Open Access
Systematic Review

# Assessing psychosocial interventions for informal caregivers of older people with early dementia: a systematic review of randomized controlled evidence

Shanshan Wang1,Johanna de Almeida Mello1,2,Anja Declercq1,3
1
LUCAS – Centre for Care Research & Consultancy KU Leuven, 3000 Leuven, Belgium
2
Population studies Oral health KU Leuven, 3000 Leuven, Belgium
3
CeSO - Centre for Sociological Research KU Leuven, 3000 Leuven, Belgium
DOI: 10.52586/4967 Volume 26 Issue 9, pp.556-571
Submited: 07 June 2021 Revised: 26 July 2021
Accepted: 02 August 2021 Published: 30 September 2021
(This article belongs to the Special Issue The polyhedral aspects of dementia)
Abstract

Dementia affects not only the patients, but also the caregivers. Timely targeted supporting for informal caregivers of people with dementia can improve their health and life quality, as well as contribute to sustainable healthcare. However, which interventions could efficiently support them and why still remains unclear. This systematic review aims to close this gap by critically assessing the current state of randomized controlled evidence concerning informal caregivers of older people with early dementia. We searched the electronic databases PubMed, CINAHL, Embase, Cochrane and Web of Science and assessed the methodological quality of the selected studies using the validated PEDro scale. A total of 2067 studies were identified in the initial searching, and 29 randomized controlled studies were finally selected based on the rigorous inclusion and exclusion criteria. Through completely assessing the methodological quality of studies, and the essentials and effectiveness of the 22 different types of interventions, we identified which interventions were effective and why. Timely targeted interventions for this caregiver group remains scarce. Furthermore, we highlight that there is a lack of systematic caregiver needs assessments prior to or when delivering the interventions.

Key words

Review; Informal caregivers; Aged; Psychosocial interventions; Early dementia; Cognitive decline

## 2. Introduction

Cognitive decline and dementia affect not only older people but also their informal caregivers [1, 2, 3]. In the face of growing numbers of people living with dementia, ensuring that those who support them can remain healthy is a policy priority [4, 5]. Worldwide, around 50 million people have dementia, and there are nearly 10 million new cases every year [6]. People with dementia are mostly cared for by their family members, friends or neighbors, who are referred to as informal caregivers. The input from informal caregivers is a complex area, but regardless of how the input is calculated, it is estimated by Alzheimer’s Disease International that the annual global number of informal care hours provided to people with dementia living at home was about 82 billion hours in 2015. This is equivalent to 2089 hours per year or 6 hours per day. This figure was equal to the input of more than 40 million full time workers in 2015, a figure that will increase to 65 million full time workers by 2030. This contribution is substantial for the health care system [7]. While the contribution is important, informal caregivers are often exposed to emotional strain, relationship deprivation, family conflicts and financial burden, which can impact their health and life quality [8]. Compared to other informal caregivers, those who care for older people with cognitive decline experience an even greater burden. This greater burden includes higher stress [9], increasing isolation and burden of care [10], higher levels of depression due to severe psychiatric and behavioral problems of the cared person [11, 12], lower quality of life [13], and poorer health [14]. A growing body of evidence points out that it is essential to develop effective interventions for this type of informal caregivers [15, 16, 17, 18, 19, 20].

Informal caregivers of older people with cognitive decline bear increasing responsibility and burden with the progress of the disease. Even a newly acquired role as a caregiver affects other roles and often results in additional burden and emotional strain. This case will become worse especially when a caregiver has no prior experience in caregiving [8]. Moreover, family members often need to transition their relationship with the parent or spouse from that of a family member to that of a proactive caregiver. Early adjustment into this transition is needed because unprepared informal caregivers experienced frustration, resentment, grief, as well as relational deprivation [21].

Offering timely interventions for informal caregivers of people with dementia can help them better adapt to the transition, feel more competent to care and experience less psychological problems [22]. Timely supporting informal caregivers at risk of adverse outcomes showed an added value to the health care system [23]. Furthermore, this timely support can contribute to the caregiver’s resilience to stress [24]. At this point, timely targeted supporting for informal caregivers of people with dementia can improve their health and life quality, as well as contribute to sustainable healthcare.

However, much remains unknown about how to best support informal caregivers of older people with early dementia. Most interventions developed focus on the persons who are affected by early dementia, but not on the informal caregivers. These interventions aim to improve the patients’ physical and cognitive functions, quality of life, and the skills to perform activities of daily living [25]. A recent meta-review recommended that interventions should be developed to meet informal caregivers’ changing needs in the course of dementia [26]. Scientific evidence shows that appropriate information and professional service for informal caregivers of people with early dementia are still lacking [27, 28]. Moreover, most systematic reviews focused on informal caregivers of people with moderate or advanced stages of dementia. These reviews assessed the effectiveness of interventions [29, 30, 31, 32, 33] concerning informal caregivers’ outcomes, such as health-related quality of life [34], care burden, depression, disruptions in health and social support [35], and cost-effectiveness of the interventions [36], and the effects of content of the interventions [37]. The current state of randomized controlled evidence, particularly concerning informal caregivers of older people with early dementia, has not yet been systematically assessed. We aim to close this gap and explore which psychosocial interventions exist for informal caregivers of older people with early dementia. We also addressed the following questions: (1) What components of psychosocial interventions are effective for informal caregivers of older people with early dementia? (2) What theories underpin these interventions? (3) What caregivers’ needs were assessed in these interventions?

## 3. Methods

A systematic review protocol was developed to identify and assess the intervention studies for informal caregivers of older people with early dementia. The review followed the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement [38]. Details of the protocol can be found in Appendix.

