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Mild Cognitive ImpairmentNCT02854085

Art Therapy and Music Reminiscence Activity in the Prevention of Cognitive Decline

A study testing Art Therapy and Music Reminiscence Activity in people with Mild Cognitive Impairment, run by National University of Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Art Therapy and Music Reminiscence Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteSingapore
Study dates
Jul 2016to May 2017
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 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Older person between 60 and 85 years of age, living in the community and fulfills the operational criteria/definition of MCI:
  • At least one age-education adjusted neuropsychological test Z score <-1.5
  • Do not meet DSM V criteria for a Major Neurocognitive Disorder
  • Memory/Cognitive complaint preferably corroborated by a reliable informant
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Training and Research Academy

    Singapore, 648886

Other trials in Singapore

About this study

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.

Read the 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.

Being tested
Art Therapy, Music Reminiscence Activity
Keywords
Prevention of Cognitive Decline, Art Therapy, Music Reminiscence Activity, Elderly
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Art TherapyBehavioural

    Also called AT

    The Art Therapy will consist of creating art pieces, narrating thoughts and inner experiences in relation to the pieces produced (2 sessions a month) and guided visits to the art gallery (one session a month) and art museum (one session a month); there will be 12 sessions weekly for 12 weeks. For the next 6 months, sessions will be fortnightly and consist of creating an art piece once a month alternating with a visit to either the art museum or gallery, once a month; there will be 12 sessions in 6 months. Each session will last 45 minutes and will begin with 5 minutes of mindful relaxation to help participants focus on the task ahead.

  • Music Reminiscence ActivityBehavioural

    Also called MRA

    Music Reminiscence activity will be held weekly for 12 weeks and fortnightly for 6 months. Each session will last 45 minutes and will begin with 5 minutes of mindful relaxation to help participants focus on the task ahead. Session will entail listening and watching music videos and discussing activities, events and experiences related to the music; additional prompts such as photographs may be used to facilitate therapy.

Study groups in NCT02854085
Study groupRoleWhat they receive
Art TherapyExperimentalArt Therapy, 24 sessions
Receives: Behavioral: Art Therapy
Music Reminiscence ActivityExperimentalMusic Reminiscence Activity, 24 sessions
Receives: Behavioral: Music Reminiscence Activity
ControlNo interventionParticipants will not participate in either of the interventions and will continue life as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuropsychological Test: Change from baseline in Rey Auditory Verbal Learning Test scores at 3 months and 9 months

    Measure: Number of items from a list of 15 items participant is able to recall immediately and 30 minutes later.

    Measured: Measured at Baseline, 3 months and 9 months

  2. Neuropsychological Test: Change from baseline in Digit Span Task scores at 3 months and 9 months

    Digit Span Task [(Digit Span Forward (DSF) and Digit Span Backward (DSB)]

    DSF Measure: 1 point for each correct sub-item response, Minimum: 0; Maximum 16 DSB Measure: 1 point for each correct sub-item response, Minimum: 0; Maximum 14

    Measured: Measured at Baseline, 3 months and 9 months

  3. Neuropsychological Test: Change from baseline in Colour Trails Test scores at 3 months and 9 months

    Colour Trails Test (CTT) 1 and 2

    Measure: Time to completion, in seconds for Trial 1 and Trial 2. Time Limit: 240s

    Measured: Measured at Baseline, 3 months and 9 months

  4. Neuropsychological Test: Change from baseline in Block Design Test scores at 3 months and 9 months

    Block Design (sub-test of the Wechsler Adult Intelligence Scale Tests)

    Measure: Respective sub-item test scores, based on time of completion and accuracy; Maximum score: 68

    Measured: Measured at Baseline, 3 months and 9 months

  5. Change from baseline fMRI scan at 3 months

    Task-free Functional Magnetic Resonance Imaging (fMRI) will be employed to examine changes in functional connectivity.

    Measured: Measured at Baseline and 3 months

Secondary outcomes (1)
  1. Change from baseline telomere lengths at 3 months and 9 months

    Blood investigations to detect changes in telomere length

    Measured: Measured at Baseline, 3 months and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionApr 2017
  4. Study completionMay 2017

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02854085
Sponsor's protocol ID
B-16-095
Status last verified
Jan 2018
First submitted
7 Jul 2016
Last updated
26 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 26178378
  • 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.

  • 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.

    PubMed 26305648
  • 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.

    PubMed 26305649
  • 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.

    PubMed 24121964
  • 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.

    PubMed 25672767
  • 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.

    PubMed 25771249
  • 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.

    PubMed 22079938
  • 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.

    PubMed 23019264
  • 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.

    PubMed 23385846
  • 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.

    PubMed 24866046
  • 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.

    PubMed 8035962
  • 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.

    PubMed 30413216
  • 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.

    PubMed 28701205

Questions about this trial

What is this clinical trial studying?

A study testing Art Therapy and Music Reminiscence Activity in people with Mild Cognitive Impairment, run by National University of Singapore at 1 site 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Neuropsychological Test: Change from baseline in Rey Auditory Verbal Learning Test scores at 3 months and 9 months (time frame: Measured at Baseline, 3 months and 9 months). The study lists 5 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 NCT02854085, which also lists 15 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 26 Jan 2018.

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