Development and Evaluation of a Novel Treatment Intervention for People With Acquired Brain Injury
Phase: NA
Conditions: Acquired Brain Injury
Sponsor: NHS Greater Glasgow and Clyde

 
 
 
 
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Title: Development and Evaluation of a Novel Treatment Intervention for People  
 
 
 
with Acquired Brain Injury 
 
Running title: 
Integrated PRocess and StrategieS training: I-PRESS 
Training  
Protocol Version:  
 
1.2 
Date: 
 
 
 
6th January 2021 
REC Reference Number:  
 
Sponsor’s Protocol Number: 
R&D reference number: GN19NE479 
Sponsor:  
 
 
NHS Greater Glasgow & Clyde 
Funder: 
 
 
 
Neurosciences Foundation/ Sackler Foundation 
Investigators:  
 
 
Professor Jonathan Evans, University of Glasgow 
Dr Kristin Flegal, University of Glasgow 
Dr Satu Baylan, University of Glasgow 
Miss Katerina Pappa, University of Glasgow 
 
Protocol version:   
 
Version 1.2 (January 2021) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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Summary 
There is a pressing need to develop more effective interventions to remediate cognitive 
deficits in highly prevalent disabling conditions such as stroke, head injury and other forms 
of acquired brain injury (ABI). Neuropsychological rehabilitation interventions developed 
in a clinical setting have shown some beneficial effects, but the effectiveness of clinical 
interventions have potential to be enhanced if informed by findings from cognitive 
neuroscience. Research into cognitive training using methods such as functional magnetic 
resonance imaging (fMRI) has contributed to an understanding of factors that promote 
changes in brain function, but this approach seldom includes individuals with brain 
damage or cognitive deficits. Its potential for application with clinical populations is 
therefore uncertain, meaning that people who may benefit do not have access to 
interventions that may improve their health and wellbeing. 
The proposed research brings together methods from neuropsychological rehabilitation 
and cognitive neuroscience to investigate 1) the feasibility of, and effect sizes arising from, 
combining an existing clinical intervention targeting mental strategies with an adaptive 
training programme targeting core cognitive processes, and 2) whether the novel 
treatment combination promotes changes in brain function that are detectable using fMRI. 
This project will develop and evaluate a training intervention that aims to improve 
outcomes from a strategy-based rehabilitation intervention, Goal Management Training 
(GMT), by adding process-based cognitive training with adaptive difficulty to enhance the 
executive function of working memory updating (WMU). People with ABI (n=32) will 
complete 9 sessions of GMT, a recommended treatment for deficits in frontal-lobe 
executive functions, with the addition of 8 WMU training sessions with or without adaptive 
training. Measures of feasibility, acceptability, and fidelity will be taken, and effect sizes of 
differences in pre- to post-training changes on neural, cognitive, and functional 
measurements will be determined by comparing two experimental groups in which 
difficulty of the WMU training tasks either adaptively increases in response to performance 
or is fixed. 
 
1. 
Introduction 
 
Globally, stroke and head injury are leading causes of disability. Deficits in cognitive 
functions are common in these conditions, including impairment in frontal-lobe ‘executive’ 
functions such as working memory and the ability to solve problems, plan, and regulate 
actions in order to achieve intended goals. These deficits affect individuals’ ability to live 
independently, work, and maintain social relationships. We propose that improving 
outcomes for people with acquired brain injury (ABI) requires an interdisciplinary approach 
in which neuropsychological rehabilitation and cognitive neuroscience complement one 
another. 
In neuropsychological rehabilitation, interventions are classified as ‘restorative’ 
(restoration of underlying core cognitive processes including executive functions) or 
‘compensatory’ (compensation of function through the use of external aids or learned 
strategies). Clinical guidelines recommend the use of ‘meta-cognitive strategy training’ for 
the treatment of deficits in frontal-lobe executive functions (Cicerone et al. 2011). Goal 
Management Training (GMT) is one such validated meta-cognitive strategy. GMT trains 
compensatory mental strategies to manage attention during multi-step tasks. GMT has 
been evaluated behaviourally in randomised controlled trials with positive, albeit modest, 
outcomes in individuals with ABI (Tornås et al., 2016).   

 
 
 
 
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In cognitive neuroscience, an emerging research area concerns experience-induced 
neural changes referred to as neural plasticity. These may involve neural changes in: 1) 
task-based functional activation patterns, i.e. activity increases, decreases, or 
reorganisation, 2) brain structure, i.e., grey matter and white matter volume changes 
(Brehmer et al., 2014) and 3) functional connectivity, i.e. changes in connectivity between 
brain regions that are recruited for a mental procedure as well as changes in the strength 
and magnitude (Constantinidis & Klingberg, 2016).  
Neuroimaging studies have demonstrated that programmes to train core cognitive 
processes including working memory (WM) executive functions can drive changes both 
in behavioural and neural measures (Klingberg, 2010; Hsu et al., 2014). Performance 
gains after process-based training have been observed by several authors employing 
different training tasks and including both younger and older populations (Westerberg and 
Klingberg 2007; Dahlin et al., 2008; Jaeggi et al., 2008; Jolles et al., 2010; Buschkuel et 
al., 2014). In addition, generalisation to broad cognitive abilities such as reasoning, 
episodic memory, after process-based training, has been observed in both young and 
older adults (Dahlin et al., 2008;2009; Brehmer et al., 2014) although this area is under 
debate (Melby-Lervag & Hulme 2013; Brehmer et al., 2014). This work has primarily 
involved healthy adults and whether the same findings apply to those with ABI needs to 
be investigated. 
This research study aims to develop and evaluate a novel treatment intervention for 
people with ABI that combines a process-based cognitive training with a strategy-based 
GMT rehabilitation intervention, and to acquire functional magnetic resonance imaging 
(fMRI) data before and after the intervention to measure patterns of brain activity 
associated with a task requiring executive functions. 
We propose that outcomes from GMT might be improved by an adaptive, process-based 
intervention aimed at enhancing working memory processes. Adaptive task difficulty 
involves dynamic adjustment of training task demands so that the individual remains within 
an optimal range of performance. In a cognitive training literature review, Dahlin et al. 
(2009) identified adaptive difficulty as a common feature of interventions that reported 
significant training gains. Lövdén et al. (2010) explained this by theorising that a mismatch 
between functional "supply" (i.e., neural resources) and environmental "demands" (e.g., 
a continuously challenging training task) is a necessary condition for cognitive and neural 
plasticity to occur. If training task difficulty does not tax the upper limits of available 
resources, there is no mismatch between supply and demand, thus no impetus for plastic 
change. However, if difficulty is progressively increased, and continues to tax increasing 
levels of proficiency, then more neural resources will become available through plastic 
change. 
There is some promising evidence that cognitive deficits in clinical populations can be 
remediated through behavioural interventions (Bahar-Fuchs et al., 2013; Hallock et al., 
2016; van de Ven et al., 2016), and clinical research is starting to use fMRI to investigate 
normalisation of brain activation patterns after cognitive training (Nordvik et al., 2014). Yet, 
the results of these studies will be more interpretable, and the design of future intervention 
studies will be better informed, if theoretically-driven research is carried out to identify the 
factors that promote training gains. Adaptive difficulty may be one such factor. A recent 
study conducted by Flegal et al. (2019), in which healthy adults completed a process-
based intervention aimed at enhancing the executive function of working memory 
updating (WMU), found that adaptive training task difficulty influences neural plasticity, 
consistent with the Lövdén et al. (2010) theoretical framework. This is an important 
hypothesis to test further in the context of neurological conditions, where there is a 
reduction in neural resources from premorbid levels. 
 

