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Trial registered on ANZCTR


Registration number
ACTRN12619000820101
Ethics application status
Approved
Date submitted
17/05/2019
Date registered
6/06/2019
Date last updated
6/06/2019
Date data sharing statement initially provided
6/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring the impact of attention training experienced by older adults with or without MCI

MCI- Mild cognitive impairment
Scientific title
Exploring the impact of attention training on attention difficulties experienced by older adults with or without Mild Cognitive Impairment (MCI).

Secondary ID [1] 298346 0
Nil known
Universal Trial Number (UTN)
U1111-1230-5654
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 312109 0
Condition category
Condition code
Mental Health 310667 310667 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test whether an Attention Training program affects attention abilities of participants with and without MCI (Mild Cognitive Impairment). Participants from each sample (with and without MCI) will be randomly allocated to two equal groups - one will receive the research intervention namely the Attention Training Program, the other group will form the control group who will receive the Relaxation Training. This comparison group will allow us to understand whether the attention training tasks help improve attention abilities of the treatment groups but not the control groups, keeping other factors constant (age, cognitive range).
Each Attention Training session will consist of: psychoeducation, an individual attention training task, a group attention training task- both of which primarily targets one or more aspects of attention namely selective, sustained and alternating attention but not divided attention, followed by discussion and feedback. As there are 64 participants for each group-training will be provided in smaller groups of 8 participants at a time. This means 8 groups will be run for each training program (Attention Training and Relaxation Training) to service the desired number of participants (128 in total; 60 participants in each training program).
Both trainings (Attention Training and Relaxation Training) will be delivered in 10 sessions- once weekly for 2 hours. Both groups will be facilitated by the Principal Investigator who is a psychologist with clinical endorsement from the APS and has the necessary skills to provide the above programs. Follow up sessions will be provided to the participants if they miss any session for both groups, by the Principal Investigator. The trainings will be manualised so that the exact same training is delivered in all groups and follow-up sessions.
No external fidelity checks will be done due to confidentiality and dynamic nature of group interaction, however the manualised program will be strictly adhered to that elaborates the activities and items used for the individual and group trainings offered for both the intervention and control groups. Moreover, all groups are run by the principal researcher which will ensure standardised delivery of contents.
The Attention Training Psychoeducation sessions will include the following topics: the brain and neuroplasticity, general functions of the brain, cognition in everyday life, types of attention, aging and cognition, difficulties in attention, factors impacting brain health, cognitive training and its use and how can we keep healthy.
The Relaxation training sessions will consist of psychoeducation and training in relaxation techniques.
Participants with Mild Cognitive Impairment recruited from the Memory Clinic, Toowoomba Hospital, Darling Downs Health will be serviced at the Hospital whereas participants recruited from the community (healthy older adults) will be serviced at the Psychology Clinic, University of Southern Queensland, Toowoomba campus.

Intervention code [1] 314002 0
Treatment: Other
Comparator / control treatment
Relaxation training is the control group treatment. These sessions will consist of psychoeducation on the following topics: education on the brain and neuroplasticity, general functions of the brain, factors impacting brain health, stress as we understand it, relaxation, breathing and relaxation, types of relaxation, progressive muscle relaxation, guided imagery and visualisation and how we can keep healthy and training in relaxation techniques.
Relaxation training that will be delivered, include the following: autogenic breathing, progressive muscle relaxation with and without tension, visualization, guided imagery, mindful walking and relaxed socialization.
This group will also be provided by the Principal Investigator who is a psychologist with clinical endorsement from the APS and has the necessary skills to provide the above program. This training will be delivered in 10 sessions- once weekly for 2 hours. Follow up sessions will be provided to the participants if they miss any session, by the Principal Investigator. The training will be manualised so that the exact same training is delivered in all sessions including follow-up sessions.
Participants from the Relaxation Training groups will be offered the research intervention namely Attention Training program once the research is completed.
Participants with Mild Cognitive Impairment will be recruited from the Memory Clinic, Toowoomba Hospital, Darling Downs Health will be serviced at the Hospital whereas participants recruited from the community (healthy older adults) will be serviced at the Psychology Clinic, University of Southern Queensland, Toowoomba campus.
Control group
Active

Outcomes
Primary outcome [1] 319513 0
General cognition as measured by the total index score obtained from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and interrelation between the following domains of the RBANS)- immediate memory, delayed memory, visuospatial/constructional domain, and language domain.
Timepoint [1] 319513 0
2 time points- At baseline before receiving the interventions and at end point, after completion of the intervention.
Primary outcome [2] 319549 0
Measures of Attention as obtained from the Test of Everyday Attention (TEA) - outcome from the 4 subscales of the TEA namely selective attention, sustained attention, attentional switching, and divided attention.
Timepoint [2] 319549 0
2 time points- At baseline before receiving the interventions and at end point, after completion of the intervention. .
Secondary outcome [1] 368638 0
Nil
Timepoint [1] 368638 0
Nil

Eligibility
Key inclusion criteria
Group 1: People with MCI- Participants will be recruited from the Memory Clinic, Geriatric Adult Rehabilitation and Stroke Services, GARSS, Toowoomba Hospital. MCI status need to be recent within 3 months of recruitment to this study. The MCI status in GARSS is determined by the consultant geriatrician after the patient goes through a thorough clinical assessment by the Memory Clinic team formed of the consultant geriatrician, psychologist, pharmacist and the geriatric clinical nurse consultant. Additional to their MCI status given at the Memory clinic within 3 months of recruitment to this study, participants’ will be screened by the research assistant for their eligibility by using RBANS. Their general cognition as measured by the total RBANS score should be between 1 and 2 SD below the mean or between 3rd and 16 percentiles for their age and education matched peers on culturally appropriate normative data (American Psychiatric Association, 2013). If they qualify for this study, this RBANS measure obtained will be used as one of the primary outcome measure administered before delivering intervention. Cognitive impairment maybe seen in one or more cognitive domains measured by the RBANS. However, participants will be independent with all their activities of daily living as reported by them, significant others or their GP. Participants of this group will be assessed with the RBANS at regular intervals of 3 months during their participation period, to ensure that they continue to hold their eligibility status. This 3 months’ time frame is followed because a) test-retest of RBANS is 3 months b) for a review in the Memory clinic for MCI status, a minimum of 3 months interval is maintained only if the clients have not had any rapid cognitive decline in the interim c) As MCI status is variable over time, regular monitoring of MCI status is also recommended in the practice guidelines update summary for MCI (Petersen et al., 2018).

Group 2: Healthy Older Adults (without MCI diagnosis):
Participants will be recruited from the community and should be aged between 60 years and 80 years, do not hold a diagnosis of Mild Cognitive Impairment (MCI) and/or Dementia in the last 3 months prior to recruitment. Their general cognition as measured by the total RBANS score should be at least equal or above the mean, for their age and education matched peers on culturally appropriate normative data (APA, 2013). If they qualify for this study, this RBANS measure obtained will be used as one of the primary outcome measure administered before delivering intervention. No reports of functional or cognitive decline as noted by client, significant other or GP. Participants will be re-assessed of their eligibility status by using RBANS, if they or their significant other or their GP report any rapid cognitive decline, during their participation period.

For both groups 1 and 2 other inclusion criteria include -age of the sample population, which is between 60-80 years and participants must be able to read and write..
Minimum age
60 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
Exclusion criteria for participants of Group 1 (participants with a MCI status)- exclusion will be if these participants have a current diagnosis of Dementia or they progress to having Dementia while they are a participant in this study.

Exclusion criteria for Group 2 (healthy older adults)- exclusion criteria will be if they have a diagnosis of MCI or Dementia or they progress to having MCI or Dementia during the course of their participation in this study.

Other exclusion criteria for both MCI and Healthy older adults groups include severe sensory impairment that could potentially impact on their performance, acute medical condition or a severe medical condition needing intensive treatment, and intellectual impairment. These people are excluded as such conditions will hinder their ability to participate in the interventions.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer generated randomised numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer computerised sequence generation from "Random.org"
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size:
Sample size was determined by G power analysis. This was calculated for medium effect size (.20 to .50) for 4 groups (namely two- treatment and control groups of participants with MCI and two- treatment and control healthy older adult groups), and with one repeated measure. Hence total number of participants was calculated to be 128: 32 in the treatment group of participants with MCI, 32 in the control group of participants with MCI, 32 in the treatment group of healthy older adults and finally 32 in the control group of healthy older adults.
Data Analysis
The pre-training assessment data namely the RBANS and the TEA scores will be analysed using the correlation analysis and the logistic regression discussed below:
1.Correlation analysis:
The correlation between the various attention measures (selective attention, sustained attention, attentional switching, and divided attention and various domains of the RBANS namely immediate memory, delayed memory, visuospatial and language measures and overall cognition will be investigated by completing a correlation matrix. This will measure and describe the strength and direction of the relationship existing among these variables.
2.Logistic Regression:
This analysis will determine what subscales of the Test of Everyday Attention (TEA) namely (selective attention, attentional switching, divided attention, and sustained -four subtests in total) and what subtests/domains of the RBANS (namely attention, immediate memory, delayed memory, language or visuospatial) best predict the group of participants with MCI.
The above two analyses will be conducted after collection of pre-training assessment data.
3.Regression Slope and Correlation
For treatment groups only for both Groups 1 (people with MCI) and 2 (healthy older adult groups), each participant’s score for tasks completed on each session (10 sessions) will be recorded. For each individual session, each participant’s score on the allocated task is the number of correct responses out of the total number of items to be completed within the specified time limit. Individual participant’s score on treatment intervention is the sum of the scores obtained from each individual session (10 in total).
Regression slopes will be calculated for each participant and these regression slopes will be correlated with the TEA (alternate form) change scores. This would allow the quantification of change as well as map the direction of change. Participants will receive training in 3 aspects of attention namely selective, sustained and attention switching but not divided attention. This will help us to determine whether training in the specific tasks of attention influence participants’ attentional abilities in the 4 examined aspects of attention. This record of task performance and the measures of the TEA share the same aspects of attention

4. 2X2 Two-way repeated Analysis of Variance (ANOVA):
The pre and post training assessment data (RBANS and TEA) will be analysed using the 2 X 2 two-way repeated ANOVA. The independent variable in this study is the Attention Training Program. Independent variable groups are: 1. Treatment group of participants with MCI, 2. Control group of participants with MCI. 3. Treatment group of healthy older adults and 4. Control group of healthy older adults. Control group of participants will be offered an unrelated relaxation training program during the research.
There are 5 dependent variables that will be assessed namely selective attention, sustained attention, divided attention and attentional switching – the four components of the Test of everyday Attention (TEA) and the total score of the Repeatable battery for the Assessment of Neuropsychological Status (RBANS). Delta scores will be used here.
Statistical comparisons will focus on determining the following:
• Differences noted between treatment groups versus control groups.
• Differences noted between the healthy older adults’ treatment group and the treatment group of participants with MCI.
• Whether there will be reliable changes pre-versus post-intervention?
Data will be analysed using the SPSS version 25.

