ANZCTR - Registration

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618001542280

Ethics application status

Approved

Date submitted

12/09/2018

Date registered

14/09/2018

Date last updated

13/05/2022

Date data sharing statement initially provided

5/02/2019

Date results information initially provided

13/05/2022

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]

CogMax

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Older adults

Cognitive impairment

Psychological wellbeing

Condition category

Condition code

Neurological

Dementias

Neurological

Parkinson's disease

Neurological

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]

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]

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]

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]

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]

Baseline, post-intervention follow-up and long-term follow-up.

Secondary outcome [2]

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]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [3]

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]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [4]

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]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [5]

Change in family-member/friend self-reported aspects of psychosocial functioning including mood (15-item Geriatric Depression Scale; Geriatric Anxiety Scale).

Timepoint [5]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [6]

Goal attainment, using the Bangor Goal Setting Interview.

Timepoint [6]

Post-intervention follow-up, long-term follow-up.

Secondary outcome [7]

Participant satisfaction/evaluation of the program, using the structured Healthy Brain Ageing Satisfaction questionnaire.

Timepoint [7]

Post-intervention follow-up.

Secondary outcome [8]

Change in participant self-reported aspects of psychosocial functioning including quality of life (WHO Quality of Life BREF).

Timepoint [8]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [9]

Change in participant self-reported aspects of psychosocial functioning including mood (15-item Geriatric Depression Scale; Geriatric Anxiety Scale).

Timepoint [9]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [10]

Change in participant self-reported aspects of psychosocial functioning including sleep disturbance (Pittsburgh Sleep Quality Index).

Timepoint [10]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [11]

Change in participant self-reported aspects of psychosocial functioning including memory complaints and strategy use (Multi-factorial Memory Questionnaire).

Timepoint [11]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [12]

Change in participant self-reported aspects of psychosocial functioning including self-efficacy (General Self-Efficacy Scale).

Timepoint [12]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [13]

Change in family-member/friend self-reported aspects of psychosocial functioning including quality of life (WHO Quality of Life BREF).

Timepoint [13]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [14]

Change in family-member/friend self-reported aspects of psychosocial functioning including perceived burden (Zarit Burden Inventory).

Timepoint [14]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [15]

Engagement in cognitively stimulating activities (Cognitively Stimulating Activities - Revised).

Timepoint [15]

Baseline, post-intervention follow-up, long-term follow-up.

Secondary outcome [16]

Objective measurement of sleep functioning using actigraphy

Timepoint [16]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities
Participant recruitment difficulties

Date of first participant enrolment

Anticipated

24/09/2018

Actual

5/12/2018

Date of last participant enrolment

Anticipated

Actual

3/06/2021

Date of last data collection

Anticipated

Actual

23/02/2022

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

University

Name [1]

Brain and Mind Centre

Address [1]

94 Mallett Street
Camperdown, NSW, 2050

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NHMRC National Institute for Dementia Research

Address [2]

Level 1, 16 Marcus Clarke Street
Canberra City, ACT, 2601

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Parkinson's NSW

Address [3]

Macquarie Hospital, Building 17
51 Wicks Road
North Ryde, NSW, 2113

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Prof Sharon Naismith

Address [1]

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Prof Simon Lewis

Address [2]

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Haley LaMonica

Address [3]

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Miss Alena Rahmanovic

Address [4]

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Ms Claire Burrows

Address [5]

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Mr Johannes Michaelian

Address [6]

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country [6]

Australia

Other collaborator category [7]

Individual

Name [7]

Miss Stacey West

Address [7]

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country [7]

Australia

Other collaborator category [8]

Individual

Name [8]

Miss Ashlee Turner

Address [8]

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country [8]

Australia

Other collaborator category [9]

Individual

Name [9]

Ms Bonnie Tran

Address [9]

Level 2, Building M02G, Brain and Mind Centre, 100 Mallett Street, Camperdown NSW 2050

Country [9]

Australia

Other collaborator category [10]

Individual

Name [10]

Dr Andrew McKinnon

Address [10]

Level 2, Building M02G, Brain and Mind Centre, 100 Mallett Street, Camperdown NSW 2050

Country [10]

Australia

Other collaborator category [11]

Individual

Name [11]

Mr Jake Palmer

Address [11]

Level 2, Building M02G, Brain and Mind Centre, 100 Mallett Street, Camperdown NSW 2050

Country [11]

Australia

Other collaborator category [12]

Individual

Name [12]

Mr Bradley Skinner

Address [12]

Level 2, Building M02G, Brain and Mind Centre, 100 Mallett Street, Camperdown NSW 2050

Country [12]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics Committee (HREC)

Ethics committee address [1]

Human Ethics Office
Level 2, Margaret Telfer Building (K07)
The University of Sydney
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/06/2018

Approval date [1]

31/08/2018

Ethics approval number [1]

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

Dr Loren Mowszowski

Address

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country

Australia

Phone

+612 93510757

Fax

[email protected]

Contact person for public queries

Name

Dr Loren Mowszowski

Address

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country

Australia

Phone

+612 93510757

Fax

[email protected]

Contact person for scientific queries

Name

Dr Loren Mowszowski

Address

Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050

Country

Australia

Phone

+612 93510757

Fax

[email protected]

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.

How or where can data be obtained?

Access subject to approval by the Principal Investigator.

What supporting documents are/will be available?

Doc. No.	Type	Email
5705	Study protocol	[email protected]
5706	Statistical analysis plan	[email protected]
5707	Informed consent form	[email protected]
5708	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically