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

September 9, 2020 updated by: Andy Hau Yan Ho, PhD, EdD, Nanyang Technological University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

102

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 Locations

      • Singapore, Singapore, 768828
        • Khoo Teck Puat Hospital
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital (Centre for Geriatric Medicine)
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital (Department of Palliative Medicine)

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

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Intervention Group
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.
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.
Experimental: Waitlist Control Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in scores on Caregiver Distress (HADS) from baseline
Time Frame: 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].
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
Time Frame: 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].
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
Time Frame: 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].
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
Time Frame: 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].
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
Time Frame: 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].
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
Time Frame: 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].
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
Time Frame: 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].
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
Time Frame: 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].
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].

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: 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].
Heart Rate Variability (HRV), a reliable biomarker that reflects an individual's cardiovascular stress regulation, is used to assess participants' psychophysiological well-being (Wheat & Larkin, 2010). Ithlete, a small non-invasive portable HRV measurement device, together with a smart tablet installed with the ithlete HRV App, is used for this assessment. Concisely, an Infrared Pulse Plethysmography finger sensor is attached to participants' index finger while following a series of brief breathing instruction on the screen of the smart tablet, and during this 1-2 minute exercises, data of their psychophysiological performance are collected.
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].

Collaborators and Investigators

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

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 (Actual)

October 3, 2019

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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