Brain Injuries, Traumatic, Cognitive Impairment
Conditions
Keywords
Cognitive Rehabilitation, Supported employment, Mild and moderate TBI, Return to work, Randomized Controlled Trial
Brief summary
A considerable number of patients with mild and 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 in this group are scarce. Furthermore, there have traditionally been weak collaborations among rehabilitation services in the health sector, the Labor and Welfare Administration (NAV), and the work-places. The current project proposal describes an innovative randomized controlled trial (RCT) which will explore the effect of combined manualized cognitive rehabilitation efforts and supported employment in real-life competitive work settings for patients who have not returned to work 8 weeks post-injury. The project combines the rehabilitation and vocational science perspectives; it involves multidisciplinary collaboration, and explores the efficacy of increased cross-sectorial collaboration between specialized health care services and the welfare system. If the intervention proves efficient, the project will further describe the cost-effectiveness and utility of the program, and thereby provide important information of use for policy makers. In addition, the study aims at generating knowledge on the RTW-process both for the persons with TBI, and their workplaces, and to disseminate this knowledge in order to create new multidisciplinary and collaborative practices. The project has potential to generate knowledge of relevance for other patients with neurological deficit.
Detailed description
Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954
Interventions
BEHAVIORALCombined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)
The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place.
BEHAVIORALControl Group
The Control Group receives usual assessment and treatment at Oslo University Hospital.
Sponsors
The Research Council of Norway
Sunnaas Rehabilitation Hospital
Oslo Metropolitan University
Norwegian Labour and Welfare Administration
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Particpant are blinded to Group allocation, and all assessments are blinded to Group allocation.
Intervention model description
Randomized controlled trial with active treatment group compared to treatment as usual
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* reside in Oslo and Akershus counties in Norway * mild-to-moderate TBI (Glasgow Coma scale score 10-15 at injury site). Confirmation of diagnosis of mild TBI will be done through documenting that acute symptoms adhere to the American Congress of Rehabilitation Medicine's (ACRM) definition of mild TBI. * loss of consciousness \<24 hours * posttraumatic amnesia (PTA) \<7 days * employed in a minimum 50% position at the time of injury * sick listed at the 50% or higher level due to post-concussive symptoms 2 months post-injury
Exclusion criteria
* history of severe psychiatric or neurological illness * active substance abuse * inability to speak and read Norwegian
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return to work | 18 months post injury | The effect of the intervention on return to work rates throughout the follow-up period |
| Work stability | 18 months post injury | The effect of the intervention on work stability rates throughout the follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rivermead post-concussion questionnaire | 18 months | Questionnaire; The effect of the study intervention on post concussive symptoms |
| Euro-Qol - 5D (EQ-5D) | 18 months | Questionnaire; The effect of the study intervention on health-related quality-of-life throughout the follow-up period |
| Quality of life after brain injury (Qolibri) | 18 months | Questionnaire; The effect of the study intervention on disease-related quality-of-life throughout the follow-up period |
Other
| Measure | Time frame | Description |
|---|---|---|
| General Self-efficacy Scale | 18 months | Questionnaire; The effect of the study intervention on self-efficacy throughout the follow-up period |
| Fatigue Severity Scale | 18 months | Questionnaire; The effect of the study intervention on fatigue throughout the follow-up period |
| Neuropsychological functioning | 18 months | Screening test battery including measures of general ability Level, attention, Processing speed, Learning and memory executive functioning, and performance validity |
| Insomnia Severity Index | 18 months | Questionnaire; The effect of the study intervention on sleep throughout the follow-up period |
| Cognitive Failures Questionnaire | 18 months | Questionnaire; The effect of the study intervention on self-reported cogntiive symptoms throughout the follow-up period |
| Generalized Anxiety Disorder (GAD-7) | 18 months | Questionnaire; The effect of the study intervention on anxiety throughout the follow-up period |
| Patient Health Questionnaire (PHQ-9) | 18 months | Questionnaire; The effect of the study intervention on depression throughout the follow-up period |
Countries
Norway
Outcome results
None listed