Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000604000
Ethics application status
Approved
Date submitted
25/07/2010
Date registered
26/07/2010
Date last updated
15/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Boosting the Cognitive Capacity and Mental Wealth of Working Australians.
Scientific title
Efficacy of computerized cognitive brain training compared to active control training in a group of Australian office-based workers on cognitive performance, psychological well being and workplace productivity.
Secondary ID [1] 252302 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition 257537 0
Psychological Well Being 257538 0
Work Productivity 257543 0
Condition category
Condition code
Mental Health 257705 257705 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Computerised Cognitive Brain Training (CCBT) will be conducted during normal work hours and delivered via the ‘Spark!’ online system directly to the subject’s normal work computer. Regime is 3 sessions a week, of 20 minutes each for a total of 16 weeks.

The Spark! CCBT program comprises 36 of HappyNeuron Inc’s suite of cognitive exercises. These exercises target the cognitive domains of memory, attention, language, executive functions and visuospatial abilities in a drill and practice fashion. Multi-domain training is likely to be maximally effective as suggested by our recent systematic review . During each session, subjects will practice a number of exercises from across a range of cognitive domains, and gradually be challenged by exercises of greater complexity and cognitive demand during the course of the 4-month period in an individualized manner prescribed by the system’s in-built algorithms.

This system is propriety software of The Brain Department Pty Ltd.
Intervention code [1] 256631 0
Treatment: Other
Comparator / control treatment
Active control comprises viewing a series of educational National Geographic videos at subjects' work station and answering related multiple choice questions delivered via an online survey. Frequency and duration of this computer-based audiovisual stimulation matches the CCBT intervention
Control group
Active

Outcomes
Primary outcome [1] 258600 0
Cognitive Domain scores:
1. Memory: Verbal memory and Non-verbal memory
2. Attention: Divided attention Part I and Part II
3. Visual Spatial: Visual Spatial Orientation
4. Language: Controlled Oral Word Association Test (COWAT)
5. Disinhibition: Stroop
6. Reasoning and problem solving: Matrix
7. Speed: Staged Information Processing Speed, Visual Sequence Comparison.

In addition, two General Cognitive summary scores will be calculated:
8. Average of domain scores
9. First principal component of baseline cognitive tests results

All cognitive tests will be administered to the intervention and active control group by a combination of computerised neuropsychological software tests and paper-and-pencil test format.
Timepoint [1] 258600 0
Baseline
Proximal follow up (after 16-week intervention)
Longitudinal follow-up (6 months after proximal follow up)
Primary outcome [2] 258601 0
Psychological Well Being
1. Job Satisfaction:
Overall job satisfaction scale for positive appraisals
Intention to quit scale for negative appraisals

2. Psychological wellbeing:
Relative absence of Psychological Distress: this will be measured by the Depression, Anxiety and Stress Scales (DASS).
Self-Esteem: Professional self esteem scale
Quality of Life: the Quality of Life Scale (QOLS) and Ryff?s Scales of Psychological Wellbeing (SPWB)

Two primary outcomes of job satisfaction and psychological wellbeing will be calculated as the sum of standardized z-scores.























These self report scales will be administered via email and online survey at baseline, proximal follow-up and longitudinal follow-up.
Primary Outcome Measures: job satisfaction and psychological wellbeing will be calculated as the sum of standardized z-scores.
Timepoint [2] 258601 0
Baseline
Proximal follow up (after 16-week intervention)
Longitudinal follow-up (6 months after proximal follow up)
Primary outcome [3] 258602 0
Workplace Productivity
Calculated as the sum of standardized z-scores across each of the following productivity measures:
a) average handling time
b) conversion rates
c) work quality ratings
Timepoint [3] 258602 0
Baseline
Proximal follow up (after 16-week intervention)
Longitudinal follow-up (6 months after proximal follow up)
Secondary outcome [1] 264500 0
Each individual cognitive, psychological wellbeing and workplace productivity score.
Timepoint [1] 264500 0
Baseline
Proximal follow up (after 16-week intervention)
Longitudinal follow-up (6 months after proximal follow up)

Eligibility
Key inclusion criteria
Volunteers employed for a minimum of 6 months at the Australian Taxation Office (ATO) Debt Capability division.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. No other current form of brain training
2. No forecast leave of work for more than 3 continuous weeks
3. No current mental health issue affecting cognition - absence of medical treatment for major depression, schizophrenia or bipolar disorder
4. No history of recurrent mental health issue - absence of three or more episodes of major depression or bipolar disorder requiring medical treatment in last 5 years
5. No current or history of alcohol or drug abuse
6. No history of suicide attempt

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)
Workplace presentation by lead investigators and then invitation to enroll and provide informed consent.

Concealment of randomisation is by central off-site administration and communicated via email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based generation of random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Multi-centre, longitudinal follow-up
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2988 0
2000
Recruitment postcode(s) [2] 2989 0
4000
Recruitment postcode(s) [3] 3047 0
4122
Recruitment postcode(s) [4] 3048 0
3175
Recruitment postcode(s) [5] 3049 0
5000
Recruitment postcode(s) [6] 3050 0
2150
Recruitment postcode(s) [7] 3052 0
3000

Funding & Sponsors
Funding source category [1] 257333 0
Commercial sector/Industry
Name [1] 257333 0
The Brain Department Pty Limited
Country [1] 257333 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Valenzuela
Address
School of Psychiatry
University of New South Wales
c/o Neuropsychiatric Institute
Prince of Wales Hospital
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 256576 0
University
Name [1] 256576 0
University of New South Wales
Address [1] 256576 0
University of New South Wales
Sydney
NSW 2052
Country [1] 256576 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259158 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 259158 0
Ethics committee country [1] 259158 0
Australia
Date submitted for ethics approval [1] 259158 0
06/04/2010
Approval date [1] 259158 0
11/05/2010
Ethics approval number [1] 259158 0
10103

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31274 0
Address 31274 0
Country 31274 0
Phone 31274 0
Fax 31274 0
Email 31274 0
Contact person for public queries
Name 14521 0
Dr Michael Valenzuela
Address 14521 0
Neuropsychiatric Institute
Prince of Wales Hospital
Randwick NSW 2031
Australia
Country 14521 0
Australia
Phone 14521 0
+61 2 9382 2712
Fax 14521 0
+61 2 9382 3774
Email 14521 0
[email protected]
Contact person for scientific queries
Name 5449 0
Dr Michael Valenzuela
Address 5449 0
Neuropsychiatric Institute
Prince of Wales Hospital
Randwick NSW 2031
Australia
Country 5449 0
Australia
Phone 5449 0
+61 2 9382 2712
Fax 5449 0
+61 2 9382 3774
Email 5449 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
No additional documents have been identified.