrolled in the project were initially contacted by telephone. If they met eligibility criteria, their relative with AD was screened. Conversely, if the individual with AD did not meet the eligibility criteria, the study proceeded only with the CG enrollment. Subsequently, the potential participants were interviewed face-to-face by an occupational therapist, and they were provided with verbal and written information regarding the project. Those who accepted to participate, whether both the individual and CGs or just the CGs, signed the informed consent and were assessed before randomization to obtain the baseline measurements.
After completing baseline evaluations, CGs were randomized (1:1) to the MBHC or TAU groups using a random number sequence generated using the randomize R package (Uschner et al., 2018). Team members involved in assessments and implementation of the MBHC program were masked to group assignment, mitigating potential selection bias. One week before the start of the intervention program, the participants were informed by telephone of their assigned group. Participants completed assessments again at post-intervention and at a 3-month follow-up.
Treatment Conditions
Mindfulness Intervention
The MBHC intervention program was based on the Mindfulness-Based Stress Reduction program or MBSR (Kabat-Zinn, 2005). The MBHC program included (i) practices aimed to cultivate awareness of the somatic and sensory experiences of the present moment, promoting a non-reactive and non-judgmental attitude towards these experiences; (ii) home-based exercises; and (iii) participation in one-weekly session over 8 weeks. MBHC weekly sessions were shorter in comparison to MBSR, 2 hr instead of 2.5–3 hr. Additionally, the MBHC included practices focused on cultivating healthy mental and prosocial habits and behaviors such as kindness and compassion. To improve participants’ adherence to MBHC and to limit their burden, the 1-day silent retreat conducted in the MBSR was eliminated based on previous studies within the same population (Kor et al., 2019).
In addition to the MBSR changes and adaptations, several recommendations from previous studies (Brown et al., 2016; Leach et al., 2015; Oken et al., 2010; Waelde et al., 2017; Whitebird et al., 2013) were included in the MBHC program. Specifically, (i) MBHC groups included 8 to 15 participants and (ii) participants were provided with printed materials about each session and a WhatsApp link containing recordings with guided meditations for home-based practice. Furthermore, to mitigate the risk of dropouts during the intervention program, participants were offered a free-of-charge care service if they attended the intervention with a family member such as a child or their relative with AD.
The MBHC program structure and its session content have been published elsewhere (Sánchez-Pérez et al., 2022). Each MBHC session included mindful movement, formal and informal meditation techniques, and sharing personal experiences and reflections, as well as explanations of the home-based exercises. The sessions were developed to facilitate communication with the participants and to create a supportive learning environment. Thus, non-violent communication practices and person-centered group dynamics were employed in all sessions (Rogers, 2018; Rosenberg, 2016). To ensure program consistency, the different sessions were conducted by the same facilitator who developed the program and has 12 years of expertise in mindfulness instruction. Finally, to assess the program implementation and fidelity, an external observer familiar with the MBHC program recorded participants’ attendance and employed a checklist to evaluate adherence to the intervention protocol.
Treatment as usual
The TAU group included six monthly visits to the neurologist, provision of psychoeducational information, and consultations with their reference social worker. In adherence to ethical standards, the control group was invited to participate in an online MBHC intervention program for free after the end of the project.
Measures
Sociodemographic Information
During the baseline assessment, several sociodemographic variables regarding caregivers were collected including age, gender, educational level, marital status, employment status, if the caregiver lived with the family member with AD, months of caring, if the caregiver received help with household chores/with the care for the relative, and if they had to abandon their job due to the caregiver status. Additionally, the age, gender, academic level, marital status, and the Global Deterioration Scale (Reisberg et al., 1982) of the individuals with AD were also recorded.
Caregiver Burden
Caregiver burden was measured using the validated Spanish version of the Zarit Burden Interview (Martín-Carrasco, 1996; Martin-Carrasco et al., 2010). This consists of 22 items that offer a measure of the caregiving burden, encompassing aspects such as consequences of caregiving, the patient’s level of dependence, the feeling of exhaustion and uncertainty, guilt or self-criticism, embarrassment/anger, or frustration, psychological burden and emotional reactivity, personal strain, and role strain (Zarit et al., 1980). These items can be rated on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always) where higher scores indicate greater burden (maximum score = 88 points, Cronbach’s alpha = 0.92).
Caregiver Occupational Balance
The validated Spanish version of The Occupational Balance Questionnaire (OBQ-E) was employed to assess the caregivers’ occupational balance (Peral-Gómez et al., 2022). It is an instrument developed to evaluate an individual’s occupational performance according to their satisfaction with both the amount and variation in occupation (Wagman & Håkansson, 2014). This questionnaire consists of 13 items rated on a scale from 0 (completely disagree) to 5 (completely agree). A total score ranging from 0 to 65 can be obtained by summing the scores of these items (Cronbach’s alpha = 0.87). Higher scores imply better occupational balance.
Functional Capacity of Participants with AD
The functional capacity of participants with AD was assessed using the validated Spanish version of the Disability Assessment for Dementia (DAD-E) (Sánchez-Pérez et al., 2015). This assessment tool was designed to measure functional disability in people with dementia through the evaluation of their activities of daily living (Gélinas et al., 1999). Specifically, it comprises 40 items covering basic activities of daily living (hygiene, dressing, continence, and eating), instrumental activities of daily living (meal preparation, telephone use, going out, managing finances and correspondence, medication management, and household activities), and leisure activities (Cronbach’s alpha = 0.96). The tool assesses the abovementioned activities of daily living to determine if the person shows initiative in carrying out the task, her/his ability to plan or organize it, and if he/she can execute it. The total score ranges from 0 to 40. This score was transformed to percentage terms where higher percentage scores indicate greater competence in performing activities of daily living.
Data Analyses
The statistical analysis was conducted using the R software version 4.2.2. (R Foundation for Statistical Computing, Vienna, Austria; http://www.R-project.org). All the tests were bilateral, and the significance level was set at 0.05. The normality of quantitative variables was explored by applying the Lilliefors-corrected Kolmogorov–Smirnov test.
Initially, Little’s test from the “naniar” R package was employed to verify that data was missing completely at random (MCAR) (Little, 1988). Given that the data met the MCAR assumption, thereby avoiding a selection bias, a per-protocol analysis was performed.
Firstly, the participants’ sociodemographic characteristics by group (TAU versus MBHC) were described using frequency and percentages for qualitative variables. For quantitative variables, mean and standard deviation, or median and interquartile range were employed, depending on the normality of the data distribution. In addition, the sociodemographic differences within groups were explored using the chi-square test or Fisher’s exact test for qualitative data and Student’s t-test or Mann–Whitney U-test for quantitative variables. The characteristics of the people with AD were also examined by groups as abovementioned.
Secondly, the differences in the CGs’ burden, occupational balance, and functional capacity of people with AD between TAU and MBHC groups were explored. Student’s t-test or Mann–Whitney U-test were used to assess these differences at baseline, post-intervention, and follow-up. When comparing baseline vs post-intervention and baseline vs follow-up differences, the Mann–Whitney U-test was employed. Additionally, Cliff’s delta was utilized as an indicator of the magnitude of the effect of the variable changes.
Finally, the differential effect of the TAU vs MBHC on CGs’ burden, occupational balance, and functional capacity of people with AD were examined using multiple linear regression (baseline vs post-intervention) and generalized linear mixed models with random effects (baseline vs post-intervention vs follow-up). The linear regression models were employed to evaluate confounding. Covariates that showed p < 0.20 in the bivariate analysis TAU vs MBHC were incorporated to form the core models (Mickey & Greenland, 1989). In addition, variables that changed the magnitude of the main effects by more than 15% in a backwards-forward elimination procedure were also included (Mickey & Greenland, 1989), even if they were not statistically significant in the initial bivariate analysis.
COVID-19 Pandemic Trial Interruption
On 14 March 2020, the government of Spain started a lockdown in response to the COVID-19 pandemic, resulting in the suspension of the MBHC intervention. Even though movement restrictions gradually softened in the following months, residential centers for people with AD continued to limit the presence of external CGs and even relatives because of the vulnerability of this population. Consequently, the recruitment of new participants and the 3-month follow-up of the third MBHC group was suspended in March 2019. Missing the final evaluation for the third group and the inability to recruit new participants implicates a reduction of the study’s power, as the protocol calculations aimed for 145 participants (Sánchez-Pérez et al., 2022). Nevertheless, before the trial’s suspension, a total of 50 participants had completed the intervention and the post-intervention assessments.
Results
Population Characteristics
The sociodemographic and clinical characteristics of the study participants by group (TAU vs MBHC) are shown in Table 1. The vast majority of CGs were women (82%) and the mean age was 59 (SD = 12) years. A total of 17 (34%) CGs were currently employed. When comparing the TAU and MBHC CGs, the bivariate analysis did not reveal significant differences. Particularly, CGs in the MBHC group had a higher median duration of caring for their relatives with AD (p = 0.055). Regarding people with AD, a total of 27 were women and the mean age was 80 (SD = 8) years. In addition, most of these people presented a deterioration score between 5 and 6 (n = 37). No differences between groups were observed when comparing the people with AD.
Table 1
Sociodemographic and clinical characteristics of participants (n = 50)
MBHC group (n = 23)
TAU group (n = 27)
p-value
Caregivers (n = 50)
Age, mean (SD), years
61.1 (12.1)
57.4 (12.2)
0.286a
Gender, n (%)
Female
18 (78.3)
23 (85.2)
0.715b
Education level, n (%)
Primary
5 (21.8)
5 (18.6)
0.960c
Secondary
9 (39.1)
11 (40.7)
Higher education
9 (39.1)
11 (40.7)
Marital status, n (%)
Married/living with partner
17 (73.9)
18 (66.7)
0.758b
Employment status, n (%)
Active
9 (39.1)
8 (29.6)
0.304c
Living with family member with AD, n (%)
Yes
12 (52.2)
17 (63.0)
0.567b
Months of caring, median (IQR)
48 (21, 82)
24 (12, 60)
0.055d
Receive help with household chores, n (%)
Yes
16 (69.6)
15 (55.6)
0.387b
Receive help with the care for the relative, n (%)
Yes
18 (78.3)
20 (74.1)
1.000b
Job abandonment, n (%)e
No
17 (89.5)
17 (70.8)
0.257b
People with AD (n = 50)
Age, mean (SD), yearsf
79.6 (8.0)
78.3 (8.0)
0.559a
Gender, n (%)g
Female
13 (72.2)
14 (63.6)
0.737b
Academic level, n (%)g
Uneducated
7 (38.9)
8 (36.4)
0.834c
Primary
6 (33.3)
6 (27.3)
Secondary or higher education
5 (27.8)
8 (36.4)
Marital status, n (%)g
Married/living with partner
9 (52.9)
12 (54.5)
1.000b
GDS, n (%)h
3–4
7 (30.4)
5 (19.2)
0.508b
5–6
16 (69.6)
21 (80.8)
SD, standard deviation; IQR, interquartile range; AD, Alzheimer’s disease; GDS, Global Deterioration Scale; ap-value obtained from student's t; bp-value obtained from Fisher’s exact test; cp-value obtained from the chi-square test; dp-value obtained from Mann–Whitney U. en = 43. fn = 46. gn = 40. hn = 49
MBHC Effect on CGs’ Burden and Occupational Balance, and on Functional Capacity of People with AD
The TAU and MBHC measurements at baseline, post-intervention and 3-month follow-up, and baseline vs post-intervention and baseline vs follow-up changes are shown in Table 2.
