Overview

This trial is active, not recruiting.

Condition mild cognitive impairment
Treatments art therapy, music reminiscence activity
Sponsor National University, Singapore
Start date July 2016
End date April 2017
Trial size 68 participants
Trial identifier NCT02854085, B-16-095

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Art Therapy, 24 sessions
art therapy 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.
(Experimental)
Music Reminiscence Activity, 24 sessions
music reminiscence activity 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.
(No Intervention)
Participants will not participate in either of the interventions and will continue life as usual.

Primary Outcomes

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
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
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
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
Change from baseline fMRI scan at 3 months
time frame: Measured at Baseline and 3 months

Secondary Outcomes

Measure
Change from baseline telomere lengths at 3 months and 9 months
time frame: Measured at Baseline, 3 months and 9 months

Eligibility Criteria

Male or female participants from 60 years up to 85 years old.

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

Additional Information

Official title Art Therapy and Music Reminiscence Activity in the Prevention of Cognitive Decline
Principal investigator Rathi Mahendran, MBBS
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 12 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by National University, Singapore.