Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial
Howe et al. Trials
Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial
Emilie I. Howe 0 1 2
Knut-Petter S. Langlo 0 2 3
Hans Christoffer Aargaard Terjesen 8
Cecilie Røe 1 2
Anne-Kristine Schanke 3 7
Helene L. Søberg 2 6
Unni Sveen 2 6
Eline Aas 5
Heidi Enehaug 8
Daniele E. Alves 8
Pål Klethagen 8
Kjersti Sagstad 10
Christine M. Moen 10
Karin Torsteinsbrend 10
Anne-Margrethe Linnestad 7
Tonje Haug Nordenmark 2
Birte Sand Rismyhr 9
Grete Wangen 6
Juan Lu 4
Jennie Ponsford 13
Elizabeth W. Twamley 11 14
Helene Ugelstad 10
Øystein Spjelkavik 8
Marianne Løvstad 3 7
Nada Andelic 2 12
0 Equal contributors
1 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo , Oslo , Norway
2 Department of Physical Medicine and Rehabilitation, Oslo University Hospital , Oslo , Norway
3 Department of Psychology, Faculty of Social Sciences, University of Oslo , Oslo , Norway
4 Department of Family Medicine and Population Health, Division of Epidemiology, Virginia Commonwealth University , Richmond, VA , USA
5 Department of Health Economics, Institute of Health and Society, Faculty of Medicine, University of Oslo , Oslo , Norway
6 Faculty of Health Sciences, Oslo and Akershus University College of Applied Science , Oslo , Norway
7 Department of Research, Sunnaas Rehabilitation Hospital , Nesoddtangen , Norway
8 The Work Research Institute, Oslo and Akershus University College of Applied Science , Oslo , Norway
9 The Norwegian User Organization (Personskadeforbundet LTN) , Oslo , Norway
10 Department of Vocational Rehabilitation, Norwegian Labor and Welfare Administration , Oslo , Norway
11 Department of Psychiatry, University of California , San Diego, San Diego, CA , USA
12 Center for Habilitation and Rehabilitation Models and Services (CHARM), Institute of Health and Society, Faculty of Medicine, University of Oslo , Oslo , Norway
13 School of Psychological Sciences and Monash Institute of Cognitive and Clinical Neurosciences, Monash University, Faculty of Medicine, Nursing and Health Sciences , Clayton, Victoria , Australia
14 Center of Excellence for Stress and Mental Health, VA San Diego Healthcare System , San Diego, CA , USA
Background: A considerable proportion of patients with mild to moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological, and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabilitation services, the labor and welfare sector, and workplaces. Methods/design: This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18-60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcussive symptoms 2 months postinjury will be included in the study. A comprehensive assessment of neurocognitive function, self-reported symptoms, emotional distress, coping style, and quality of life will be performed at baseline, immediately after CCT (3 months after inclusion), following the end of SE (6 months after inclusion), and 12 months following study inclusion. The primary outcome measures are the proportion of participants who have returned to work at 12-month follow-up and length of time until RTW, in addition to work stability as well as work productivity over the first year following the intervention. Secondary outcomes include changes in self-reported symptoms, emotional and cognitive function, and quality of life. Additionally, a qualitative RTW process evaluation focused on organizational challenges at the workplace will be performed. (Continued on next page)
(Continued from previous page)
Discussion: The proposed study will combine cognitive and vocational rehabilitation and explore the efficacy of
increased cross-sectoral collaboration between specialized health care services and the labor and welfare system. If the
intervention proves effective, the project will describe the cost-effectiveness and utility of the program and thereby
provide important information for policy makers. In addition, knowledge about the RTW process for persons with TBI
and their workplaces will be provided.
Trial registration: ClinicalTrials.gov, NCT03092713. Registered on 10 March 2017.
Successful return to work (RTW) is a major challenge
after traumatic brain injury (TBI) [
]. Personal factors
such as educational level and occupational status, as well
as injury-related characteristics, may predict vocational
]. The person’s own perceptions and
motivations regarding RTW, as well as aspects of the
workplace environment, also have been associated with RTW
and work participation after sickness-related absence
]. Existing literature suggests that the proportion
of individuals with TBI who return to work varies from
13 to 85% [
7, 8, 12
]. Many TBI survivors return to work
prematurely and fail to cope with work demands over
time once the full impact of the injury is realized. This is
probably due to insufficiently coordinated and managed
RTW processes and results in low work stability [
For many individuals with mild to moderate TBI, it is
a major challenge to maintain employment over time
while experiencing somatic, cognitive, and emotional
]. Impaired executive functioning,
learning, memory, and attention are strongly associated
with RTW across a variety of disorders affecting brain
function and can result in slowness in work
performance; difficulties with learning work tasks; distractibility;
and problems with planning, organization, and
goaldirected behavior. All of these factors may lead to work
]. However, large-scale literature reviews
have documented that rehabilitation programs aimed at
teaching patients with mild to moderate cognitive
problems strategies to manage and compensate for their
problems should be a practice standard [
work outcomes following cognitive rehabilitation
interventions have been reported in studies on moderate to
severe TBI , but the evidence is insufficient to draw
strong conclusions. Compensatory cognitive
interventions typically teach clients strategies to compensate for
their cognitive deficits in daily living activities, but
vocational rehabilitation is rarely addressed specifically in
these TBI programs. Authors of a review published in
2009 found that supported employment (SE), based on
long-term support and job skills reinforcement through
on-the-job coaching, could overcome the limitations of
program-based vocational rehabilitation [
Furthermore, authors of a systematic review assessing effective
RTW interventions found that involvement of patient
and employer and work or workplace accommodations
were among the components incorporated in the most
effective interventions [
To date, only a couple of randomized controlled trials
(RCTs) have combined cognitive and vocational
rehabilitation/SE for patients with mild to moderate TBI [
only study resembling our present protocol was performed
by Twamley et al. [
]. Their 12-week compensatory
cognitive rehabilitation intervention (Cognitive Symptom
Management and Rehabilitation Therapy [CogSMART])
was offered in addition to SE for U.S. veterans with mild to
moderate TBI. All participants were unemployed but wished
to return to work. This group was compared with a control
group (CG) that received enhanced SE only. Participants
assigned to both SE and CogSMART demonstrated
significant reductions in postconcussive symptoms and
improvements in prospective memory, but there were no effects on
RTW. The authors noted that their study was a pilot in need
of replication. Moreover, a process evaluation was not
performed in their study, and there are significant differences
between the United States and Norway regarding the labor
market as well as the welfare system. There is a need to
explore different stakeholders’ experiences and processes at
the workplace in the RTW process. Finally, there are no
RCTs in which researchers have examined the
costeffectiveness of vocational rehabilitation following TBI.
Approaches, hypotheses, and choice of methods
The present study was based on Twamley et al.’s 2014
pilot study that targeted individuals with mild and
moderate TBI with persistent cognitive and postconcussive
symptoms. The aim of their study was to assess the
effect of the CogSMART intervention in combination
with SE on improving postconcussive symptoms,
neuropsychological performance, quality of life, functional
capacity, emotional symptoms, and work participation
]. Compensatory Cognitive Training (CCT) is a
further development of CogSMART [
]. It is a
groupbased, manualized intervention that includes ten weekly
sessions, and it is theoretically based on elements derived
from prior cognitive training programs for people with TBI
and severe mental illness [
21, 23, 24
]. The intervention is
focused on psychoeducation and compensatory strategy
training, and it targets postconcussive symptom
management and cognitive symptoms. It is focused on the effect
that postconcussive symptoms (such as sleep disturbance,
pain, fatigue, headache, tension, and emotional distress) can
have on cognitive symptoms and functional recovery. The
CCT intervention stresses a biopsychosocial understanding,
and it is aimed at educating participants about this complex
interrelationship and teaching them stress reduction
techniques and strategies to compensate for the functional
consequences of the symptoms they are experiencing. The
compensatory cognitive strategies target prospective
memory, attention and concentration, learning and
memory, and executive function [
]. Pilot studies of patients
with mild to moderate TBI have demonstrated the efficacy
of CogSMART and CCT in improving emotional problems,
functional capacity, quality of life, and performance on
neurocognitive measures [
A novel approach to vocational rehabilitation based on
the “place-then-train principles” in SE involves support in
real-life competitive work settings and is aimed at providing
professional services to people with disabilities to help them
participate in the competitive labor market [
FiveStep Process describes support activities in the inclusion
process: engagement, vocational profiling, job finding,
employer engagement, and on-/off-job support. The
Individual Placement and Support (IPS) Fidelity Scale is based on
eight principles: competitive employment, eligibility based
on client choice, integration of rehabilitation and health care
services, attention to client preferences, personalized
benefits counseling, rapid job search, systematic job
development, and time-unlimited and individualized support. SE
has not been evaluated in RTW for individuals with TBI in
the Norwegian context, but IPS has gained empirical
support with positive results in terms of both work inclusion
and non-work-related outcomes for people with mental
]. SE will be implemented in this RCT in
combination with CCT. To determine the feasibility of the
proposed interventions and the implementation of
procedures in a Norwegian context, a feasibility study will be
conducted. In the RCT, the effectiveness of a combined
cognitive and vocational rehabilitation intervention
compared with treatment as usual (TAU; a nonstandardized
rehabilitation provided by a multidisciplinary
rehabilitation team) will be evaluated.
The following are the main study hypotheses:
Combined CCT and SE will result in a faster RTW
and better work stability, as well as reduced
postconcussive symptoms and improved cognition,
Combined CCT and SE will result in reduced
emotional distress and improved quality of life
compared with TAU.
Combined CCT and SE will be a cost-effective
alternative compared with the TAU condition.
Factors related both to the workplace and to the
patient’s motivation for RTW will affect the RTW
The proposed study will be a parallel-group RCT with a
mixed method in design. Based on the Standard Protocol
Items: Recommendations for Interventional Trials (SPIRIT),
the study flowchart, standard protocol items, and SPIRIT
checklist are provided in Figs. 1 and 2, and Additional file 1,
respectively. Once included, participants will undergo a
baseline assessment of cognitive and emotional status (T1),
with further assessments immediately following the CCT
intervention (3 months after study inclusion [T2]), following
the end of SE (maximum 6 months after inclusion [T3]),
and 12 months after study inclusion (T4). All study
assessments will be conducted at Oslo University Hospital
(OUH). A process evaluation will be performed to explore
participants’ experiences with the intervention, as well as
individual and workplace-related mechanisms of importance
in the RTW process. A qualitative evaluation study
regarding patient experiences with CCT is also being planned.
Participants will be recruited from OUH and from general
practitioners’ practices. OUH is the trauma referral center
for the southeastern region of Norway and has a
population base of more than half of the Norwegian population
(i.e., 2.9 million). A feasibility study was conducted in the
spring of 2017; recruitment for the RCT began in July
2017; and recruitment will continue until the required
sample size has been achieved.
The study population will consist of patients with mild
to moderate TBI as assessed by a Glasgow Coma Scale
(GCS) score of 10–15, loss of consciousness (LOC) for <
24 h, and posttraumatic amnesia (PTA) for < 7 days [
Confirmation of the diagnosis of mild TBI will be done
by documenting that acute symptoms adhere to the
American Congress of Rehabilitation Medicine’s
definition of mild TBI [
]. This will be either extracted from
preexisting medical records or established at the time of
screening for study eligibility. Patients will be considered
eligible for study inclusion if they are employed in a
minimum 50% position at the time of injury and are
sick-listed at the 50% or higher level because of
postconcussive symptoms 2 months postinjury as assessed by
the Rivermead Post-Concussion Symptoms Questionnaire
]. Participants will be aged 18–60 years and reside in
Oslo or Akershus County. Patients with a history of severe
psychiatric or neurological illness, active substance abuse,
or inability to speak and read Norwegian will be excluded.
The following sociodemographic variables will be recorded:
age, sex, marital status, living conditions, educational level,
description of preinjury employment, workplace, and work
stability (days on sickness benefits 1 year prior to the injury).