### 3.1 Initial search

We searched electronic databases PubMed, CINAHL, Embase, Cochrane and Web of Science using search terms in accordance with the following concepts: psychosocial interventions, evaluation, informal caregivers, older persons, dementia and cognitive problems. We did not impose data limits, and this review reflects the latest search through July 2021. Two independent reviewers constructed a comprehensive list of Medical Subject Headings (MeSH), which was designed for 5 explicit categories: (1) interventions; (2) evaluation; (3) informal caregivers; (4) older persons; and (5) dementia (Table 1). Terms were coupled with relevant MeSH terms and were truncated as appropriate. We hand-searched references in reviews and published literature to include more potential studies that could have been missed in the database searching.

### 3.2 Studies selection

After removing duplicates, abstracts were identified upon the initial search, and two independent raters selected abstracts for full review based on inclusion/exclusion criteria. After each rater independently reviewed the abstracts, findings were reviewed to find a consensus producing a final list of studies for full-text examination. Full-text examination was also performed by the two raters independently.

All papers selected for final inclusion met the following criteria.

#### 3.2.1 Inclusion criteria

• Only peer-reviewed journal articles written in English were included.

• Only randomized controlled trial designs were included.

• Interventions had to specifically focus on informal caregivers of people with early dementia delivered in the community setting. Studies were also included when people with early dementia were part of their care population, even when they also included more severe cases.

• Informal caregivers were viewed as those who are primarily responsible for the care and wellbeing of care recipients. They may be spouses, children or other family members, either or not living with the care recipient.

• Studies included efficacy evaluation of the interventions for informal caregivers intended to enhance their health and life quality (possibly also of the care recipient).

#### 3.2.2 Exclusion criteria

• The intervention must primarily focus on informal caregivers. Interventions intended primarily for care recipients where the caregivers assisted with implementation were excluded.

•Studies were also excluded if the caregivers were professionals, and the care recipients were institutionalized.

• Descriptive studies such as protocol trials were excluded.

• Studies only focusing on older people with moderate or advanced stages of dementia were not the target of our review and were also excluded.

### 3.3 Data extraction

Two independent raters read the full text of each study included in the review, and extracted key content of the studies using an ad-hoc data collection form to record the following information: (1) author, year and country, (2) theoretical underpinnings, (3) caregiver needs assessment, (4) sample, (5) people delivering the intervention, (6) intervention duration, (7) intervention elements, (8) main outcomes of care recipients, (9) main outcomes of caregivers, (10) main findings, (11) study limitations. Studies were categorized based on the composing elements of an intervention (e.g., training, counseling) to facilitate synthesis of the studies.

Two independent raters selected the studies and rated them independently for their quality using a modified 11-item version of the PEDro scale [39, 40]. Differences in scoring were discussed and resolved collaboratively. According to the rating rule of PEDro scale, criteria 1 (i.e., Specification of eligibility criteria) is not included in the final score. Hence the PEDro scale consists of 10 quality ratings, each receiving either a yes (value 1) or no (value 0) score, which is based on the Delphi list developed by Verhagen et al. [41] PEDro score 9–10 is categorized as of excellent quality, PEDro score 6–8 is categorized as good quality, PEDro score 4–5 is categorized as of fair quality, and PEDro score $\leq$3 is categorized as of poor quality. The checklist identifies studies that are generalizable, internally valid, and contain interpretable data. Two raters followed the guidelines of PRISMA, so the consensus came after discussion and, when there was a doubt, once again raters assessed the paper to see whether they could come to an agreement. When the full text could not be located or when published articles did not present all necessary information, authors were contacted about the required information.

## 4. Results

As illustrated in Fig. 1, a total of 2067 studies were finally identified through online databases and hand-searching. A total of 343 duplicates were removed. After full-text eligibility screening for 156 records, 29 randomized controlled studies were included based on rigorous inclusion and exclusion criteria. Raters then performed data extraction and quality of assessment on the included studies.

### 4.1 Quality assessment

The methodological quality of the included studies ranged from good to excellent (Table 2). Amongst the 29 studies [42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70], 9 studies [43, 53, 54, 55, 56, 57, 59, 60, 61] were categorized as of excellent quality (PEDro score = 9–10). As included studies were trials examining psychosocial interventions, subject and therapist blinding were unattainable. Moreover, because of the nature of the population studied, ‘concealed allocation’ and ‘assessor blinding’ were poorly met. The scores of ‘intention to treat analysis’ and of ‘over 85% follow-up of at least one key outcome’ were relatively poor. However, all included studies appeared to have good methodological rigor including specification of eligibility criteria, loss to follow-up information provided, point estimates and measures of variability of at least one key outcome and use of a treatment fidelity protocol.

### 4.2 Study characteristics

The intervention components, intervention delivery and duration, as well as sample characteristics varied in a total of 22 different types of interventions described in 29 studies (see Tables 3,4, Ref. [42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70]). Most studies were performed in the USA (14 studies), and others were performed in the UK (5 studies), China (2 studies), Japan (1 study), India (1 study), Germany (1 study), Netherlands (3 studies), Norway (1 study), Denmark, Poland and Spain (1 study). In addition, the years of these published studies varied from 2003 to 2021. In most studies, informal caregivers of relatives with early and later stages of dementia are the sample participants, except for 5 studies [49, 50, 58, 62, 66] where the participants are solely informal caregivers of older people with early dementia. Four studies evaluated a single-element intervention (i.e., education, training) [42, 43, 44, 45], and the remaining 25 studies evaluated a multi-component intervention (i.e., support group + training) [46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70]. The interventions are delivered by a wide array of individuals (e.g., nurse, counselor, etc.), and two internet-based interventions are carried out by participants themselves [42, 47]. In two studies [51, 52], the intervention was carried out by an interdisciplinary team, including a home care advisor, lay counselor, nurse, psychiatrist and coordinator. Most interventions were delivered by therapists or nurses [44, 45, 46, 48, 53, 54, 55, 56, 57, 58, 63, 64, 69], and only interventionists of the NYU Caregiver intervention (NYUCI) and Resources for Enhancing Alzheimer’s Caregiver Health (REACH) were officially certified [53, 54, 55, 56, 57]. Of the 29 studies, only 5 studies specifically targeted informal caregivers of people with early dementia [49, 50, 58, 62, 66]. The remaining 25 studies evaluated the interventions for informal caregivers of people with early and later stages of dementia.

### 4.3 Theory basis and caregiver needs assessment for interventions

Table 3 shows the theory basis of interventions and caregiver needs assessment matched with the interventions. Not all studies reported the theory basis of the interventions, except for the following studies: (1) A home-based caregiver training program was based on the Progressively Lowered Stress Threshold Model (PLST), which is tailored to individual needs of caregivers to improve their self-efficacy [46]. (2) A behavioral home-based Care of Persons with Dementia in their Environments (COPE) intervention was based on the Competence-Environmental Press theory, which targeted modifiable environmental stressors to maximize physical function in people with dementia and build dementia management skills in caregivers [48]. (3) A PST intervention was based on the Problem-Solving Therapy (PST) which focuses on training caregivers in adaptive problem-solving attitudes and skills [49, 50]. (4) An evidence-based multi-component intervention (NYUCI) and the Acquiring New Skills While Enhancing Remaining Strengths (ANSWERS) intervention are conceptually grounded in the Stress Process Model, which aims to build and improve the resources of caregivers in adapting to and managing care demands [53, 54, 55, 56, 68]. and (5) A multi-component individualized intervention (REACH) was based on the Schulz’s Stress–health Process Model, which aims at reducing risks in five caregiver domains (see below caregiver needs assessment) [57]. (6) A 5-week behavioral intervention reported in 2 studies [44, 45] and an individual therapy program (START, STrAtegies for RelaTives) reported in 3 studies [59, 60, 61] were based on the Coping with Caregiving (CWC), which was based on principles of cognitive behavioral therapy to reduce caregiver distress related to neuropsychiatric symptoms of people with dementia and general caregiver burden. (7) A group-based multicomponent psychoeducation intervention was grounded in the Adult learning theory, Stress, appraisal and coping theory and Cognitive behavior therapy, which aims to reduce caregiver depression, and improve caregiving appraisals and coping skills, and improve the conditions of people with dementia [64]. In addition, the mechanism of a modified mindfulness-based cognitive therapy is the mindful coping model [67].

Of all the 29 studies, only 12 studies mentioned the use of a caregivers’ needs assessment, including: (1) An individualized, comprehensive assessment battery for caregivers in the NYUCI systematically assessed the caregiving role, physical health and emotional health of caregivers, social support, caregiver understanding and response to the illness and social support [53, 54, 55, 56]. (2) An initial interview consisted of a core battery of caregiver assessment used by all REACH sites [48]. (3) The COPE used the Johns Hopkins Dementia Care Needs Assessment (JHDCNA) consisting of 4 major caregiver domains (i.e., caregiver education, resource referral, mental healthcare, medical healthcare) [52]. (4) Individual treatment strategies in the REACH intervention were selected based on an individualized risk assessment of five caregiver domains (i.e., knowledge of dementia, ability to care, perceived social support, emotional and physical well-being and challenging behavior) [57]. (5) The caregiver’s situation was explored by a nurse with a capacity and burden questionnaire to formulate a care plan [58]. (6) The START intervention used a brief COPE, a validated self-completed measure of coping strategies by the caregiver, with subscales measuring problem focused, emotion focused, and dysfunctional coping [59, 60, 61]. (7) The ANSWERS intervention applied a strength-based inventory assessing care dyad’s strengths across different domains, including cognitive, physical health, social activities, personality, life roles, leisure activities, and history and culture [68].

### 4.4 Components and effectiveness of interventions

All interventions were categorized into a single-element or a multi-component group based on the intervention components and most interventions reported effective outcomes on informal caregivers. These studies reported a variety of health outcomes in informal caregivers, including depression, stress, anxiety, caregiver self-efficacy, caregiver burden and quality of life. Some studies also collected other outcomes including social support, role captivity, positive affectivity, self-rated health, wellbeing, appraisal of study benefits, completion of a care plan, use of services, dyadic relationship functioning, potentially abusive behavior by caregivers towards the care recipients and caregiver’s appraisals of behavior problems in care recipients [43, 48, 53, 54, 55, 56, 57, 59, 60, 61, 62, 68]. In 14 studies, outcomes about the care recipients were also evaluated, such as quality of life, functional dependence, depression, completion of a care plan, use of services, dyadic relationship functioning, wellbeing, program satisfaction, activity engagement, assistance needed with ADL, mood, number of social contacts and leisure activities, behavioral problems, frequency of challenging behavior, and neuropsychiatric symptom severity [44, 45, 46, 48, 51, 57, 58, 59, 60, 62, 63, 64, 67, 69]. Detailed information of the interventions is shown on Table 4.

#### 4.4.1 Single-element interventions

Four studies that evaluated a single-element intervention were identified [42, 43, 44, 45]. Three of them had good methodological quality [42, 44, 45]. One of the four studies (25%), whose intervention is to provide informal caregivers with befriending support, did not report significant effects [43]. Three studies whose single intervention element is training reported statistically significant effects, including lower levels of neuropsychiatric symptoms severity in care recipients, reduced caregiver stress, a greater sense of self-efficacy in providing care, less depressive symptoms and less distress about the neuropsychiatric symptoms [42, 44, 45]. Among the three training programs, one’s [42] intervention emphasis is to provide stress management training for informal caregivers, and it was carried out via internet by a video tape. The other two interventions [44, 45] mainly focused on the training on behavior management of care recipients, planning of pleasant events and relaxation techniques, and these interventions were delivered by therapists.