 
 
 
 
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2. 
Aims 
The primary aim of the study is to investigate whether it is feasible and acceptable to 
deliver a novel intervention combining GMT with WMU training, within a randomised 
controlled trial (RCT) context in a sample of ABI individuals. A further aim is to examine 
the behavioural and neural changes related to the novel intervention as well as the effect 
sizes. 
 
3. 
Research Question 
 
This project will combine methods from neuropsychological rehabilitation and cognitive 
neuroscience to answer the following: 1) Is it feasible to combine an existing treatment for 
executive dysfunction, GMT, with an adaptive WMU training and how much benefit is 
gained? 2) Does the novel treatment combination promote neural plasticity that is 
detectable using fMRI? 
 
i. 
Primary 
Primary outcomes will be measures of feasibility, acceptability, and fidelity.   
ii. 
Secondary 
Secondary outcomes will be pre- to post-training change in behavioural data (i.e., neuro-
psychological assessment battery, measures of cognitive task performance and everyday 
functioning) and fMRI data (i.e., task-related brain activity), analysed by training condition. 
In addition, exploratory analyses of individual differences in responsiveness to WMU 
training will be performed, by calculating correlations between amount of adaptive training 
task improvement and pre- to post-training change on neural, cognitive, and functional 
measurements. 
 
4. 
Design and Methodology 
 
i. 
Design  
Randomised controlled trial methodology; specifically stratified randomisation in 
conjunction with permuted block random allocation, using an active control group will 
compare two conditions: (1) GMT combined with adaptive training [AT]; (2) GMT combined 
with non-adaptive [NA] training. Thirty-two adults with non-progressive ABI sustained in 
adulthood will be recruited from the NHS.. Participants will complete a combination of 
standard GMT (9 sessions) and 8 WMU (AT or NA) training sessions, delivered in small 
groups. Neuropsychological and functional assessments will be performed before and after 
the intervention. In addition, fMRI scanning sessions will be conducted pre- and post-
training at the Clinical Research Imaging Facility (CRIF), Queen Elizabeth University 
Hospital (QEUH) in a 3T Prisma Siemens scanner. 
 
ii. 
Participants 
Adults with non-progressive ABI sustained in adulthood will be recruited primarily from the 
Community Treatment Centre for Brain Injury (CTCBI), the main service for community 
based cognitive rehabilitation in Glasgow. Participants will also be recruited from other 
NHS services within Scotland. 

 
 
 
 
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Inclusion Criteria 
-Only those able to give informed consent and able to comply with the training protocol 
will be included.  
- ≥ 6 months post-ABI at time of recruitment (expression of interest to participate either 
verbally or in writing) 
- Adults over the age of 18.  
- English language fluency (speaking) 
- a combination of self/relative/friend/carer reports of everyday organisation/memory problems  
 
Exclusion Criteria 
-Individuals with contra-indications to MRI (e.g. heart pacemaker) 
-Comorbid progressive neurological disorder or neurodegenerative condition (e.g. 
dementia) 
-Major psychiatric disorder considered likely to prevent engagement in the intervention 
programme (pre-ABI history of mood disorder or stable antidepressant medication will 
not lead to exclusion) 
-History of major substance abuse problems if the clinical and research team think it is 
likely to prevent engagement in and/or interfere with the intervention programme. There 
will be a degree of flexibility on this and the clinical team will be consulted on an individual 
basis when deemed necessary.  
-Unable to give informed consent 
-Unable to cooperate with the study protocol (e.g. severe impairment of hearing, vision 
or language) 
These criteria are necessary in order that the outcome measures can be administered 
validly, and to increase the likelihood that any neuropsychological impairment present is 
due to ABI rather than any other pre-existing disorder. 
COVID-19 mitigating circumstances regarding inclusion/exclusion criteria 
Even though collecting neuroimaging data remains one of the main components of this 
research project, we understand there may be some participants who feel uncomfortable 
with travelling and/or coming in contact with others during the COVID-19 crisis. Therefore, 
individuals with MRI contraindications can still be included to take part in the behavioural 
intervention sessions without completing the fMRI sessions as an exception; nevertheless 
the focus still remains on recruiting participants suitable for brain imaging. 
iii. 
Procedure 
The study will entail 12 visits overall. Details regarding the components and content of 
each visit are described in the following subsections of the protocol (please also refer to 
Table 1 below for a brief summary).  No changes in routine care will take place while 
participating in the study. 

 
 
 
 
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Table 1: Research procedure  
Visit 
Number 
Visit 0 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Visit 7 
Visit 8 
Visit 9 
Visit 10 
Visit 11 
Visit 12 
Type of 
Visit 
Screenin
g 
Baseline 
T0 
fMRI 
Time 1 
(T1) 
Treat Wk 
1 
Treat Wk 
2 
Treat Wk 
3 
Treat Wk 
4 
Treat Wk 
5 
Treat Wk 
6 
Treat Wk 
7 
Treat Wk 
8 
fMRI 
Time 2 
(T2) 
Immediat
e Follow-
up T3 
Time since 
last visit  
 
 
≤ 1 wk 
from Visit 
1 
≤ 1 wk 
from visit 
2 
1 wk 
from visit 
3 
1 wk 
from visit 
4 
1 wk 
from visit 
5 
1 wk 
from visit 
6 
1 wk 
from visit 
7 
1 wk 
from visit 
8 
1 wk 
from visit 
9 
≤1 wk 
from visit 
10 
≤1 wk 
from visit 
10 
fMRI 
session  
 
 
x 
 
 
 
 
 
 
 
 
x 
 
GMT 
Introductor
y session 
 
x 
 
 
 
 
 
 
 
 
 
 
 
GMT 
session 
 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
WMU AT 
session 
 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
WMU NA 
session 
 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Neuropsyc
hology 
Assessmen
t 
 
x 
 
 
 
 
 
 
 
 
 
 
x 
Functional 
Assessmen
t 
 
x 
 
 
 
 
 
 
 
 
 
 
x 

 
 
 
 
Page 7 - Version 1.2 January 2021 
 
Post-
Interventio
n 
Participant 
Feedback 
 
 
 
 
 
 
 
 
 
 
 
 
x 
Wk: week,  T: Time, GMT: Goal Management Training, WMU: Working Memory Updating, AT: Adaptive, NA: Non Adaptive, fMRI: functional Magnetic Resonance 
Imaging.

 
 
 
 
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iv. 
Recruitment 
The sample will be recruited, screened and enrolled into the study from the CTCBI, NHS 
Greater Glasgow and Clyde (NHS GGC) and other NHS sites. The estimated recruitment 
period will be twelve months. Potential participants will be initially identified by the direct team 
working in CTCBI. These will then be approached by Dr Nicola Goudie, the clinical 
psychologist at the CTCBI. Dr Goudie will provide the study information sheet, discuss the 
study and ascertain interest. If the client expresses definite interest to participate at this point, 
they will undergo screening by Dr Goudie to determine eligibility according to the above 
criteria. If the patients have given permission, then Dr Goudie will pass their details to the 
PhD researcher (Katerina Pappa) undertaking the study who will then contact the participant 
to schedule a time to further discuss the study and obtain consent (Please see relevant 
consent form document). The PhD researcher will only obtain consent if certain the client 
has had sufficient time to study the participant information leaflet and is making an informed 
decision. Baseline neuropsychological and functional assessments will take place either the 
same day as taking consent or at a separate session, according to the participants’ 
preferences and availability.  
If the client has been discharged from CTCBI before being consented into the study, Dr 
Goudie will contact them to obtain verbal permission for the PhD researcher to make contact 
with them. The PhD researcher will then ascertain interest, screen the participant and obtain 
written informed consent. With the participant’s permission, relevant medical information 
about their medical history will be obtained from their medical notes. The PhD researcher will 
not be able access this information before written informed consent has been obtained. The 
recruitment procedure will be adapted for other NHS sites with a member of the immediate 
care team performing the initial identification and then passing on the details to the PhD 
researcher to proceed with taking consent. 
 
 
Recruitment Sites 
1. NHS GGC 
2. NHS Lanarkshire 
The same recruitment procedure will be followed across the different sites. More 
specifically the lead contact for each study site is: 
1. Dr Nicola Goudie, CTCBI, NHS GGC 
2. Dr Jane Moir, Community Brain Injury Team, NHS Lanarkshire  
3. Dr Louise Roach, Stroke team, NHS Lanarkshire 
 
v. 
MRI Safety Assessment 
One of the radiographers at the CRIF at QEUH, will go over the MRI Screening form to ensure 
the participants are safe to undergo an MRI scan (please see the MRI screening form for 
further details). This procedure will take place on two occasions: On each fMRI session 
prior to entering the MRI scanning room, i.e. study visits 2 and 11.  The radiographers on site 
are:  Rosie Woodward, Evonne McLennan, Laura Dymock, Nicola Tynan and Fiona Savage. 
The lead research radiographer on site is Tracey Hopkins.  
 
vi. 
Letter to General Practitioner (GP)  

 
 
 
 
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The PhD researcher will inform the participants’ GP of their participation in the study. The 
PhD researcher will send a letter addressed to the GP practice enclosing the study 
information sheet (Please see GP letter for further details)  
 
