The Existential Cognitive Intervention to Enhance Positive Aspect of Caregiving (EXCITE-PAC) in a Dementia Context

The global prevalence of dementia is escalating. Alzheimer's Disease International reports that 10 million people worldwide are diagnosed with dementia each year, indicating that there will be 78 million people living with dementia (PLwD) by 2030 and 139 million by 2050. The economic implications are significant, with the global cost of care estimated to total US$2 trillion by 2030. Figures from 2019 suggest that about 50% of this cost can be attributed to informal care, the majority of it provided by family caregivers. Supporting family carers of PLwD has therefore been recognised by the World Health Organisation as a high priority in the Global Action Plan on Dementia 2017-2025.

As a progressive debilitating syndrome characterised by cognitive deficits, mood and behavioural problems, and subsequent disability, dementia makes family caregiving for PLwD highly challenging, stressful and frustrating. A nationwide study on the health impact of family caregiving for PLwD found that family carers reported poorer health-related quality of life in the aspects of mobility, self-care, activity, pain/discomfort and emotions than non-carers, with the disparity remaining significant after three years. Sustaining invaluable informal care support for PLwD thus demands effective strategies for enhancing carers' role adaptation and health status.

Mainstream research on the adaptation process of family carers focuses on reducing their stressful caregiving experience and the associated health threats. Although research evidence is emerging on the co-existence of a positive caregiving experience in the physically and psychosocially taxing dementia care context, little attention has been paid to promoting the positive aspects of caregiving (PAC) among family carers. PAC is conceptualised as the extent to which the caregiving experience is seen as enriching an individual's life space and yielding positive consequences. Instead of being located at the opposite end of a caregiving burden continuum, PAC is a separate dimension that captures the experience of carers. A significant body of research has accumulated on the protective effects of PAC against the detrimental health impact of caregiving among family carers of PLwD, including lessening anxiety and depression, reducing the perceived disturbance of behavioural symptoms, and enhancing subjective health. A high level of PAC among family carers is also associated with a reduced risk of PLwD institutionalisation. The lack of a proactive method to enhance PAC for carers may be related to PAC being cultivated internally among family carers through a complex process of adjusting values and reframing the caregiving experience to schemata that are compatible with carers' own life philosophies, missions and priorities. Theoretical guidance on the evolving PAC process is therefore warranted to inform the development of interventions to promote PAC.

The investigators have developed an integrative theoretical model based on the stress coping paradigm and existential paradigm to predict PAC in the dementia context. Empirical evaluation of the model in a longitudinal cohort study elucidated the underlying mechanism explaining such evolvement. Based on these findings, the investigators adopt the paradigm of existential positive psychology, which integrates cognitive behavioural theory, construal level theory and Antonovsky's theory of salutogenesis, to pioneer an existential-cognitive intervention to enhance PAC (EXCITE-PAC), and therefore the health outcomes of family carers of PLwD. A randomised controlled trial is proposed to evaluate the effects of EXCITE-PAC on carers' health and to explore whether those effects (if any) are mediated through a change in PAC. Post-trial interviews with carers will elucidate the experience and perceived effects.

The proposed study will bring about important theoretical and public health advances. Theoretically, the study will inform the validity of an integrative theoretical paradigm to enrich the life space of family carers in the dementia care context by increasing the carer's encounters with PAC. This theoretical paradigm, if valid, can complement the stress coping paradigm to reshape the caregiving experience of family carers of PLwD. As for the public health implications, EXCITE-PAC, if proved effective, will respond to the Global Action Plan on Dementia by promoting carers' health. More importantly, as enriching the PAC of carers involves empowering them to internalise a new perspective on the experience of dementia caregiving, a more sustainable and ever-evolving positive effect on their role adaptation and health status can be expected. Together with a comprehensive evaluation of outcomes and end-users' experience, the knowledge generated from this study can be readily translated into dementia care service development and policy settings.

Overall aim \& objectives

This sequential mixed-method study aims to:

i) evaluate the effects of the 12-week EXCITE-PAC programme on PAC (primary outcome), Health-related quality of life (HRQoL), depression, caregiving self-efficacy and meaning-making among the family carers of PLwD; ii) explore whether the health benefits of EXCITE-PAC, if any, are mediated through improved PAC at the 36-week (i.e., about 6 months) follow-up endpoints; and iii) explore carers' perceptions of the benefits, limitations and acceptability of the EXCITE-PAC programme.

Objectives i) To evaluate the effects of the existential-cognitive intervention to enhance the positive aspects of caregiving (EXCITE-PAC) on PAC and the health outcomes of family carers of persons living with dementia (PLwD).

ii) To evaluate whether the positive health effects of EXCITE-PAC, if any, are mediated through a change in PAC.

iii) To explore the experience of family carers in engaging with EXCITE-PAC, as well as the perceived intervention effects.

Hypotheses

Family carers who receive the 12-week EXCITE-PAC programme will report more positive changes in i) PAC, ii) HRQoL, iii) depression, iv) self-efficacy in caregiving, and v) meaning-making upon programme completion (12 weeks), and at 24 weeks and 36 weeks, than those who receive a 12-week education programme on dementia caregiving.

The changes in HRQoL and depression among family carers from baseline to the three post-test endpoints will be mediated by an improvement in PAC.

Research method

1. Study setting and participants

This sequential mixed-method study will include a double-blind randomised controlled trial and a post-trial qualitative study. Blinding procedures will be achieved in that the data collectors for the post-test results will be blinded to group status, and participants will not be informed about whether EXCITE-PAC or structured education is the tested intervention. They will only be informed that they have been assigned to Programme A or Programme B. Family carers of PLwD will be recruited from dementia caregiver hubs supported by various NGOs. The inclusion criteria are: i) family carers of Chinese PLwD diagnosed at least six months previously; ii) caregiving for ≥ 4 hours/day; iii) Chinese-speaking; iv) having a mobile device to access virtual meetings via GoToMeeting or Zoom; and v) providing consent to participate. Power analysis guides the sample size estimation. Although no study to date has adopted the existential positive psychology paradigm to improve PAC, a systematic review reported the effect size (Hedges' g) of a non-pharmacological intervention on PAC to be 0.31 and 0.89 for the post-intervention and follow-up evaluations, respectively, with the inclusion of counselling or psychotherapy further enhancing the effect. The investigators thus conservatively assume that EXCITE-PAC will achieve at least a small effect of 0.35 on PAC. A total of 304 family carers will be needed (power: 80%; α: 0.05; attrition rate: 15%). Permuted block randomisation (block size: 8, 12, 16) with computer-generated random codes will be performed to allocate participants in a 1:1 ratio to the EXCITE-PAC or education programme using the "sequentially numbered, opaque sealed envelopes" procedure. This sample size is sufficient to conduct path analysis examining the mediating effects of PAC.

For the qualitative interviews, a purposive subsample of 30 family carers who have completed the EXCITE-PAC programme will be recruited. To optimise sample variation, participants with different treatment responses to EXCITE-PAC will be recruited, with 10 participants each from the 0-35th percentile, \>35th-70th percentile and \>70th percentile ranges of change in PAC, and variation in the sample's socio-demographic characteristics will also be maximised. The interviews will be audio-recorded for analysis. 2. Tested intervention: EXCITE-PAC

The 12-week EXCITE-PAC programme is underpinned by existential positive psychology, which integrates the use of self-distancing cognitive reappraisal techniques to enhance emotional regulation and meaning-making with respect to the purpose and significance of dementia caregiving. A strength-based approach that includes narrative and empowerment strategies will be integrated to further optimise meaning-making in the dimensions of sense of coherence (SOC) and self-efficacy in caregiving. A research assistant (RA1) with a Bachelor's degree in psychology, gerontology or social science will deliver the intervention. The multi-disciplinary research team, which has expertise in cognitive-behavioural, narrative and empowerment interventions, and dementia caregiving, will provide two weeks of training. A standard protocol has been developed to guide the implementation of EXCITE-PAC, the overall design of which is outlined in Figure 2.

The 12-week EXCITE-PAC programme adopts a hybrid mode, including a face-to-face home visit (Week 1), group-based virtual meetings (Weeks 2-8), and telephone follow-ups (Weeks 10-12). EXCITE-PAC will commence with a home visit to establish narrative-based caregiver biographies. Over the next seven weeks, weekly virtual group-based meetings will be held, during which video-guided self-distancing cognitive reappraisal will be used to enhance emotional regulation and meaning-making. The goal-oriented empowerment approach will be used in the virtual meetings to facilitate carers' use of reframing and refocusing techniques in the day-to-day caregiving process to promote the PAC. Thereafter, two bi-weekly telephone calls will be made to continue supporting goal attainment.

• The Medical Outcomes Study Short Form Health Survey [Срок оценки: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).]
• Positive Affect Index [Срок оценки: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).]
• The Intrinsic Motivations to Care [Срок оценки: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).]