#### 4.4.2 Multi-component interventions

The other 25 studies evaluated multi-component interventions. 17 studies were categorized as of good methodological quality [46, 47, 48, 49, 50, 51, 52, 58, 62, 63, 64, 65, 66, 67, 68, 69, 70], and 8 studies even had excellent methodological quality [53, 54, 55, 56, 57, 59, 60, 61]. 4 of the 25 studies (16%) did not show statistically significant benefits [52, 58, 63, 69]. 11 of 12 studies which had a common intervention component (i.e., social support) reported benefits for caregivers, such as improvements in mental health, emotional support, caregiving appraisals and coping skills, mastery, increased use of services [46, 47, 51, 53, 54, 55, 56, 57, 62, 64, 70], except for 1 study [58]. 10 of 12 studies which shared a common intervention component (i.e., training) all reported significant effectiveness for caregivers, such as improved quality of life and caregiver self-efficacy, reduced caregiver burden, less emotional health strain, less dyadic relationship strain, less role captivity, less distress and depressive symptoms [46, 48, 49, 50, 57, 59, 60, 64, 68, 70], except for 2 studies [52, 69]. 14 out of 16 studies which had a common intervention component (i.e., education) reported benefits for caregivers, such as increased caregiver self-efficacy, mastery, coping skills, improved wellbeing and quality of life, reduced caregiver burden and depressive symptoms, less role captivity [47, 48, 49, 50, 51, 57, 59, 60, 62, 64, 65, 67, 68, 70], except for 2 studies [52, 63].

Six interventions that had common intervention components (i.e., education and social support) demonstrated beneficial effects on caregiver’s depressive symptoms, caregiver’s mental health and perceived burden, caregiving appraisals, coping skills, and quality of life [47, 51, 57, 62, 64, 70]. 9 of 10 studies which shared common intervention component (i.e., education, training) reported such benefits for caregivers as improved quality of life, reduced caregiver burden, improved caregiving mastery [48, 49, 50, 57, 59, 60, 64, 68, 70], except for one study [52]. Among them, the COPE intervention consisting of education and training components improved patient functioning and activity engagement as well as caregiver wellbeing at 4 months, yet no significant effect was found in outcomes during the 9 months follow-up period [48]. Similarly, one study reported that the REACH intervention composed of education, training and support group based on individualized assessment of caregivers’ needs, had a reduced stabilization effect on the burden caused by care in the follow-up period [57]. Of all the effective interventions, only the NYUCI and the START intervention presented sustained benefits after years of follow-up due to its unique intervention elements, not found in other interventions (i.e., on-going support group participation, ad hoc counseling, plans of maintaining skills learnt) [53, 54, 55, 56, 59, 60]. Sustained effective outcomes include fewer depressive symptoms for 3.1 years, better self-rated health for 2 years, higher levels of satisfaction with social support network in caregivers for 5 years [53, 54, 55, 56], improved mental health and reduced anxiety and depression for 2 years [59, 60].

## 5. Discussion

This systematic review identified 29 studies describing 22 different types of interventions for informal caregivers of older people with early dementia. Most studies reported effective outcomes on informal caregivers, and 19 of the 22 different types of interventions comprised two or more components (i.e., education, training, support group). Only 10 different types of interventions mentioned the theoretical underpinnings. This paper represents the very first to systematically assess randomized controlled trials (RCTs) for informal caregivers of older people with early dementia.

Well-established evidence emphasized the great benefits of timely support for informal caregivers of older people with early dementia [71]. One recent systematic review also reported that informal caregivers of people with dementia felt it was the right time to receive information and support directly after or at the time of diagnosis [72]. However, 15 different types of interventions identified in our systematic review are effective for informal caregivers of older people with early and later stages of dementia [42, 44, 45, 46, 47, 48, 51, 52, 53, 54, 55, 56, 57, 59, 60, 61, 63, 64, 65, 67, 68, 70]. Furthermore, 3 different types of effective interventions solely focused on informal caregivers of older people with early dementia [49, 50, 62, 66]. To provide timely target support for this type of caregivers, future research should consider more clinical trials to develop and implement effective interventions for them.

Psychosocial interventions for informal caregivers need to be person-centered through structured needs assessment, as interventions for the persons with dementia [73, 74]. A needs-matched intervention for informal caregivers of people with cognitive decline should be developed further [75]. Yet our review showed that only five studies applied a structured needs assessment for informal caregivers prior to or when delivering the intervention [53, 54, 55, 56, 57]. Namely, only 2 different types of psychosocial interventions (i.e., NYUCI, REACH) were person-centered and tailored to informal caregivers’ comprehensive needs. Moreover, just one study developed and validated a screener based on interRAI assessments to assess informal caregivers’ wellbeing [76]. A validation study of a systematic assessment for informal caregivers is still lacking.

In addition, one systematic review summarizing systematic reviews of psychosocial interventions for caregivers of people with dementia showed that the most effective interventions should include both the education and therapeutic component [77]. Compared to previous systematic reviews, this systematic review firstly identified which interventions could better support informal caregivers of older people with early dementia on one hand, determining which elements are essential for this caregiver group and why on the other hand. Our systematic review revealed that intervention components, including caregiving skills training, dementia education, counseling and social support have beneficial effects on different caregiver outcomes. In addition, ongoing intervention support (e.g., ad-hoc counseling, plans of maintaining skills learnt) is of great significance for the sustainable effects of the interventions [53, 54, 55, 56, 59, 60]. This can also be supported in another two studies identified in our review, which reported the intervention effects decreased or disappeared during the follow-up period [48, 57]. We also pointed out the theoretical underpinnings of effective interventions directly, including Progressively Lowered Stress Threshold, Competence-Environmental Press Theory, Stress process model and Schulz’s stress-health process, and Adult learning theory, Stress, appraisal and coping theory, Cognitive behavior therapy. These findings could improve our understanding of the effects of interventions and facilitate future successful translation studies in this area. Furthermore, it will be possible to provide timely targeted interventions specifically for informal caregivers of people with early dementia. Beyond the implications for dementia care, the essentials of effective interventions identified in this review will inform the future development, adaptation and implementation of evidence-based interventions in similar caregiving practices (e.g., chronic diseases). Finally, future research could also consider the cost effectiveness potential in different combinations of intervention essentials, given that the dementia care is considerably expensive.

