Caregiver BurnoutNCT04548089
Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) : A Waitlist Randomized Controlled Trial
A study testing Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) in people with Caregiver Burnout and Caregiver Stress, run by Nanyang Technological University at 3 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burnout, Caregiver Stress
- What is being tested?
- Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesSingapore
- Study dates
- 3 Oct 2019to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informal caregiver of a family member with diagnosed with dementia
- Fluent in written and verbal english
Who cannot join
- Unable to provide informed consent
- Diagnosed with major mental conditions or cognitive impairment
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
Tan Tock Seng Hospital (Centre for Geriatric Medicine)
Singapore, 308433
Tan Tock Seng Hospital (Department of Palliative Medicine)
Singapore, 308433
Khoo Teck Puat Hospital
Singapore, 768828
About this study
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
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.
Read the 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.
- Conditions
- Caregiver Burnout, Caregiver Stress
- Being tested
- Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)
- Keywords
- Dementia Caregiving, Caregiver Stress, Caregiver Burden
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention Group | Experimental | 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. Receives: Behavioral: Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) |
| Waitlist Control Group | Experimental | 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. Receives: Behavioral: Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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 (6)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start3 Oct 2019
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Khoo Teck Puat Hospital
- Responsible party
- Principal investigator, Andy Hau Yan Ho, PhD, EdD, Nanyang Technological University
- Investigators
- Andy HY Ho, PhD, EdD, Principal investigator, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548089
- Sponsor's protocol ID
- IRB-2019-05-021
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alessandri G, Vecchione M, Caprara G, Letzring TD. The ego resiliency scale revised. European Journal of Psychological Assessment. 2011 Nov 28.
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.
PubMed 22583455Herth 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.
PubMed 1430629Ho 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.
PubMed 31287010Hogan 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.
PubMed 12243195Bredle 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.
Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.
PubMed 19996233Tang JY, Ho AH, Luo H, Wong GH, Lau BH, Lum TY, Cheung KS. Validating a Cantonese short version of the Zarit Burden Interview (CZBI-Short) for dementia caregivers. Aging Ment Health. 2016 Sep;20(9):996-1001. doi: 10.1080/13607863.2015.1047323. Epub 2015 May 27.
PubMed 26016419Wheat AL, Larkin KT. Biofeedback of heart rate variability and related physiology: a critical review. Appl Psychophysiol Biofeedback. 2010 Sep;35(3):229-42. doi: 10.1007/s10484-010-9133-y.
PubMed 20443135Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Tan-Ho G, Choo PY, Ma SHXY, Hum AYM, Yap PLK, Bte Ali N, Tan MKB, Ho AHY. Mindful-Compassion Art-Based Therapy for Dementia Care (MCAT-DC): A multicomponent approach to enhancing resilience in dementia family caregivers. Psychol Trauma. 2026 May 11. doi: 10.1037/tra0002172. Online ahead of print.
PubMed 42113188Ho AHY, Tan-Ho G, Ngo TA, Ong G, Chong PH, Dignadice D, Potash J. A Novel Mindful-Compassion Art-Based Therapy for Reducing Burnout and Promoting Resilience Among Healthcare Workers: Findings From a Waitlist Randomized Control Trial. Front Psychol. 2021 Oct 21;12:744443. doi: 10.3389/fpsyg.2021.744443. eCollection 2021.
PubMed 34744918
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04548089
- Acronym / sponsor ID
- IRB-2019-05-021
- Conditions
- Caregiver Burnout, Caregiver Stress
- Keywords
- Dementia Caregiving, Caregiver Stress, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Khoo Teck Puat Hospital
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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].
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Behavioral: Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)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. |
| Waitlist Control Group | Experimental | Behavioral: Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informal caregiver of a family member with diagnosed with dementia
- Fluent in written and verbal english
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Diagnosed with major mental conditions or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)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. | Behavioural | Immediate Intervention Group, Waitlist Control Group |
Primary outcome
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)
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).
6 secondary outcomes
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].
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].
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].
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].
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].
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].
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- BackgroundAlessandri G, Vecchione M, Caprara G, Letzring TD. The ego resiliency scale revised. European Journal of Psychological Assessment. 2011 Nov 28.
- Background: PubMed 22583455da 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.
- Background: PubMed 1430629Herth 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.
- Background: PubMed 31287010Ho 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.
- Background: PubMed 12243195Hogan 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.
- BackgroundBredle 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.
- Background: PubMed 19996233Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.
- Background: PubMed 26016419Tang JY, Ho AH, Luo H, Wong GH, Lau BH, Lum TY, Cheung KS. Validating a Cantonese short version of the Zarit Burden Interview (CZBI-Short) for dementia caregivers. Aging Ment Health. 2016 Sep;20(9):996-1001. doi: 10.1080/13607863.2015.1047323. Epub 2015 May 27.
- Background: PubMed 20443135Wheat AL, Larkin KT. Biofeedback of heart rate variability and related physiology: a critical review. Appl Psychophysiol Biofeedback. 2010 Sep;35(3):229-42. doi: 10.1007/s10484-010-9133-y.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Derived from this study: PubMed 42113188Tan-Ho G, Choo PY, Ma SHXY, Hum AYM, Yap PLK, Bte Ali N, Tan MKB, Ho AHY. Mindful-Compassion Art-Based Therapy for Dementia Care (MCAT-DC): A multicomponent approach to enhancing resilience in dementia family caregivers. Psychol Trauma. 2026 May 11. doi: 10.1037/tra0002172. Online ahead of print.
- Derived from this study: PubMed 34744918Ho AHY, Tan-Ho G, Ngo TA, Ong G, Chong PH, Dignadice D, Potash J. A Novel Mindful-Compassion Art-Based Therapy for Reducing Burnout and Promoting Resilience Among Healthcare Workers: Findings From a Waitlist Randomized Control Trial. Front Psychol. 2021 Oct 21;12:744443. doi: 10.3389/fpsyg.2021.744443. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy HY Ho, PhD, EdD principal investigator
Nanyang Technological University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) in people with Caregiver Burnout and Caregiver Stress, run by Nanyang Technological University at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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].). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04548089, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.