Art Therapy and Music Reminiscence Activity in the Prevention of Cognitive Decline
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|ClinicalTrials.gov Identifier: NCT02854085|
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : January 26, 2018
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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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Behavioral: Art Therapy Behavioral: Music Reminiscence Activity||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Art Therapy and Music Reminiscence Activity in the Prevention of Cognitive Decline|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||May 2017|
Experimental: Art Therapy
Art Therapy, 24 sessions
Behavioral: Art Therapy
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.
Other Name: AT
Experimental: Music Reminiscence Activity
Music Reminiscence Activity, 24 sessions
Behavioral: Music Reminiscence Activity
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.
Other Name: MRA
No Intervention: Control
Participants will not participate in either of the interventions and will continue life as usual.
- 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 ]Measure: Number of items from a list of 15 items participant is able to recall immediately and 30 minutes later.
- Neuropsychological Test: Change from baseline in Digit Span Task scores at 3 months and 9 months [ Time Frame: Measured at Baseline, 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
- Neuropsychological Test: Change from baseline in Colour Trails Test scores at 3 months and 9 months [ Time Frame: Measured at Baseline, 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
- Neuropsychological Test: Change from baseline in Block Design Test scores at 3 months and 9 months [ Time Frame: Measured at Baseline, 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
- Change from baseline fMRI scan at 3 months [ Time Frame: Measured at Baseline and 3 months ]Task-free Functional Magnetic Resonance Imaging (fMRI) will be employed to examine changes in functional connectivity.
- Change from baseline telomere lengths at 3 months and 9 months [ Time Frame: Measured at Baseline, 3 months and 9 months ]Blood investigations to detect changes in telomere length
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|Ages Eligible for Study:||60 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854085
|Training and Research Academy|
|Singapore, Singapore, 648886|
|Principal Investigator:||Rathi Mahendran, MBBS||National University of Singapore|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Rathi Mahendran, Senior Consultant Psychiatrist, National University of Singapore|
|Other Study ID Numbers:||
|First Posted:||August 3, 2016 Key Record Dates|
|Last Update Posted:||January 26, 2018|
|Last Verified:||January 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Prevention of Cognitive Decline
Music Reminiscence Activity