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Trial registered on ANZCTR


Registration number
ACTRN12614000820606
Ethics application status
Approved
Date submitted
9/07/2014
Date registered
1/08/2014
Date last updated
15/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of mindfulness on older adults with mild cognitive impairment
Scientific title
The effects of mindfulness on the cognitive function, psychological health, mindfulness and functional abilities in activities of daily living of older adults with mild cognitive impairment.
Secondary ID [1] 284957 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 292445 0
Condition category
Condition code
Neurological 292759 292759 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The mindfulness training program will be customised for persons with mild cognitive impairment. It is a 8-week group program delivered by mindfulness experts once weekly for 1.5 hour each session.
Intervention code [1] 289784 0
Treatment: Other
Comparator / control treatment
Single group research study with no control group. The same intervention will be applied to all study participants.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303390 0
Cognitive function assessed using Montreal Cognitive Assessment.
Timepoint [1] 303390 0
(1) Before intervention time frame (2) After intervention time frame (3) One-year follow-up period
Secondary outcome [1] 309322 0
Psychological health assessed using DASS-21.
Timepoint [1] 309322 0
(1) Before intervention time-frame;
(2) After intervention time-frame; and
(3) One-year follow-up period.
Secondary outcome [2] 309658 0
Mindfulness assessed using Freiburg Mindfulness Inventory.
Timepoint [2] 309658 0
(1) Before intervention time-frame;
(2) After intervention time-frame; and
(3) One-year follow-up period.
Secondary outcome [3] 309660 0
Functional abilities of activities of daily living assessed using Bayer Activities of Daily Living Scale.
Timepoint [3] 309660 0
(1) Before intervention time-frame;
(2) After intervention time-frame; and
(3) One-year follow-up period.
Secondary outcome [4] 309661 0
Adherence of mindfulness practices as assessed using Mindfulness Adherence Questionnaire.
Timepoint [4] 309661 0
(1) Before intervention time-frame; (2) After intervention time-frame; and (3) One-year follow-up period.
Secondary outcome [5] 309719 0
Information on the participants' demographic, health and lifestyle as provided on the Demographic, Health and Lifestyle questionnaire.
Timepoint [5] 309719 0
(1) Before intervention time-frame;
(2) After intervention time-frame; and
(3) One-year follow-up period.
Secondary outcome [6] 338815 0
Semi-structured interviews with the MCI participant and his/her familiar support person to elicit responses about their mindfulness training program experience and expectations about mindfulness practice and the perceived effects of mindfulness on them, and the MCI participants’ challenges in practising mindfulness.
Timepoint [6] 338815 0
(1) After intervention time-frame; and (2) One-year follow-up period.
Secondary outcome [7] 338816 0
Participant observation of the 8-week mindfulness training program to evaluate how the MCI participants and familiar support persons engage with the program and to assess the nature of group interactions during the program.
Timepoint [7] 338816 0
During the 8-week mindfulness training program.

Eligibility
Key inclusion criteria
i. Clinical diagnosis of Mild Cognitive Impairment;
ii. Must be able to give informed consent to participate by signing the Consent Form; and
iii. At least 60 years old.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Current active/past significant experience with meditation or yoga;
ii. Current use of prescribed cognitive intervention or electromagnetic stimulation;
iii. Acquired/Traumatic brain injury;
iv. Started new neurological/psychoactive medication within 3 months prior to the first data collection session;
v. Current intake of drugs that significantly alter cognition;
vi. Illicit drug/alcohol abuse or dependence within the previous 5 years;
vii. Current intake of cholinesterase inhibitors;
viii. Current severe psychiatric condition; or neurological/cerebrovascular condition; or chronic medical condition that requires intensive medical treatment and monitoring; or advanced cognitive decline;
ix. Major impairments in eyesight, hearing or upper limb motor movements; or
x. English language difficulties.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
'Allocation is not concealed'.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To investigate whether mindfulness practice improves the MCI participants’ outcome measures at the 3 time points (pre-intervention, T1; post-intervention, T2; one-year follow-up, T3), one-way repeated measures analyses of variance (ANOVAs) were conducted to measure the effects of mindfulness practices on each of the dependent variables. Post-hoc tests using Bonferroni confidence interval adjustment were used to establish which pair of time points was significantly different for each dependent variable for which the ANOVA yielded a significant effect.

To examine whether the degree to which any improvement in the outcome measures varies with the duration/level of formal and informal mindfulness practices, Pearson product-moment correlation coefficient analyses were used to investigate any relationship between the score improvement in each of these outcome measures with the average weekly length of mindfulness meditation (in minutes), and with the average weekly informal mindfulness practice rating at T1, T2 and T3.

Additionally, Mann-Whitney U tests were used to examine differences between MCI participants who practised below and above the average weekly length of mindfulness meditation (formal practice), as well as between those who rated below and above the average weekly informal mindfulness level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2792 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 4413 0
Caulfield Hospital - Caulfield

Funding & Sponsors
Funding source category [1] 289577 0
University
Name [1] 289577 0
Monash University
Address [1] 289577 0
Department of General Practice
Faculty of Medicine, Nursing and Health Sciences
Monash University, Notting Hill campus
Building 1, 270 Ferntree Gully Road, Notting Hill VIC 3168
Country [1] 289577 0
Australia
Funding source category [2] 297523 0
Government body
Name [2] 297523 0
Research Training Program (RTP) Stipend
Address [2] 297523 0
Australian Government
Department of Education and Training
GPO Box 9880
Canberra ACT 2601
Country [2] 297523 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of General Practice
Faculty of Medicine, Nursing and Health Sciences
Monash University, Notting Hill campus
Building 1, 270 Ferntree Gully Road, Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 288261 0
None
Name [1] 288261 0
Address [1] 288261 0
Country [1] 288261 0
Other collaborator category [1] 278647 0
Hospital
Name [1] 278647 0
Western Health
Address [1] 278647 0
Footscray Hospital, 160 Gordon Street, Footscray, VIC 3011.
Country [1] 278647 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291314 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 291314 0
Melbourne Health Office For Research
City Campus, Level 2, South West
300 Grattan Street, Parkville, Victoria 3050
Australia
Ethics committee country [1] 291314 0
Australia
Date submitted for ethics approval [1] 291314 0
24/10/2014
Approval date [1] 291314 0
11/02/2015
Ethics approval number [1] 291314 0
Ethics committee name [2] 291418 0
Western Health
Ethics committee address [2] 291418 0
Western Health Office for Research
3rd Floor, Western Centre for Health Research and Education
Sunshine Hospital
Furlong Rd. St Albans VIC 3021
Ethics committee country [2] 291418 0
Australia
Date submitted for ethics approval [2] 291418 0
16/02/2015
Approval date [2] 291418 0
15/07/2015
Ethics approval number [2] 291418 0
Ethics committee name [3] 291419 0
Monash University Human Research Ethics Committee
Ethics committee address [3] 291419 0
Monash Research Office
26 Sports Walk, Monash University, Wellington Road, Clayton, Victoria 3800, Australia
Ethics committee country [3] 291419 0
Australia
Date submitted for ethics approval [3] 291419 0
24/06/2015
Approval date [3] 291419 0
29/06/2015
Ethics approval number [3] 291419 0
Ethics committee name [4] 293620 0
Alfred Health Research Governance Office
Ethics committee address [4] 293620 0
Alfred Health Office of Ethics and Research Governance
Ground Floor, Linay Pavilion, The Alfred
PO Box 315
Prahran, VIC 3181
Ethics committee country [4] 293620 0
Australia
Date submitted for ethics approval [4] 293620 0
30/06/2015
Approval date [4] 293620 0
14/07/2015
Ethics approval number [4] 293620 0
HREC/14/MH/324

Summary
Brief summary
This study aims to investigate whether mindfulness practice can improve the cognitive function, psychological health, mindfulness level and functional abilities in activities of daily living of persons with MCI over time.

Furthermore, it will address the issues about the way in which the MCI participants and familiar support persons engage with the mindfulness training program, the nature of group interactions during the program, their program experience and expectations about mindfulness practice, the perceived effects of mindfulness on them, and the MCI participants’ challenges in practising mindfulness.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 569 569 0 0
Attachments [2] 1098 1098 0 0

Contacts
Principal investigator
Name 49838 0
Prof Jan Coles
Address 49838 0
Department of General Practice
Faculty of Medicine, Nursing and Health Sciences
Monash University, Notting Hill campus
Building 1, 270 Ferntree Gully Road, Notting Hill
VIC 3168
Country 49838 0
Australia
Phone 49838 0
+61399024461
Fax 49838 0
Email 49838 0
jan.coles@monash.edu
Contact person for public queries
Name 49839 0
Ms Ping Wong
Address 49839 0
Department of General Practice, Faculty of Medicine, Nursing and Health Sciences, Monash University, Notting Hill campus, Building 1, 270 Ferntree Gully Road, Notting Hill, VIC 3168
Country 49839 0
Australia
Phone 49839 0
+61399024461
Fax 49839 0
Email 49839 0
ping.wong@monash.edu
Contact person for scientific queries
Name 49840 0
Ms Ping Wong
Address 49840 0
Department of General Practice, Faculty of Medicine, Nursing and Health Sciences, Monash University, Notting Hill campus, Building 1, 270 Ferntree Gully Road, Notting Hill, VIC 3168
Country 49840 0
Australia
Phone 49840 0
+61399024461
Fax 49840 0
Email 49840 0
ping.wong@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary