Abstract
Background:
Many studies have highlighted the effect of training with mindfulness-based interventions (MBIs) on the psycho-physical rebalancing of patients suffering from various pathologies, and their families.
Objective:
In this study, the effect of a training with mindfulness-based stress reduction (MBSR) on quality of life and emotion regulation (depression) was verified in caregivers (CGs) of patients affected by Alzheimer’s disease at early stage (AD-P).
Methods:
In this randomized controlled study, 22 CGs (age≥60 years) were treated with MBIs, in particular MBSR, and 22 CGs had no treatment. Tests (T0-T1 six months) included: SF 36-Quality of Life (QoL); Caregiver Burden Inventory (CBI); FACIT-Spiritual-Well-Being; Beck Depression Inventory (BDI); Everyday Cognition scales; and Mini-Mental State Examination (for AD-P).
Results:
Significant differences emerged between T0 and T1 for CGs with MBSR in the following dimensions: Depression-BDI (p > 0.001), Burden CBI-Total (0.001), CBI-Time dependent burden (p < 0.001), CBI-Developmental burden (p < 0.001), CBI-Physical burden (p < 0.001); and pain (p = 0.002) all decreased; while CBI-Social burden (p = 0.004), QoL-Health Role Limitation (p < 0.000), QoL-Role-Limitation-Emotional-Problem (p < 0.000), QoL-Energy-fatigue (p < 0.000), QoL-Emotional Well-Being (p < 0.001), QoL-Social Well Being (p = 0.010), and QoL-General Health (p = 0.004) increased. The control group of untreated CG showed a significant worsening in the dimensions of Physical functioning (p = 0.036) and pain (p = 0.047).
Conclusions:
AD-CGs treated with MBI reduced their burden and depression and experienced an improvement in all the dimensions of quality of life.
INTRODUCTION
Elderly people, more and more numerous, particularly in Italy, are often affected by one or more age-related diseases with a marked increase in degenerative brain diseases.
The consequence is that there is an increasing demand for assistance, which in Italy is mainly carried out by family members, with consequences on their psycho-physical balance.
This suggests the need to plan appropriate interventions to preserve their health, well-being, and quality of life (QoL) [1, 2]. This is of particular importance for caregivers (CGs) of patients affected by Alzheimer’s disease (AD-P) who are coping with all the troubling symptoms linked to the degeneration of personality of their AD family members (e.g., depression, agitation, wandering, aggression). These so-called neuropsychiatric symptoms create a significant burden for caregivers and are a source of great stress and depression [3, 4] with consequences on their psycho-physical health [1, 6].
Existing studies indicate that mindfulness-based interventions (MBIs) can be used to promote quality of life, and physical and mental health, and can be employed as primary and secondary preventive interventions for adults and older adults [7–11].
On the basis of these considerations, training with mindfulness-based stress reduction (MBSR) [10], one of the most widely used MBIs [10], was planned to favor the restoration and/or maintenance of the quality of life in these CGs. MBSR is evaluated in studies with clinical and non-clinical populations with positive effects on stress reduction improving quality of life through focused attention, meditation, cognitive restructuring, and adaptive learning techniques [11–13].
MBSR is a practice of effortless, non-judgmental attention to the psychic contents of the present moment, resulting in a reduction in rumination and promotion of a state of calm and quiet [11–18]. From this position of “observation without effort”, psychic contents and intrapsychic conflicts can be welcomed and integrated, managing to achieve a psycho-physical rebalancing [19–22].
Therefore, we believed that a practice with MBSR could help CGs to cope with stress and find strategies for positive adaptation to the difficult condition of caring for a patient with AD [23–25]. Moreover, we planned to make a long intervention of six months, believing that a short intervention (two, three months) was too short to address the difficulties of these CGs. This also started from the consideration that the degeneration of the sick family member’s personality is for them a trauma like mourning: the patient is no longer the known beloved one.
We believe that the group setting, foreseen in our intervention, is essential for the need for support and sharing of these CGs and constitutes another relevant aspect of our study.
Whether our treatment is effective it will be possible to propose MBSR it will be possible to propose MBSR as a treatment method for CGs of AD-P.
MATERIALS AND METHODS
Study design
The present study is a prospective randomized controlled trials for the evaluation of the effects on quality of life and mood of MBSR in caregivers of patients affected by AD.
Participants
Caregivers of patients affected by AD, with diagnosis of early stage AD (Mini-Mental State Examination (MMSE) score 18 to 27) made by the NINDS-ADRDA criteria, and their caregiver were enrolled at the Neurology Department of INRCA-IRCCS Ancona, Italy [26].
Seventy-seven CGs were contacted by the physician. Only fifty-four of them met all the inclusion criteria and joined the study signing a consent form. They also filled out the tests required by the study. Ten CGs did not answer all the questions of the questionnaires, therefore they were not admitted to the study. Our sample included forty-four CGs, 22 of which were randomly assigned to the treatment group with MBSR and 22 without treatment.
Bioethic Advisory Committee of IRCCS-INRCA, Ancona, Italy: code no. 19009 approved the study.
Inclusion criteria
Principal caregiver of AD-P at early stage: being at least 40 years of age; having good health (no diagnosis of cancer and/or no neurological or cognitive impairments); being proficient in Italian language; providing a written, informed consent.
Exclusion criteria
Principal caregiver: refusal to participate; use of antidepressant; psychiatric disorders; psychotherapy in the previous year.
Randomization
Twenty-two CGs were allocated in the MBSR treatment group and 22 CGs as control (no treatment) by randomization.
Intervention structure (six months)
Intervention groups of up to 12 CGs and a total of 22 CGs treated. MBSR practice was 2 hours a week for six months taught by a single psychotherapist.
Intervention program
For the first month, participants learned the Jacobson relaxation practice at home 3 times a day. From the 2nd month, CGs participated in meditation practice with MBSR for 15–20 min three times a week. Expected effects were psycho-physical relaxation, calm, increased quality of life, and reduction of stress, burden, and psychological symptoms.
Interviews (T0-T1-six months)
Trained psychotherapists conducted pre- and post-intervention personal interviews with aim of understanding the difficulties of the individual CG as well as for the administration of the tests.
With this information, shared reflection in the group setting can help the individual caregiver find the understanding and support needed to formulate realistic individual goals to achieve balancing self-care and that of a family member with dementia.
The CGs in the control group without treatment will be evaluated at T0 and at T1 (six months).
The interviews (T0-T1) with them were carried out by two psychotherapists in hospital. Both had attended a one-year training in learning and administering the SASB Model.
One of them, who held the intervention groups, was trained in Brief Psychotherapies and Mindfulness training, with experience in mindfulness (meditative techniques) with patients for more than 10 years.
Measures
A social schedule for descriptive variables for CGs:
Descriptive social schedule of the independent variables such as sex, age, marital status, cultural level with indications on social support and welfare burden. The Caregiver Burden Inventory (CBI) [27] evaluates the care burden through 24 items. It is a self-filled questionnaire. It is divided into 5 sections: Time-Dependence Burden, Developmental Burden, Physical Burden, Social Burden and Emotional Burden. This tool has the reliability and validity for use in clinical trials for evaluating CGs stress. The SF36 test is a 36-item HRQOL [28, 29] to measure the quality of life through items that evaluate the limitations of physical activities and functioning due to psycho-physical health conditions. It comprises eight individual dimensions: General Health, Physical Functioning, Health Role Limitation, Emotional Problem, Fatigue, Emotional Well-Being, Social Well-Being, and Pain. This tool has the reliability and validity to evaluate the quality of life for use in clinical trials. The Beck Depression Inventory (BDI) by Aaron T. Beck [30] is a questionnaire describing depressive symptoms and attitudes. The number and frequency and intensity of symptoms are directly related to the severity of depression. This questionnaire has the reliability and validity for use in clinical trials. SASB Questionnaire-Form A (36 items described by 8 clusters) by L.S. Benjamin [31, 32] has the appropriate reliability and validity to evaluate personality structure at the intrapsychic and interpersonal levels from normal to pathological. It is validated on the basis of DSMV. It is used in the field of clinic and research for the diagnosis, planning, and verification of psychotherapeutic intervention. The Neuropsychiatric Symptoms (NPI) Inventory (NPI) [33] is the most widely used rating scale for noncognitive impairments associated with dementia. The NPI scale rates 12 neuropsychiatric disorders. This evaluation scale is used both for clinical purposes, to evaluate the psycho-behavioral disorders associated with cognitive impairment, and to evaluate the stress load to which the patient subjects the caregiver. The 12 criteria are evaluated for their frequency, severity and emotional or psychological stress caused to caregivers, attributing a numerical value to each index.
Test for AD-P
The MMSE [34] is a test to evaluate the neuro-cognitive and functional status of a patient, through a few and simple questions to probe different domains of brain function, such as orientation, memory, attention and calculation, the ability to recall certain acquisitions, and language. If performed correctly, the test offers important immediate information but is also extremely useful to follow the course of any malfunctions found. It is a questionnaire used extensively in clinical and research settings.
Statistical analysis
The data will be entered, using blocks and standard checks. The checking and cleaning of the data will be verified manually. Reliability for data consistency and quality will be assessed. As regards the lack of responses to the survey, the subjects in the sample will be compared with the subjects who did not respond to certain characteristics. We will start with the exploratory and descriptive analysis of the sample through bivariate statistics. Significant results will be obtained through specific tests according to the nature and distribution of the variables. We will use the ANOVA model for Repeated Measurements in order to evaluate intra-class (before-after) and inter-class (case-control) differences, and the generalized linear model for repeated measurements in order to compare different detection times. In other words, we will compare quality of life, depression, and other studied variables for CH before and after MBSR, also comparing cases with controls for CH. We will use the correlation coefficient to evaluate the relationships between the studied variables. Statistics will be performed with SPSS software (version 19.0) and p < 0.05 will be the level of significance.
RESULTS
The AD-P in the early stages have MMSE scores in the range of 18 to 26.
No differences emerged between the MBSR group and no-treatment group of CG for age, sex, educational level, health status, working conditions, caregiving reasons, and hours of caregiving (Table 1).
Caregivers: Demographics (n = 44)
Caregivers: Demographics (n = 44)
AD, Alzheimer’s disease.
From the results emerged significant differences in the BDI at the end of MBSR treatment (Table 2). In particular, decreases emerged in the following dimensions: CBI-Time dependent burden (p < 0.001), CBI-Developmental (p < 0.001), CBI-Physical (p < 0.001) CBI-Social (p = 0.004), and CBI-Tot (<0.001). There was no difference in Emotional burden.
Caregivers: MBI Treatment
Caregivers: MBI Treatment
Furthermore, improvements in the following dimensions of SF-36: Health Role Limitation (p < 0.000), Emotional Problem (p < 0.000), Fatigue (p < 0.000), Emotional Well-Being (p < 0.001), Social Well-Being (p = 0.010), and General Health (p = 0.004) emerged. Pain decreased (p = 0.002). No difference in physical functioning emerged. Furthermore, depression decreased (BDI: p < 0.001).
Caregivers showed a reduction in stress due to neuropsychiatric symptoms of AD-P at the end of treatment with MBSR in the dimensions of agitation (p = 0.024), depression (p = 0.033), anxiety (p < 0.001), apathy (p < 0.000), irritability (p < 0.001), sleep disturbances (p = 0.0037), and eating disorders (p = 0.025) (Table 2).
No effects on caregiver’s changes emerged in the following AD-P neuropsychiatric disorders: delirium, hallucination, disinhibition, and aberrant motor behavior.
The untreated caregivers showed a worsening in CBI-Time dependent (p = 0.008); CBI-Tot and other dimensions of burden remains unchanged (Table 3).
Untreated Caregiver
Furthermore, a worsening in Physical functioning (p = 0.036) and Pain (p = 0.047-tendency) of QoL emerged.
No differences in the following QoL dimensions: General Health, Health Role Limitation, Emotional Problem, Fatigue, Emotional Well-Being, and Social Well-Being.
The untreated caregiver’s stress due to the neuropsychiatric symptoms of AD-P was increased (retest six months) in anxiety (p = 0.024), apathy (p = 0.050-tendency), sleep disorders (p = 0.015), and eating disorders (p = 0.009).
No change of burden of the following neuropsychiatric symptoms of AD patients on CGs stress: delirium, hallucination, agitation, depression, euphoria, irritability, aberrant motor behavior.
DISCUSSION
The effects of six-month MBSR training on AD-CGs quality of life, burden, and depression were evaluated. A random comparison was performed with a group of untreated caregivers.