Table 2
Caregivers’ burden, occupational balance, and functional capacity of people with AD in the Mindfulness-Based Health Care Program and treatment as usual groups (n = 50)
Baseline
Post-intervention
Follow-up (3 months)a
Baseline vs post-intervention
Baseline vs follow-upa
Mean (SD)
p
Median (IQR)
p
Median (IQR)
p
Median (IQR)
Interaction p, δ
Median (IQR)
Interaction p, δ
ZBI total
TAU
32.3 (13.0)
0.731
34.0 (21.5, 46.0)
0.093
37.5 (13.3, 43.8)
0.169
2.0 (− 3.5, 5.5)
0.004, 0.47
0.0 (− 6.8, 13.5)
0.045, 0.43
MBHC
33.8 (17.5)
26.0 (16.0, 34.5)
18.0 (13.5, 27.8)
− 7.0 (− 16.0, − 2.0)
− 9.0 (− 14.5, − 3.5)
OBQ-E total
TAU
36.2 (11.6)
0.288
34.0 (26.5, 45.0)
0.005
40.5 (26.8, 52.3)
0.394
1.0 (− 4.5, 5.0)
0.138, − 0.25
1.5 (− 1.5, 4.0)
0.883, 0.03
MBHC
40.0 (13.3)
48.0 (42.0, 54.5)
44.5 (39.8, 55.3)
2.0 (− 1.0, 11.5)
− 0.5 (− 5.0, 14.0)
DAD-E total %
TAU
35.7 (27.5)
0.211
27.0 (7.5, 46.7)
0.141
25.3 (11.9, 38.1)
0.560
− 2.5 (− 15.0, 5.0)
0.279; − 0.18
3.4 (− 8.1, 7.7)
0.454, 0.17
MBHC
46.6 (33.4)
48.7 (15.0, 78.2)
30.5 (9.6, 72.9)
0.0 (− 4.9, 5.7)
− 0.1 (− 13.1, 3.0)
ZBI, Spanish version of the Zarit Burden Interview; OBQ-E, Spanish version of the Occupational Balance Scale; DAD-E, Spanish version of the Disability Assessment for Dementia; TAU, treatment as usual group; MBHC, Mindfulness-Based Health Care course group; SD, standard deviation; IQR, interquartile range; p, p-value obtained from student's t or U of Mann–Whitney when comparing TAU vs MBHC; δ, effect size assessed with Cliff’s delta. an = 30
In comparison to TAU, the MBHC group showed a median burden (ZBI) points decrease of − 7 (IQR = − 16.0, − 2.0; p = 0.004; Cliff’s δ = 0.47, small effect size) immediately after intervention. Additionally, a median reduction of − 9 (IQR = − 14.5, − 3.5; Cliff’s δ = 0.43, small effect size) ZBI points was observed at the 3 months after MBHC completion (baseline vs follow-up), and this reduction was significantly greater compared to TAU (p = 0.045). When observing the effect of MBHC on CGs’ burden (Table 3), MBHC intervention was associated with a post-intervention CGs’ burden reduction (β = − 7.04; 95% CI: − 13.19, − 0.88; p = 0.026). However, this decrease was not statistically significant at the 3-month follow-up.
Table 3
Differential effect of the Mindfulness-Based Health Care Program vs treatment as usual on caregivers’ burden and occupational balance, and functional capacity of people with AD immediately post-intervention and at 3-month follow-up (n = 50)
ZBI, Spanish version of the Zarit Burden Interview; OBQ-E, Spanish version of the Occupational Balance Scale; DAD-E, Spanish version of the Disability Assessment for Dementia; CI, confidence interval; TAU, treatment as usual group; MBHC, Mindfulness-Based Health Care course group; Ref, reference group. Model 1, linear regression model. Models 2–3, mixed model with random effects. aModel 1 adjusted for months of caring, Model 2 adjusted for Model 1 + caregivers’ employment status, Model 3 adjusted for Model 2 + caregivers’ gender. bModels 1 and 2 adjusted for if the caregiver receives help with household chores, Model 3 adjusted for Model 2 + caregivers’ gender. cModel 1 adjusted for caregivers’ age, Model 2 adjusted for Model 1 + caregivers’ employment status, Model 3 adjusted for Model 2 + caregivers’ gender
Regarding CGs’ occupational balance and functional capacity of people with AD, no significant differences were observed in these measurements at baseline vs post-intervention or baseline vs follow-up between groups (Table 2). However, the MBHC group showed a higher median occupational balance (median = 44.5, IQR = 39.8, 55.3) versus TAU immediately post-intervention (p = 0.005). In addition, MBHC intervention was statistically associated with an increment of the CGs’ occupational balance right after intervention (β = 6.54; 95% CI: 1.85, 11.22; p = 0.007). This positive effect did not remain significant at follow-up (Table 3). Finally, a positive effect of MBHC on the functional capacity of people with AD was observed, but it did not reach statistical significance at either baseline vs post-intervention or 3-month follow-up.
Discussion
In this randomized controlled trial, we examined the differential effect of a MBHC program versus TAU on CGs’ burden and occupational balance, and on the functional capacity of the people with AD who were cared for. In comparison to TAU, CGs in the MBHC group showed a burden reduction and an increase in occupational balance at post-intervention. However, these effects were not statistically significant at the 3-month follow-up. The functional capacity of the people with AD showed inconsistent and non-relevant changes.
In contrast to our findings, a recent meta-analysis conducted by Saragih et al. evaluating MBIs in CGs of people with dementia found no significant effect on CGs’ burden right after the interventions (Saragih et al., 2024). However, this result should be interpreted with caution, as the authors stated limitations including small number of analyzed studies (n = 4) and study heterogeneity. Particularly, only two of these studies implemented an 8-week MBI program, and two had randomized sample sizes of < 40 participants (Saragih et al., 2024). In addition, the two studies which implemented an 8-week MBI employed a social support program as the control group (Brown et al., 2016; Whitebird et al., 2013). These programs highlighted aspects such as self-care and emotional support that could have similar beneficial effects on the CGs’ burden (Brown et al., 2016).
In our study, we observed a post-intervention burden reduction. In line with the mindfulness theory, we suggest that MBIs may help CGs manage negative emotions, reducing the impact of negative feedback systems, and facilitating proactive psychological adaptation during caregiving activities (Schultz & Ryan, 2015). Nevertheless, it should be noted that although a beneficial effect on CGs’ burden was still present in the within-group regression analysis at the 3-month follow-up, however, this effect was not significantly different from the TAU group. This could potentially be explained by the reduced sample size analyzed during the follow-up period, resulting in a loss of statistical power.
Regarding occupational balance, we found a significant increase post-intervention. To our knowledge, this is the first study examining the effect of a MBI on the occupational balance of CGs of people with AD. Although there is little information about occupational balance in CGs, there is evidence indicating that CGs consider occupational balance important (Röschel et al., 2022). The findings from our study suggest that MBIs may reduce CGs’ stress and burden, leading to the resumption of leisure and self-care activities, and subsequent increase in their occupational balance (del-Pino-Casado et al., 2018; Han, 2022; Wagman & Håkansson, 2019). Another possible explanation is that MBIs facilitate CGs to positively reevaluate and accept their experience, including new leisure activities to perform with their loved ones with AD and find meaning in the opportunity to spend time together (Groezinger et al., 2023; Hooper & Collins, 2019; Spigelmyer et al., 2023), leading all of this to improve the perception of their occupational balance. Unfortunately, we observed that the implemented MBHC program effect on the CGs’ occupational balance was not statistically significant at the 3-month follow-up. Similar to burden, this could be explained by the loss of statistical power. However, the cessation of meditation due to the end of the program could have led to a decrease in the long-term MBHC potential benefits (Birtwell et al., 2019; Li & Leshed, 2022) in both CGs’ occupational balance and burden. As maintained by Cheng et al. (2020), the multiple demands and tasks faced by CGs, and the progressive care dependency caused by AD, can lead to a decrease in meditation practices by CGs.
