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Trial registered on ANZCTR


Registration number
ACTRN12614000257662
Ethics application status
Approved
Date submitted
30/01/2014
Date registered
11/03/2014
Date last updated
14/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The TWIN-E Brain Training Trial: A waitlist controlled trial of computerised training for improving mental wellbeing in healthy twins
Scientific title
Impact of cognitive training on improving emotional and cognitive function and wellbeing: Testing predictors and moderators of treatment response in healthy twins.
Secondary ID [1] 283917 0
Nil
Universal Trial Number (UTN)
Trial acronym
TWIN-E (Twin Study in Wellbeing using Integrative Neuroscience of Emotion)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resilience and wellbeing 290916 0
Condition category
Condition code
Mental Health 291269 291269 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MyBrainSolutions (www.mybrainsolutions.com) cognitive training intervention.

Twin pairs are randomly assigned to either a training group or a waitlist control group.

Participants in the training group are requested to register online, complete a web assessment, after which they receive their personal brain scores. They are then instructed to play the recommended cognitive games (suited to their profile) for 30 minutes, 2-3 times a week, over a period of 30 days. These participants are then asked to complete the web assessment again, following the 30 days of training.

At the 30-day period, matched waitlist control participants are provided access to the web platform to complete their web assessment, and then are provided access to the training program.

To encourage adherence, participants are contacted by phone and/or email on a fortnightly basis. The online program also sends out automated reminders prior to the 30-day assessment period, encouraging adherence. Log-in time and date, game type and playing duration data are automatically collected by the cognitive training program.
Intervention code [1] 288599 0
Behaviour
Comparator / control treatment
The control group is a waitlist control group. These participants are not required to do anything during the 30-day trial, but following the 30 days, they are provided access to the training portal to use like the treatment group were provided.
Control group
Active

Outcomes
Primary outcome [1] 291272 0
Mean Emotion Identification reaction time using an online Emotion Identification task (Mathersul et al 2009).

Mathersul D, Palmer D, Gur RC, Gur RE, Cooper N, Gordon E, Williams LM. (2009). Explicit identification and implicit recognition of facial emotions: II. Identifying core domains and relationships with general cognition. Journal of Clinical and Experimental Neuropsychology, 31, 278-291.
Timepoint [1] 291272 0
At baseline and at 30 days after intervention commencement
Primary outcome [2] 291296 0
Mean Cognitive Performance scores (memory, attention, executive functioning, response inhibition) using online cognitive tasks including the Motor Tapping task, Go-Nogo, Continuous Performance Test, Switching of Attention Test, Verbal Interference, Choice Reaction Time, Digit Span, Memory Recognition test and the Executive Maze (Mathersul et al. 2009).

Mathersul D, Palmer D, Gur RC, Gur RE, Cooper N, Gordon E, Williams LM. (2009). Explicit identification and implicit recognition of facial emotions: II. Identifying core domains and relationships with general cognition. Journal of Clinical and Experimental Neuropsychology, 31, 278-291.
Timepoint [2] 291296 0
At baseline and at 30 days after intervention commencement
Secondary outcome [1] 306386 0
Mean DASS depression, anxiety and stress scores
Timepoint [1] 306386 0
At baseline and at 30 days after intervention commencement
Secondary outcome [2] 306387 0
Mean mDES positive and negative emotion scores
Timepoint [2] 306387 0
At baseline and at 30 days after intervention commencement
Secondary outcome [3] 306391 0
Mean ERQ emotion regulation scores
Timepoint [3] 306391 0
At baseline and at 30 days after intervention commencement
Secondary outcome [4] 306392 0
Mean SWLS life satisfaction scores
Timepoint [4] 306392 0
At baseline and at 30 days after intervention commencement
Secondary outcome [5] 306393 0
Mean WHO-QoL quality of life scores
Timepoint [5] 306393 0
At baseline and at 30 days after intervention commencement
Secondary outcome [6] 306441 0
Mean COMPAS-W wellbeing scores
Timepoint [6] 306441 0
At baseline and at 30 days after intervention commencement

