Objectives of the study: Project 1 - To assess early adaptive deficits in a multicentre cohort of mild to moderate TBI patients and their relation to outcome. Project 2 - Early intervention study of Cognitive Behavioural Therapy (CBT) to assess…
ID
Source
Brief title
Condition
- Other condition
- Cognitive and attention disorders and disturbances
Synonym
Health condition
traumatisch hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the intervention study the primary outcome measure is level of resumption
of work or study 12 months, measured with the RTW subscale of the RRL (Van den
Burg & van Zomeren, 1985).
Secondary outcome
-Working status defined as total days off work at 12 months
-GOS-E, determined by an experienced neurologist at 12 months
-Differential Outcome Scale (DOS, van der Naalt, 2000), determined at 12 months
-Role resumption (RRL; Rolhervattingslijst, Spikman et al, 2010)
Background summary
Rationale: Traumatic brain injury (TBI) may have profound impact on functional
outcome. The majority of patients sustain a mild to moderate injury (85-90%). A
subgroup of these patients (20-25%) experiences persistent cognitive complaints
interfering with resumption of work. Six months after injury 30-40% of patients
has not resumed previous work. Lost work productivity is considered the largest
component of TBI related costs. Often explanatory structural brain damage is
not demonstrated by imaging techniques despite these impairments. The actual
mechanism may be more complex as specific premorbid patient characteristics are
also relevant. Illness perception and coping style are decisive for the
development of postconcussive complaints and related to unfavourable outcome.
Given the long-term consequences it is mandatory to predict which patients will
develop persistent cognitive complaints.
The aim of this study is to unravel the role of adaptive deficits for outcome
of mild to moderate TBI. A prospective clinical cohort multicentre study is
combined with a Randomized Controlled Trial of cognitive behavioural therapy.
Simultaneously an imaging study applying functional and structural MRI-studies
will be performed to assess the contribution of pre-existent or brain-injury
related changes to the frontal network dysfunction.
Study objective
Objectives of the study:
Project 1 - To assess early adaptive deficits in a multicentre cohort of mild
to moderate TBI patients and their relation to outcome.
Project 2 - Early intervention study of Cognitive Behavioural Therapy (CBT) to
assess whether early CBT reduces cognitive complaints and improves coping style
with a positive effect on outcome defined as return to of work.
Project 3 - To determine the relation between adaptive deficits and frontal
network dysfunction in TBI patients assessed by the application of functional
(fMRI) and structural (DTI) imaging.
Study design
Study design: A prospective longitudinal multicenter cohort study, comprising a
single blind randomised placebo-controlled trial (RCT), in mild to moderate TBI
patients in four hospitals spanning major regions in the Netherlands, i.e. the
UMCG (Groningen), the VU Medical Center (Amsterdam), St. Elisabeth Hospital
(Tilburg), MST Enschede.
Study population: Mild to moderate TBI patients (GCS 9-15), age >15 yrs,
comprehension of Dutch language, admitted to the emergency department of the
participating Trauma Centres.
A selection of patients will be included in the intervention study and
MRI-studies for which separately informed consent will be asked. The
fMRI-studies will only be done in the NeuroImaging Center (Groningen) due to
specialized expertise in this centre.
Intervention
The Cognitive Behavioral Therapy (CBT) is aimed at improving coping skills and
diminishing ineffective thoughts and catastrophizing illness perception related
to the TBI comprising an intervention group and an control intervention.
For details see page 20 of the research protocol.
Study burden and risks
Measurements and treatment in this study do not have adverse consequences for
those involved, and there are no risks or burden associated with participation.
The mental burden will be minimal; patients have to fill in questionnaires at 4
occasions in a one-year period. For a subgroup, involvement might be more
intensive, with a treatment of 5 sessions and/or fMRI measurements. This will
be counseled carefully by the professionals (psychologist, neurologist)
involved.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Patients with mild to moderate TBI who are admitted to the emergency department of one of the participating hospitals. All patients admitted within the one-year inclusion period will be asked to participate in the follow up study.
Inclusion criteria:
Project 1 - GCS scores on admission from 9-15 with loss of consciousness or Posttraumatic Amnesia. Age >15 years. Comprehension of Dutch language.
Project 2 - Same as for study 1, but age range between 18-65 years. At least 3 complaints determined with a questionnaire 2 weeks postinjury comprising minimally one complaint in the cognitive domain and minimally one in the emotional/social domain (based on the actual incidence of PCS).
Project 3 - age range between 18-65 years.
Exclusion criteria
Inability to follow-up, drug or alcohol abuse, psychiatric co-morbidity, previous TBI, language barriers prohibiting understanding and completion of questionnaires.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41188.042.12 |