### Strengths and limitations

A strength of this systematic review is the fact that we used the PEDro scale to assess the methodological quality of the studies. This rigorous scale made it possible to evaluate the studies and find which ones were more robust and met the quality criteria. A limitation is the fact that we only included peer-reviewed journal articles written in English in our systematic review. Maybe we have missed some interventions reported in ‘grey literature’ or written in another language than English, which might have had a significant effect on caregiver outcomes. Another limitation is that we only included RCT studies, as this was a choice we have made to make sure studies had some standardization in the measurements, as well as a control group to evaluate the effectiveness of the interventions.

## 6. Conclusions

Through rigorous searching and screening, we finally identified 29 RCT-studies and a total of 22 different types of interventions. The methodological quality of studies and the intervention essentials combined with corresponding effectiveness of these interventions were critically assessed. The findings of this systematic review can provide knowledge on which and why psychosocial interventions are effective for informal caregivers of older people with early dementia.

The review findings revealed that there is a paucity of effective interventions on supporting informal caregivers of older people with early dementia. Future research should consider more evaluation trials to develop and implement compact interventions for them, given that timely support for this caregiver group has considerable benefits to the health care systems. The development or adaptation of this compact interventions should consider carefully the following essentials: a validated theoretical underpinning (e.g., stress process model, health-stress theory, PLST), tailored support matched with a systematic assessment of caregiver needs, ongoing support provision (e.g., ad-hoc counseling, plans of maintaining skills learnt) and the inclusion of multi-components in an intervention (e.g., education, social support, training). Furthermore, we highlight there is a lack of systematic caregiver needs assessment prior to or when delivering an intervention and further studies needed. The findings from our systematic review could serve as a comprehensive summary of the current state of effective psychosocial interventions for informal caregivers of older people with early dementia. This is informative for policymakers and researchers from several disciplines to further develop and implement effective interventions for caregivers in similar caregiving contexts.

## 7. Author contributions

Study concept and design: SW, JM, AD; Drafting of the manuscript: SW; Critical revision of the manuscript for important intellectual content: SW, JM, AD; all authors agreed with the final manuscript.

Not applicable.

## 9. Acknowledgment

We thank all the peer reviewers for their comments. We also thank the China Scholarship Council (CSC).

## 10. Funding

Shanshan Wang is supported by the China Scholarship Council (CSC) (File No. 201806330119).

## 11. Conflict of interest

The authors declare no conflict of interest.

## Appendix

Review question

Assessing psychosocial interventions for informal caregivers of people with early dementia: A systematic review of randomized controlled evidence.

We aim to answer the following questions:

(1) What components of psychosocial interventions are effective for informal caregivers of older people with early dementia?

(2) What theories underpin these interventions?

(3) What caregivers’ needs are assessed in these interventions?

Searches

PubMed, CINAHL, Embase, Cochrane and Web of Science.

Types of study design to be included

Randomized controlled trials (RCTs).

Condition or domain studies to be included

Early dementia or early cognitive decline or memory loss.

Participants

Informal caregivers of older people with early dementia.

Interventions

Psychosocial interventions, including counselling, education, training, support, problem solving, coping strategy, cognitive behavior therapy, art, music, singing and museums.

Context

Home setting.

Outcomes

All outcomes related to health and life quality in informal caregivers (and care recipients).

Study selection

Two reviewers will select studies for inclusion and exclusion against the criteria through screening the titles and abstracts. Uncertainties will be resolved through discussion with a third reviewer.

Study quality assessment

Two reviewers will assess the quality of each study using a modified 11-item version of the PEDro scale. Differences in scoring will be discussed and resolved collaboratively with a third reviewer.

Data extraction

Two reviewers will read the full text of each study included in the review and extract key content of the studies. According to our research aim and questions, the following characteristics will be extracted with a standardized electronic form: (1) author, year and country, (2) theoretical underpinning, (3) caregiver needs assessment, (4) sample, (5) people delivering the intervention, (6) intervention duration, (7) intervention elements, (8) main outcomes of care recipients, (9) main outcomes of caregivers, (10) main findings, (11) study limitations.

References
• [1] Papastavrou E, Kalokerinou A, Papacostas SS, Tsangari H, Sourtzi P. Caring for a relative with dementia: family caregiver burden. Journal of Advanced Nursing. 2007; 58: 446–457.
• [2] Wolfs CAG, Kessels A, Severens JL, Brouwer W, de Vugt ME, Verhey FRJ, et al. Predictive factors for the objective burden of informal care in people with dementia: a systematic review. Alzheimer Disease and Associated Disorders. 2012; 26: 197–204.
• [3] Chiao C, Wu H, Hsiao C. Caregiver burden for informal caregivers of patients with dementia: a systematic review. International Nursing Review. 2015; 62: 340–350.
• [4] Schneider U, Sundström G, Johannson L, Tortosa MA. Policies to support informal care. In Gori C, Fernandez JL, Wittenberg R (eds). Long-term care reforms in OECD countries. Bristol: Policy Press. 2015.
• [5] Shaji KS, Reddy MS. Caregiving: a public health priority. Indian Journal of Psychological Medicine. 2012; 34: 303–305.
• [6] World Health Organization. Dementia. 2020. Available at: https://www.who.int/news-room/fact-sheets/detail/dementia (Accessed: 9 March 2021).
• [7] Wimo A, Gauthier S, Prince M. Global estimates of informal care. London: Alzheimer’s Disease International (ADI). 2018.
• [8] Varik M, Medar M, Saks K. Informal caregivers’ experiences of caring for persons with dementia in Estonia: a narrative study. Health & Social Care in the Community. 2020; 28: 448–455.
• [9] Bertrand RM, Fredman L, Saczynski J. Are all caregivers created equal? Stress in caregivers to adults with and without dementia. Journal of Aging and Health. 2006; 18: 534–551.
• [10] Bramble M, Moyle W, McAllister M. Seeking connection: family care experiences following long-term dementia care placement. Journal of Clinical Nursing. 2009; 18: 3118–3125.
• [11] Mohamed S, Rosenheck R, Lyketsos CG, Schneider LS. Caregiver burden in Alzheimer disease: cross-sectional and longitudinal patient correlates. American Journal of Geriatric Psychiatry. 2010; 18: 917–927.
• [12] van der Lee J, Bakker TJEM, Duivenvoorden HJ, Dröes R. Multivariate models of subjective caregiver burden in dementia: a systematic review. Ageing Research Reviews. 2014; 15: 76–93.
• [13] Srivastava G, Tripathi RK, Tiwari SC, Singh B, Tripathi SM. Caregiver Burden and Quality of Life of Key Caregivers of Patients with Dementia. Indian Journal of Psychological Medicine. 2016; 38: 133–136.
• [14] Karg N, Graessel E, Randzio O, Pendergrass A. Dementia as a predictor of care-related quality of life in informal caregivers: a cross-sectional study to investigate differences in health-related outcomes between dementia and non-dementia caregivers. BMC Geriatrics. 2018; 18: 189.
• [15] Cohen G, Russo MJ, Campos JA, Allegri RF. Living with dementia: increased level of caregiver stress in times of COVID-19. International Psychogeriatrics. 2020; 32: 1377–1381.
• [16] Giebel C, Cannon J, Hanna K, Butchard S, Eley R, Gaughan A, et al. Impact of COVID-19 related social support service closures on people with dementia and unpaid carers: a qualitative study. Aging & Mental Health. 2020; 25: 1281–1288.
• [17] Barros D, Borges-Machado F, Ribeiro Ó, Carvalho J. Dementia and COVID-19: the Ones not to be Forgotten. American Journal of Alzheimer’s Disease & other Dementiasr. 2020; 35: 153331752094750.
• [18] Vaitheswaran S, Lakshminarayanan M, Ramanujam V, Sargunan S, Venkatesan S. Experiences and Needs of Caregivers of Persons with Dementia in India during the COVID-19 Pandemic—a Qualitative Study. American Journal of Geriatric Psychiatry. 2020; 28: 1185–1194.
• [19] Mok VCT, Pendlebury S, Wong A, Alladi S, Au L, Bath PM, et al. Tackling challenges in care of Alzheimer’s disease and other dementias amid the COVID‐19 pandemic, now and in the future. Alzheimer’s & Dementia. 2020; 16: 1571–1581.
• [20] Park SS. Caregivers’ Mental Health and Somatic Symptoms During COVID-19. Journals of Gerontology, Series B: Psychological Sciences and Social Sciences. 2021; 76: e235–e240.
• [21] Adams KB. The transition to caregiving: the experience of family members embarking on the dementia caregiving career. Journal of Gerontological Social Work. 2006; 47: 3–29.
• [22] de Vugt ME, Verhey FRJ. The impact of early dementia diagnosis and intervention on informal caregivers. Progress in Neurobiology. 2013; 110: 54–62.
• [23] Schulz R, Beach SR, Czaja SJ, Martire LM, Monin JK. Family Caregiving for Older Adults. Annual Review of Psychology. 2020; 71: 635–659.
• [24] Joling KJ, Windle G, Dröes R, Meiland F, van Hout HPJ, MacNeil Vroomen J, et al. Factors of Resilience in Informal Caregivers of People with Dementia from Integrative International Data Analysis. Dementia and Geriatric Cognitive Disorders. 2016; 42: 198–214.
• [25] McDermott O, Charlesworth G, Hogervorst E, Stoner C, Moniz-Cook E, Spector A, et al. Psychosocial interventions for people with dementia: a synthesis of systematic reviews. Aging & Mental Health. 2019; 23: 393–403.
• [26] Cheng S, Zhang F. A comprehensive meta-review of systematic reviews and meta-analyses on nonpharmacological interventions for informal dementia caregivers. BMC Geriatrics. 2020; 20: 137.
• [27] Killen A, Flynn D, De Brún A, O’Brien N, O’Brien J, Thomas AJ, et al. Support and information needs following a diagnosis of dementia with Lewy bodies. International Psychogeriatrics. 2016; 28: 495–501.
• [28] Innes A, Szymczynska P, Stark C. Dementia diagnosis and post-diagnostic support in Scottish rural communities: experiences of people with dementia and their families. Dementia. 2014; 13: 233–247.
• [29] Teahan Á, Lafferty A, McAuliffe E, Phelan A, O’Sullivan L, O’Shea D, et al. Psychosocial Interventions for Family Carers of People with Dementia: a Systematic Review and Meta-Analysis. Journal of Aging and Health. 2020; 32: 1198–1213.
• [30] Vandepitte S, Van Den Noortgate N, Putman K, Verhaeghe S, Faes K, Annemans L. Effectiveness of Supporting Informal Caregivers of People with Dementia: a Systematic Review of Randomized and Non-Randomized Controlled Trials. Journal of Alzheimer’s Disease. 2016; 52: 929–965.
• [31] Pusey H, Richards D. A systematic review of the effectiveness of psychosocial interventions for carers of people with dementia. Aging & Mental Health. 2001; 5: 107–119.
• [32] Smits CHM, de Lange J, Dröes R, Meiland F, Vernooij-Dassen M, Pot AM. Effects of combined intervention programmes for people with dementia living at home and their caregivers: a systematic review. International Journal of Geriatric Psychiatry. 2007; 22: 1181–1193.
• [33] Boots LMM, de Vugt ME, van Knippenberg RJM, Kempen GIJM, Verhey FRJ. A systematic review of Internet-based supportive interventions for caregivers of patients with dementia. International Journal of Geriatric Psychiatry. 2014; 29: 331–344.
• [34] Lee M, Ryoo JH, Crowder J, Byon HD, Wiiliams IC. A systematic review and meta‐analysis on effective interventions for health‐related quality of life among caregivers of people with dementia. Journal of Advanced Nursing. 2020; 76: 475–489.
• [35] Abrahams R, Liu KPY, Bissett M, Fahey P, Cheung KSL, Bye R, et al. Effectiveness of interventions for co-residing family caregivers of people with dementia: Systematic review and meta-analysis. Australian Occupational Therapy Journal. 2018; 65: 208–224.
• [36] Jones C, Edwards RT, Hounsome B. A systematic review of the cost-effectiveness of interventions for supporting informal caregivers of people with dementia residing in the community. International Psychogeriatrics. 2012; 24: 6–18.
• [37] Cooke DD, Mcnally L, Mulligan KT, Harrison MJG, Newman SP. Psychosocial interventions for caregivers of people with dementia: a systematic review. Aging & Mental Health. 2001; 5: 120–135.
• [38] Moher D, Liberati A, Tetzlaff J, Altman DG, Prisma Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Medicine. 2009; 6: e1000097.
• [39] PEDro. PEDro Scale. 1999. Available at: https://www.pedro.org.au/english/downloads/pedro-scale/ (Accessed: 7 May 2021).
• [40] Waldron EA, Janke EA, Bechtel CF, Ramirez M, Cohen A. A systematic review of psychosocial interventions to improve cancer caregiver quality of life. Psycho-Oncology. 2013; 22: 1200–1207.
• [41] Verhagen AP, De Vet HC, De Bie RA, Kessels AG, Boers M, Bouter LM, et al. The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. Journal of clinical epidemiology. 1998; 51: 1235–1241.
• [42] Kajiyama B, Thompson LW, Eto-Iwase T, Yamashita M, Di Mario J, Marian Tzuang Y, et al. Exploring the effectiveness of an internet-based program for reducing caregiver distress using the iCare Stress Management e-Training Program. Aging & Mental Health. 2013; 17: 544–554.
• [43] Charlesworth G, Shepstone L, Wilson E, Reynolds S, Mugford M, Price D, et al. Befriending carers of people with dementia: randomized controlled trial. British Medical Journal. 2008; 336: 1295–1297.
• [44] Gonyea JG, O’Connor MK, Boyle PA. Project CARE: a Randomized Controlled Trial of a Behavioral Intervention Group for Alzheimer’s Disease Caregivers. Gerontologist. 2006; 46: 827–832.
• [45] Gonyea JG, López LM, Velásquez EH. The Effectiveness of a Culturally Sensitive Cognitive Behavioral Group Intervention for Latino Alzheimer’s Caregivers. Gerontologist. 2016; 56: 292–302.
• [46] Huang H, Shyu YL, Chen M, Chen S, Lin L. A pilot study on a home-based caregiver training program for improving caregiver self-efficacy and decreasing the behavioral problems of elders with dementia in Taiwan. International Journal of Geriatric Psychiatry. 2003; 18: 337–345.
• [47] Núñez-Naveira L, Alonso-Búa B, de Labra C, Gregersen R, Maibom K, Mojs E, et al. UnderstAID, an ICT Platform to Help Informal Caregivers of People with Dementia: a Pilot Randomized Controlled Study. BioMed Research International. 2016; 2016: 1–13.
• [48] Gitlin LN, Winter L, Dennis MP, Hodgson N, Hauck WW. A biobehavioral home-based intervention and the well-being of patients with dementia and their caregivers: the COPE randomized trial. Journal of the American Medical Association. 2010; 304: 983–991.
• [49] Garand L, Rinaldo DE, Alberth MM, Delany J, Beasock SL, Lopez OL, et al. Effects of Problem Solving Therapy on Mental Health Outcomes in Family Caregivers of Persons with a New Diagnosis of Mild Cognitive Impairment or Early Dementia: a Randomized Controlled Trial. American Journal of Geriatric Psychiatry. 2014; 22: 771–781.
• [50] Garand L, Morse JQ, ChiaRebecca L, Barnes J, Dadebo V, Lopez OL, et al. Problem-solving therapy reduces subjective burden levels in caregivers of family members with mild cognitive impairment or early-stage dementia: Secondary analysis of a randomized clinical trial. International Journal of Geriatric Psychiatry. 2019; 34: 957–965.
• [51] Dias A, Dewey ME, D’Souza J, Dhume R, Motghare DD, Shaji KS, et al. The effectiveness of a home care program for supporting caregivers of persons with dementia in developing countries: a randomised controlled trial from Goa, India. PLoS ONE. 2008; 3: e2333.
• [52] Tanner JA, Black BS, Johnston D, Hess E, Leoutsakos J, Gitlin LN, et al. A Randomized Controlled Trial of a Community-Based Dementia Care Coordination Intervention: Effects of MIND at Home on Caregiver Outcomes. American Journal of Geriatric Psychiatry. 2015; 23: 391–402.
• [53] Mittelman MS, Roth DL, Coon DW, Haley WE. Sustained benefit of supportive intervention for depressive symptoms in caregivers of patients with Alzheimer’s disease. American Journal of Psychiatry. 2004; 161: 850–856.
• [54] Mittelman MS, Roth DL, Clay OJ, Haley WE. Preserving health of Alzheimer caregivers: impact of a spouse caregiver intervention. American Journal of Geriatric Psychiatry. 2007; 15: 780–789.
• [55] Mittelman MS, Roth DL, Haley WE, Zarit SH. Effects of a caregiver intervention on negative caregiver appraisals of behavior problems in patients with Alzheimer’s disease: results of a randomized trial. Journals of Gerontology. Series B, Psychological Sciences and Social Sciences. 2004; 59: P27–P34.
• [56] Drentea P, Clay OJ, Roth DL, Mittelman MS. Predictors of improvement in social support: Five-year effects of a structured intervention for caregivers of spouses with Alzheimer’s disease. Social Science & Medicine. 2006; 63: 957–967.
• [57] Berwig M, Heinrich S, Spahlholz J, Hallensleben N, Brähler E, Gertz H. Individualized support for informal caregivers of people with dementia - effectiveness of the German adaptation of REACH II. BMC Geriatrics. 2017; 17: 286.
• [58] Jansen APD, van Hout HPJ, Nijpels G, Rijmen F, Dröes R, Pot A, et al. Effectiveness of case management among older adults with early symptoms of dementia and their primary informal caregivers: a randomized clinical trial. International Journal of Nursing Studies. 2011; 48: 933–943.
• [59] Livingston G, Barber J, Rapaport P, Knapp M, Griffin M, King D, et al. Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomized controlled trial. British Medical Journal. 2013; 347: f6276.
• [60] Livingston G, Barber J, Rapaport P, Knapp M, Griffin M, King D, et al. Long-term clinical and cost-effectiveness of psychological intervention for family carers of people with dementia: a single-blind, randomized, controlled trial. Lancet Psychiatry. 2014; 1: 539–548.
• [61] Cooper C, Barber J, Griffin M, Rapaport P, Livingston G. Effectiveness of START psychological intervention in reducing abuse by dementia family carers: randomized controlled trial. International Psychogeriatrics. 2016; 28: 881–887.
• [62] Whitlatch CJ, Heid AR, Femia EE, Orsulic-Jeras S, Szabo S, Zarit SH. The Support, Health, Activities, Resources, and Education program for early stage dementia: Results from a randomized controlled trial. Dementia. 2019; 18: 2122–2139.
• [63] Bruvik FK, Allore HG, Ranhoff AH, Engedal K. The effect of psychosocial support intervention on depression in patients with dementia and their family caregivers: an assessor-blinded randomized controlled trial. Dementia and Geriatric Cognitive Disorders Extra. 2013; 3: 386–397.
• [64] Seike A, Sumigaki C, Takeuchi S, Hagihara J, Takeda A, Becker C, et al. Efficacy of group‐based multi‐component psycho - education for caregivers of people with dementia: A randomized controlled study. Geriatrics & Gerontology International. 2021; 21: 561–567.
• [65] van Wezel N, van der Heide I, Devillé WL, Kayan Acun E, Meerveld JHCM, Spreeuwenberg P, et al. Effects of an educational peer-group intervention on knowledge about dementia among family caregivers with a Turkish or Moroccan immigrant background: a cluster randomised controlled trial. Patient Education and Counseling. 2021; 104: 1726–1735.
• [66] Brown KW, Coogle CL, Wegelin J. A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia. Aging & Mental Health. 2016; 20: 1157–1166.
• [67] Kor PP, Liu JY, Chien WT. Effects of a modified mindfulness-based cognitive therapy for family caregivers of people with dementia: A randomized clinical trial. Gerontologist. 2020. (in press)
• [68] Judge KS, Yarry SJ, Looman WJ, Bass DM. Improved Strain and Psychosocial Outcomes for Caregivers of Individuals with Dementia: Findings from Project ANSWERS. Gerontologist. 2013; 53: 280–292.
• [69] Wenborn J, O’Keeffe AG, Mountain G, Moniz-Cook E, King M, Omar RZ, et al. Community Occupational Therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID]) study: A single-blind, randomised controlled trial. PLOS Medicine. 2021; 18: e1003433.
• [70] Boots LM, de Vugt ME, Kempen GI, Verhey FR. Effectiveness of a Blended Care Self-Management Program for Caregivers of People with Early-Stage Dementia (Partner in Balance): Randomized Controlled Trial. Journal of Medical Internet Research. 2018; 20: e10017.
• [71] Zwar L, König H, Hajek A. Psychosocial consequences of transitioning into informal caregiving in male and female caregivers: Findings from a population-based panel study. Social Science & Medicine. 2020; 264: 113281.
• [72] Miles L, McCausland BMS, Patel HP, Amin J, Osman-Hicks VC. A systematic review of the provision and efficacy of patient and carer information and support (PCIS) interventions for patients with dementia and their informal carers. Aging Clinical and Experimental Research. 2019; 32: 2439–2448.
• [73] Leven NV, de Lange J, Groenewoud J, van der Ploeg E, Pot AM. Exploring the usefulness of indicators for referring people with dementia and their informal caregivers to activating interventions: a qualitative analysis of needs assessments. BMC Geriatrics. 2019; 19: 230.
• [74] Manthorpe J, Samsi K. Person-centered dementia care: current perspectives. Clinical Interventions in Aging. 2016; 11: 1733–1740.
• [75] Novais T, Dauphinot V, Krolak-Salmon P, Mouchoux C. How to explore the needs of informal caregivers of individuals with cognitive impairment in Alzheimer’s disease or related diseases? A systematic review of quantitative and qualitative studies. BMC Geriatrics. 2017; 17: 86.
• [76] Betini RSD, Hirdes JP, Curtin-Telegdi N, Gammage L, Vansickle J, Poss J, et al. Development and validation of a screener based on interRAI assessments to measure informal caregiver wellbeing in the community. BMC Geriatrics. 2018; 18: 310.
• [77] Dickinson C, Dow J, Gibson G, Hayes L, Robalino S, Robinson L. Psychosocial intervention for carers of people with dementia: What components are most effective and when? A systematic review of systematic reviews. International Psychogeriatrics. 2017; 29: 31–43.
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Shanshan Wang, Johanna de Almeida Mello, Anja Declercq. Assessing psychosocial interventions for informal caregivers of older people with early dementia: a systematic review of randomized controlled evidence. Frontiers in Bioscience-Landmark. 2021. 26(9); 556-571.