Finally, we also explored the potential effect of an MBI for CGs on the functional status of the individuals they cared for. While there is some evidence suggesting a possible positive impact, probably due to stress and burden reduction experienced by CGs, such research is scarce and conducted in different caregiving contexts such as intellectual disabilities (Singh et al., 2023). Our findings, however, did not reveal statistically significant changes in functionality when comparing median values or when conducting mixed models. In contrast with the abovementioned research, these results could be attributed to the progressive neurodegenerative nature of AD which could potentially reduce the intervention benefits soon after they manifest (Berk et al., 2018).
Limitations and Future Research
This study presents several limitations. Firstly, the COVID-19 situation caused a notable reduction in the sample size in comparison with the original estimation (Sánchez-Pérez et al., 2022). In this context, we consider that a future online or hybrid MBI study could be more feasible to recruit larger sample sizes (Kor et al., 2021). Nevertheless, even with a reduced sample size, we observed statistically significant results regarding CGs’ burden and their occupational balance post-intervention.
Secondly, after completing the 8 weeks of intervention, the CGs’ meditation practices were not monitored. To facilitate regular meditation practice at post-intervention, in future research, it would be important to implement maintenance practice groups, provide online monitoring and support, and include informal meditation in caregiving and daily living activities. Carrying out comparative studies between groups of CGs who continue and do not continue meditating after completing the MBI may be key to demonstrating the importance of turning meditation into a habit and ensuring its long-term benefits in this population. Additionally, this study did not include a specific measure of mindfulness and future studies would benefit from incorporating mindfulness-specific measures to better understand the relationship between outcome changes.
Thirdly, the functional status of the individuals with AD was reported by their CGs, leading to a possible non-differential variation. The additional use of other instruments that evaluate basic and instrumental activities of daily living in this population, as well as other sources of information (not only CGs), could provide more accurate data on the indirect influence of MBIs on people with AD. Furthermore, we conducted multiple statistical models adjusted for potential confounding factors. However, the possibility of residual confounding or bias due to missing information cannot be ruled out.
Finally, although our study indicates that mindfulness may enhance occupational balance for caregivers (e.g., by helping them navigate their changing roles and remain present and attuned to their own needs amidst the demands of caregiving), the specific mechanisms by which this occurs remain unclear. More research is needed to explore how mindfulness influences caregivers’ occupational functioning and their satisfaction with daily activities. In addition, taking into account the multi-dimensional nature of the CGs’ burden (Zarit et al., 1980), a future mixed methodology trial conducting qualitative interviews and focus groups might add an essential value to these studies. Among the strengths of the present study, it is important to highlight its randomized controlled trial design, conducted by a highly qualified multidisciplinary team.
In conclusion, this randomized controlled trial conducted in CGs of people with AD showed that a MBI could have a positive impact in reducing CGs’ burden and improving their occupational balance. These benefits were observed post-intervention, but their maintenance at 3-month follow-up was not statistically significant probably due to the reduced sample size and the possible cessation of meditation. In addition, the functional capacity of the people with AD showed no relevant changes. However, these results highlight the feasibility of a MBI as a low-cost community-based care program to improve mental health in a burden-susceptible population as CGs of individuals with AD.
Acknowledgements
The authors would like to thank all caregivers and their family members who participated in this study. Additionally, we would like to express our gratitude to all the entities involved in recruiting the sample for this study.
Declarations
Ethical Statement
This study was approved by the ethical committees of the Miguel Hernández University (2017.413.E.OEP; 2017.470.E.OEP), the University Hospital of San Juan de Alicante (18/317), and the University General Hospital of Elche (44/2019).
Informed Consent
All participants provided written informed consent before participation in this study.
Conflict of Interest
The authors declare no competing interests.
Use of Artificial Intelligence
The authors declare that they did not employ any AI tools in the present study, except for minor language refinement.
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Auteurs
Daniel Prieto-Botella Paula Peral-Gómez Daniel Mendialdua-Canales Paula Fernández-Pires Gemma Benavides-Gil Verónica Company-Devesa Fermín Martínez-Zaragoza José-Ángel Pastor-Zaplana Carmen Lillo-Navarro Cristina Espinosa-Sempere Philippe Goldin Alicia Sánchez-Pérez