vii. 
Baseline neuropsychological and functional assessments 
Participants who meet all eligibility criteria following screening will undergo baseline 
neuropsychological and functional assessment using standardised measures prior to the 
study training interval. The assessments will be administered by the PhD researcher at the 
CTCBI or at the University of Glasgow. The assessment measures selected are those which 
would be most relevant for a future full-scale trial to determine treatment efficacy and 
mechanism of effect. Specific tests have been chosen to be relevant to current clinical 
practice and sensitive to key neuropsychological constructs while keeping administration 
time at a minimum. Equivalent parallel versions of cognitive test materials will be used during 
subsequent assessment sessions where available, to minimise practice effects. In 
recognition that some participants may experience difficulties in remembering appointments 
following ABI, participants will be offered a reminder phone call or text message of their 
appointment 1-2 days prior to neuropsychological assessment sessions.  
Baseline neuropsychological and functional assessment will last between one and one and 
a half hours taking into consideration extra time for providing instructions, task practice and 
individual differences regarding speed.  
The following neuropsychological tests will be used: 
1. Trail Making Test (TMT)  A and B (Reitan, & Wolfson, 1985) to get an estimate of 
attention, speed and mental flexibility (~5min). 
2. Hotel task (Manly et. al., 2002) to measure executive function in daily life activities 
(~20min). 
3. Digit Span taken from the Wechsler Adult Intelligence Scale (4th edition), (Wechsler, 
2008), to assess verbal memory (~7-10min). 
4. Tower test, taken from the Delis Kaplan Executive Function System battery (D-
KEFS) (Delis et al., 2001) to obtain scores in a task requiring planning, rule learning 
and inhibition (~20min). 
5. Colour Word Interference (CWI) test from the D-KEFS battery (Delis et al., 2001), 
assessing inhibition of an overlearned response and flexibility (~10min).  
6.  Functional measurements will be obtained using the Dysexecutive Questionnaire 
(DEX) (Burgess et al., 1996) (~5min). 
 
These neuropsychological tests have been carefully reviewed and selected as they have 
been previously used for assessing individuals with ABI in the following studies examining 
changes after a cognitive intervention: 1. TMT (Sohlberg et al., 2000; Novakovic Agopian et 
al., 2011;), 2. Hotel task (Manly et al., 2002; Levine et al., 2011; Tornas et al., 2016), 3. Digit 
Span (Westerberg et al., 2007; Miotto et al., 2009; Vogt et al., 2009), 4.Tower test (Levine et 
al., 2001; Tornas et al., 2016), 5. CWI test (Lundqvist et al., 2010; Novakovic Agopian et al., 
2011;) and 6. DEX (Miotto et al., 2009; Spikman et al., 2010). 
These assessments are essential in characterising the participant sample in terms of 
cognitive function and capturing changes resulting from the cognitive intervention. 
Information about participant’s current medications and ABI rehabilitation will also be 

 
 
 
 
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collected. The PhD researcher will also write to the participants’ GP to let them know that 
they are taking part in the study. 
Following all baseline neuropsychological assessments, participants will be randomly 
allocated to either (1) GMT combined with adaptive WMU training [AT]; (2) GMT combined 
with non-adaptive [NA] WMU training. The two groups will be stratified by the following factor: 
aetiology of brain injury (two strata, i.e. traumatic brain injury (TBI) or stroke). 
Please note that these neuropsychological tests are copyrighted and the relevant references 
are listed below. The test forms will be uploaded but they will have no version numbers as in 
this case it isn’t applicable. The authors of these tests are referenced in text above and in 
the end. Finally, in cases where the forms mention “Subject’s Name”, the participant ID will 
be used instead. 
References 
Burgess, P. W., Alderman, N., Wilson, B. A., Evans, J. J. and Emslie, H. 1996. “Validity of 
the battery: Relationship between performance on the BADS and ratings of executive 
problems”. In BADS: Behavioural assessment of the dysexecutive syndrome manual, Edited 
by: Wilson, B. A. 18–19. Bury St Edmunds, , UK: Thames Valley Test Company.  
Delis, D. C., Kaplan, E., & Kramer, J. H. (2001a). Delis-Kaplan executive function system: 
Examiner’s manual. San Antonio, TX: The Psychological Corporation. 
Manly, T., Hawkins, K., Evans, J., Woldt, K., & Robertson, I. H. (2002). Rehabilitation of 
executive function: facilitation of effective goal management on complex tasks using periodic 
auditory alerts. Neuropsychologia, 40(3), 271-281. 
Reitan, R. M., & Wolfson, D. (1985). The Halstead–Reitan Neuropsycholgical Test Battery: 
Therapy and clinical interpretation. Tucson, AZ: Neuropsychological Press. 
Wechsler D. Wechsler Adult Intelligence Scale–Fourth Edition. Pearson; San Antonio, TX: 
2008. 
 
viii. 
Intervention 
GMT 
GMT teaches the use of mental strategies to support sustained attention during complex 
(multi-step) task performance following an interactive programme. GMT is structured into 
nine modules, with interactive discussions designed to raise awareness of various aspects 
of goal management, tasks that illustrate goal management concepts in action, and 
homework assignments designed to facilitate the transfer of concepts to real life. GMT comes 
as a complete kit, with slides, a trainer's manual, participant workbooks, and all the necessary 
components 
to 
run 
 GMT  
sessions 
in 
a 
group 
setting 
(https://shop.baycrest.org/products/copy-of-the-goal-management-training-program). 
Except for the first introductory session, all GMT interventions will be delivered by the PhD 
researcher on a group basis (group size N = 2 - 6) taking place either at the CTCBI or 
Psychology department, University of Glasgow. Additional groups may also be run at other 
recruiting services, providing that premises, numbers and space requirements allow it. The 
GMT group sessions will last two hours.  
The first GMT module will be conducted on an individual basis for each participant separately 
prior to starting the combined GMT-WMU intervention. It will last about one hour and will take 
place on the same day as the baseline neuropsychology assessment (please see table 1). 

