Clinical trial NCT02854085: Art Therapy and Music Reminiscence Activity in the Prevention of Cognitive Decline
Official title: Art Therapy and Music Reminiscence Activity in the Prevention of Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Prevention of Cognitive Decline
Art Therapy
Music Reminiscence Activity
Elderly
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 68
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to determine the impact of Art Therapy and Music Reminiscence Activity on cognition in community living elderly with Mild Cognitive Impairment (DSM V: Mild Neurocognitive Disorder) using a randomized control design.

Specifically, the structural cerebral changes that occur with the two interventions and the extent to which the therapies may reverse cognitive impairment and/or prevent further cognitive decline, will be determined.

The hypothesis is that participants in both active intervention arms will perform better on neuropsychological tests of cognition and will show positive changes on functional imaging studies compared to controls who will not receive any intervention. Participants in the interventions will also have positive changes in blood biomarkers, enhanced psychological well-being and reductions in anxiety and depressive symptoms compared to the control group. No a priori hypotheses were developed as to whether Art Therapy or Music Reminiscence Activity is more effective as the comparison is exploratory.

Detailed description: Participants: 90 community-living elderly, with mild cognitive impairment.

Interventions: Participants will be randomized into 3 arms: Art Therapy, Music Reminiscence Activity or a Control arm. Sessions will be conducted weekly for 3 months and fortnightly for 6 months. Each intervention session will last for 40 minutes. The Control group will not receive any intervention and continue their life as usual.

Assessments: Demographic data will be collected at baseline. Neuropsychological tests of cognitive functioning will be done at baseline, 3 months and 9 months. Anxiety and depressive symptoms will be assessed at the 3 time-points. Blood sampling will occur at all time points (except control group, only at baseline and 9 months). Participants will also undergo a task-free brain fMRI scan at baseline and at 3 months.

Eligibility criteria: Inclusion Criteria:

* Older person between 60 and 85 years of age, living in the community and fulfills the operational criteria/definition of MCI:

  1. At least one age-education adjusted neuropsychological test Z score \<-1.5
  2. Do not meet DSM V criteria for a Major Neurocognitive Disorder
  3. Memory/Cognitive complaint preferably corroborated by a reliable informant
  4. Intact Activities of Daily Living
* Functions independently
* Does not have dementia
* Able to travel to the data collection site on their own and participate in the activity

Exclusion Criteria:

* Those who do not meet the above inclusion criteria (ie. do not have a MCI diagnosis)
* Those with Dementia/Major Neurocognitive Disorder or Normal Ageing
* Presence of a neurological condition e.g. epilepsy, Parkinson Disease, stroke
* Presence of a major psychiatric disorder e.g. Major Depression, Psychoses
* Terminal illness e.g. cancer
* Presence of significant visual and/or hearing impairment and Color Blindness
* Participants in another intervention study at the same time

