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

January 24, 2018 updated by: Rathi Mahendran, National University of Singapore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 648886
        • Training and Research Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • MRA
No Intervention: Control
Participants will not participate in either of the interventions and will continue life as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

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
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
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

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
Time Frame: Measured at Baseline and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at Baseline, 3 months and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Singapore

Investigators

  • Principal Investigator: Rathi Mahendran, MBBS, National University of Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-16-095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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