 
 
 
 
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The reason for administering Module 1 individually is to introduce the idea of the intervention, 
explain some key concepts, give the participant the opportunity to familiarise themselves with 
the general notion of the GMT as well as to discuss questions and concerns they might have. 
Thus, the PhD researcher will ensure each individual participant has understood and 
familiarised themselves with the GMT concepts before entering the fully combined GMT-
WMU group-based intervention. The GMT sessions will be run by the PhD researcher plus 
another member either from the supervisory research team or the clinical team from the 
respective research site. 
Brief overview of the GMT modules (Levine et al., 2012) 
In the first module the intervention begins by defining the concepts of absent mindedness, 
and present mindedness and by providing patients with illustrative examples. Absentminded 
slip-ups (e.g., forgetting to pick up your dry-cleaning on the way home) are introduced during 
module two. The “automatic pilot,” a metaphor for habitual or stimulus-bound task execution, 
is introduced in module 3. Module 4 teaches patients how to stop the automatic pilot. The 
“mental blackboard,” a metaphor for working memory (i.e., where goals are kept in mind), is 
introduced in module 5. Modules 6–9 are devoted to teaching patients how to stop, state their 
goal, and make decisions in the context of competing tasks. Patients are also taught to create 
to-do lists and to split more complex tasks into sub-tasks. Module 9 is devoted to checking 
ongoing behaviour to ensure that the patient is still staying on task. Please see table 2 below 
for further details. At the end of each training module patients are given homework 
assignments to practice the concepts they learn during each session. These will be reviewed 
and discussed during the following session. In addition, patients will perform mindfulness and 
breathing exercises both at home and during the training sessions.  
Table 2: GMT modules and concepts covered 
Module 
Concepts covered 
Module 1  
Introductory module 
 
Introduction 
of 
goal 
hierarchies, 
mental 
laboratory, 
absentmindedness and present-mindedness by providing patients 
with illustrative examples. 
Module 2 
 
Relation of absentmindedness to other abilities, consequences of 
slips, conditions for slips and how the GMT will reduce slips. 
 
Module 3 
 
The automatic pilot and how it leads to errors. 
 
Module 4 
 
Training to stop the automatic pilot. 
Module 5 
 
Mental blackboard. 
Module 6 
 
Goal loss and reinstatement. 
Module 7 
 
Goal conflict and decision-making. 
Module 8 
 
Dealing with overwhelming tasks by splitting them into smaller tasks. 
 
Module 9 
 
Checking (reducing-slip-ups). 
 
WMU   

 
 
 
 
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The training consists of computerised working memory updating tasks in which trial accuracy 
and response time are recorded. All 8 WMU interventions will be delivered by the PhD 
researcher on a group basis (group size N = 2 – 6). Two computerised WMU tasks will be 
trained based on the study conducted by Dr Flegal on healthy adults (Flegal et al., 2019). 
These tasks will be delivered via two modalities: (1) a visuospatial WMU task, i.e. Matrix 
Updating (MU) and (2) a verbal WMU task, i.e. Keep Track (KT). MU requires updating the 
location of multiple dots within a 4 x 4 matrix (Chen and Li, 2007) while KT requires updating 
the identity of the most recently studied words in multiple semantic categories (Yntema, 
1963). For both training tasks, level of difficulty can be modulated by increasing or decreasing 
the update level, i.e., the number of updates on each trial. For AT participants, difficulty of 
the training tasks is progressively increased in response to task performance, in order to 
adaptively increase environmental demands. For NA participants, however, task difficulty is 
fixed at a relatively low level across all sessions. Training of the MU task lasts between 25-
30 minutes while the KT training lasts between 20-25 minutes. The WMU training sessions 
will last between one hour to one hour and fifteen minutes taking into consideration time to 
provide instructions and practice. 
 
ix. 
Post-intervention Feedback 
After the end of the intervention all participants will have the opportunity to rate the perceived 
usefulness and experience of the interventions including any adverse effects using Likert 
scales (for further details please see the feedback form). This information will be used to 
guide the possible development of a future full-scale trial. This will be carried together with 
the immediate follow-up session after the end of the intervention (i.e. visit 12) by the PhD 
researcher.  
 
x. 
Outline of Study Visits 
Visit 1: Baseline Neuropsychological and Functional Assessment and Introductory GMT 
session 
Full details of baseline assessment is given in section V: Baseline neuropsychological and 
functional assessments. Following completion of the assessments, the PhD researcher will 
then proceed with the introductory GMT session where the idea behind the intervention as 
well as its usefulness in people with ABI will be presented. Emphasis will be given on the 
importance of having goals in everyday life and a few key concepts central to GMT will be 
mentioned. In addition, the PhD researcher will discuss the expectations clients should have 
from this intervention, i.e. learn strategies, practice relaxation techniques, take control by 
stopping and thinking about their goals when performing a task. The overall duration of Visit 
1 will be around three hours (approximately one to one and half hours for the 
neuropsychology assessment, half an hour for a break and one hour for the first introductory 
GMT session). 
There is a very small possibility the PhD student might be required to make a few home visits 
as an exception (assuming the participant has a great difficulty travelling themselves on a 
day) in order to complete neuropsychological assessments, which carry a potential personal 
safety risk. To minimise these risks, all home visits will be carried out during office hours and 
the PhD student will be required to carry mobile phones and to let a member of the research 
team (or if not possible, a member of staff at their usual place of work) know when and where 
their appointments are and when they have finished. Hence, the University of Glasgow lone 

 
 
 
 
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study policy will be followed. Please follow this link for further information  
https://www.gla.ac.uk/media/Media_500540_smxx.pdf 
 
Visits 2 and 11: Time 1 and Time 2 fMRI sessions 
There will be two fMRI sessions, Time 1 (T1) and Time 2 (T2), to measure functional brain 
activity pre and post intervention respectively. These sessions will last approximately two 
hours in total. The PhD researcher together with one of the qualified radiographers at the 
CRIF will first perform the MRI screening form. Then the PhD researcher will  give a detailed 
description of the scanning procedure and answer any potential questions; this step will last 
approximately half hour. The PhD researcher together with the radiographer will then move 
the participant to the scanner area. At both T1 and T2, participants will perform three tasks 
inside the scanner: (1) Matrix Updating serving as the criterion task, i.e. scanner version of 
visuospatial WMU training task, (2) Spatial N-Back task assessing transfer of learning to a 
closely related untrained task, i.e. near transfer, and (3) Object-Location Association, a visual 
episodic memory task assessing transfer of learning to an unrelated untrained task, i.e. far 
transfer. In each task run, a gradient-echo EPI sequence will be used to obtain functional 
images sensitive to BOLD contrast. 
One of the radiographers at the CRIF will conduct the 
scanning sessions together with the PhD researcher at all times. 
 
