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

September 3, 2026 updated by: Prof. Yu, Doris Sau Fung, The University of Hong Kong

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).

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

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.

Study Type

Interventional

Enrollment (Estimated)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sau Fung YU, PhD
  • Phone Number: +852-39176319
  • Email: dyu1@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong
        • Contact:
          • Sau Fung YU, PhD
          • Phone Number: +852-39176319
          • Email: dyu1@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Usual care
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
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.
Experimental: Experimental : EXCITE-PAC program

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
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.
Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
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.
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
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.
Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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).
To evaluate the participants' positive affect toward the dementia patient. The higher score indicate higher positive affect of respondant.
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).
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.
Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: YU YU, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

December 14, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EXCITE-PAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data (IPD) available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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