The Readiness for Return to Work scale [
] will be applied
at baseline to assess the participants’ perceptions regarding
RTW. To measure the impact of the work environment on
the RTW process, the Copenhagen Psychosocial
Questionnaire (COPSOQ) short version [
] will be applied at
baseline. Medical variables include injury characteristics and
clinical severity (GCS, LOC, PTA), neuroimaging results,
length of hospitalization, medical treatment modalities,
postconcussion symptoms, fatigue, and insomnia.
The primary outcome measures are work participation as
measured by the proportion of participants who have
returned to work at 12-month follow-up and length of time
before return to work (in days), work productivity (hours
worked, work-related changes [i.e., reduced productivity,
increased supervision, work content changes], and work
stability [i.e., sickness absence after initial RTW and
throughout the study period]). To provide descriptive information
and group comparisons, an IQ estimate (Vocabulary,
Similarities, Block Design, and Matrix Reasoning subscales of the
Wechsler Adult Intelligence Scale–Fourth Edition) will be
included at baseline (T1) only [
Postconcussive symptoms and quality of life will be used
as secondary outcome measures at all time points (T1–T4),
whereas outcome will also be measured in the domains of
fatigue, sleep, emotional distress, self-efficacy, and cognition.
The instruments that will be applied are listed in Table 1.
Neuropsychological evaluation will not be conducted at T2.
Process evaluation: qualitative perspective on RTW process
The aim of the qualitative process evaluation is to
explore features of the “train and maintain” elements
that take place at the workplace during the RTW
process (i.e. types of support, as well as if and how the
employment specialists manage to generate partnerships
with employers for job adjustments and adapt work, job
development, and job carving to fit the needs of
employees with TBI). Additionally, we will assess how
risks, challenging behavior, and conflicts are dealt with,
as well as how natural internal company support and
increased inclusion competencies within the workplaces
may be developed. In line with theory [
], we assume
that increased practical knowledge of opportunities and
obstacles for work inclusion at the workplace generates
increased commitment among the relevant stakeholders.
This knowledge and learning process in the work
organization may increase the possibility for successful
RTW and job tenure. Furthermore, via the qualitative
evaluation process, we will seek to identify which
(anxiety and depressive
stress symptoms, and self-efficacy) sGeevneenr-aitliezmed(GAnAxDie-7ty) sDciasloerd[5e4r]
The Patient Health Questionnaire
Neuropsychological test measures
Learning and memory
managerial styles are most effective in creating secure
work environments and promoting successful RTW
processes for the targeted population.
The process evaluation will be based on
semistructured interviews in individual RTW case processes. Each
case process will include three informant groups:
participant, workplace employer, and employment specialist
(intervention group only) or supervisor at the local office
of the public Norwegian Labor and Welfare Service
(NAV) (CG only). Interviews will be conducted at two
different time points in each case process: 1 month and
12 months following RTW. The interviews will provide
an empirical base for additional knowledge on job
Symptoms Questionnaire (RPQ) [
EuroQol five dimensions (EQ-5D) [
Quality of Life After Brain Injury
instrument (Qolibri) [
Fatigue Severity Scale (FSS) [
Insomnia Severity Index (ISI) [
Cognitive Failures Questionnaire
Posttraumatic Symptom Scale
General Self-Efficacy Scale (GSS) [
California Verbal Learning Test–Second
Edition (CVLT-II) [
Memory for Intentions Screening
Test (MIST) [
Color Word Interference Test from
the Delis-Kaplan Executive Function
System (D-KEFS) [
Trail Making Test (TMT) from the
Delis-Kaplan Executive Function
System (D-KEFS) [
Coding from the Wechsler Adult
Intelligence Scale–Fourth Edition
Ruff 2 and 7 Selective Attention
Modified Six Elements Test from
the Behavioral Assessment of the
Dysexecutive Syndrome (BADS) (to
be applied at T4 only) [
Forced Choice Recognition index
from the CVLT-II [
content and skill requirements (i.e., possibilities for
adapted/alternative work tasks); work environment quality
(i.e., demands, control, support); the role of management as
well as types and features of work organization (i.e., division
of tasks, specialization, interdependencies), and what kind
of external support is needed (i.e., the employment
specialists’ contributions that influence job match achievement
and the sustainability of the work relationship).
The contents of the interview questionnaires are
developed on the basis of selected elements from the COPSOQ
], the Multifactor Leadership Questionnaire [
the SE Five-Step Process and IPS Fidelity Scale [
the interviews in both the intervention and control groups,
we will seek to achieve the following:
Identify the employment specialist’s methods as well
as cooperation between the employment specialist
and the CCT team, the employment specialist and
the employer, and the employment specialist and the
person with TBI
Identify attributes and workplace conditions (e.g.,
work tasks/production, internal company training
systems, work environment, and management
factors) that may influence the RTW process
Identify work organizational indicators for successful
RTW and job stability
Identify significant changes in individual inclusion
and exclusion processes at the work organization
Identify effective managerial styles that promote
Regarding RTW, an OR of 2.0 between the Compensatory
Cognitive Training–Supported Employment (CCT-SE) and
CG is regarded as the smallest relevant clinical and societal
OR. Thus, the required total sample size calculated using
G*Power is 110 (i.e., 55 persons in each group; α = 0.05,
power level of 0.80) [
]. With an estimated loss to
followup of 15% [
], 125 participants will be required. On the
basis of an ongoing TBI study [
], we assume that this will
be achievable within 12–18 months. An OR of 2.0 is
equivalent to a 33% absolute difference in employment
status between the two groups. According to Twamley et
], 50% of patients attained competitive work at
12-month follow-up. If the proportion of employed
patients in the CG is 50% at 12-month follow-up, the
proportion for the intervention group in this study will
be expected to be 83% or above on the basis of the
Two strategic samples will be drawn for the process
evaluation, comprising 40 cases from the intervention
group and 20 from the CG. It is a goal to achieve a
heterogeneous sample with variation in severity of TBI,
sex, age, type of job and workplace, company size,
industry, and sector.
A permuted block randomization sequence will be
generated by an independent statistician prior to the start of the
trial. Eligible patients who consent to study participation will
be randomly allocated in a 1:1 ratio in each block to receive
either the study intervention or TAU (CG). An investigator
who is independent of the patient screening process will be
responsible for allocating the patients to the study
conditions. Blinding of the patients and rehabilitation
professionals is not possible, but the outcome assessors will be
blinded to study allocation.
The CCT-SE intervention will comprise a 10-week
manualized group intervention that includes weekly CCT group
sessions with three to seven participants, which will be
provided by a psychologist at OUH. CCT includes
psychoeducation, strategy training, and establishment of new habits in
several domains. Patients learn about the natural course of
postconcussive symptoms and are introduced to sleep
hygiene and stress reduction techniques. Compensatory
cognitive strategies are taught regarding organization and
prospective memory (task management), attention and
concentration (during tasks and social interaction), planning
and goal setting, learning and memory (internal and external
strategies), and executive function (problem solving and
self-monitoring). The CCT manual has been translated into
Norwegian and adapted to Norwegian conditions in
collaboration with the original author of the manual (Twamley
]). The Norwegian user organization
(Personskadeforbundet LTN) has participated in the translation process
The vocational part of the intervention is based on SE
principles and will be provided by three trained employment
specialists from the NAV Department of Vocational
Rehabilitation. For the purpose of this study, the participants
will receive vocational intervention for a maximum of
6 months. A main emphasis will be on stages 1 (client
engagement), 4 (employer engagement), and 5 (on- and
offthe-job support) of the SE Five-Stage Process [
all participants will be in regular employment at the time of
injury. The initial contact with the participant will be
focused on establishing a trustful relationship between the
employment specialist and the participant. The employment
specialists will use the approach of “discovery,” a process for
involving the participant in his/her own RTW process. The
next step is mapping the patient’s resources, limitations, and
work tasks, as well as establishing common goals between
the employment specialist and the participant. The following
sessions will be customized to the employee’s needs and
may include consultations, guidance and advice, learning/
training, work task adaptations, and assistive technology.
The sessions may also include the employer and the
supervisor at the local NAV office if considered beneficial. The
vocational intervention will be integrated with standard
Norwegian statutory sick leave follow-up. The International
Classification of Health Interventions (ICHI) will be applied
for the standardization and documentation of the
individualized interventions [
]. ICHI is a tool developed by the
World Health Organization for reporting and analyzing
health interventions and covers interventions carried out by
a broad range of health care providers, including acute care,
postacute care, and rehabilitation, as well as assistance with
functioning, health prevention, and public health matters.
ICHI is still under development, and the last published
version is denoted as alpha version 2. The classification will be
ready for operational use during the study period.
For the CCT-SE, three NAV employment specialists in
the project will follow one group program each to become
well acquainted with CCT content and ensure
implementation of strategies and compensatory techniques at the
workplace. Continuous cooperation between the CCT team,
employee, and SE personnel will be emphasized.
Employment specialists have participated in formalized
postgraduate SE education at Oslo and Akershus University College
of Applied Sciences (HiOA). The content of the education
is based on the SE Five-Stage Process and the SE Fidelity
]. Supervision of the employment specialists
will be provided by HiOA, with special attention given to
discovery, working with employers, on- and off-the-job
training, and ongoing support.
The two doctoral candidates in the project will be
responsible for provision of the CCT intervention.
They are both experienced psychologists and will
work in close collaboration with their doctoral
program supervisors and the intervention developer
(E. W. Twamley). The feasibility study will ensure
adequate training and provide an opportunity to make
necessary adjustments to the Norwegian version
before inclusion in the RCT.
The CG will receive TAU, which includes follow-up
assessment and treatment provided by the
multidisciplinary TBI rehabilitation team at OUH. The team
consists of six rehabilitation professionals, thus fulfilling
requirements for complex rehabilitation [
will undergo a medical examination and assessment of
physical, cognitive, and mental health and functioning,
followed by individually tailored services. The CG will
be followed for 6 months after inclusion. These patients
will also receive the Norwegian statutory sick leave
follow-up, and the treatment received will be registered
and mapped according to the ICHI.
Descriptive statistics will be used to describe the baseline
and injury characteristics of the variables related to
participants and services. The t test will be used to
analyze between-group mean comparisons for normally
distributed continuous data, and the Mann-Whitney U
tests will be used to analyze skewed data. For the
primary outcome measures, a logistic regression model will
be used to compare the proportions of participants
returning to work at T4 in the CCT-SE and TAU groups,
adjusting for other potential confounders. In addition,
linear regression analysis will be applied to compare the
difference in the mean length to RTW between the
intervention groups at T4, adjusting for other potential
confounders. For the secondary outcome measures,
repeated measures analysis of variance will be used with
time (T1–T4) as the repeated-measures factor and group
(CCT-SE and TAU) being a between-group factor to test
whether the CCT-SE intervention has a beneficial effect
compared with TAU on RTW, symptoms, and
functioning. The intention-to-treat principle will be applied for
all proposed analyses.
Process evaluation analysis
Each semistructured interview will be audio-recorded
and last approximately 60 minutes. After the interview,
the researchers will complete a table describing the main
topics that emerged. Each interview will be summarized
into keywords and coded into the table. Each case
process will be coded into one overarching table,
including different informant groups’ perspectives within
the same case over time. Finally, all cases will be
Health economic analysis
Information concerning costs will be gathered at
follow-up (T2–T4) using a cost registration form. For
the calculation of the total costs, direct health care
costs (i.e., health care provider costs), direct nonhealth
costs (i.e., costs of informal health care), and indirect
costs (i.e., loss of paid and unpaid work productivity)
will be determined. Costs of interventions and patient
income will be calculated in Norwegian kroner.
Cost-effectiveness and cost-utility analyses will be
performed to determine the cost-effectiveness of the
intervention. The analysis will be based on the effect of the
intervention on RTW/work participation and effect on
functioning, including health-related quality of life
(HRQoL). First, we will calculate the economic benefit
as a result of the employment effect of the intervention
(income and cost of intervention) as compared with the
CG. Second, the cost of the intervention will be seen in
terms of health benefits (improved HRQoL). Using
standardized conversion tools, it is possible to convert
health benefits into an index of HRQoL as measured by
the EuroQol five dimensions questionnaire (EQ-5D).
