Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000570987
Ethics application status
Approved
Date submitted
16/05/2011
Date registered
3/06/2011
Date last updated
8/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring neuroplasticity associated with a combined computerised cognitive training and psychoeducation program in patients with mild cognitive impairment and /or a lifetime history of depression
Scientific title
Exploring neuroplasticity with cognitive training: A healthy brain ageing program for older people with depression or mild cognitive impairment
Secondary ID [1] 1111 0
Nil
Universal Trial Number (UTN)
U1111-1111-0917
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 251969 0
mild cognitive impairment 251970 0
Mental health 268015 0
Condition category
Condition code
Mental Health 252160 252160 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combined Cognitive Training (CT) and psychoeducation program covering healthy brain ageing. This consists of a two hour group-based (8-10 people) session twice every week for 7 weeks. The psychoeducation sessions are delivered by specialists including clinical neuropsychologists, clinical psychologists, psychogeriatricians, chronobiologists, and experts in diet and exercise. The computer-based cognitive training sessions are facilitated by trained clinical neuropsychologists. The first hour delivers information pertinent to healthy ageing including use of cognitive strategies and information on diet and exercise, vascular risk factors, depression, anxiety and sleep. The second hour is a computer based cognitive training program.
Intervention code [1] 241382 0
Lifestyle
Intervention code [2] 266697 0
Treatment: Other
Intervention code [3] 266698 0
Behaviour
Comparator / control treatment
Treatment as usual. This includes standard clinical care by usual health care professionals. There is no prescribed intervention administered by the trial. The control arm is a waitlist control arm. It also runs for 7-weeks, and then participants are re-assessed, and offered the opportunity to participate in the cognitive training groups.
Control group
Active

Outcomes
Primary outcome [1] 253028 0
Formal neuropsychological testing will assess performance in a number of cognitive domains including learning and memory, language, speed of processing, attention and working memory, and executive functioning.

The primary outcome is memory which will be measured using the Rey Auditory Verbal Learning Test and the Logical Memory subtest of the Wechsler Memory Scale-III
Timepoint [1] 253028 0
Participants are assessed at trial entry, and again after 7 weeks of either 'cognitive training' or 'treatment as usual' (ie. waitlist).
Secondary outcome [1] 257844 0
Depression, as assessed by a Psychogeriatrician using the Structured Clinical Interview for DSM-IV Disorders.

Patients are also asked to complete questionnaires pertaining to their mood (Geriatric Depression Scale; Hospital Anxiety Depression Scale).
Timepoint [1] 257844 0
Participants are assessed at trial entry, and again after 7 weeks of either 'cognitive training' or 'treatment as usual' (ie. waitlist).
Secondary outcome [2] 257845 0
Evoked related potentials as assessed by neurophysiological testing (EEG).
Timepoint [2] 257845 0
Participants are assessed at trial entry, and again after 7 weeks of either 'cognitive training' or 'treatment as usual' (ie. waitlist).
Secondary outcome [3] 257846 0
Blood tests to examine genotypes relevant to depression and dementia.
Timepoint [3] 257846 0
Participants are assessed at trial entry.
Secondary outcome [4] 257847 0
social cognition as measured by eye tracking technology during exposure to emotional facial stimuli
Timepoint [4] 257847 0
Participants are assessed at trial entry, and again after 7 weeks of either 'cognitive training' or 'treatment as usual' (ie. waitlist).
Secondary outcome [5] 257848 0
Vascular brain changes as measured by Magnetic resonance imaging (MRI)
Timepoint [5] 257848 0
Participants are assessed at trial entry

Eligibility
Key inclusion criteria
Cognitive impairment or depression or vascular risk factors
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke, transient ischaemic attack (TIA), poor English skills, unable to attend 10-weeks of therapy, neurological disorder, dementia, psychiatric disorder, medical illness with known cognitive effects, prior head injury.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After referral, telephone screening for inclusion/exclusion, baseline medical and neuropsychological assessments, participants receive a sealed envelope with a letter informing them about which group they have been allocated to. The envelopes are prepared by a person who is not involved in the intake, assessment or intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/08/2009
Actual
24/08/2009
Date of last participant enrolment
Anticipated
Actual
11/01/2012
Date of last data collection
Anticipated
30/12/2017
Actual
Sample size
Target
100
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 243843 0
Government body
Name [1] 243843 0
National Health and Medical Research Council (NHMRC)
Country [1] 243843 0
Australia
Primary sponsor type
Individual
Name
Sharon Naismith
Address
94 Mallett St, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 237193 0
Individual
Name [1] 237193 0
Ian Hickie
Address [1] 237193 0
94 Mallett St, Camperdown NSW 2050
Country [1] 237193 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243968 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 243968 0
Camperdown NSW 2050
Ethics committee country [1] 243968 0
Australia
Date submitted for ethics approval [1] 243968 0
Approval date [1] 243968 0
12/08/2009
Ethics approval number [1] 243968 0
08-2009/11962

Summary
Brief summary
While many studies have shown that cognitive training in older people is associated with improved cognitive abilities, little is known about the predictors of change, or whether cognitive training is associated with improvements in neurophysiological activity or in ‘real world’ functions such as social relationships. In older individuals ‘at risk’ of cognitive decline, this study therefore aims to determine the neurobiological, clinical and cognitive predictors of ability to benefit from a ‘healthy brain ageing’ cognitive training program. It is expected that those who participate in the treatment will improve in terms of memory functioning.
Trial website
www.bmri.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30361 0
Prof Sharon Naismith
Address 30361 0
Healthy Brain Ageing Program
Brain and Mind Centre
The University of Sydney
94 Mallett St
Camperdown, NSW, Australia 2050
Country 30361 0
Australia
Phone 30361 0
+612 9351 0781
Fax 30361 0
Email 30361 0
[email protected]
Contact person for public queries
Name 13608 0
Dr Loren Mowszowski
Address 13608 0
94 Mallett St, Camperdown NSW 2050
Country 13608 0
Australia
Phone 13608 0
+612 9351 0757
Fax 13608 0
+61 2 9351 0551
Email 13608 0
[email protected]
Contact person for scientific queries
Name 4536 0
Prof Sharon Naismith
Address 4536 0
94 Mallett St, Camperdown NSW 2050
Country 4536 0
Australia
Phone 4536 0
+61 2 9351 0781
Fax 4536 0
+612 9351 0551
Email 4536 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomized controlled trial of a healthy brain ageing cognitive training program: Effects on memory, mood, and sleep.2015https://dx.doi.org/10.3233/978-1-61499-542-5-355
EmbaseCognitive training enhances pre-attentive neurophysiological responses in older adults 'at risk' of dementia.2014https://dx.doi.org/10.3233/JAD-131985
N.B. These documents automatically identified may not have been verified by the study sponsor.