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

Primary Purpose

Mild Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Art Therapy

Music Reminiscence Activity

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Prevention of Cognitive Decline, Art Therapy, Music Reminiscence Activity, Elderly

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Training and Research Academy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Art Therapy

Music Reminiscence Activity

Control

Arm Description

Art Therapy, 24 sessions

Music Reminiscence Activity, 24 sessions

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

Outcomes

Primary Outcome Measures

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.

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

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

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

Change from baseline fMRI scan at 3 months

Task-free Functional Magnetic Resonance Imaging (fMRI) will be employed to examine changes in functional connectivity.

Secondary Outcome Measures

Change from baseline telomere lengths at 3 months and 9 months

Blood investigations to detect changes in telomere length

Full Information

NCT ID

NCT02854085

First Posted

July 7, 2016

Last Updated

January 24, 2018

Sponsor

National University of Singapore

1. Study Identification

Unique Protocol Identification Number

NCT02854085

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Singapore

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

Prevention of Cognitive Decline, Art Therapy, Music Reminiscence Activity, Elderly

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Art Therapy

Arm Type

Experimental

Arm Description

Art Therapy, 24 sessions

Arm Title

Music Reminiscence Activity

Arm Type

Experimental

Arm Description

Music Reminiscence Activity, 24 sessions

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Art Therapy

Other Intervention Name(s)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Music Reminiscence Activity

Other Intervention Name(s)

MRA

Intervention Description

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.

Primary Outcome Measure Information:

Title

Neuropsychological Test: Change from baseline in Rey Auditory Verbal Learning Test scores at 3 months and 9 months

Description

Measure: Number of items from a list of 15 items participant is able to recall immediately and 30 minutes later.

Time Frame

Measured at Baseline, 3 months and 9 months

Title

Neuropsychological Test: Change from baseline in Digit Span Task scores at 3 months and 9 months

Description

Time Frame

Measured at Baseline, 3 months and 9 months

Title

Neuropsychological Test: Change from baseline in Colour Trails Test scores at 3 months and 9 months

Description

Colour Trails Test (CTT) 1 and 2 Measure: Time to completion, in seconds for Trial 1 and Trial 2. Time Limit: 240s

Time Frame

Measured at Baseline, 3 months and 9 months

Title

Neuropsychological Test: Change from baseline in Block Design Test scores at 3 months and 9 months

Description

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

Time Frame

Measured at Baseline, 3 months and 9 months

Title

Change from baseline fMRI scan at 3 months

Description

Task-free Functional Magnetic Resonance Imaging (fMRI) will be employed to examine changes in functional connectivity.

Time Frame

Measured at Baseline and 3 months

Secondary Outcome Measure Information:

Title

Change from baseline telomere lengths at 3 months and 9 months

Description

Blood investigations to detect changes in telomere length

Time Frame

Measured at Baseline, 3 months and 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rathi Mahendran, MBBS

Organizational Affiliation

National University of Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Training and Research Academy

City

Singapore

ZIP/Postal Code

648886

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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.

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

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