With this analysis, we can compare quality of life in the
intervention group and the CG. Standard discounting
will be performed for both costs and outcomes together
with sensitivity and uncertainty analysis. Full- or
parttime work will be accounted for.
Ethics and dissemination
The study has been presented to and approved by the
Norwegian Regional Committee for Medical and Health
Research Ethics (REK) (REK number 2016/2038). The
project will be conducted according to the ethical
guidelines of the Helsinki declaration [
]. Information about
the study will be presented to the patients in written and
oral form. Written informed consent will be obtained,
and the right to withdraw from the project at any time
without any explanation necessary will be emphasized.
We consider the randomization procedure to be
ethically acceptable. All data will be unidentifiable when
sharing between partners, and personal data will not be
identifiable in the analysis or presentations.
The study will be conducted in close collaboration
with the user organization [
]. The user organization is
represented in the management committee and has had
an active role in the translation and adaptation of the
cognitive intervention manual to the Norwegian setting.
The anonymized quantitative data will be stored in the
database on the research server at OUH. In the
qualitative part of the study, additional informed consent will
be obtained from workplace managers, employment
specialists, and supervisors at the local NAV office who
will be interviewed. The qualitative data (the audio
recordings of the interviews) will be properly stored in
controlled access folders on an HiOA research server.
Both tapes and transcripts will be kept locked at the
Work Research Institute/HiOA. All data will be securely
contained for 5 years after the end of the project.
The trial report and other dissemination documents
will be written according to the Consolidated Standards
of Reporting Trials (CONSORT) statement to facilitate
complete and transparent reporting and aid in critical
appraisal and interpretation [
]. The dissemination plan
reflects the research communities involved in this
multidisciplinary project. We aim to publish reports of
the project in journals of neurology, neuropsychology,
brain injury rehabilitation, occupational research, and
social sciences. Experiences with and results of the
project will also be disseminated in relevant expert
forums, national and international meetings,
conferences, popular scientific journals, and reports. The
results will also be shared with the user organization and
its members through their communication channels in
print and on the Internet.
This project is highly innovative by involving
crosssectoral partnerships (between specialized health care
and research services, the labor and welfare system, and
work and social scientist milieus) in a well-controlled
RCT on cognitive and vocational rehabilitation after
TBI. The project results can inform decisions and
ultimately labor and welfare system practice. Because
cognitive difficulties and challenges in RTW are not limited to
TBI, this study has potential relevance to other patient
groups whose cognitive symptoms complicate work
participation. The RCT will provide knowledge about the
cost-effectiveness of the treatment program. The project
will have an impact on knowledge of the “train and
maintain” aspects of support systems and businesses
dealing with sick leave and RTW, as well as on the
further development of the SE approach, especially
concerning the role of the employment specialist at the
workplace. Because TBI tends to affect young people,
there is considerable potential societal monetary gain,
given that the intervention results in faster and more
stable long-term RTW. Thus, the project can serve as a
benchmark study regarding the efficacy of combined
cognitive rehabilitation and SE efforts.
The present protocol has limitations that should be
addressed. First, this is a pragmatic clinical trial in which the
nature of the interventions prevents blinding of participants
and therapists. Furthermore, outcome assessment will be
performed by personnel unaware of group assignment.
Second, the participants will be allocated to one of two
groups, TAU or CCT combined with SE, potentially making
it difficult to tease apart the active ingredients of the
CCT-SE intervention. However, as mentioned previously,
what makes this study innovative is the combination of
rehabilitation and vocational science perspectives, in
addition to strong cross-sectoral collaboration between
specialized health care services and the welfare system. If
we had decided to include a CG with traumatic injury but
without head trauma, it would have been possible to
identify nonspecific effects of traumatic injury that may
contribute to symptoms and lasting functional impairment.
The grant provided to us unfortunately prevents us from
implementing this. Furthermore, the main aim of this
study is to affect work participation through a
combination of cognitive remediation and SE. For this purpose, a
TAU CG seems appropriate because etiology and
causation will be comparable across groups.
A third possible limitation is the risk of nonadherence
to the interventions and losing patients to follow-up
(i.e., risk of dropout). To facilitate study adherence and
keep the dropout rates as low as possible, the research
team will be well-trained, perform outreach, and be
flexible with respect to timing of the intervention. Last, this
trial is taking place in the southeastern region of Norway,
and participants might not be representative of the whole
population of Norway. It should also be mentioned that this
is a single-center trial, which could potentially limit external
validity. However, we are confident that the results could
be generalizable, because more than half of the Norwegian
population resides in this region.
This is protocol version 1.0. A feasibility study including
six patients has been performed and concluded in July
2017. The results of the feasibility study are being
prepared for publication. No major changes to the
protocol were made as a result of the feasibility study.
Recruitment and randomization of participants for the main
study commenced in July 2017 and will end when we have
enrolled the estimated sample size (approximately in
Additional file 1: SPIRIT checklist. (PDF 128 kb)
CCT: Compensatory Cognitive Training; CCT-SE: Compensatory Cognitive
Training–Supported Employment; CG: Control group; CogSMART: Cognitive
Symptom Management and Rehabilitation Therapy; CONSORT: Consolidated
Standards of Reporting Trials; COPSOQ: Copenhagen Psychosocial
Questionnaire short version; CVLT-II: California Verbal Learning Test–Second
Edition; EQ-5D: EuroQol five dimensions questionnaire; GCS: Glasgow Coma
Scale; HiOA: Oslo and Akershus University College of Applied Sciences;
HRQoL: Health-related quality of life; ICHI: International Classification of
Health Interventions; IPS: Individual Placement and Support; LOC: Loss of
consciousness; NAV: Norwegian Labor and Welfare Service; OUH: Oslo
University Hospital; PTA: Posttraumatic amnesia; RCT: Randomized controlled
trial; REK: Norwegian Regional Committee for Medical and Health Research
Ethics; RTW: Return to work; SE: Supported employment; SPIRIT: Standard
Protocol Items: Recommendations for Interventional Trials; TAU: Treatment as usual;
TBI: Traumatic brain injury; WAIS-IV: Wechsler Adult Intelligence Scale–Fourth Edition
The project is funded by the Research Council of Norway (Norges
Forskningsråd) with NOK 14,887,000 (project number 256689/H10).
Availability of data and materials
EIH, KPSL, and HCAT are doctoral fellows in the project; they contributed to
the study design and will also carry out recruitment and screening of
participants, set up the intervention and collect baseline data, and perform
statistical analysis and interpretation of results. CR, AKS, HLS, and US are
senior researchers; they have participated in developing the study protocol
and will help interpret the results. EA is responsible for the design of the
health economic part of the study and will contribute to analyzing the cost
data. HE, DEA, and PK are senior researchers, have designed the process
evaluation, and will collect and interpret qualitative data. KS, CMM, and KT
are employment specialists and will carry out the vocational part of the
intervention. AML will perform a qualitative evaluation of the cognitive
intervention. THN is a senior researcher who helped design the study and
will interpret results. BSR is a representative from the user organization who
has contributed to the adaptation of the cognitive intervention to the
Norwegian context and also has contributed to the study design. GW has
contributed to the design of the study and is the supervisor of the
employment specialists. JL, JP, and EWT have contributed to the design the
study, choice of outcome measures, and adaptation of the interventions. HU,
ØS, ML, and NA are chief investigators and members of the steering
committee; they have designed the study and will partake in analyzing and
interpreting the results. ØS, ML, and NA are the main supervisors of the
doctoral fellows and are responsible for the main statistical outcome analysis.
All authors helped draft the manuscript and consent to publication. All
authors read and approved the final manuscript.
Ethical approval and consent to participate
The study has been presented to and approved by the Norwegian Regional
Committee for Medical and Health Research Ethics (REK) (REK number 2016/
2038). The project will be conducted according to the ethical guidelines of
the Helsinki declaration. Information about the study will be presented to
the patients in written and oral form. Written informed consent will be
obtained, and the right to withdraw from the project at any time without
any explanation necessary will be emphasized. All participants will be
assigned an identification number, and all the questionnaires and datasets
will be anonymized. Only the project team will have access to the document
that links study identifiers with participant names.
Consent for publication
The authors declare that they have no competing interests.
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