Recruitment
Recruitment status
Recruiting
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)
QLD
Recruitment hospital [1] 13461 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 26068 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 302293 0
University
Name [1] 302293 0
University of Southern Queensland
Address [1] 302293 0
487-535 West Street, Toowoomba Qld 4350, Australia.
Country [1] 302293 0
Australia
Funding source category [2] 302294 0
Hospital
Name [2] 302294 0
Toowoomba Hospital
Address [2] 302294 0
Pechey St, Toowoomba, QLD 4350
Country [2] 302294 0
Australia
Primary sponsor type
Individual
Name
Mousumi Singh
Address
Toowoomba Hospital
Geriatric Adult Rehabilitation and Stroke Services
Private Mail bag 2
Toowoomba, Qld 4350
.
Country
Australia
Secondary sponsor category [1] 302169 0
None
Name [1] 302169 0
Address [1] 302169 0
Country [1] 302169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302968 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 302968 0
Darling Downs Health
Toowoomba Hospital
Private Mail Bag 2, Queensland 4350
Ethics committee country [1] 302968 0
Australia
Date submitted for ethics approval [1] 302968 0
26/09/2018
Approval date [1] 302968 0
01/02/2019
Ethics approval number [1] 302968 0
HREC/19/QTDD/44877
Ethics committee name [2] 302969 0
University of Southern Queensland Human Research Ethics Committee
Ethics committee address [2] 302969 0
University of Southern Queensland
West Street
Toowoomba Qld 4350
Australia
Ethics committee country [2] 302969 0
Australia
Date submitted for ethics approval [2] 302969 0
01/03/2019
Approval date [2] 302969 0
13/03/2019
Ethics approval number [2] 302969 0
H19REA038

Summary
Brief summary
Aging slows down our mental abilities. However, some older adults may experience greater decline in their mental abilities than their peers. The study investigates how much age affects older people’s ability to pay attention and remember things. Attention is a core mental ability needed for other mental work and daily functioning. Most studies to date have shown problems with memory in older adults. Few studies have looked at whether a decline in attention affects other mental abilities in older adults. This study may help us to understand whether worsening of attention is a sign of MCI in older adults. Attention training is not a common therapy for older adults with difficulties in attention and memory. There is also limited information on the effect of such training on older adults. Understanding the usefulness of attention training in older people may help in deciding whether it should be used as a regular form of therapy. One hundred and twenty eight older adults will take part in this study. Half of the participants will come from the community and the other half from the Toowoomba Hospital Memory Clinic. The Hospital Memory Clinic group of people will have a diagnosis of Mild Cognitive Impairment whereas the community group of people will not have such a diagnosis. Each of these groups of people will be further assigned to two groups of 32 people each. Each of the 2 groups of people will receive either the Attention Training or the Relaxation Training. For this to take place efficiently, each group of 32 people will receive the weekly group training in smaller groups of 8 participants at a time. This study will continue for 2 years, until all 128 participants have received training. Pre-post evaluation of data will be completed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92014 0
Mrs Mousumi Singh
Address 92014 0
Toowoomba Hospital
Geriatric Adult Rehabilitation and Stroke Services
Private Mail bag 2
Toowoomba, Qld 4350
Country 92014 0
Australia
Phone 92014 0
61746166124
Fax 92014 0
Email 92014 0
Mousumi.Singh@health.qld.gov.au
Contact person for public queries
Name 92015 0
Mrs Mousumi Singh
Address 92015 0
Toowoomba Hospital
Geriatric Adult Rehabilitation and Stroke Services
Private Mail bag 2
Toowoomba, Qld 4350
Country 92015 0
Australia
Phone 92015 0
61746166124
Fax 92015 0
Email 92015 0
Mousumi.Singh@health.qlg.gov.au
Contact person for scientific queries
Name 92016 0
Mrs Mousumi Singh
Address 92016 0
Toowoomba Hospital
Geriatric Adult Rehabilitation and Stroke Services
Private Mail bag 2
Toowoomba, Qld 4350
Country 92016 0
Australia
Phone 92016 0
61746166124
Fax 92016 0
Email 92016 0
moudeep70@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For confidentiality reasons to protect interests of individual participants
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2126 0
Study protocol
Citation [1] 2126 0
Link [1] 2126 0
Email [1] 2126 0
Other [1] 2126 0
Type [2] 2127 0
Ethical approval
Citation [2] 2127 0
Link [2] 2127 0
Email [2] 2127 0
Other [2] 2127 0
Type [3] 2128 0
Ethical approval
Citation [3] 2128 0
Link [3] 2128 0
Email [3] 2128 0
Other [3] 2128 0
Summary results
No Results