An interventional study of Existential-cognitive intervention to enhance PAC and Usual care in Dementia Caregiver, sponsored by The University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
Research evidence is emerging on the co-existence of a positive caregiving experience in the physically and psychosocially taxing dementia care context, but 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 pilot mixed-method study comprising a randomised controlled trial and a post-trial qualitative interview 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.
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.
Research evidence is emerging on the co-existence of a positive caregiving experience in the physically and psychosocially taxing dementia care context, but 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).
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
This sequential mixed-method study will include a double-blind randomised controlled trial and a post-trial qualitative study.
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. 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.
For the qualitative interviews, a purposive subsample of 30 family carers who have completed the EXCITE-PAC programme will be recruited.
The 12-week EXCITE-PAC programme is underpinned by existential positive psychology, 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.
The 12-week EXCITE-PAC programme adopts a hybrid mode, including a face-to-face home visit, group-based virtual meetings, and telephone follow-ups.
The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
The EXCITE-PAC program is an overall 12-week training and comprises of three phases as follows: Face-to-face home visit to establish narrative-based caregiver biographies. Group-based virtual meetings with video-guided self-distancing cognitive reappraisal to enhance emotional regulation and meaning-making. The goal-oriented empowerment approach will be used to facilitate carers' use of reframing and refocusing techniques in the day-to-day caregiving proces. Telephone follow-ups will be made to continue supporting goal attainment.
Behavioral: Existential-cognitive intervention to enhance PAC
Usual care will be provided to the control group which mainly covers the social activities offered by the affiliated center. The participants are requested not to join any activities relating to cognitive training or auditory training before the post-test data collection.
Other: Usual care
The EXCITE-PAC program is an overall 12-week training and comprises of three phases as follows: Face-to-face home visit to establish narrative-based caregiver biographies. Group-based virtual meetings with video-guided self-distancing cognitive reappraisal to enhance emotional regulation and meaning-making. The goal-oriented empowerment approach will be used to facilitate carers' use of reframing and refocusing techniques in the day-to-day caregiving proces. Telephone follow-ups will be made to continue supporting goal attainment.
Usual care will be provided to the control group which mainly covers the social activities offered by the affiliated center. The participants are requested not to join any activities relating to cognitive training or auditory training before the post-test data collection.
The Positive Aspect of Caregiving Instrument
To evaluate self-affirmation and outlook on life. It is a 5-point Likert scale, with higher total scores (ranging from 11-55) indicating a more positive perception of the caregiving role.
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
The Caregiving Self-Efficacy Scale
To evaluate self-efficacy of carers in managing disturbing behaviour, controlling upsetting thoughts and obtaining a respite in caring for of the PLwD, with higher scores representing greater self-confidence. It is a 15-item tool used to assess caregivers' confidence in managing caregiving situations, rated on a 0-100 scale. Higher score indicate stronger self-efficacy.
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
The Meaning-Focused Coping Scale
To evaluate meaning-focused coping, including changes in situational and global beliefs, goals, meaning making, long-term prevention strategies, rational resource use, acceptance and heuristic thinking. It is a 26-items tool using a 7-point Likert scale, higher scores indicating a higher level of meaning-focused coping.
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
The 10-item Centre of Epidemiological Studies Depression Scale
To evaluate affective symptoms reflecting depression on an ascending 4-point scale of increasing severity.
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
The Medical Outcomes Study Short Form Health Survey
To evaluate the quality of life with 8 dimensional scores and two component scores to capture physical and mental health. Higher scores indicate less disability
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
Positive Affect Index
To evaluate the participants' positive affect toward the dementia patient. The higher score indicate higher positive affect of respondant.
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
The Intrinsic Motivations to Care
To evaluate the intrinsic motivations of family caregivers to provide care to the PWD. The scale generally uses a 7-point Likert scale (ranging from 1, "not at all true" to 7, "very true") to gauge the intensity of motivation.
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
Plan to share: No — There is not a plan to make individual participant data (IPD) available.
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