Eligibility
Key inclusion criteria
Healthy same-sex monozygotic (MZ) and dizygotic (DZ) twins aged 18-65 years with pure European ancestry, and English as primary language.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current or lifetime psychiatric illness;
History of stroke or neurological disorder;
Genetic disorder;
Brain injury (causing loss of consciousness for more than 10 minutes);
Chronic and serious medical conditions (e.g., cancer, heart disease);
Blood-borne illnesses;
Drug/Alcohol substance abuse;
Sensory impairments to hearing, hand movement, or vision not corrected by glasses/lenses.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the coin-toss method
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
The project involves 1652 participants, or 826 twin pairs. The sample size is large enough to be robust, even with a possible 20% attrition rate (n=1322). For the MANOVAs there will be 83% power to detect the smallest effects at p<.01.
A minimum of 321 twin pairs is required to detect small to moderate genetic effects (>0.20). There is 82% power to detect the smallest effects (1.5-5%) of specific genes or environment at p<.01, with up to 15 predictors in the multiple regression model.

Repeated-measures MANOVAs will be used to compare training and control groups over the two time periods (pre- and post-intervention), with training frequency and type incorporated as moderating factors.
Genetic and environmental variation will be estimated using multivariate structural equation modeling.

Recruitment
Recruitment status
Completed
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288558 0
Government body
Name [1] 288558 0
An appended study to a past Australian Research Council Linkage Grant (LP0883621), with Brain Resource as Industry Partner.
Address [1] 288558 0
GPO Box 2702, Canberra ACT 2601
Country [1] 288558 0
Australia
Primary sponsor type
Individual
Name
Dr Justine M Gatt
Address
Brain Dynamics Centre, University of Sydney
Cnr Hawkesbury Rd and Darcy St, Westmead Hospital
Westmead 2145
NSW
Country
Australia
Secondary sponsor category [1] 287310 0
Individual
Name [1] 287310 0
Prof Leanne Williams
Address [1] 287310 0
Psychiatry and Behavioral Sciences VA Palo Alto (Sierra-Pacific MIRECC)
401 Quarry Rd,
Stanford University
Stanford, CA 94305

Country [1] 287310 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290422 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 290422 0
Office of Ethics Administration, Level 6, Jane Foss Russell Building G02, The University of Sydney NSW 2006
Ethics committee country [1] 290422 0
Australia
Date submitted for ethics approval [1] 290422 0
Approval date [1] 290422 0
26/05/2010
Ethics approval number [1] 290422 0
03-2009/11430

Summary
Brief summary
This project evaluates the effectiveness of a web-based cognitive training tool, MyBrainSolutions, in improving emotional and cognitive function over 30 days.
The impact of the cognitive training on both trained and untrained real-world functions will be determined, as well as the minimum time commitment required to see improvement. By comparing identical to non-identical twins, a comparison of the relative impact of genetics versus environment in improving scores can be evaluated.
Trial website
Trial related presentations / publications
Gatt, J.M. et al. (2012), The TWIN-E project in emotional wellbeing: Study protocol and preliminary heritability results across four MRI and DTI measures. Twin Research and Human Genetics, 15(3), 419-441. doi: 10.1017/thg.2012.12.
Public notes

Contacts
Principal investigator
Name 45402 0
Dr Justine M Gatt
Address 45402 0
Neuroscience Research Australia, and School of Psychology, UNSW; Barker St, Randwick, NSW, Australia 2031
Country 45402 0
Australia
Phone 45402 0
+61 2 93991812
Fax 45402 0
N/A
Email 45402 0
j.gatt@neura.edu.au
Contact person for public queries
Name 45403 0
Dr Justine M Gatt
Address 45403 0
Neuroscience Research Australia, and School of Psychology, UNSW; Barker St, Randwick, NSW, Australia 2031
Country 45403 0
Australia
Phone 45403 0
+61 2 9399 1812
Fax 45403 0
N/A
Email 45403 0
j.gatt@neura.edu.au
Contact person for scientific queries
Name 45404 0
Dr Justine M Gatt
Address 45404 0
Neuroscience Research Australia, and School of Psychology, UNSW; Barker St, Randwick, NSW, Australia 2031
Country 45404 0
Australia
Phone 45404 0
+61 2 93991812
Fax 45404 0
N/A
Email 45404 0
j.gatt@neura.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary