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Completed

NCT Number: NCT02854085

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Training and Research Academy

Singapore, 648886

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Art Therapy

Behavioral

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

Music Reminiscence Activity

Behavioral

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2016
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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