Primary outcomes:
measure: Neuropsychological Test: Change from baseline in Rey Auditory Verbal Learning Test scores at 3 months and 9 months
timeFrame: Measured at Baseline, 3 months and 9 months
measure: Neuropsychological Test: Change from baseline in Digit Span Task scores at 3 months and 9 months
timeFrame: Measured at Baseline, 3 months and 9 months
measure: Neuropsychological Test: Change from baseline in Colour Trails Test scores at 3 months and 9 months
timeFrame: Measured at Baseline, 3 months and 9 months
measure: Neuropsychological Test: Change from baseline in Block Design Test scores at 3 months and 9 months
timeFrame: Measured at Baseline, 3 months and 9 months
measure: Change from baseline fMRI scan at 3 months
timeFrame: Measured at Baseline and 3 months
Secondary outcomes:
measure: Change from baseline telomere lengths at 3 months and 9 months
timeFrame: Measured at Baseline, 3 months and 9 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Training and Research Academy
Study officials:
affiliation: National University of Singapore
name: Rathi Mahendran, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kua EH, R Mahendran, L Feng, XF Tan, TP Ng. Preventive Psychiatry in Late Life: Studies on Depression and Dementia from the Singapore gerontology Research program. Taiwanese J Psychiatry 2013;27(4):267-275.
citation: Rawtaer I, Mahendran R, Yu J, Fam J, Feng L, Kua EH. Psychosocial interventions with art, music, Tai Chi and mindfulness for subsyndromal depression and anxiety in older adults: A naturalistic study in Singapore. Asia Pac Psychiatry. 2015 Sep;7(3):240-50. doi: 10.1111/appy.12201. Epub 2015 Jul 15.
citation: Fam J, Yu Sun, Yu Chen, Tien HS, Feng L, EH Kua, R Mahendran. The Effects of Mindfulness Practice on mild cognitive impairment: a resting state functional connectivity study. Submission Pending.
citation: Sink KM, Espeland MA, Castro CM, Church T, Cohen R, Dodson JA, Guralnik J, Hendrie HC, Jennings J, Katula J, Lopez OL, McDermott MM, Pahor M, Reid KF, Rushing J, Verghese J, Rapp S, Williamson JD; LIFE Study Investigators. Effect of a 24-Month Physical Activity Intervention vs Health Education on Cognitive Outcomes in Sedentary Older Adults: The LIFE Randomized Trial. JAMA. 2015 Aug 25;314(8):781-90. doi: 10.1001/jama.2015.9617.
citation: Chew EY, Clemons TE, Agron E, Launer LJ, Grodstein F, Bernstein PS; Age-Related Eye Disease Study 2 (AREDS2) Research Group. Effect of Omega-3 Fatty Acids, Lutein/Zeaxanthin, or Other Nutrient Supplementation on Cognitive Function: The AREDS2 Randomized Clinical Trial. JAMA. 2015 Aug 25;314(8):791-801. doi: 10.1001/jama.2015.9677.
citation: Chancellor B, Duncan A, Chatterjee A. Art therapy for Alzheimer's disease and other dementias. J Alzheimers Dis. 2014;39(1):1-11. doi: 10.3233/JAD-131295.
citation: Subramaniam M, Chong SA, Vaingankar JA, Abdin E, Chua BY, Chua HC, Eng GK, Heng D, Hia SB, Huang W, Jeyagurunathana A, Kua J, Lee SP, Mahendran R, Magadi H, Malladi S, McCrone P, Pang S, Picco L, Sagayadevan V, Sambasivam R, Seng KH, Seow E, Shafie S, Shahwan S, Tan LL, Yap M, Zhang Y, Ng LL, Prince M. Prevalence of Dementia in People Aged 60 Years and Above: Results from the WiSE Study. J Alzheimers Dis. 2015;45(4):1127-38. doi: 10.3233/JAD-142769.
citation: Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
citation: Forsman AK, Nordmyr J, Wahlbeck K. Psychosocial interventions for the promotion of mental health and the prevention of depression among older adults. Health Promot Int. 2011 Dec;26 Suppl 1:i85-107. doi: 10.1093/heapro/dar074.
citation: Koepsell TD, Monsell SE. Reversion from mild cognitive impairment to normal or near-normal cognition: risk factors and prognosis. Neurology. 2012 Oct 9;79(15):1591-8. doi: 10.1212/WNL.0b013e31826e26b7. Epub 2012 Sep 26.
citation: Hilal S, Ikram MK, Saini M, Tan CS, Catindig JA, Dong YH, Lim LB, Ting EY, Koo EH, Cheung CY, Qiu A, Wong TY, Chen CL, Venketasubramanian N. Prevalence of cognitive impairment in Chinese: epidemiology of dementia in Singapore study. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):686-92. doi: 10.1136/jnnp-2012-304080. Epub 2013 Feb 5.
citation: Paradise M, McCade D, Hickie IB, Diamond K, Lewis SJ, Naismith SL. Caregiver burden in mild cognitive impairment. Aging Ment Health. 2015 Jan;19(1):72-8. doi: 10.1080/13607863.2014.915922. Epub 2014 May 28.
citation: Burnside I, Haight B. Reminiscence and life review: therapeutic interventions for older people. Nurse Pract. 1994 Apr;19(4):55-61. doi: 10.1097/00006205-199404000-00011.
citation: Mahendran R, Gandhi M, Moorakonda RB, Wong J, Kanchi MM, Fam J, Rawtaer I, Kumar AP, Feng L, Kua EH. Art therapy is associated with sustained improvement in cognitive function in the elderly with mild neurocognitive disorder: findings from a pilot randomized controlled trial for art therapy and music reminiscence activity versus usual care. Trials. 2018 Nov 9;19(1):615. doi: 10.1186/s13063-018-2988-6.
citation: Mahendran R, Rawtaer I, Fam J, Wong J, Kumar AP, Gandhi M, Jing KX, Feng L, Kua EH. Art therapy and music reminiscence activity in the prevention of cognitive decline: study protocol for a randomized controlled trial. Trials. 2017 Jul 12;18(1):324. doi: 10.1186/s13063-017-2080-7.