NCT02854085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

July 7, 2016

Last Update Submit

January 24, 2018

Conditions

Keywords

Prevention of Cognitive DeclineArt TherapyMusic Reminiscence ActivityElderly

Outcome Measures

Primary Outcomes (5)

  • 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 at Baseline, 3 months and 9 months

  • 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 at Baseline, 3 months and 9 months

  • 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 at Baseline, 3 months and 9 months

  • 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 at Baseline, 3 months and 9 months

  • 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 at Baseline and 3 months

Secondary Outcomes (1)

  • Change from baseline telomere lengths at 3 months and 9 months

    Measured at Baseline, 3 months and 9 months

Study Arms (3)

Art Therapy

EXPERIMENTAL

Art Therapy, 24 sessions

Behavioral: Art Therapy

Music Reminiscence Activity

EXPERIMENTAL

Music Reminiscence Activity, 24 sessions

Behavioral: Music Reminiscence Activity

Control

NO INTERVENTION

Participants will not participate in either of the interventions and will continue life as usual.

Interventions

Art TherapyBEHAVIORAL

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.

Also known as: AT
Art Therapy

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.

Also known as: MRA
Music Reminiscence Activity

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Training and Research Academy

Singapore, 648886, Singapore

Location

Related Publications (15)

  • 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.

    BACKGROUND
  • 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.

    PMID: 26178378BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26305648BACKGROUND
  • 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.

    PMID: 26305649BACKGROUND
  • 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.

    PMID: 24121964BACKGROUND
  • 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.

    PMID: 25672767BACKGROUND
  • 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.

    PMID: 25771249BACKGROUND
  • 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.

    PMID: 22079938BACKGROUND
  • 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.

    PMID: 23019264BACKGROUND
  • 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.

    PMID: 23385846BACKGROUND
  • 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.

    PMID: 24866046BACKGROUND
  • 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.

    PMID: 8035962BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Rathi Mahendran, MBBS

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant Psychiatrist

Study Record Dates

First Submitted

July 7, 2016

First Posted

August 3, 2016

Study Start

July 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations