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Trial registered on ANZCTR


Registration number
ACTRN12618001542280
Ethics application status
Approved
Date submitted
12/09/2018
Date registered
14/09/2018
Date last updated
5/02/2019
Date data sharing statement initially provided
5/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
CogMax: A Healthy Brain Ageing cognitive training and psychoeducation program for older adults.
Scientific title
CogMax: A Healthy Brain Ageing cognitive training and psychoeducation program for older adults – comparing facilitated vs independent delivery.
Secondary ID [1] 296065 0
CogMax
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adults 309619 0
Cognitive impairment 309620 0
Psychological wellbeing 309621 0
Condition category
Condition code
Neurological 308435 308435 0 0
Dementias
Neurological 308436 308436 0 0
Parkinson's disease
Neurological 308437 308437 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CogMax is a ten-week psychoeducation and cognitive training program targeting common cognitive concerns experienced by many older adults, as well as modifiable risk factors for dementia. Based on previously published work reporting outcomes from a group-based multifaceted Healthy Brain Ageing intervention program (for example, see Diamond et al., 2015, J Alz Dis; Naismith et al., 2011, Am J Geriatr Psychiatry; Mowszowski et al., 2014, J Alz Dis); we now seek to evaluate an adapted version of the program for completion on a one-to-one basis or independently, which will enable a broader group of older people to access the intervention.

The program has been adapted to a structured workbook format, with topics arranged into five core ‘cognitive’ modules and five health/psychosocial/lifestyle modules addressing risk factors for dementia. Each module will provide participants with education and practical instruction on a variety of strategies targeting cognition, mood disturbance, and medical or lifestyle factors known to affect cognition and psychosocial wellbeing.

All participants will complete a total of 10-weekly modules over the course of the intervention period. Ideally, this period will therefore last 10-weeks; however, if needed, the 10 modules may be completed over a maximum of 12-weeks, to allow for some flexibility in the event of pre-existing travel plans or unanticipated changes in availability (e.g. due to illness).
The modules include:
1. Introduction to the Brain and Cognitive Changes in Ageing, including Goal Setting
2. Introduction to Learning and Memory
3. External Memory Strategies
4. Internal Memory Strategies
5. Executive Functions
6. Vascular Risk Factors
7. Diet and Exercise
8. Sleep Habits and Sleep Quality
9. Depression and Anxiety
10. Behavioural and Psychological Strategies for Wellbeing

Therapist-facilitated condition:
Participants allocated to the facilitated condition will attend the Brain and Mind Centre (BMC) in Sydney, Australia, once a week at a mutually agreed time to meet with a trained neuropsychologist or closely supervised postgraduate neuropsychology student, for one hour. During these one-on-one sessions, participants will complete one module from the workbook, starting with Module 1 (Introduction to the Brain and Cognitive Changes in Ageing). The neuropsychologist will work through the psychoeducation material and cognitive strategies with the participant, to actively facilitate and maximise optimal comprehension and applicability to their individual circumstances, using personalised examples. Additionally, the neuropsychologist will utilise clinical techniques such as collaborative goal-setting and motivational interviewing to identify the most clinically relevant issues for each individual. With this information, the therapist may recommend that the participant complete the modules in a different order to that set out in the workbook, to ensure optimal engagement and the ability to address critical or significant issues as a matter of priority. Each session, the therapist will also review the homework tasks completed by the participant following the previous session, to aid in the participant’s self-evaluation of their progress and address any barriers to meeting their goals.
Intervention code [1] 312399 0
Treatment: Other
Comparator / control treatment
Participants allocated to the independent condition will receive the entire workbook to take home and complete independently, without clinical facilitation or assistance. They will be instructed to complete one module per week for ten weeks, in the order presented in the workbook. They will be asked to complete all exercises, questionnaires and homework activities as specified in the workbook. Participants will not attend the Brain and Mind Centre during the 10-week intervention period. However, in order to maintain study engagement as well as to monitor compliance, all participants will receive a telephone call weekly from a member of the research team. During this call, they will be asked how many modules and which modules were completed in the previous week, and whether they also completed the relevant homework tasks for the previous week.
Control group
Active

Outcomes
Primary outcome [1] 307402 0
Learning and memory will be assessed using the California Verbal Learning Test (CVLT) for verbal learning/memory, and the Paired Associates Learning subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB) for non-verbal learning.
Timepoint [1] 307402 0
Baseline (before randomization), post-intervention follow-up (within two weeks of completing the intervention), and long-term follow-up (six months after completing the intervention).
All timepoints are considered primary.
Secondary outcome [1] 351831 0
Objective change in speed of information processing as measured by the Trail Making Test (Part A) and the Reaction Time subtest from the CANTAB.
Timepoint [1] 351831 0
Baseline, post-intervention follow-up and long-term follow-up.
Secondary outcome [2] 351832 0
Objective change in language ability as measured by the Condition 2 – Category Fluency from the Delis Kaplan Executive Function Scale (DKEFS; Verbal Fluency subtest).
Timepoint [2] 351832 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [3] 351833 0
Objective change in executive functions as measured by Condition 1 – Letter Fluency and Condition 3 – Category Switching from the DKEFS Verbal Fluency subtest; longest digit span backwards sub-score from the Digit Span subtest, Wechsler Adult Intelligence Scale (3rd edition); and the Multi-Tasking Test (CANTAB).
Timepoint [3] 351833 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [4] 351835 0
Change in participant self-reported aspects of psychosocial functioning including self-rated and informant rated activities of daily living (using the Healthy Brain Ageing Functional Assessment Scale).
Timepoint [4] 351835 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [5] 351836 0
Change in family-member/friend self-reported aspects of psychosocial functioning including mood (15-item Geriatric Depression Scale; Geriatric Anxiety Scale).
Timepoint [5] 351836 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [6] 351837 0
Goal attainment, using the Bangor Goal Setting Interview.
Timepoint [6] 351837 0
Post-intervention follow-up, long-term follow-up.
Secondary outcome [7] 351838 0
Participant satisfaction/evaluation of the program, using the structured Healthy Brain Ageing Satisfaction questionnaire.
Timepoint [7] 351838 0
Post-intervention follow-up.
Secondary outcome [8] 351880 0
Change in participant self-reported aspects of psychosocial functioning including quality of life (WHO Quality of Life BREF).
Timepoint [8] 351880 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [9] 351882 0
Change in participant self-reported aspects of psychosocial functioning including mood (15-item Geriatric Depression Scale; Geriatric Anxiety Scale).
Timepoint [9] 351882 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [10] 351884 0
Change in participant self-reported aspects of psychosocial functioning including sleep disturbance (Pittsburgh Sleep Quality Index).
Timepoint [10] 351884 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [11] 351885 0
Change in participant self-reported aspects of psychosocial functioning including memory complaints and strategy use (Multi-factorial Memory Questionnaire).
Timepoint [11] 351885 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [12] 351886 0
Change in participant self-reported aspects of psychosocial functioning including self-efficacy (General Self-Efficacy Scale).
Timepoint [12] 351886 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [13] 351887 0
Change in family-member/friend self-reported aspects of psychosocial functioning including quality of life (WHO Quality of Life BREF).
Timepoint [13] 351887 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [14] 351888 0
Change in family-member/friend self-reported aspects of psychosocial functioning including perceived burden (Zarit Burden Inventory).
Timepoint [14] 351888 0
Baseline, post-intervention follow-up, long-term follow-up.
Secondary outcome [15] 366426 0
Engagement in cognitively stimulating activities (Cognitively Stimulating Activities - Revised).
Timepoint [15] 366426 0
Baseline, post-intervention follow-up, long-term follow-up.

Eligibility
Key inclusion criteria
• >= 50 years of age;
• Subjective Memory Impairment (SCI), Mild Cognitive Impairment (MCI) or Parkinson’s Disease (PD) with cognitive complaints;
• Mini Mental State Examination (MMSE) score >24 or Montreal Cognitive Assessment score >=26;
• Willing and able to attend the BMC once a week at a mutually agreed time for therapy sessions, if randomly allocated to the facilitated condition;
• Willing and able to remain in contact with the study team for the duration of the trial, including attending the BMC for baseline and follow-up assessments.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Intellectual or developmental disability
• Previous head injury with loss of consciousness > 30 minutes
• History of stroke or seizures
• History of neurological illness (other than Parkinson’s disease)
• History of psychiatric illness (other than affective disorder – e.g., schizophrenia, bipolar disorder, PTSD)
• History of electroconvulsive therapy or deep brain stimulation
• Current/past alcohol or substance dependence (other than nicotine)
• Current medical condition which may affect cognition (e.g., cancer, chronic fatigue syndrome)
• Concurrent use of other psychological or computerized CT therapy (internet or clinician-delivered)

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)
Sealed opaque envelopes.
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample sizes for the SCI, MCI and PD subgroups have been determined with the intention to analyse data from these groups separately. We expect a medium effect size (d ~ 0.4) improvement in all groups following completion of the CogMax program. However, investigation of the specific delivery method is novel and within this pilot study, we seek to determine the actual effect size differences between the two active conditions. It is estimated that we will have 80% power to detect a medium effect size within the PD and MCI samples of 40 participants each, and 56% power to detect a medium effect size within the SCI sample of 20 participants.

Analyses will follow an intention-to-treat approach. All data will be assessed for violation of assumptions (e.g., normality, heterogeneity etc.) and appropriate non-parametric or other statistical procedures will be adopted accordingly. Baseline group differences between the two delivery methods will be assessed using independent t-tests. Repeated measures ANOVA will then be used to assess primary and secondary outcomes with delivery methods as the between-groups condition and time as the within-groups condition. All analyses will be two-tailed and p = 0.05.

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)
NSW
Recruitment postcode(s) [1] 23962 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 300651 0
University
Name [1] 300651 0
Brain and Mind Centre
Address [1] 300651 0
94 Mallett Street
Camperdown, NSW, 2050
Country [1] 300651 0
Australia
Funding source category [2] 300654 0
Government body
Name [2] 300654 0
NHMRC National Institute for Dementia Research
Address [2] 300654 0
Level 1, 16 Marcus Clarke Street
Canberra City, ACT, 2601
Country [2] 300654 0
Australia
Funding source category [3] 300655 0
Charities/Societies/Foundations
Name [3] 300655 0
Parkinson's NSW
Address [3] 300655 0
Macquarie Hospital, Building 17
51 Wicks Road
North Ryde, NSW, 2113
Country [3] 300655 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Level 3, F23 Administration Building
Corner of Eastern Avenue and City Road
The University of Sydney
NSW, 2008
Country
Australia
Secondary sponsor category [1] 300171 0
None
Name [1] 300171 0
Address [1] 300171 0
Country [1] 300171 0
Other collaborator category [1] 280340 0
Individual
Name [1] 280340 0
Prof Sharon Naismith
Address [1] 280340 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [1] 280340 0
Australia
Other collaborator category [2] 280341 0
Individual
Name [2] 280341 0
Prof Simon Lewis
Address [2] 280341 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [2] 280341 0
Australia
Other collaborator category [3] 280342 0
Individual
Name [3] 280342 0
Dr Haley LaMonica
Address [3] 280342 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [3] 280342 0
Australia
Other collaborator category [4] 280343 0
Individual
Name [4] 280343 0
Miss Alena Rahmanovic
Address [4] 280343 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [4] 280343 0
Australia
Other collaborator category [5] 280344 0
Individual
Name [5] 280344 0
Ms Claire Burrows
Address [5] 280344 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [5] 280344 0
Australia
Other collaborator category [6] 280345 0
Individual
Name [6] 280345 0
Mr Johannes Michaelian
Address [6] 280345 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [6] 280345 0
Australia
Other collaborator category [7] 280346 0
Individual
Name [7] 280346 0
Miss Stacey West
Address [7] 280346 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [7] 280346 0
Australia
Other collaborator category [8] 280347 0
Individual
Name [8] 280347 0
Miss Ashlee Turner
Address [8] 280347 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [8] 280347 0
Australia
Other collaborator category [9] 280515 0
Individual
Name [9] 280515 0
Ms Bonnie Tran
Address [9] 280515 0
Level 2, Building M02G, Brain and Mind Centre, 100 Mallett Street, Camperdown NSW 2050
Country [9] 280515 0
Australia
Other collaborator category [10] 280516 0
Individual
Name [10] 280516 0
Dr Andrew McKinnon
Address [10] 280516 0
Level 2, Building M02G, Brain and Mind Centre, 100 Mallett Street, Camperdown NSW 2050
Country [10] 280516 0
Australia
Other collaborator category [11] 280517 0
Individual
Name [11] 280517 0
Mr Jake Palmer
Address [11] 280517 0
Level 2, Building M02G, Brain and Mind Centre, 100 Mallett Street, Camperdown NSW 2050
Country [11] 280517 0
Australia
Other collaborator category [12] 280518 0
Individual
Name [12] 280518 0
Mr Bradley Skinner
Address [12] 280518 0
Level 2, Building M02G, Brain and Mind Centre, 100 Mallett Street, Camperdown NSW 2050
Country [12] 280518 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301440 0
University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 301440 0
Human Ethics Office
Level 2, Margaret Telfer Building (K07)
The University of Sydney
NSW 2006
Ethics committee country [1] 301440 0
Australia
Date submitted for ethics approval [1] 301440 0
08/06/2018
Approval date [1] 301440 0
31/08/2018
Ethics approval number [1] 301440 0
2018/546

Summary
Brief summary
This feasibility pilot study will compare two methods of delivery, facilitated by a Neuropsychologist or completed independently, for an evidence-based, structured Healthy Brain Ageing (HBA) cognitive training (CT) and psychoeducation program, designed to improve cognitive and psychosocial functioning in people with Subjective Cognitive Impairment (SCI), Mild Cognitive Impairment (MCI) or Parkinson’s Disease (PD). While the program has been shown to be successful in over 350 participants to-date, it has previously only been offered in-person in group-based sessions, which has limited translational capacity. We now seek to evaluate other delivery methods with a view to more readily providing this program to individuals in the community in the future, pending trial outcomes.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87006 0
Dr Loren Mowszowski
Address 87006 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country 87006 0
Australia
Phone 87006 0
+612 93510757
Fax 87006 0
Email 87006 0
loren.mowszowski@sydney.edu.au
Contact person for public queries
Name 87007 0
Dr Loren Mowszowski
Address 87007 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country 87007 0
Australia
Phone 87007 0
+612 93510757
Fax 87007 0
Email 87007 0
loren.mowszowski@sydney.edu.au
Contact person for scientific queries
Name 87008 0
Dr Loren Mowszowski
Address 87008 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country 87008 0
Australia
Phone 87008 0
+612 93510757
Fax 87008 0
Email 87008 0
loren.mowszowski@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication of the main results, no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
By what mechanism will data be made available?
Access subject to approval by the Principal Investigator.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
Not applicable