The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial
Fleming et al. Trials
The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial
Jennifer Fleming 1
Tamara Ownsworth 0
Emmah Doig 1
Lauren Hutton 0
David H. K. Shum 0
0 Menzies Health Institute Queensland and School of Applied Psychology, Griffith Health Institute, Griffith University , Mount Gravatt, QLD , Australia
1 School of Health and Rehabilitation Sciences, University of Queensland , Brisbane 4072, QLD , Australia
Background: Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI. Methods/design: This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, selfawareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups. (Continued on next page) © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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Discussion: This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM
performance and level of psychosocial integration in adults with moderate to severe TBI. The findings will advance
theoretical understanding of the role of self-awareness in compensatory PM rehabilitation and skills generalization.
COMP-MST has the potential to reduce the cost of rehabilitation and lifestyle support following TBI because the
intervention could enhance generalization success and lifelong application of PM compensatory strategies.
Trial registration: New Zealand Clinical Trials Registry, ACTRN12615000996561. Registered on 23 September 2015;
retrospectively registered 2 months after commencement.
Memory problems are the most common cognitive
complaint in people with traumatic brain injury (TBI) [1, 2].
Prospective memory (PM) refers to the ability to
remember to carry out a planned action or intention at a future
point in time . Examples of PM are remembering to
pay a bill by the due date, remembering to take
medication each morning, or remembering to pass on a
message the next time you see a particular person.
Successfully remembering to perform an intended action
is a critical cognitive skill in daily life. We are constantly
making mental notes of tasks that we need to complete
in the future, and failures of PM are associated with
feelings of having let oneself or others down. Despite its
relevance to daily life, PM is a relatively new construct
in the scientific literature compared to retrospective
memory (RM), which involves the recall or recognition
of previously learnt information and past events.
However, over the past 10 years research on PM has grown
rapidly. Research has shown that people with TBI
experience debilitating PM deficits [4–6] which impact on
independent living (e.g., requiring a carer at home), social
participation (e.g., failure to keep engagements), and
employability (e.g., workers are seen as unreliable) .
Therefore, PM impairment is a target for rehabilitation
efforts which often focus on the use of compensatory
strategies to minimize the impact of PM impairment in
everyday life [8, 9].
PM is a complex ability that involves multiple
processes and components. According to Ellis , there
are five stages of PM: (1) formation and encoding of
intention and action, (2) retention interval, (3)
performance interval, (4) initiation and execution of intended
action, and (5) evaluation of the outcomes. The first stage
involves realizing that an action needs to be carried out
in the future and encoding what the action is and when
to execute it. In the second stage, the person stores the
intended action and engages in one or more other
activities. The action is initiated and executed in the third
and fourth stages. During the last stage, the person
records and evaluates the outcome of the intended action.
Therefore, PM involves a combination of RM (to encode
and recall the action), executive function (to plan and
initiate the action at the correct time), and
metacognitive function (to monitor performance and evaluate the
outcome). These functions are commonly impaired after
TBI; the prefrontal lobes which are vulnerable to trauma
are implicated in executive and metacognitive functions
and are also considered the neural basis of PM .
Three subtypes of PM have been identified in the
scientific literature, according to task characteristics and
the type of cue for recalling the intention . These
include: time-based PM activities when an action needs to
be initiated at a particular time or window of time (e.g.,
in 10 min or before the close of business on Friday);
event-based PM activities where an action is performed
in response to an external cue (e.g., turn off the stove
when the timer rings or ring a friend for their birthday
when a reminder appears on your phone); and
activitybased PM activities where an action is performed as part
of or at the end of a sequence of actions or behaviors
(e.g., put on your seatbelt after you get in the car or add
sugar to your coffee after the milk). A study of the
subtypes of PM using a computerized task showed that
people with TBI performed significantly worse than
controls on all subtypes . In another study, patients with
TBI had more difficulties compared to controls when
the cognitive demand of the ongoing task was high,
indicating their PM failures could be attributed to reduced
processing capacity and problems allocating cognitive
resources . In previous research, significant others of
patients with TBI reported that patients had significantly
more instances of forgetting daily activities compared to
non-injured controls . In contrast, patients with TBI
rated their own frequency of forgetting as similar to
controls and reported fewer PM failures than their
significant others, thus indicating a lack of self-awareness of
their PM problems .
Like traditional RM rehabilitation, approaches to PM
rehabilitation can be categorized as remedial or
compensatory . Remedial training approaches aim to restore
or ameliorate the underlying impairment through
repetitive practice of PM activities; for example,
remembering to perform time- and event-based PM tasks
embedded within a filler activity that may be
pen-andpaper- or computer-based. In contrast, compensatory
approaches focus on teaching the patient to use
strategies to minimize the impact of PM impairment in
everyday life; for example, training in diary or calendar
use . Case studies have found positive effects of
remedial PM training [14, 15]; however, the training
programs involved in these studies required substantial
commitments of time and effort; for example, 4–6 h
per week over several months. It is also not clear to
what extent gains generalized beyond the ability to
perform the simple, non-goal directed remedial activities
used in training. Compensatory approaches to PM
rehabilitation have been less investigated and overall the
evidence is weak . This is despite the common
prescription of compensatory memory strategies in brain
injury rehabilitation settings and the recommendation
that training in external memory compensations should
be standard practice . Such strategies include the
use of a diary, note-taking, routines, checklists, alarms,
and paging systems, and are more relevant to everyday
functioning, and may be more easily generalized to
naturalistic settings compared to remedial activities.
Furthermore, compensatory approaches to PM rehabilitation can
assist patients with reduced cognitive capacity .
Trials with small TBI samples and case studies have
described the use of electronic devices (e.g., palmtop
computer, television-assisted prompting, Voice
Organizer, and the NeuroPage paging system) as effective to
compensate for PM deficits [19–24]. For an overview of
these studies see the systematic review by de Joode
et al. . Fish et al.  evaluated the use of a
“content-free” cue in the form of a text message, to remind
20 people with brain injury to monitor behavior, and
found a greater improvement in performance on cued
days compared to non-cued days. Ownsworth and
McFarland  demonstrated that a metacognitive
approach was more effective in training people with TBI
to regularly use a memory notebook (n = 10) than a
procedural learning approach (n = 10). Das Nair and
Lincoln  compared the effectiveness of
compensatory training, remedial training, and a self-help group
in a group of 72 adults with memory problems (16 with
TBI). They found that greater use of internal memory
aids was reported post test by individuals in the two
training groups compared to the self-help group, and
that significantly better emotional status was reported
by those in the compensation group.
In previous research, we developed an 8-week
intervention program (consisting of two self-awareness
training sessions and six compensatory training sessions)
with the aim of rehabilitating the PM of three patients
with TBI . The promising findings of this pilot led to
a larger-scale randomized controlled trial (RCT) of PM
rehabilitation strategies , which demonstrated that the
six-session compensatory rehabilitation program was
more effective than a control intervention in improving
PM in people with TBI, as measured by the Cambridge
Prospective Memory Test (CAMPROMPT). The control
intervention involved a remedial approach of repetitive
practice of PM activities over six weekly sessions. The
compensatory intervention involved the use of external
strategies to both trigger the intention (prospective
component) and support retrieval of content salient to the
task (retrospective component) over the same time
period. Event-based tasks (i.e., taking a cake out of the
oven when a timer goes off ) are easier than self-initiated
or time-based tasks (i.e., remembering to take the cake
out of the oven in 40 min) . Therefore, this approach
uses compensatory strategies that convert time-based
tasks into event-based tasks which provide a cue to
initiate performance of the action. Examples are use of an
alarm, or linking the task to an event (e.g., taking
medication at mealtimes). The significantly greater
improvement in PM performance for the compensatory
intervention group was attributed to the use of strategies
during the PM task. However, these gains did not extend
to significantly greater improvements in everyday PM
performance or psychosocial function as anticipated.
Further research is needed to specifically investigate the
generalization of PM compensatory strategies to
occupational performance in daily life .
One of the difficulties with generalization in TBI
rehabilitation is the problem of impaired self-awareness.
Estimates of the rates of impaired self-awareness in
people with severe TBI are as high as 97% . Impaired
self-awareness refers to an inability to recognize
limitations due to brain injury and to understand the
functional implications of these . It poses significant
obstacles to rehabilitation engagement and outcomes in
the TBI population and, therefore, is the target of
rehabilitation efforts . For example, individuals with
poor self-awareness of their impairments post TBI do
not see the need to apply strategies learnt in
rehabilitation in everyday life to improve their performance. A
fundamental principle of cognitive rehabilitation is that
individuals need to recognize their impairments before
being able to independently employ a strategy to
compensate for these problems in daily living .
Therefore, to enhance the rehabilitation of PM, it is
important that impairments of self-awareness are
addressed to maximize engagement and use of strategies
in everyday life.
Metacognitive skills training (MST) is a cognitive
rehabilitation approach which facilitates the development
of self-awareness in patients with TBI [33–35]. The
objective of MST is to teach individuals how to
selfmonitor their performance, identify and self-correct
errors, and generate strategies for future use. A
metacognitive approach targets both on-line awareness (i.e.,
recognition and self-correction of errors in task
performance) and intellectual awareness (i.e.,
selfknowledge of strengths and limitations). This approach
incorporates elements of self-awareness training, such
as psychoeducation and role modeling of strategy use,
and also uses timely verbal, video, and experiential
feedback and self-prediction and self-evaluation of
performance in therapy activities and everyday life
. A MST approach has potential to enhance the
outcomes of compensatory PM rehabilitation and lead
to better generalization of strategy use beyond the
This paper outlines the protocol for a RCT comparing
the efficacy of compensatory (COMP) and COMP-MST
training for improving everyday PM performance,
psychosocial function, strategy use, self-awareness, and level
of care in a sample of adults with TBI.
Study objectives and hypotheses
The primary aim of this RCT is to evaluate the
effectiveness of a MST approach to compensatory PM training for
improving everyday PM performance, maintaining PM
gains, and improving level of psychosocial reintegration in
community-dwelling adults with moderate to severe TBI.
The secondary aim is to evaluate the effectiveness of a
MST approach to compensatory PM training for
improving and maintaining PM function on psychometric testing,
strategy use, self-awareness, and level of care following
It is proposed that, with the addition of MST to the
compensatory program, individuals with TBI will
become aware of the extent of their PM failures, and the
gains in PM performance will extend to everyday life as
the participants will be able to generalize their strategy
use to situations beyond the training setting. Therefore,
it is hypothesized that:
1. COMP training will demonstrate significant
improvement at post intervention and maintenance
at 3-months post intervention on PM performance
and level of psychosocial integration compared to
no intervention (i.e., waitlist), and that
compensatory PM rehabilitation combined with
metacognitive skills training (COMP-MST) will be more
effective than COMP training alone
2. Compared to participants in the waitlist condition,
participants who receive COMP training will
demonstrate significant improvement and
maintenance of PM function on psychometric
testing, strategy use, self-awareness, and level of
The research design entails a RCT with three
treatment groups: COMP-MST, COMP, and waitlist
control. After completing baseline assessment measures
(see “Measures” section), participants will be randomly
allocated to the COMP-MST, COMP, or waitlist
control group (see “Randomization” section). The
COMPMST and COMP groups will participate in a 6-week
treatment intervention (see “Intervention procedures”
section), and the waitlist control group will receive
usual care for 6 weeks. At the end of the 6-week
period, all participants will be reassessed on measures
used at baseline by a blind assessor. Three months
after conclusion of the intervention programs and
waitlist control condition, all participants will receive
a follow-up assessment to evaluate the maintenance of
treatment effects. At this time, participants in the
waitlist group will be offered the COMP-MST
program. Six months after completing the intervention
programs, all treatment groups will receive further
follow-up assessment to determine maintenance of
gains. The trial design flowchart is listed in Fig. 1 and
the Standard Protocol Items: Recommendations for
Interventional Trials (SPIRIT) diagram in Fig. 2.
Recruitment of 90 participants with moderate to severe
TBI and their significant others will be carried out over a
4-year period. Potential participants will be identified by
treating therapists or case managers providing
rehabilitation to people with TBI in a specialist brain injury
rehabilitation unit at a large metropolitan hospital in Queensland,
and a Queensland statewide brain injury outreach service.
A treating therapist or case manager will provide potential
participants with a brief summary of the study. If the
individual is interested in taking part, they will be asked to
provide verbal consent to be contacted by the project
manager. Flyers advertising the project will also be
provided to private brain injury rehabilitation practices in
Brisbane, Australia and interested participants will be
invited to contact the project manager. The project manager
will then explain the study and provide participants with a
Participant Information Sheet and a Consent Form (see
Additional file 1).
Participants will be eligible for the study if they are aged
18–65 years; have a significant other who is available to
Fig. 1 Trial design flowchart (COMP compensatory training, COMP-MST compensatory training plus metacognitive skills training)
participate in the study; have a diagnosis of moderate or
severe TBI (as determined by Glasgow Coma Scale (GCS)
score and/or duration of post-traumatic amnesia (PTA));
score within the impaired range on baseline assessment of
PM performance or if PM problems are reported by the
participant or their significant other on the Brief
Assessment of Prospective Memory (BAPM); are at least 1 month
post discharge from hospital; have had no prior brain
injury or hypoxic injury; have adequate receptive and
expressive English communication skills; are ambulant
or independently mobile in a manual or electric
wheelchair; and are able to attend the hospital for the 6-week
intervention program. Suitability for the study will be
confirmed at the preintervention assessment.
Participants will be excluded from the study if they are
unable to provide informed consent; have not emerged
from PTA; are confused or disoriented; have
communication difficulties limiting their comprehension of
written or spoken language; and/or who are assessed by
their treating occupational therapist as having
impairment of cognitive function at a basic level.
Ethics, consent, and permissions
The ethical aspects of this research project have been
approved by the Human Research Ethics Committees,
Queensland (HREC) of Metro South (HREC/15/QPAH/
90 – SSA/15/QPAH/92), the University of Queensland
(2015000644), and Griffith University (PSY/93/14/
Fig. 2 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram
HREC), Queensland, Australia. The trial is registered
with the Australian and New Zealand Clinical Trials
Registry (ACTRN12615000996561). The trial is being
monitored by the research monitoring officer, Centre for
Health Research, Princess Alexandra Hospital. This
study protocol conforms to the SPIRIT reporting
guidelines. See the SPIRIT Checklist in Additional file 2.
Informed consent will be obtained from each participant
prior to commencement in the study. See the Participant
Information Sheet and Consent Form in Additional file 1.
The blind assessor will conduct preintervention
assessments with each participant in the clinic, which will
involve completing a series of questionnaires and
neuropsychological tests. The participant’s significant other will
also provide informed consent and complete a set of
questionnaires (see “Measures” section).
Personal information about potential and enrolled
participants will remain confidential and data will be
deidentified using participant numbers. A dedicated project
manager will oversee data collection, organization,
storage, and security. Only the project researchers and the
research monitoring officer will have access to the data.
At the conclusion of the study, data will be stored in
accordance with the National Health and Medical
Research Council retention of study data policy.
Participants will be provided with a summary of their results
approximately 6 months after their final assessment. It
is anticipated that the results of this research will be
published and/or presented in a variety of forums. In
any publications and/or presentations, information will
be provided in such a way that participants cannot be
Participants’ impairment of PM function as assessed on
the CAMPROMPT (“impaired/borderline” or “less
impairment”) will be used to determine their stratification
subgroup for random allocation to the three groups.
This stratified approach is designed to ensure a relatively
equal proportion of individuals in each group with
severe PM impairment, as determined using cutoffs in the
Table 1 Overview of COMP and COMP-MST training techniques
Prospective memory education
To develop participants’
understanding of what PM is and
the impact of TBI on PM ability
Use of a memory aid To assist participants in identifying
E.g., diary or organizational device and learning to use a portable
compensatory aid that meets their
individual needs and preferences
Writing reminders, appointments, To demonstrate basic note-taking
note-taking skills for recording reminders
To maximize organization and time
management within participants’
existing routines and home
To involve significant others in
participants’ memory aid training
in order to increase others’
understanding of PM strategies
and reinforce the use of memory
aids outside of the training
To encourage self-generation of a
range of suitable strategies for use
within the context of “real-life” PM
failures that impact on independent
living, community integration, and
To reinforce use of the memory aid
and note-taking skills, and devise a
plan for maintenance of strategy
use in the future
CAMPROMPT manual . The random assignment
will be conducted independent of the project staff
involved in the interventions and the blind assessor. For
each subgroup (i.e., severe or less severe), participants
will be randomly allocated to COMP, COMP-MST, or
waitlist control groups using sequentially numbered and
sealed opaque envelopes. The envelopes will contain
group allocation on a written insert, based on a
predetermined, random, computer-generated sequence.
Manualized treatment protocols have been developed
for the COMP and COMP-MST training programs
based on previous research conducted by the research
team . The COMP treatment manual has been
amended for use in the current study to incorporate
electronic devices used as compensatory aides (i.e.,
mobile phones). The MST component of the COMP-MST
treatment manual has been developed by the research
team . The techniques of the COMP and
COMPMST training procedures are shown in Table 1.
Registered occupational therapists who are
experienced in working with people with brain injury will
deliver the intervention program by one-to-one
consultation in an outpatient clinic setting. Treatment
fidelity will be monitored using a checklist based on
Borelli’s framework . Sessions will be audiotaped
to enable therapists’ adherence to the treatment
protocol to be examined for a random sample (20%) of
sessions by experts who are independent of the study. At
the end of the intervention, the effectiveness of
blinding will be checked by asking the assessor to state if
they became aware of which group the participant
belongs to. Throughout the study, participant
compliance will be monitored by recording the number of
sessions that each participant attends. Strategies to
improve participation include the provision of financial
support for transportation to therapy sessions, and
extending the intervention period from 6 weeks to
8 weeks in the case of illness or other absence.
Participants can continue to receive other rehabilitation
services which are not focused on PM rehabilitation
during the intervention period and these will be
The primary outcome measures assess everyday PM
performance and level of psychosocial reintegration.
Secondary outcome measures assess PM performance
and strategy use, global self-awareness, self-awareness
of PM failure, and level of support needs. Primary and
secondary outcome measures will be administered at
pre and post intervention, and at 3-month and
Strategy generation practice
E.g., video scenarios of everyday
Future memory aid agreement
Cognitive activity (completed in COMP only)
Cognitive activity To provide an active control or filler
E.g., workbook exercises, attention task for metacognitive skills training,
tasks i.e., a similar amount of therapy
time allocated to tasks unrelated to
PM or self-awareness
Metacognitive skills training (completed in COMP-MST only)
Role modeling To allow participants to identify
E.g., watching a video of someone similarities between the PM
else discussing their PM difficulties problems being modeled and their
and demonstrating ways they own experience, to increase
overcame their PM failure self-awareness of personal
challenges and potential usefulness
To provide an opportunity for
participants to gain insight into
their PM performance, self-reflect
on their performance, and generate
strategies for future use
Self-reflection activities To encourage participants to
E.g., self-prediction of PM per- self-monitor their performance,
formance prior to performance gain insight into how to self-correct
and self-evaluation following per- errors, and practice generating
formance; journal of PM failures strategies for future use
and strategy use in everyday life;
discussion of impact of TBI
The Brief Assessment of Prospective Memory (BAPM;
) is a 16-item self-report scale which measures
frequency of PM failure in everyday life over the past
month. The BAPM consists of two subscales: basic
activities of daily living (eight items) and instrumental
activities of daily living (eight items). Subscale scores range
from 0 to 5, with higher scores reflecting more frequent
PM failure. Internal consistency and test-retest reliability
have been reported . Significant other ratings will be
used in this study, rather than self-ratings, in order to
overcome confounding scores due to the development
of self-awareness in TBI participants over the course of
The Sydney Psychosocial Reintegration Scale version 2
(SPRS-2; [39, 40]) is a 12-item questionnaire which
assesses an individual’s level of psychosocial reintegration
following TBI. The SPRS-2 contains two forms which
reflect different comparison standards: Form A measures
change since injury and Form B measures current status.
Each form uses the same 12 items which measure three
domains of functioning including occupational activities,
independent living skills, and interpersonal relationships.
Each domain contains four items, which are rated on a
5-point scale ranging from “no change” to “extreme
change” (Form A) and “very good” to “extremely poor”
(Form B). Scores range from 0–48, with higher scores
indicative of better psychosocial functioning. The
SPRS2 (Form B) will be completed by participants’ significant
others. Sound psychometric properties have been
reported for the SPRS-2 .
The Cambridge Prospective Memory Test
(CAMPROMPT; ) is a psychometric test of PM function.
The CAMPROMPT consists of a total of six PM tasks,
three cued by time and three cued by events.
Participants are allowed to spontaneously use strategies, such
as taking notes, to help them remember during tasks.
Total scores are out of 36 (time-based and event-based
subscale scores are each out of 18), with higher scores
representing better PM performance. The validity and
reliability of the CAMPROMPT has been documented
in a number of studies [36, 41]. In addition to total
CAMPROMPT scores, participants’ spontaneous use of
note-taking as a PM strategy during the CAMPROMPT
will be measured as a dichotomous variable.
The Awareness Questionnaire (AQ; ) is a 17-item
scale that assesses self-awareness of brain injury-related
impairments across sensory, physical, cognitive, and
behavioral domains. Ratings on the AQ compare
participants’ post-injury abilities on each item to their
preinjury functioning (1 = much worse, 5 = much better).
The AQ has two versions, a self-report and a
significantother report which may be completed by a family
member, friend, or therapist. Positive discrepancy scores
(selfreport minus significant-other report) indicate impaired
self-awareness. The AQ has been found to have sound
psychometric properties  and has demonstrated
sensitivity to change in the context of awareness
Self-awareness specifically for PM impairment will be
measured using the BAPM by calculating the
discrepancy between participant self-ratings and significant
other ratings of the frequency of PM failure in everyday
The Care and Needs Scale (CANS; ) is a clinician
rating scale, designed to measure the types and level of
support needs of a person with TBI. The types of
support needs are assessed using a 24-item checklist,
hierarchically grouped into categories reflecting the intensity
of support required (such as support with special needs,
basic activities of daily living, instrumental activities of
daily living, and psychosocial supports). The information
on types of support needs required by the individual is
then used to evaluate the level of support needs, as
indexed by the length of time that a person can be left
alone. The CANS rating ranges from 0 (is completely
independent) to 7 (cannot be left alone). Reliability of the
CANS has been investigated by Soo et al. . The
CANS will be completed in conjunction with the
participant’s referring occupational therapist.
Data collection and management
All measures will be completed at the four time points
by an assessor who is blind to group allocation. At the
preintervention assessment, the assessor will also
administer a brief neuropsychological battery consisting of
tests of attention (e.g., Digit Span, Trail Making Test A),
memory (e.g., Hopkins Verbal Learning Test), and
executive function (e.g., Controlled Oral Word Association
Test, Trials B, Hayling Sentence Completion Test) in
order to provide data on the level of cognitive
impairment of the sample. Data on demographic and
diagnostic variables (GCS score, duration of PTA, length of
hospitalization, and cause of injury) will be retrieved
from the participant’s medical records. Significant others
will complete the SPRS-2 and BAPM at the clinic if they
attend the assessment sessions with the participant with
TBI. If they do not attend they will complete the
measures at home, with telephone assistance from the
assessor if required, and return the questionnaires by post.
Participant retention will be promoted via transport
assistance where required and follow-up telephone
contact from the project manager. The data management
procedure includes cross checking of data using
computed and manually scored totals and range checks for
data values. Any adverse events will be reported to the
To determine the required sample size, a power
calculation was conducted using the primary outcome variable
with the most conservative effect size from our previous
RCT (i.e., the change score between pre-and
post-SPRS2 scores) . Comparison between the group that
received compensatory plus self-awareness training and
the group that received compensatory training alone
produced an effect size of 0.70 (Cohen’s d). Using
G*Power  and setting the effect size to 0.70, alpha
level to 0.05, and power to 0.80 it was calculated that a
sample size of n = 26 for each group is required. The
sample size has been inflated to n = 30 per group to
allow for an estimated dropout rate of approximately
10% based on dropout rates from another RCT currently
being conducted within the same setting . Therefore,
it is calculated that a total sample size of n = 90 will be
required for the study to be adequately powered to
detect significant differences between groups.
Between-group differences will be calculated, accounting
for baseline scores, for all three groups on all outcomes.
To address the primary aim, unstructured linear mixed
regression will be used to test for group differences on
the primary outcomes, with group allocation
(COMPMST, COMP, waitlist control) as the between-subject
factor, and time (baseline, post intervention, 3-month
follow-up) as the within-subject or repeated variable.
Any demographic or neuropsychological variables that
are significantly associated with the primary outcome
and unevenly distributed between the groups will be
included as covariates. The same approach will be used
with secondary outcome variables to address the
secondary aim. Missing data will be handled using an
intention-to-treat analysis (i.e., most recent available
data will be imputed). Using planned comparisons, data
from the 6-month follow-up will be compared with
post-intervention and/or 3-month follow-up results to
evaluate whether or not any significant gains on
variables have been maintained over time.
Interim analysis and stopping rules
We do not have a plan for an interim analysis as we do
not expect a situation that would lead us to stop the
study. However, in the event of an extreme situation, we
will temporarily cease data collection to assess the
implications on the study design.
Impairment of PM is common following TBI and may
have serious repercussions for an individual’s
independent living, social engagement, and employability .
Whilst research shows that compensatory approaches to
PM rehabilitation minimize the impact of PM
impairments in adults with TBI [8, 9], poor self-awareness after
TBI poses a major barrier to the generalization of
compensatory strategies in daily life . By comparing the
efficacy of COMP and COMP-MST, this project will
determine if integrating MST into compensatory
approaches to PM rehabilitation improves everyday PM
performance, strategy use, and self-awareness after TBI.
The findings are expected to have important theoretical
and practical implications for treatment approaches that
can potentially be used to enhance individuals’ capacity
to generalize compensatory training strategies to daily
life, which in turn will increase independent living and
reduce the personal and social burden of TBI in the
The main methodological challenge in this study
relates to avoiding therapist bias, as the same occupational
therapist will deliver both intervention programs to
participants. The use of manualized procedures, close
supervision, fidelity checks to ensure adherence to
protocol, and the therapists being blinded to hypotheses
will reduce potential therapist bias. Furthermore, using
the same therapist provides consistency across
interventions (e.g., consistent level of expertise, rapport, other
AQ: Awareness Questionnaire; BAPM: Brief Assessment of Prospective
Memory; CAMPROMPT: Cambridge Prospective Memory Test; CANS: Care
and Needs Scale; COMP: Compensatory approaches to prospective memory
rehabilitation; COMP-MST: Compensatory approaches to prospective memory
rehabilitation plus metacognitive skills training; GCS: Glasgow Coma Scale;
HREC: Human Research Ethics Committees; MST: Metacognitive skills training;
PM: Prospective memory; PTA: Post-traumatic amnesia; RCT: Randomized
controlled trial; RM: Retrospective memory; SPRS-2: Sydney Psychosocial
Reintegration Scale version 2; TBI: Traumatic brain injury
JF, DS, and TO are the chief investigators and were responsible for the study
design and research protocol and intervention development. ED is the trial
coordinator and wrote the intervention manuals. JG and MK are associate
investigators and provide clinical advice to the project. LH drafted the
manuscript. All authors critically reviewed and revised the manuscript for
important intellectual content, and read and approved the final manuscript.
1. Canty AL , Shum DHK , Levin HS , Chan RCK. Memory impairments after traumatic brain injury . In: Levin HS, Shum DHK , Chan RCK, editors. Understanding traumatic brain injury: current research and future directions . New York : Oxford University Press ; 2014 . p. 71 - 98 .
2. Vakil E. The effect of moderate to severe traumatic brain injury on different aspects of memory: a selective review . J Clin Exp Neuropsychol . 2005 ; 27 : 977 - 1021 .
3. Kvavilashvili L , Ellis J. Varieties of intention: some distinctions and classifications . In: Brandimonte M, Einstein GO , McDaniel MA, editors. Prospective memory: theory and applications . Mahwah: Erlbaum; 1996 . p. 23 - 51 .
4. Maujean A , Shum DHK , MacQueen R. Effect of cognitive demand on prospective memory in individuals with traumatic brain injury . Brain Impair . 2003 ; 4 : 135 - 45 .
5. Roche N , Fleming J , Shum DHK . Self-awareness of prospective memory failure in adults with traumatic brain injury . Brain Inj . 2002 ; 16 : 931 - 46 .
6. Shum D , Levin H , Chan RCK. Prospective memory in patients with closed head injury: a review . Neuropsychologia . 2011 ; 49 : 2156 - 65 .
7. Winograd E. Some observations on prospective remembering . In: Gruneberg MM , Morris PE , Sykes RN, editors. Practical aspects of memory: current research as issues . Chichester: Wiley; 1998 . p. 348 - 53 .
8. Fleming J , Shum DHK , Strong J , Lightbody S. Prospective memory rehabilitation for adults with traumatic brain injury: a compensatory training programme . Brain Inj . 2005 ; 19 : 1 - 13 .
9. Shum D , Fleming J , Gill H , Gullo M , Strong J. A randomised controlled trial of prospective memory rehabilitation in adults with traumatic brain injury . J Rehabil Med . 2011 ; 43 : 216 - 33 .
10. Ellis J. Prospective memory or the realization of delayed intentions: a conceptual framework for research . In: Brandimonte M, Einstein GO , McDaniel MA, editors. Prospective memory: theory and applications . Mahwah: Erlbaum; 1996 . p. 1 - 22 .
11. Stuss D , Alexander M. Executive functions and the frontal lobes: a conceptual view . Psychol Res . 2000 ; 63 : 289 - 98 .
12. Shum D , Valentine M , Cutmore T. Performance of traumatic brain-injured individuals on time-, event-, and activity-based prospective memory tasks . J Clin Exp Neuropsychol . 1999 ; 21 : 49 - 58 .
13. Shum D , Fleming J , Neulinger K. Prospective memory and traumatic brain injury: a review . Brain Impair . 2002 ; 3 : 1 - 16 .
14. Raskin SA , Sohlberg MM . The efficacy of prospective memory training in two adults with brain injury . J Head Trauma Rehab . 1996 ; 11 : 32 - 51 .
15. Sohlberg MM , White O , Evans E , Mateer C. Background and initial case studies into the effects of prospective memory training . Brain Inj . 1992 ; 6 : 129 - 38 .
16. Piras F , Borella E , Incoccia C , Carlesimo GA . Evidence-based practice recommendations for memory rehabilitation . Eur J Phys Rehab Med . 2011 ; 47 : 149 - 75 .
17. Cicerone KD , Langenbahn DM , Braden C , Malee JF , Kalmar K , Fraas M , et al. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008 . Arch Phys Med Rehab . 2011 ; 92 : 519 - 30 .
18. Manly T , Evans JJ , Fish J , Gracey F , Bateman A. Cognitive rehabilitation following traumatic brain injury . In: Levin HS, Shum DHK , Chan RCK, editors. Understanding traumatic brain injury: current research and future directions . New York : Oxford University Press ; 2014 . p. 215 - 34 .
19. Boman IL , Lindberg Stenvall C , Hemmingsson H , Bartfai A. A training apartment with a set of electronic memory aids for patients with cognitive problems . Scand J Occup Ther . 2010 ; 17 : 140 - 8 .
20. de Joode E , Proot I , Slegers K , van Heugten C , Verhey F , van Boxtel M. The use of standard calendar software by individuals with acquired brain injury and cognitive complaints: a mixed methods study . Disabil Rehabil Assist Technol . 2012 ; 7 : 389 - 98 .
21. Kim HJ , Burke DT , Dowds MM , Boone KA , Park GJ. Electronic memory aids for outpatient brain injury: follow-up findings . Brain Inj . 2000 ; 14 : 187 - 96 .
22. Kirsch NL , Shenton M , Rowan J. A generic, “in house”, alphanumeric paging system for prospective activity impairments after TBI . Brain Inj . 2004 ; 18 : 725 - 34 .
23. Lemoncello R , Sohlberg MM , Fickas S , Prideaux J. A randomized controlled crossover trial evaluating television assisted prompting (TAP) for adults with acquired brain injury . Neuropsychol Rehabil . 2011 ; 21 : 825 - 46 .
24. van den Broek MD , Downes J , Johnson Z , Dayus B , Hilton N. Evaluation of an electronic memory aid . Brain Inj . 2000 ; 14 : 455 - 62 .
25. de Joode E , van Heugten CM , Verhey F , van Boxtel M. Efficacy and usability of assistive technology for patients with cognitive deficits: a systematic review . Clin Rehabil . 2010 ; 24 : 701 - 14 .
26. Fish J , Evans JJ , Nimmo M , Martin E , Kersel D , Bateman A , Wilson BA , Manly T. Rehabilitation of executive dysfunction following brain injury: contentfree cueing improves everyday prospective memory performance . Neuropsychologia . 2007 ; 45 : 1318 - 30 .
27. Ownsworth TL , McFarland K. Memory remediation in long-term acquired brain injury: two approaches to diary training . Brain Inj . 1999 ; 13 : 605 - 26 .
28. Das Nair R , Lincoln NB . Evaluation of rehabilitation of memory in neurological disabilities (ReMIND): a randomized controlled trial . Clin Rehabil . 2012 ; 26 : 894 - 903 .
29. Radomski MV , Anheluk M , Bartzen MP , Zola J. Effectiveness of interventions to address cognitive impairments and improve occupational performance after traumatic brain injury: a systematic review . Am J Occup Ther . 2016 . doi:10.5014/ajot.2016.020776.
30. Sherer M , Boake C , Levin E , Silver BV , Ringholz G , High WM . Characteristics of impaired awareness after traumatic brain injury . J Int Neuropsych Soc . 1998 ; 4 : 380 - 7 .
31. Fleming JM , Strong J , Ashton R. Self-awareness of deficits in adults with traumatic brain injury: how best to measure? Brain Inj . 1996 ; 10 : 1 - 16 .
32. Fleming JM , Ownsworth TL . A review of awareness interventions in brain injury rehabilitation . Neuropsychol Rehabil . 2006 ; 16 : 474 - 500 .
33. Ownsworth T , Fleming J , Desbois J , Strong J , Kuipers PIM. A metacognitive contextual intervention to enhance error awareness and functional outcome following traumatic brain injury: a single-case experimental design . J Int Neuropsychol Soc . 2006 ; 12 : 54 - 63 .
34. Ownsworth T , Quinn H , Fleming J , Kendall M , Shum D. Error self-regulation following traumatic brain injury: a single case study evaluation of metacognitive skills training and behavioural practice interventions . Neuropsychol Rehabil . 2010 ; 20 : 59 - 80 .
35. Schmidt J , Fleming J , Ownsworth T , Lannin NA . Video feedback on functional task performance improves self-awareness after traumatic brain injury: a randomized controlled trial . Neurorehabil Neural Repair . 2013 ; 27 : 316 - 24 .
36. Wilson B , Emslie H , Foley J , Shiel A , Watson P , Hawkins K , et al. Cambridge Prospective Memory Test (CAMPROMPT ) manual. Oxford: Harcourt Assessment ; 2005 .
37. Borelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials . J Public Health Dent . 2011 ; 71 : s52 - 63 .
38. Man DWK , Fleming J , Hohaus L , Shum D. Development of the Brief Assessment of Prospective Memory (BAPM) for use with traumatic brain injury populations . Neuropsychol Rehabil . 2011 ; 21 : 884 - 98 .
39. Tate R , Hodgkinson A , Veerabangsa A , Maggiotto S. Measuring psychosocial recovery after traumatic brain injury: psychometric properties of a new scale . J Head Trauma Rehabil . 1999 ; 14 : 543 - 57 .
40. Tate R , Simpson G , Lane-Brown A , Soo C , de Wolf A , Whiting D. Sydney Psychosocial Reintegration Scale (SPRS-2): meeting the challenge of measuring participation in neurological conditions . Aust Psychol . 2012 ; 47 : 20 - 32 .
41. Fleming J , Riley L , Gill H , Gullo MJ , Strong J , Shum D. Predictors of prospective memory in adults with traumatic brain injury . J Int Neuropsychol Soc . 2008 ; 14 : 823 - 31 .
42. Sherer M , Bergloff P , Boake C , High WM , Levin E. The Awareness Questionnaire: factor structure and internal consistency . Brain Inj . 1998 ; 12 : 63 - 8 .
43. Sherer M , Bergloff P , Boake C , Levin E , High W , Gollaher K. Factor structure of the awareness questionnaire . Arch Clin Neuropsychol . 1997 ; 12 : 403 - 4 .
44. Tate RL . Assessing support needs for people with traumatic brain injury: the care and needs scale (CANS) . Brain Inj . 2004 ; 18 : 445 - 60 .
45. Soo C , Tate RL , Aird V , Allaous J , Browne S , Carr B , Coulston C , Diffley L , Gurka J , Hummell J. Validity and responsiveness of the care and needs scale for assessing support needs after traumatic brain injury . Arch Phys Med Rehabil . 2010 ; 91 : 905 - 12 .
46. Faul F , Erdfelder E , Lang A , Buchner A. G * Power 3: a flexible statistical power analysis program for the social , behavioral and biomedical sciences. Behav Res Methods . 2007 ; 39 : 175 - 91 .
47. Ownsworth T , Fleming J , Tate R , Shum D , Griffin J , Schmidt J , Lane-Brown A , Kendall M , Chevignard M. Do people with severe traumatic brain injury benefit from making errors? A study protocol for a randomized controlled trial of the efficacy of error-based and errorless learning training . Trials . 2013 ; 14 :369.1- 8 .
48. Maylor EA , Darby RJ , Logie RH , Della Sala S , Smith G. Prospective memory across the lifespan . In: Graf P, Ohta N , editors. Lifespan development of human memory . Cambridge: MIT Press ; 2002 . p. 235 - 56 .