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

NCT07396298 | Not Yet Recruiting

• 1 other identifier: EXCITE-PAC
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia Caregiver

Keywords

Positive aspect of caregiving; dementia caregiver; existential-cognitive intervention

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).

• Positive Affect Index

  Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).

• The Intrinsic Motivations to Care

  Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).

Study Arms (2)

Experimental : EXCITE-PAC program

EXPERIMENTAL

The EXCITE-PAC program is an overall 12-week training and comprises of three phases as follows: 1. Face-to-face home visit (week 1) - it will commence with a home visit to establish narrative-based caregiver biographies. 2. Group-based virtual meetings (Weeks 2-8), Over the next 7 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 evolvement of PAC. 3. telephone follow-ups (Weeks 10-12) - Thereafter, two bi-weekly telephone calls will be made to continue supporting goal attainment.

Other: 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.

Other: Usual care

Interventions

existential-cognitive intervention to enhance PAC OTHER

The EXCITE-PAC program is an overall 12-week training and comprises of three phases as follows: 1. Face-to-face home visit (week 1) - it will commence with a home visit to establish narrative-based caregiver biographies. 2. Group-based virtual meetings (Weeks 2-8), Over the next 7 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 evolvement of PAC. 3. telephone follow-ups (Weeks 10-12) - Thereafter, two bi-weekly telephone calls will be made to continue supporting goal attainment.

Experimental : EXCITE-PAC program

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (40)

• Younas A, Pedersen M, Durante A. Characteristics of joint displays illustrating data integration in mixed-methods nursing studies. Journal of Advanced Nursing, 2020. 76(2): 676-686.

  BACKGROUND

• Elo, S., & Kyngäs, H. The qualitative content analysis process. Journal of Advanced Nursing, 2008, 62(1):107-115.

  BACKGROUND

• Preacher, K. J., & Hayes, A. F. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behavior Research Methods, 2008, 40(3): 879-891.

  BACKGROUND

• Hu, 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.

  BACKGROUND

• 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.

  BACKGROUND

• Singer JD, Willett JB. Applied longitudinal data analysis: modelling change and event occurrence. New York: Oxford University Press, 2003.

  BACKGROUND

• 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.

  BACKGROUND

• Quinn C, Clare L, Woods RT. What predicts whether caregivers of people with dementia find meaning in their role? International Journal of Geriatric Psychiatry 2012; 27:1195-1202.

  BACKGROUND

• Bengston, 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

• Leung VP, Lam LC, Chiu HF, Cummings JL, Chen QL. Validation study of the Chinese version of the neuropsychiatric inventory. International Journal of Geriatric Psychiatry, 2000, 16(8):789-93.

  BACKGROUND

• Lam CL, Tse EY, Gandek B. Is the standard SF-12 Health Survey valid and equivalent for a Chinese population? Quality of Life Research. 2005, 4:539-547.

  BACKGROUND

• Amirkhan, 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

  BACKGROUND

• Cheng, S., & Chan, A. The Center for Epidemiologic Studies Depression Scale in older Chinese: Thresholds for long and short forms. International Journal of Geriatric Psychiatry, 2005, 20(5): 465-470.

  BACKGROUND

• Gan Y, Guo M, Tong J. Scale development of meaning-focused coping. Journal of Loss and Trauma, 2013; 18: 10-26.

  BACKGROUND

• Au A, Lai M, Lau K, Pan P, Lam L. Social support and well-being in dementia family caregivers.: the mediating role of self-efficacy. Aging & Mental Health 2009, 3:761-768.

  BACKGROUND

• Lou VWQ, Lau BHP, Cheung KSL. Positive aspects of caregiving: Scale validation among Chinese dementia caregivers (CG). Achieves of Gerontology & Geriatrics 2015, 60: 299-306.

  BACKGROUND

• Yu DSF, Cheng ST, Wang J. Unravelling positive aspects of caregiving in dementia: An integrative review of research literature. International Jouranl of Nursing Studies. 2018 Mar;79:1-26.

  BACKGROUND

• Yu DSF, Cheng ST, Chow EOW, Kwok T, McCormack B, Wu W. The effects of a salutogenic strength-based intervention on sense of coherence and health outcomes of dementia family carers: A randomized controlled trial, Age and Ageing, 2023, 52(9): afad160

  BACKGROUND

• Loehlin, John C. Latent Variable Models: An Introduction to Factor, Path, and Structural Equation Analysis (4th ed.). Psychology Press, 2004.

  BACKGROUND

• Park CL. The Meaning Making Model: A framework for understanding meaning, spirituality, and stress-related growth in health psychology. The Eur Health Psychologist, 2013; 15: 40-47.

  BACKGROUND

• Hedeker, D., Gibbons, R., & Waternaux, C. Sample Size Estimation for Longitudinal Designs with Attrition: Comparing Time-Related Contrasts between Two Groups. Journal of Educational and Behavioural Statistics, 1999, 24(1): 70-93.

  BACKGROUND

• Cheng ST, Li KK, Losada A, Zhang F, Au A, Thompson LW, Gallagher-Thompson D. The effectiveness of nonpharmacological interventions for informal dementia caregivers: An updated systematic review and meta-analysis. Psychology and Aging, 2020, 35(1):55-77.

  BACKGROUND

• Mittelmark MB, Bauer GF. Salutogenesis as a Theory, as an Orientation and as the Sense of Coherence. 2022 Jan 1. In: Mittelmark MB, Bauer GF, Vaandrager L, et al., editors. The Handbook of Salutogenesis [Internet]. 2nd edition. Cham (CH): Springer; 2022.

  BACKGROUND

• Tropen Y, Liberman N. "Construal-level theory of psychological distance". Psychological Review. 2010, 117 (2): 440-463.

  BACKGROUND

• González-Prendes, A., & Resko, S. M. (2012). Cognitive-behavioral theory. Trauma: Contemporary directions in theory, practice, and research, 14-41.

  BACKGROUND

• Wong PT P. Existential positive psychology. In S. Lopez (Ed.), Encyclopedia of positive psychology (2nd ed.). Oxford, UK: Wiley Blackwell

  BACKGROUND

• Yu DSF, Cheng ST, Chen K, Predicting positive aspect of caregiving in a dementia caregiving context: a longitudinal model testing. International Journal of Nursing Studies. Under review.

  BACKGROUND

• Yu DSF, Cheng ST, Kwok T. Developing and testing of an integrative theoretical model to predict positive aspects of caregiving among family caregivers of persons with dementia: A study protocol. Journal of Advanced Nursing. 2021 Jan;77(1):401-410.

  BACKGROUND

• Mausbach BT, Coon DW, Depp C, Rabinowitz YG, Wilson-Arias E, Kraemer HC, Thompson LW, Lane G, Gallagher-Thompson D. Ethnicity and time to institutionalization of dementia patients: a comparison of Latina and Caucasian female family caregivers. Journal of American Geriatric Society 2004; 52:1077-1084.

  BACKGROUND

• Hirschfeld M. Home care versus institutionalization: family caregiving and senile brain disease. Int J Nurs Stud 2003; 40:463-469.

  BACKGROUND

• Cohen CA, Gold DP, Shulman KI, Zucchero CA. Positive aspects in caregiving: An overlooked variable in research. Canadian Journal of Aging 1994; 13:378-391.

  BACKGROUND

• Rapp SR, Chao D. Appraisals of strain and of gain: Effects on psychological wellbeing of caregivers of dementia patients. Aging and Mental Health 2000; 4:142-147.

  BACKGROUND

• Williams IC. Emotional health of black and white dementia caregivers: A contextual examination. J Gerontol B Psychol Sci Soc Sci 2005; 60: P287-P295.

  BACKGROUND

• Narayan S, Lewis M, Tornatore J, Hepburn K, Corcoran-Perry S. Subjective responses to caregiving for a spouse with dementia. Journal of Gerontological Nursing 2001; 27:19-28.

  BACKGROUND

• Andrén S, Elmståhl S. Family caregivers' subjective experiences of satisfaction in dementia care: aspects of burden, subjective health and sense of coherence. Scandinavian Journal of Caring Science 2005; 19:157-168.

  BACKGROUND

• Valimaki T.H., Martikainen J.A., Hongisto K., Vaatainen S., Sintonen H., Koivisto A.M. Impact of Alzheimer's disease on the family caregiver's long-term quality of life: Results from an ALSOVA follow-up study. Qual. Life Res. 2016;25:687-697.

  BACKGROUND

• Shin JH, Kim JH. Family Caregivers of People with Dementia Associate with Poor Health-Related Quality of Life: A Nationwide Population-Based Study. International Journal of Environmental Research and Public Health. 2022 Dec 5;19(23):16252.

  BACKGROUND

• Papastavrou E, Kaloderinou A, Papacostas SS, Tsangari H, Sourtzi P. Caring for a relative with dementia: Family caregiver burden. Journal of Advanced Nursing 2007; 58: 446-457.

  BACKGROUND

• Global action plan on the public health response to dementia 2017-2025. Geneva: World Health Organization; 2017. License: CC BY-NC-SA 3.0 IGO.

  BACKGROUND

• Alzhimer disease international. Dementia statistics. Access from https://www.alzint.org/about/dementia-facts-figures/dementia-statistics/ on 27th Sept 2023

  BACKGROUND

Study Officials

• YU YU, RN, PhD, FHKAN, FAAN, FGSA

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YU Sau Fung, RN, PhD, FHKAN, FAAN, FGSA

CONTACT

852 + 39176319; dyu1@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The pilot randomized controlled trial will be conducted in two elderly community centers of a non-government organization in Hong Kong. Participants will be randomized into intervention group and control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proferssor

Model Details: The EXCITE-PAC program is an overall 12-week training and comprises of three phases as follows: 1. Face-to-face home visit (week 1) - it will commence with a home visit to establish narrative-based caregiver biographies. 2. Group-based virtual meetings (Weeks 2-8), Over the next 7 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 evolvement of PAC. 3. telephone follow-ups (Weeks 10-12) - Thereafter, two bi-weekly telephone calls will be made to continue supporting goal attainment.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: February 9, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)