MBI CGs show reduced stress due to the following AD-P neuropsychiatric symptoms: agitation-anxiety, euphoria, apathy-indifference, irritability, sleep disorders, eating disorders, and a tendency in depression. No effects on caregiver’s changes emerged in the following AD-P psychiatric disorders: delirium, hallucination, disinhibition, and aberrant motor behavior.
Furthermore, the MBSR CGs showed at the end of treatment an improvement of quality of life in particular in the following dimensions: general health, role limitation, emotional problem, energy-fatigue, emotional well-being, social well-being; while pain decreased.
Furthermore, depression decreased from medium-high to normal ranges. Overcoming the depressive state is one of the relevant results of this study and confirms the effectiveness of mindfulness practice, highlighted by other studies [35] in helping to overcome emotional difficulties, such as a negative decline in mood. It is interesting to highlight that as the dimensions of emotional and social well-being improve and as depression decreases, the dimension of pain also decreases. Some authors showed the practical efficacy of mindfulness in pain management precisely because it improves QoL [36] and consequently the physical functioning [37], particularly in patients with chronic pain.
We can state that the function of self-awareness, promoted by mindfulness training in treated CGs, which increases in our sample, is precisely that of creating an emotional rebalancing and mood stability that influences the perception of physical pain. Moreover, the practice of self-awareness (MBSR) with the discovering and listening of real needs allows the overcome of the maladaptive elements of one’s lifestyle, thus favoring the recovery of a good quality of life [38–40].
Our results can be explained by the mindfulness practice promoting an emotional-affective rebalancing. In this process, the caregiver finds within him/herself greater resources available to face and overcome the stress of the burden and satisfy his/her self-care needs.
On the other hand, the untreated CGs showed a worsening of physical functioning of QoL, while the other dimensions of QoL and burden remain unchanged. Thus, untreated CGs maintained a high burden and a general poor quality of life after six months. On the other hand, they showed an increase in time dependent burden and a reduction in QoL-physical functioning. The other dimensions of burden and quality of life remain unchanged.
CGs need some time to organize daily life based on the family member’s illness after first diagnosis and the signs of antisocial behavior. We hypothesize that they have difficulties and need outside help to reorganized their daily life on the basis of the patient’s need for assistance in order to create a minimum of adaptation and reduce the time dependent burden and the physical functioning.
In general, untreated CGs maintain a high burden and a poor quality of life after six months. The following consideration emerges from these results: it is right from the start of the diagnosis of AD in a family member that puts a strain on the psycho-physical balance of the family member. This suggests the need for these CGs for support at a much earlier stage of the disease (immediately after onset).
We think, through our interaction with the caregivers, that one of their reasons for great discomfort is the degeneration of the AD-P’s personality, which in addition to requiring a reorganization of daily life, involves considerable stress. The familiar with AD is no longer the known beloved one. We believe that interventions with CGs should address this issue.
This topic has been addresses in MBSR group. These CGs were helped to become aware of and rework the trauma of the patient’s personality degeneration.
In conclusion, our study demonstrates the efficacy of six months of Mindfulness training, in group setting, on improving the QoL and reducing the burden on caregivers of patients with early stage AD.
This suggests that the caregiver needs practical and emotional support to face on the onset of AD in a family member.
Limitations
Our sample is small, and caution should be exercised in extrapolating these data to CG of patients with other severities of AD. Also, all CGs come from only one hospital, and this presents a sampling bias. Therefore, they are not representative of AD-CG in general. Furthermore, we were unable to make a comparison between women and men due to the limited number of cases. This is another limitation of the study. Future studies may investigate these topics.
CREDIT AUTHOR STATEMENT
Maria Velia Giulietti (Conceptualization; Methodology; Resources; Writing – original draft); Paolo Fabbietti (Formal analysis); Roberta Spatuzzi (Methodology; Writing – original draft; Writing – review & editing); Anna Vespa (Conceptualization; Formal analysis; Methodology; Resources; Supervision; Writing – original draft; Writing – review & editing).
Footnotes
ACKNOWLEDGMENTS
The authors have no acknowledgments to report.
FUNDING
This work was supported by the Italian Ministry of Health.
CONFLICT OF INTEREST
The authors have no conflict of interest to report.
DATA AVAILABILITY
The data can be requested from the authors under reasonable request.
