Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02854085
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Rathi Mahendran, National University, Singapore

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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Art Therapy Behavioral: Music Reminiscence Activity Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

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 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Singapore
Training and Research Academy
Singapore, Singapore, 648886
Sponsors and Collaborators
National University, Singapore
Investigators
Layout table for investigator information
Principal Investigator: Rathi Mahendran, MBBS National University, Singapore
Publications:
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.
Fam J, Yu Sun, Yu Chen, Tien HS, Feng L, EH Kua, R Mahendran. The Effects of Mindfulness Practice on mild cognitive impairment: a resting state functional connectivity study. Submission Pending.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rathi Mahendran, Senior Consultant Psychiatrist, National University, Singapore
ClinicalTrials.gov Identifier: NCT02854085    
Other Study ID Numbers: B-16-095
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
Keywords provided by Rathi Mahendran, National University, Singapore:
Prevention of Cognitive Decline
Art Therapy
Music Reminiscence Activity
Elderly
Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders