Clinical trial NCT04548089: Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) : A Waitlist Randomized Controlled Trial
Official title: Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) - Empowering Resilience and Holistic Wellbeing for Sustaining Family Caregiving: A Waitlist Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caregiver Burnout
Caregiver Stress
Keywords: Dementia Caregiving, Caregiver Stress, Caregiver Burden
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
Collaborators: name: Tan Tock Seng Hospital
name: Khoo Teck Puat Hospital
First posted: 2020-09-14
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Upon referrals made by the collaborating institutions and other community dementia-care organizations, consenting caregivers will be allocated to either the immediate treatment group or wait-list control group. Baseline assessment \[T1\] is conducted through face-to-face interviews, or self-administered questionnaires, facilitated by the research team.

Participants assigned to the treatment group will then attend a 4-week MCAT-DC programme conducted jointly by an experienced mindfulness practitioner and a credentialed art therapist or artist. Thereafter, immediate post intervention assessment \[T2\] will be carried out, with follow-up assessments at 4 weeks \[T3\], 3-months \[T4\] and 6-month \[T5\]. Participants assigned to the wait-list control group will be assessed at second baseline \[T2\], thereafter, attend a 4-week MCAT-DC programme, followed by an immediate post intervention assessment \[T3\], as well as follow-up assessments at 3-months \[T4\] and 6-months \[T5\].
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The current study builds on the empirical foundation of Mindful-Compassion Art Therapy (MCAT) to test its efficacy as a multicomponent, holistic, psycho-socio-spiritual intervention for supporting dementia family caregivers. MCAT is a group-based intervention that integrates mindfulness meditation and art therapy, with reflective awareness complementing emotional expression, to foster self-compassion and inner-resilience among professional caregivers. A wait-list RCT design is adopted to refine and extend the application of MCAT to empower self-care and resilience among 102 dementia family caregivers recruited via community-based dementia-care organizations in Singapore. The expected outcomes will advance theory and practice for sustainable dementia family caregiving in Singapore and around the globe.

Detailed description: Background: Dementia is a neurodegenerative disease that leads to irreversible decline in one's cognitive and functional capacity, identity, and personhood. In Singapore, the number of persons with dementia is expected to soar to 187,000 by 2050. Hence, it is imperative to render comprehensive support to dementia sufferers, and especially their family caregivers. While local initiatives have raised public awareness and developed services for dementia care, they do not adequately address the psycho-socio-spiritual needs of family caregivers, as caregiving stress can greatly impede one's mental and emotional health. International research for dementia family caregivers has thus focused on developing multicomponent interventions that accentuate holistic support to promote healthy and sustainable caregiving.

Objective and Methods: Building on the established MCAT protocol (Ho et al., 2019), this study will adopt a wait-list randomized controlled trial design to test the efficacy of the refined version of Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) among 102 dementia family caregivers in Singapore. This study aims to: 1) develop a disease-specific version of MCAT for Dementia Care (MCAT-DC); 2) assess MCAT-DC's effectiveness in reducing caregiver stress and burden; 3) assess MCAT-DC's effectiveness for reducing caregivers' depressive symptoms and psychophysiological distress, while enhancing resilience, hope, spirituality, meaning and quality-of-life; and 4) assess the feasibility and acceptability of a standardized MCAT-DC protocol for large-scale implementation.

Significance: MCAT is an effective psycho-social-spiritual intervention for reducing stress and promoting holistic wellbeing among professional caregivers. It has received wide recognition and distinction among palliative care and research communities for its clinical innovation and effectiveness. Given the robust evidence on MCAT's positive impact on professional caregivers, it is anticipated that a refined version of MCAT will have similar, if not greater, benefits for family caregivers. The study findings will form new knowledge to advance both theory and practice for sustainable dementia family caregiving in Singapore and around the globe.

Eligibility criteria: Inclusion Criteria:

* Informal caregiver of a family member with diagnosed with dementia
* Fluent in written and verbal english

Exclusion Criteria:

* Unable to provide informed consent
* Diagnosed with major mental conditions or cognitive impairment

Primary outcomes:
measure: Change in scores on Caregiver Distress (HADS) from baseline
timeFrame: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].
measure: Change in scores on Caregiver Burden (ZBI-12) from baseline
timeFrame: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].
Secondary outcomes:
measure: Change in scores on Depressive Symptoms (PHQ-4) from baseline
timeFrame: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].
measure: Change in scores on Resilience (ER89-R) from baseline
timeFrame: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].
measure: Change in scores on Hope (HHI) from baseline
timeFrame: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].
measure: Change in scores on Spirituality (FACIT-Sp) from baseline
timeFrame: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].
measure: Change in scores on Support with Grief (ISS) from baseline
timeFrame: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].
measure: Change in scores on Quality of Life (WHOQoL-8) from baseline
timeFrame: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].
Other outcomes:
measure: Heart Rate Variability
timeFrame: Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital (Centre for Geriatric Medicine)
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital (Department of Palliative Medicine)
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
Study officials:
affiliation: Nanyang Technological University
name: Andy HY Ho, PhD, EdD
role: PRINCIPAL_INVESTIGATOR
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