Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) : A Waitlist Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) - Empowering Resilience and Holistic Wellbeing for Sustaining Family Caregiving: A Waitlist Randomized Controlled Trial

Conditions
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Caregiver Burnout, Caregiver Stress

Intervention / Treatment
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* Behavioral: Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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].
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention Group<br>Participants assigned to the immediate intervention group will engage in a 4-week 2.5-hour Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) with intervention elements of brief psycho-education, weekly mindfulness meditation, facilitated creative art making, reflective writing, group sharing and discussion. | Behavioral: Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)<br>* Each Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) will focus on 3 major areas that cultivate self-care, resilience and communal support. The specific intervention structure include: Week 1 - Empowering Self-Care: Introduction to the science of stress, self-care, burnout, as well as the arts and mindfulness to cultivate resilience; Week 2 - Reflective Caregiving: Reflection of caregiving experiences that demonstrates strengths and challenges; Week 3 - Understanding Loss: Introduction to the science of loss, how grief can impair hope and wellbeing, and how self-compassion can help transform suffering into blessings.; Week 4 - Meaning Reconstruction: Reflection on caregiver identities, to elicit the lessons and wisdoms learnt, and to create renewed meaning to sustain their caregiving journeys. Guided mindfulness mediation will also be professionally recorded to form a daily take-home mindfulness mediation exercise for participants, each exercise will last 10-20 minutes.<br>|
| Experimental: Waitlist Control Group<br>Participants assigned to the wait-list control group will not receive Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) until one month after baseline assessment. | Behavioral: Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)<br>* Each Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) will focus on 3 major areas that cultivate self-care, resilience and communal support. The specific intervention structure include: Week 1 - Empowering Self-Care: Introduction to the science of stress, self-care, burnout, as well as the arts and mindfulness to cultivate resilience; Week 2 - Reflective Caregiving: Reflection of caregiving experiences that demonstrates strengths and challenges; Week 3 - Understanding Loss: Introduction to the science of loss, how grief can impair hope and wellbeing, and how self-compassion can help transform suffering into blessings.; Week 4 - Meaning Reconstruction: Reflection on caregiver identities, to elicit the lessons and wisdoms learnt, and to create renewed meaning to sustain their caregiving journeys. Guided mindfulness mediation will also be professionally recorded to form a daily take-home mindfulness mediation exercise for participants, each exercise will last 10-20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on Caregiver Distress (HADS) from baseline | Caregiver Distress is assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item scale that evaluates levels of anxiety and depression (Zigmond & Snaith, 1983; Snaith, 2003) | 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]. | 
| Change in scores on Caregiver Burden (ZBI-12) from baseline | Caregiver burden is assessed by the Zarit Burden Interview-Short (ZBI-12), a 12-item self-reported questionnaire comprising of three subscales of role-strain, self-criticism, and negative emotions (Tang et al., 2016). | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on Depressive Symptoms (PHQ-4) from baseline | Depressive symptoms is assessed by the Patient Health Questionnaire (PHQ-4), a reliable and widely used self-reported scale (Kroenke, 2009). | 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]. | 
| Change in scores on Resilience (ER89-R) from baseline | Trait resilience is assessed by the 10-item Ego-Resilience Revised Scale (ER-89R) (Alessandri et al., 2011). | 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]. | 
| Change in scores on Hope (HHI) from baseline | Hope is assessed by the 12-item Herth Hope Index (HHI) (Herth, 1992). | 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]. | 
| Change in scores on Spirituality (FACIT-Sp) from baseline | Spirituality is assessed by the Peace and Meaning sub-scales (8-items) of the 'Functional Assessment of Chronic Illness Therapy - Spiritual Wellbeing Scale' (FACIT-Sp) (Bredle et al., 2011). | 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]. | 
| Change in scores on Support with Grief (ISS) from baseline | Perceived social support with grief is measured with a modified version of the 5-item 'Inventory of Social Support' (ISS). This scale assesses an individual's satisfaction with their social support networks (Hogan & Smidt, 2002). | 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]. | 
| Change in scores on Quality of Life (WHOQoL-8) from baseline | The 8-item World Health Organization Quality of Life Scale-8 (WHOQoL-8) is used to assess subjective quality of life (da Rocha et al., 2012). | 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]. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia Caregiving, Caregiver Stress, Caregiver Burden