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Trial registered on ANZCTR


Registration number
ACTRN12616000127404
Ethics application status
Approved
Date submitted
2/02/2016
Date registered
4/02/2016
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of brain games on mental illness in adolescents
Scientific title
Can brain training tasks prevent mental illness in high risk personality style adolescents
Secondary ID [1] 288248 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 297177 0
Condition category
Condition code
Mental Health 297396 297396 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For both the treatment group and control group, the intervention will consist of a brain training program available as part of the Lumosity package (http://www.lumosity.com/). For both conditions, training will take a maximum of 1 hour per day, 5 days per week, over 5 weeks (a total of 25 sessions). The brain training program for the treatment group has been developed by the lead researcher and includes ten tasks that are to be completed at each session. These tasks focus on executive functioning, and include two problem solving, two flexibility, one attention and five memory tasks. The order of presentation of these tasks has been pre-specified for each of the 25 brain training sessions by the lead researcher and is the same for each participant in the treatment group. The brain training program for the active control group has similarly been developed by the lead researcher and includes ten tasks that are to be completed at each session. Unlike the treatment group tasks, these tasks have been selected because they do not have executive functioning training potential. The tasks for the control group include six attention, two speed and two memory tasks. The order of presentation of these tasks has been pre-specified for each of the 25 brain training sessions by the lead researcher and is the same for each participant in the control group.

The training program will be administered off-site on an internet connected computer readily accessible by the participant. Prior to training, practical plans to enhance motivation and compliance with the protocol will be elaborated with each participant. In addition, participants will receive reminder emails from the research team on all days sessions are scheduled as well as a daily reminder text message telling the participant to check their inbox or login to the study website to complete their session. Training completion summaries will be sent to the research staff daily, and compliance will assessed every day during the active training phase. Reminder emails will be sent to participants when one session is missed, as well as a text message telling the participant to check their inbox or login to the study website to complete their missed session. Research staff will initiate telephone contact with the participant in the event that two sessions are missed. If three consecutive training sessions have been missed, and the participant has not responded to the email correspondence sent on these three consecutive training days, and is unable to be contacted by telephone, they will be considered withdrawn from the study.
Intervention code [1] 293531 0
Prevention
Intervention code [2] 293809 0
Behaviour
Comparator / control treatment
The treatment group training tasks will focus on executive functioning whilst the control group training tasks will only include tasks that do not have executive functioning training potential.
Control group
Active

Outcomes
Primary outcome [1] 296943 0
Psychopathology, as measured by the SDQ
Timepoint [1] 296943 0
Baseline, post-training, 3-month follow-up, 6-month follow-up and 12-month follow-up
Secondary outcome [1] 319743 0
Functioning as measured by the World Health Organisation Disability Assessment Scedule (WHODAS)
Timepoint [1] 319743 0
Baseline, post-training, 3-month follow-up, 6-month follow-up and 12-month follow-up
Secondary outcome [2] 319744 0
Alcohol consumption will be assessed by questions adapted from the School Health and Alcohol Harm Reduction Project (SHAHRP) ‘Patterns of Alcohol’ index
Timepoint [2] 319744 0
Baseline, post-training, 3-month follow-up, 6-month follow-up and 12-month follow-up
Secondary outcome [3] 319745 0
Executive functioning as measured by the N-back task, trail-making task and Stroop interference task
Timepoint [3] 319745 0
Baseline, post-training, 3-month follow-up, 6-month follow-up and 12-month follow-up
Secondary outcome [4] 320403 0
Personality risk factors for mental illness as measured by the Substance Use Risk Profile Scale
Timepoint [4] 320403 0
Baseline, post-training, 3-month follow-up, 6-month follow-up and 12-month follow-up

Eligibility
Key inclusion criteria
1) high risk personality style according to the SURPS (i.e., 1 or more standard deviations higher than the mean on any of the SURPS subscales) ; 2) ability to access the internet readily via a desktop or laptop computer (either in the participant’s home, or willingness to use public library/other suitable venue with internet access); and 3) willingness to provide current email address and phone number.
Minimum age
16 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently involved in psychotherapy or taking antidepressant or anxiety medications, benzodiazepines, opiate, thyroid, anticonvulsant or antipsychotic medications; insufficient English comprehension; history of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain haemorrhage or tumour, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism; involved in any other online brain games or brain training programs in the past month

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, allocation involved contacting the holder of the allocation schedule who was “off-site” or at 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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main outcome measure will be scores on the Substance Use Risk Profile Scale (SURPS), a personality scale that reliably predicts future mental illness in adolescents. One previous pilot study has investigated the effect of brain training on risky personality characteristics. According to this study, there were between-group effect sizes of .20-.22 for negative affect and inhibition, personality traits similar to those measured by the SURPS. A similar effect size difference on the SURPS would therefore be expected. A total sample size of n=200 (n=100 per group) is powered to have an 80% chance of detecting .20 effect size differences at p<.05. We will therefore aim to recruit n=220 (n=110 per treatment group) in order to account for potential attrition. All analyses will be undertaken using mixed-model repeated measures (MMRM) ANOVA with measurement occasion as a within-groups factor and intervention as a between-groups factor. Relationships between observations at different occasions will be modeled with an unstructured covariance matrix. For each experimental group, planned contrasts will be used to compare changes from baseline to post-test, 3-, 6-and 12-month follow-up.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2016
Actual
7/04/2016
Date of last participant enrolment
Anticipated
1/07/2017
Actual
23/06/2017
Date of last data collection
Anticipated
1/07/2018
Actual
23/08/2018
Sample size
Target
220
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292626 0
Charities/Societies/Foundations
Name [1] 292626 0
Australian Rotary Health
Country [1] 292626 0
Australia
Primary sponsor type
Individual
Name
Dr Louise Mewton
Address
National Drug and Alcohol Research Centre
22-32 King St, Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 291342 0
None
Name [1] 291342 0
Address [1] 291342 0
Country [1] 291342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294109 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 294109 0
University of New South Wales, NSW, 2052

(this is the full address - university of new south wales in the suburb, not street name or address applicable)
Ethics committee country [1] 294109 0
Australia
Date submitted for ethics approval [1] 294109 0
27/02/2015
Approval date [1] 294109 0
13/05/2015
Ethics approval number [1] 294109 0
HC15094

Summary
Brief summary
In a sample of adolescents (n=220), the current study will examine whether cognitive training is effective in reducing a range of psychopathology in youth at high risk for developing a mental illness. We hypothesise that at the end of the intervention those in the experimental group will show less psychopathology as indexed by a standardised behavioural measure.

Adolescents aged 16-24 years and at risk for a range of mental disorders will be selected based on scores from the Substance Use Risk Profile Scale (SURPS). Further inclusion criteria include: willingness and competence to give informed consent; readily available computer access; adequate English comprehension. Exclusion criteria include: meeting criteria for an affective, anxiety or substance use disorder according to structured diagnostic interview (Mini International Neuropsychiatric Interview Version 5.0.0; MINI); currently involved in psychotherapy or taking antidepressant or anxiety medications, benzodiazepines, opiate, thyroid, anticonvulsant or antipsychotic medications; history of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain haemorrhage or tumour, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism.

This study will be a randomised controlled trial with a 12-month follow-up period. Participants will be randomly allocated to one of two groups: (1) cognitive training condition, or (2) active control condition. The training tasks for both the intervention and control conditions will consist of serious gaming tasks based on classic paradigms used in cognitive neuroscience research. The intervention program will consist of games designed to target circuitry critical for executive functioning. Control games will have similar visual appeal and motivational enhancements but lack executive functioning training potential. For both conditions, training will take ~1 hour per day, 5 days per week, over 5 weeks (25 hours in total). Outcome assessments will be conducted at baseline, post-training, 3-month follow-up, 6-month follow-up and 12-month follow-up on the participant’s personal computer at home. Each assessment will consist of the following: (1) assessment of risk factors for mental illness (Strengths and Difficulties Questionnaire); (2) structured diagnostic interview (the MINI International Neuropsychiatric Interview Child Version) to determine the prevalence of substance use, anxiety and affective disorders; (3) alcohol consumption; (4) functioning and disability; (4) personality as measured by the SURPS; and (5) online executive functioning assessment focusing on working memory (n-back task), task shifting (trail-making task) and inhibition (Stroop interference task).
Trial website
http://thebraingames.org.au/
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 62506 0
Dr Louise Mewton
Address 62506 0
National Drug and Alcohol Research Centre
University of New South Wales, Sydney, 2052
Country 62506 0
Australia
Phone 62506 0
+612 89361131
Fax 62506 0
Email 62506 0
[email protected]
Contact person for public queries
Name 62507 0
Louise Mewton
Address 62507 0
National Drug and Alcohol Research Centre
University of New South Wales, Sydney, 2052
Country 62507 0
Australia
Phone 62507 0
+612 89361131
Fax 62507 0
Email 62507 0
[email protected]
Contact person for scientific queries
Name 62508 0
Louise Mewton
Address 62508 0
National Drug and Alcohol Research Centre
University of New South Wales, Sydney, 2052
Country 62508 0
Australia
Phone 62508 0
+612 89361131
Fax 62508 0
Email 62508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
EmbaseThe Brain Games study: Protocol for a randomised controlled trial of computerised cognitive training for preventing mental illness in adolescents with high-risk personality styles.2017https://dx.doi.org/10.1136/bmjopen-2017-017721
N.B. These documents automatically identified may not have been verified by the study sponsor.