Dementia CaregiverEXCITE-PACNCT07396298
The Existential Cognitive Intervention to Enhance Positive Aspect of Caregiving (EXCITE-PAC) in a Dementia Context
A study testing Existential-cognitive intervention to enhance PAC in people with Dementia Caregiver, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Caregiver
- What is being tested?
- Existential-cognitive intervention to enhance PAC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Dec 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- family carers of Chinese PLwDs diagnosed at least six months previously
- caregiving for ≥ 4 hours/day
- Chinese-speaking
- have a mobile device to access virtual meeting via Go-To-Meeting or Zoom
- consent to participate
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The University of Hong Kong
Hong Kong
Sau Fung YU, PhD, +852-39176319, dyu1@hku.hk
About this study
Official title: The Effects and Mediating Mechanism of the Existential Cognitive Intervention to Enhance Positive Aspect of Caregiving (EXCITE-PAC) in a Dementia Context: A Sequential Mixed Method Study
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).
Read more
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:
- 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.
Read the detailed description
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:
- 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.
- Conditions
- Dementia Caregiver
- Being tested
- Existential-cognitive intervention to enhance PAC, Usual care
- Keywords
- Positive aspect of caregiving, dementia caregiver, existential-cognitive intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Existential-cognitive intervention to enhance PACBehavioural
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental : EXCITE-PAC program | Experimental | 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. Receives: Behavioral: Existential-cognitive intervention to enhance PAC |
| Usual care | Placebo comparator | 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start15 Dec 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Dementia CaregiverStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The EXCITE-PAC program is an overall 12-week training and comprises of three phases as follows: 1. Face-to-face home visit. 2. 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. 3. telephone follow-ups will be made to continue supporting goal attainment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Yu, Doris Sau Fung, The University of Hong Kong
- Investigators
- YU YU, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396298
- Sponsor's protocol ID
- EXCITE-PAC
- Acronym
- EXCITE-PAC
- Status last verified
- Nov 2026
- First submitted
- 14 Dec 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available.
Publications
Younas A, Pedersen M, Durante A. Characteristics of joint displays illustrating data integration in mixed-methods nursing studies. J Adv Nurs. 2020 Feb;76(2):676-686. doi: 10.1111/jan.14264. Epub 2019 Nov 25.
PubMed 31713252Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.
PubMed 18352969Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008 Aug;40(3):879-91. doi: 10.3758/brm.40.3.879.
PubMed 18697684Hu, L., & Bentler, P. Cutoff criteria for fit indexes in covariance structure analysis: Conventional criteria versus new alternatives. Structural Equation Modeling: A Multidisciplinary Journal, 1999, 6(1): 1-55.
Rosseel Y; lavaan: An R Package for Structural Equation Modeling. Journal of Statistical Software 2012;48(2):1 - 36. doi: 10.18637/jss.v048.i02.
Singer JD, Willett JB. Applied longitudinal data analysis: modelling change and event occurrence. New York: Oxford University Press, 2003.
Lyonette, C., & Yardley, L. The influence on carer wellbeing of motivations to care for older people and the relationship with the care recipient. Ageing and Society, 2003, 23(4), 487-506.
Quinn C, Clare L, Woods RT. What predicts whether caregivers of people with dementia find meaning in their role? Int J Geriatr Psychiatry. 2012 Nov;27(11):1195-202. doi: 10.1002/gps.3773. Epub 2012 Feb 15.
PubMed 22334416Bengston, V, Schrader, S. Parent-child relations. In Mangen DJ, Peterson WA (eds.), Research Instruments in Social Gerontology (pp. 115-185). Minneapolis, MN: University of Minneapolis Press, 1982.
Leung VP, Lam LC, Chiu HF, Cummings JL, Chen QL. Validation study of the Chinese version of the neuropsychiatric inventory (CNPI). Int J Geriatr Psychiatry. 2001 Aug;16(8):789-93. doi: 10.1002/gps.427.
PubMed 11536346Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005 Mar;14(2):539-47. doi: 10.1007/s11136-004-0704-3.
PubMed 15892443Amirkhan, J., & Greaves, H. Sense of Coherence and Stress: The Mechanics of a Healthy Disposition. Psychology & Health, 2003, 18(1): 31-62. https://doi.org/10.1080/0887044021000044233
Cheng ST, Chan AC. The Center for Epidemiologic Studies Depression Scale in older Chinese: thresholds for long and short forms. Int J Geriatr Psychiatry. 2005 May;20(5):465-70. doi: 10.1002/gps.1314.
PubMed 15852439Gan Y, Guo M, Tong J. Scale development of meaning-focused coping. Journal of Loss and Trauma, 2013; 18: 10-26.
Au A, Lai MK, Lau KM, Pan PC, Lam L, Thompson L, Gallagher-Thompson D. Social support and well-being in dementia family caregivers: the mediating role of self-efficacy. Aging Ment Health. 2009 Sep;13(5):761-8. doi: 10.1080/13607860902918223.
PubMed 19882415
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Mediating Mechanism of the Existential Cognitive Intervention to Enhance Positive Aspect of Caregiving (EXCITE-PAC) in a Dementia Context: A Sequential Mixed Method Study
- ClinicalTrials.gov ID
- NCT07396298
- Acronym / sponsor ID
- EXCITE-PAC / EXCITE-PAC
- Conditions
- Dementia Caregiver
- Keywords
- Positive aspect of caregiving, dementia caregiver, existential-cognitive intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The EXCITE-PAC program is an overall 12-week training and comprises of three phases as follows: 1. Face-to-face home visit. 2. 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. 3. telephone follow-ups will be made to continue supporting goal attainment.
| Arm | Type | Receives |
|---|---|---|
| Experimental : EXCITE-PAC program | Experimental | Behavioral: Existential-cognitive intervention to enhance PACThe 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 | Placebo comparator | Other: Usual careUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- family carers of Chinese PLwDs diagnosed at least six months previously
- caregiving for ≥ 4 hours/day
- Chinese-speaking
- have a mobile device to access virtual meeting via Go-To-Meeting or Zoom
- consent to participate
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Existential-cognitive intervention to enhance PACThe 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. | Behavioural | Experimental : EXCITE-PAC program |
| Usual careUsual 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 |
Primary outcome
The Positive Aspect of Caregiving Instrument
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
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.
The Caregiving Self-Efficacy Scale
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
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.
The Meaning-Focused Coping Scale
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
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.
The 10-item Centre of Epidemiological Studies Depression Scale
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
To evaluate affective symptoms reflecting depression on an ascending 4-point scale of increasing severity.
3 secondary outcomes
The Medical Outcomes Study Short Form Health Survey
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
Positive Affect Index
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
The Intrinsic Motivations to Care
Time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 31713252Younas A, Pedersen M, Durante A. Characteristics of joint displays illustrating data integration in mixed-methods nursing studies. J Adv Nurs. 2020 Feb;76(2):676-686. doi: 10.1111/jan.14264. Epub 2019 Nov 25.
- Background: PubMed 18352969Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.
- Background: PubMed 18697684Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008 Aug;40(3):879-91. doi: 10.3758/brm.40.3.879.
- BackgroundHu, L., & Bentler, P. Cutoff criteria for fit indexes in covariance structure analysis: Conventional criteria versus new alternatives. Structural Equation Modeling: A Multidisciplinary Journal, 1999, 6(1): 1-55.
- BackgroundRosseel Y; lavaan: An R Package for Structural Equation Modeling. Journal of Statistical Software 2012;48(2):1 - 36. doi: 10.18637/jss.v048.i02.
- BackgroundSinger JD, Willett JB. Applied longitudinal data analysis: modelling change and event occurrence. New York: Oxford University Press, 2003.
- BackgroundLyonette, C., & Yardley, L. The influence on carer wellbeing of motivations to care for older people and the relationship with the care recipient. Ageing and Society, 2003, 23(4), 487-506.
- Background: PubMed 22334416Quinn C, Clare L, Woods RT. What predicts whether caregivers of people with dementia find meaning in their role? Int J Geriatr Psychiatry. 2012 Nov;27(11):1195-202. doi: 10.1002/gps.3773. Epub 2012 Feb 15.
- BackgroundBengston, V, Schrader, S. Parent-child relations. In Mangen DJ, Peterson WA (eds.), Research Instruments in Social Gerontology (pp. 115-185). Minneapolis, MN: University of Minneapolis Press, 1982.
- Background: PubMed 11536346Leung VP, Lam LC, Chiu HF, Cummings JL, Chen QL. Validation study of the Chinese version of the neuropsychiatric inventory (CNPI). Int J Geriatr Psychiatry. 2001 Aug;16(8):789-93. doi: 10.1002/gps.427.
- Background: PubMed 15892443Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005 Mar;14(2):539-47. doi: 10.1007/s11136-004-0704-3.
- BackgroundAmirkhan, J., & Greaves, H. Sense of Coherence and Stress: The Mechanics of a Healthy Disposition. Psychology & Health, 2003, 18(1): 31-62. https://doi.org/10.1080/0887044021000044233
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YU YU, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Existential-cognitive intervention to enhance PAC in people with Dementia Caregiver, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sau Fung YU, PhD (+852-39176319, dyu1@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Positive Aspect of Caregiving Instrument (time frame: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07396298, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.