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

Primary Purpose

Caregiver Burnout, Caregiver Stress

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)
Sponsored by
Nanyang Technological University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Caregiver Burnout focused on measuring Dementia Caregiving, Caregiver Stress, Caregiver Burden

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate Intervention Group

Waitlist Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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).

Secondary Outcome Measures

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).
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).
Change in scores on Hope (HHI) from baseline
Hope is assessed by the 12-item Herth Hope Index (HHI) (Herth, 1992).
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).
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).
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).

Full Information

First Posted
September 9, 2020
Last Updated
September 9, 2020
Sponsor
Nanyang Technological University
Collaborators
Tan Tock Seng Hospital, Khoo Teck Puat Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04548089
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanyang Technological University
Collaborators
Tan Tock Seng Hospital, Khoo Teck Puat Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout, Caregiver Stress
Keywords
Dementia Caregiving, Caregiver Stress, Caregiver Burden

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in scores on Caregiver Distress (HADS) from baseline
Description
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)
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].
Title
Change in scores on Caregiver Burden (ZBI-12) from baseline
Description
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).
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].
Secondary Outcome Measure Information:
Title
Change in scores on Depressive Symptoms (PHQ-4) from baseline
Description
Depressive symptoms is assessed by the Patient Health Questionnaire (PHQ-4), a reliable and widely used self-reported scale (Kroenke, 2009).
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].
Title
Change in scores on Resilience (ER89-R) from baseline
Description
Trait resilience is assessed by the 10-item Ego-Resilience Revised Scale (ER-89R) (Alessandri et al., 2011).
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].
Title
Change in scores on Hope (HHI) from baseline
Description
Hope is assessed by the 12-item Herth Hope Index (HHI) (Herth, 1992).
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].
Title
Change in scores on Spirituality (FACIT-Sp) from baseline
Description
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).
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].
Title
Change in scores on Support with Grief (ISS) from baseline
Description
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).
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].
Title
Change in scores on Quality of Life (WHOQoL-8) from baseline
Description
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).
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].
Other Pre-specified Outcome Measures:
Title
Heart Rate Variability
Description
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.
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].

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy HY Ho, PhD, EdD
Organizational Affiliation
Nanyang Technological University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital (Centre for Geriatric Medicine)
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Tan Tock Seng Hospital (Department of Palliative Medicine)
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Khoo Teck Puat Hospital
City
Singapore
ZIP/Postal Code
768828
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Alessandri G, Vecchione M, Caprara G, Letzring TD. The ego resiliency scale revised. European Journal of Psychological Assessment. 2011 Nov 28.
Results Reference
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PubMed Identifier
22583455
Citation
da Rocha NS, Power MJ, Bushnell DM, Fleck MP. The EUROHIS-QOL 8-item index: comparative psychometric properties to its parent WHOQOL-BREF. Value Health. 2012 May;15(3):449-57. doi: 10.1016/j.jval.2011.11.035. Epub 2012 Feb 9.
Results Reference
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PubMed Identifier
1430629
Citation
Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
Results Reference
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PubMed Identifier
31287010
Citation
Ho AHY, Tan-Ho G, Ngo TA, Ong G, Chong PH, Dignadice D, Potash J. A novel mindful-compassion art therapy (MCAT) for reducing burnout and promoting resilience for end-of-life care professionals: a waitlist RCT protocol. Trials. 2019 Jul 8;20(1):406. doi: 10.1186/s13063-019-3533-y.
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Hogan NS, Schmidt LA. Testing the grief to personal growth model using structural equation modeling. Death Stud. 2002 Oct;26(8):615-34. doi: 10.1080/07481180290088338.
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Bredle JM, Salsman JM, Debb SM, Arnold BJ, Cella D. Spiritual well-being as a component of health-related quality of life: the functional assessment of chronic illness therapy-spiritual well-being scale (FACIT-Sp). Religions. 2011 Mar;2(1):77-94.
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PubMed Identifier
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Results Reference
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Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) : A Waitlist Randomized Controlled Trial

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