Spatial N-Back is selected as a scanned task representing near transfer, based on the 
prediction that it and the WMU training tasks engage overlapping processing components 
and brain areas. Based on the scanned N-Back paradigm used by Flegal and colleagues 
(2019), stimuli will appear in one of eight locations and the task is to respond by pressing 
one button when the current location matches the location presented n trials earlier and 
pressing a second button when there is not a match.  
Object-Location association is a measure of visual episodic memory, selected as a scanned 
task representing far transfer. Based on a paired associate learning paradigm adapted for 
fMRI testing as in Flegal et al. (2019), the task consists of blocks of trials arranged into an 
encoding phase followed by a retrieval phase. During encoding, a sequence of stimuli will 
appear in different locations, then during retrieval, each one of the locations will be cued and 
the task is to respond by pressing a button corresponding to one of three stimuli choices 
which had appeared in that location.  
At both T1 and T2 the task runs will be followed by a T1-weighted sequence to obtain high-
resolution anatomical images. In conducting fMRI data analysis the functional images will be 
spatially realigned using a six-parameter rigid body transformation and coregistered to their 
T1-weighted anatomical image. In total, visits 2 and 11 will take around two hours to complete, 
i.e. thirty minutes for the safety procedure prior to the scan and another one hour and a half 
for the scanning procedure itself. Comparisons in scanned task performance between T1 
and T2 will allow us to examine how much benefit is gained due to the training intervention 
and if there is evidence of generalisation to other untrained tasks. In addition, we will examine 
neural changes in terms of task-related brain activity. 
The procedure and tasks will be identical at T1 and T2, with the exception of three structural 
imaging sequences acquired only at T1, in addition to the T1-weighted anatomical image, for 
the purposes of a comprehensive, accurate and detailed neuroradiologist report (please see 
sections 6 and 7 below). These additional sequences are: 1. Axial T2-weighted, 2. Axial T2-
weighted fluid attenuation recovery (FLAIR), and 3. A haemosiderin sensitive sequence.  
For both fMRI sessions, the participants will spend no more than one hour inside the scanner. 

 
 
 
 
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Visits 3- 10: GMT+WMU Intervention sessions 
There will be 8 weeks of a combined GMT and WMU intervention.  Each GMT session will 
be two hours long while the WMU session will last between one hour and one hour and fifteen 
minutes. There will be a break between the training sessions allowing participants to have a 
rest and relax lasting between thirty minutes to an hour. The intervention visits will be 
conducted either at the Psychology department, University of Glasgow or at the CTCBI. Both 
GMT and WMU sessions will be administered by the PhD researcher undertaking the project. 
These will be conducted weekly on a group level at the same day; that means each 
intervention visit will last approximately three hours and forty-five minutes to four hours 
including the break in between. If attending both intervention sessions at the same day is not 
feasible for some participants, due to reasons such as getting easily fatigued or not being 
able to commit this long on the same day, the following guidelines will be implemented: 
1. The option of coming for the two interventions separately within the same week will be 
offered, i.e. arranging the GMT and WMU interventions at two different times.  
2. The option of conducting the WMU intervention in one’s own time at home will be offered 
after the PhD researcher makes sure the necessary requirements are in place, i.e. the 
participant has a laptop at home to perform the training tasks, they have fully understood 
the tasks and are practicing according to the guidelines. Under these conditions, task 
performance will be monitored from encrypted anonymised data files (logging trial 
accuracy and response time) transmitted to the PhD researcher via e-mail at the end of 
each at-home training session. 
Visit 12: T3, Immediate follow-up: neuropsychological and functional assessments 
All standardised measures that were administered at baseline (Visit 1) will be re-administered 
after the end of the intervention (please see table 1) by the PhD researcher. An acceptable 
period between the end of the intervention and neuropsychology assessment will be within 
three weeks. In addition, a feedback form will be given to the participants to rate the perceived 
usefulness and experience of the interventions. This final visit will last around one and a half 
hours. 
The PhD researcher will have access to supervision and will be given advice regarding what 
steps to take, including sharing relevant information, if they become concerned about the 
welfare of the participant at any stage during the study. 
xi. 
COVID-19 mitigation plan- Online option for study visits 1, 3-10 and 12. 
An online alternative will be offered to run the study visits remotely in order to minimise the 
risk of infection due to COVID-19. As a result, no unnecessary travelling nor physical group 
sessions will be taking place. In more detail:  
- Neuropsychology assessment - Visits 1 and 12 
The assessments listed in section 4vii will be adapted to be conducted remotely through an 
NHS approved software. Those tests that cannot be adapted for online use will be discarded 
and no further assessments will be used in their place, or, where feasible, these assessments 
may be adapted for delivery with social distancing when people come to CRIF for the 
scanning sessions, i.e. visits 2 and 11. After each participant, the test materials will be 
disinfected for use with the next individual. Αnother alternative is the use of a validated 
software via a secure web-based, GDPR compliant platform such as CANTAB, which is 

 
 
 
 
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designed 
and 
validated 
by 
Cambridge 
Cognition: 
https://www.cambridgecognition.com/cantab . 
GMT- Visits 3-10 
The GMT sessions will be conducted remotely via NHS IT systems to ensure security and 
data protection and the PhD researcher will use an NHS approved software (please see 
further information below). The session duration will remain the same while more regular 
breaks will be introduced. The PhD researcher will provide practice sessions, so participants 
familiarise themselves and feel comfortable using the software prior to starting the 
intervention. These will be part of visit 1 or any other time that is suitable for participants. The 
material, content and duration of the GMT will remain unchanged as described earlier. The 
PhD researcher will additionally record a brief five-minute video providing: 1. a recap for each 
session, 2. a brief summary of the key concepts explored and 3. a reminder of the homework 
for the next session. The video recording will be provided at the end of each GMT session 
only to those participants that were in attendance. 
- WMU Training - Visits 3-10 
The WMU training sessions will take place remotely. A computer with Windows Vista/7/8/10 
is required to run the WMU training tasks using the Presentation software by 
Neurobehavioural Systems specifically designed for secure remote management of stimulus 
delivery in experimental research https://www.neurobs.com/ . If participants have no 
personal computer access, then the research team is able to provide the necessary 
equipment for the duration of the intervention depending on numbers and availability. The 
PhD researcher will be offering individual practice sessions and detailed step-by-step 
guidance for using the presentation software prior to starting the training sessions. The 
training tasks, session duration and content will remain unchanged as originally planned. All 
devices will be disinfected before given to a new participant using alcohol based sanitising 
products, 
i.e. 
60-80% 
alcohol, 
as 
recommended 
per 
NHS 
guidelines 
https://coronavirusexplained.ukri.org/en/article/pub0006/ 
- Scanning sessions – Visits 2 and 11 
The scanning sessions at CRIF will adhere to COVID-19 related NHS regulations and 
guidelines. Consequently, the sessions will be conducted as originally planned while 
ensuring the necessary precautions are taken to protect participant’s health and safety. If 
participants feel uncomfortable taking part in the scanning sessions for reasons relating to 
COVID-19, then those people will only participate in the intervention component of the study. 
- NHS-approved software 
The online version of the intervention will be conducted using NHS approved software, such 
as Attend anywhere, Microsoft Teams and National Video Conferencing Service (NVCS) 
Cisco Meeting Server (CMS) which have already been adopted by the NHS to run their 
service remotely, i.e. one to one sessions and group meetings. These are ideal for sharing 
content, e.g. GMT module slides, for taking part in a group chat as well as support larger size 
group meetings effectively. The softwares will be accessed remotely through NHS networks 
to ensure data security and protection.   
 
5. Randomisation and Bias prevention 
Stratified randomisation in conjunction with permuted block random allocation will be used to 
allocate participants to one of two study groups of equal size. The sample will be stratified 

 
 
 
 
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by the following factor: aetiology of brain injury (two strata, i.e. TBI or stroke. Participants will 
be blinded to study allocation. 
The sample will be randomised by Dr Kristin Flegal, a member of the PhD researcher’s 
supervisory team. Dr Flegal is a neuroscience researcher with an expertise in fMRI 
methodology and thus she is less likely to come in direct contact with the participants through 
the clinical domain. The randomisation procedure will be conducted in a computerised 
manner. A code for randomisation will be created using Matlab programming software. Two 
databases will be created: 1. a patient’s database that lists basic information such as 
participant ID, recruitment site, age, aetiology of brain injury and 2. a “randomisation” 
database that holds data on which participants have been registered and their treatment 
allocation. The participants’ database will be password protected and accessed only by Dr 
Flegal. The PhD researcher will have no way of knowing which participant is allocated into 
which intervention arm prior to the individual starting the trial or change it afterwards. For the 
purposes of the present project stratified randomisation with blocking will be used and thus 
several participants will be randomised at once. Alternatively, if Dr Flegal is unable to perform 
the randomisation for any reason Dr Viveka Biswas will conduct the procedure instead.  
1. 
Sample size 
Thirty-two participants will be randomised (16 per group) to estimate recruitment, adherence 
and retention rates, and the variance of outcome measures. The sample size was based 
upon what could be feasibly expected to be recruited as part of a small-scale PhD feasibility 
research study whilst accounting for eligibility restrictions especially in regards to MRI contra-
indications as well as the duration of the study. i.e. committing to the study for 12 weeks. 
Given that one of the primary aims is examining feasibility and acceptability of the novel 
intervention, the study is not designed to be powered to detect differences in outcomes 
between the two groups. 
 
2. 
Neuroradiologist Report of Structural Scans 
Dr Natasha Fullerton is the collaborator Neuro-radiologist in this study. She will review 
structural brain images acquired with the following sequences: 1. T1-weighted, 2. Axial T2-
weighted, 3. Axial T2-weighted FLAIR, and 4. a haemosiderin sensitive sequence (e.g., 
gradient-echo or susceptibility-weighted). These scans will be transferred to NHS PACS in 
order to be linked to each participant’s medical record. This way Dr Fullerton will be able to 
produce a comprehensive report in CRIS for each participant to:  
1. Discern between the pre-existing brain injury and any new potential incidental 
finding, as per protocol (please see section 6 below). 
2. Comment on the location and size of lesion as well as nature of injury, presence 
of atrophy or diffuse axonal injury. 
3. Compare the current anatomical images with earlier ones if available and 
comment on the differences. 
In addition to being recorded in PACS, the neuroradiologist’s report containing information 
on exact anatomical location, size, and number of lesions will facilitate accurate and high 
quality fMRI data analysis, i.e. coregistration and spatial normalisation steps, accounting for 
abnormalities in the participants’ T1-weighted anatomical images resulting from their brain 
injury. 

 
 
 
 
Page 17 - Version 1.2 January 2021 
 
The participants’ anatomical scans will be automatically transferred to NHS PACS through 
the direct link between the CRIF and NHS PACS. 
 
3. 
Incidental Findings Report  
Incidental finding generally refers to the unlikely event where an abnormality is detected, by 
chance, in the scan of a volunteer by the radiographer or one of the investigators. Because 
participants in this study all will have an existing brain injury, a modified approach will be 
taken to allow for the expectation of some abnormality. In this study, Dr Natasha Fullerton 
will examine the anatomical brain scan for each participant and provide a report (please see 
section 6 above). In cases of an incidental finding extending beyond the existing brain injury 
the following procedure will be implemented:  
1. The participant’s GP will be informed 
2. The participant will be referred to an appropriate clinician for further investigation 
The procedure will be outlined in the study information sheet (please see the participant 
information form for further details).  
 
4. 
Statistical methods 
Quantitative behavioural data will be analysed using SPSS 21 software or equivalent. Data 
on recruitment, adherence and retention rates will be summarised as percentages with 95% 
confidence interval (CI). Baseline characteristics of the sample will be presented using 
descriptive statistics. Measures of cognition (overall and domain specific composite scores) 
and psychological and functional constructs will be summarised by group and overall with 
95% CI, and analysed using correlational analyses and t-tests or their non-parametric 
equivalents to estimate effect sizes (ES). The estimated ES, Cohen’s d (Sullivan & Feinn, 
2012), will be calculated using linear regressing adjusted for baseline and factors. The 
sample means, SD and change scores on these outcome measures will form the basis of 
sample size calculations for a further full-scale study, if indicated. 
fMRI BOLD responses will be analysed using the general linear model implemented in 
SPM12 
developed 
at 
the 
Wellcome 
Center 
for 
Human 
Neuroimaging, 
UCL 
(www.fil.ion.ucl.ac.uk/spm). Data preprocessing will include each participant’s functional 
images being realigned using a six-parameter rigid body transformation and coregistered to 
their anatomical image. Covariates of interest will be constructed by convolving vectors of 
predicted neural activity with a canonical hemodynamic response function. To account for 
residual variance because of head movement, motion parameters will be estimated at the 
realignment stage of pre-processing and motion spikes will be identified using the ArtRepair 
toolbox (cibsr.stanford.edu/tools/human-brain-project/artrepair-software.html) and included 
in each model as covariates of no interest. For group analysis, functional images will be 
normalised to MNI (Montreal Neurological Institute) space using affine and nonlinear 
transformations, and spatially smoothed.  
 
5. 
Data Storage & Sharing 
All sensitive information such as participants’ names, addresses, phone numbers etc will 
remain on NHS systems. All electronic anonymised data will be stored on secure University 

 
 
 
 
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of Glasgow networked drives accessed via password-protected university (laptop) computers 
to ensure that the data is automatically backed-up. All participants will be assigned a study 
ID and all electronic data will be anonymised using this unique identification number. Physical 
data will be stored in locked filing cabinets in locked offices on University of Glasgow 
premises. The index of ID codes and identities will be stored separately from the study data. 
A secure University network drive will be used for the purpose of sharing raw data between 
the PhD researcher and investigators. If the data were to be shared, it would be completely 
anonymous (i.e. the link between participant name and study ID would be broken and a 
random ID number would be given instead). Please see further details on the data 
management plan document). 
 
6. 
PhD student training  
The PhD student, Katerina Pappa, has attended the following training opportunities to 
ensure she can produce high quality research,  perform the Goal Management Intervention 
and conduct the fMRI scanning sessions together with the qualified radiographer at the 
CRIF, QEUH.  
1. Research Data Management (October 2018), University of Glasgow  
2. Ethical Approval for People Working with Human Subjects (November 2018), 
University of Glasgow 
3. Good Clinical Practice (November 2018), NHS Greater Glasgow and Clyde  
4. MRI Safety Training, (November 2018), University of Glasgow  
5. Goal Management Training online attendance (December 2018), organised by 
Baycrest, University of Toronto, http://goalmanagementtraining.weebly.com/  
6. Applied Statistics for Postgraduate Students (January 2019), University of 
Glasgow 
7. Writing a Data Management Plan (May 2019), University of Glasgow  
8. Statistical Parametric Mapping (SPM) Course, Wellcome Centre for Human 
Neuroimaging (May 2019), University College London  
9. Visceral Mind Neuroanatomy Course, (September 2019), University of Bangor 
 
7. 
Dissemination plan 
The study participants will not be debriefed of the randomisation they underwent. However, 
they will be notified when the study results are published and the journal article will be shared 
with them. Findings from this study will be further disseminated to the funder and the wider 
research community via presentation at conferences and publication in peer reviewed 
journal(s) in line with the Neurosciences Foundation (NSF) open access policy (or in line with 
the University of Glasgow policy in the absence of NSF policy). The findings will also be 
shared with individuals with ABI and their families via local networks. No personally 
identifiable information about participants will be included in these reports and presentations. 
If the novel intervention is shown to be feasible and acceptable, we plan to arrange 
workshops for healthcare professionals in conjunction with patient, care and public 
involvement (PCPI) with a view to apply for postdoctoral funding after completion of the PhD 
research project. 
 
8. 
Timeline 

 
 
 
 
Page 19 - Version 1.2 January 2021 
 
The duration of the study is 18 months and it is anticipated that recruitment will commence 
on Autumn 2019. A summary of the study timetable is given in Figure 1.  
 
Figure 1: Study Timeline 
 
- COVID-19 mitigating circumstances – delay in study timeline 
Due to the significant delay in starting data collection for this research project, the study timeline has 
been amended as depicted in Figure 2 below. The study comprising Katerina Pappa’s PhD research 
project will reach its end around late 2021. However, data collection for the overall project will continue 
for another year to allow study completion. 
 
Figure 2: Updated study Timeline  
 
9. 
 Outcomes and Outputs 
Results from this work will contribute new knowledge that may improve outcomes for patients 
with ABI long term, and will lay the groundwork for further research extending the adjunctive 
cognitive training approach to other clinical populations with cognitive deficits. Additionally, 
by establishing a new interdisciplinary research collaboration and strengthening the links 
between cognitive neuroscientists and clinical psychologists in the west of Scotland, this 
study will facilitate further development of the pipeline for translation of basic cognitive 
neuroscience research into clinical applications.  Potential funding sources for subsequent 

 
 
 
 
Page 20 - Version 1.2 January 2021 
 
grant applications include Brain Research UK, the Medical Research Council and the 
Wellcome Trust. 
 
10. 
Funding Arrangements  
This study is supported by a Neurosciences Foundation/ Sackler Foundation PhD 
studentship (2018-2021, £75,000) awarded to Professor Jonathan Evans and Drs Kristin 
Flegal and Satu Baylan. In addition, an NHS GG&C Endowment Research Funding (£14,960) 
has been awarded to further support with MRI scanning costs.  
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