Clinical Trial

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

Study acronym: EXCITE-PAC
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Summary
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. We adopt the paradigm of existential positive psychology, integrating cognitive behavioural theory, construal level theory, and Antonovsky's theory of salutogenesis to develop an existential-cognitive intervention to enhance positive aspects of caregiving (EXCITE-PAC), and thereby improve the health outcomes of family carers of people living with dementia (PLwD). A randomised controlled trial is proposed to evaluate the effects of EXCITE-PAC on carers' health and to examine whether any such effects are mediated through changes in PAC. Post-trial interviews with carers will further elucidate their experiences of the intervention and their perceptions of its impact. The proposed study will yield important theoretical and public health advances. Theoretically, it will test the validity of an integrative paradigm designed to enrich the life space of family carers in the context of dementia care by increasing their opportunities to experience PAC. If supported, this paradigm can complement the dominant stress-coping framework and help reshape the caregiving experience of family carers of PLwD. From a public health perspective, if EXCITE-PAC proves effective, it will respond to the WHO Global Action Plan on Dementia by promoting carers' health. Crucially, by enriching carers' PAC through empowering them to internalise a new perspective on dementia caregiving, the intervention has the potential to foster more sustainable and evolving positive effects on role adaptation and health status. Together with a comprehensive evaluation of outcomes and end-user experiences, the knowledge generated from this study can be readily translated into dementia care service development and policy. This is a pilot mixed-method study comprising a randomised controlled trial and a post-trial qualitative interview. The inclusion criteria are: i) family carers of Chinese PLwDs diagnosed at least six months previously; ii) caregiving for ≥ 4 hours/day; iii) Chinese-speaking; iv) have a mobile device to access virtual meetings via Go-To-Meeting or Zoom; and iv) consent to participate. After the baseline outcome evaluation, they will be randomised to receive the 12-week EXCITE-PAC program or usual care. The program comprises three phases, including i) face-to-face home visit, ii) group-based virtual meetings, and iii) telephone follow-ups. The outcome evaluation on i) PAC, ii) Health-related quality of life (HRQoL), iii) depression, iv) self-efficacy in caregiving, and v) meaning-making upon programme completion will be assessed at baseline, in the 12th and 18th weeks. Qualitative interviews will be conducted.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-02-03; most recent amendment 2026-04-28.
Trial Details
NCT Number NCT07396298
Lead Sponsor The University of Hong Kong
Conditions Dementia Caregiver
Enrollment 304 participants
Start Date 2026-09-15
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-31