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

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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 (Estimated): September 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)