Oslo University Hospital, Dept. of physical medicine and rehabilitation
Oslo, 0424, Norway
NCT Number: NCT03092713
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Oslo, 0424, Norway
Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place.
The Control Group receives usual assessment and treatment at Oslo University Hospital.
Time frame: 18 months post injury
The effect of the intervention on return to work rates throughout the follow-up period
Time frame: 18 months post injury
The effect of the intervention on work stability rates throughout the follow-up period
Time frame: 18 months
Questionnaire; The effect of the study intervention on post concussive symptoms
Time frame: 18 months
Questionnaire; The effect of the study intervention on health-related quality-of-life throughout the follow-up period
Time frame: 18 months
Questionnaire; The effect of the study intervention on disease-related quality-of-life throughout the follow-up period
Time frame: 18 months
Questionnaire; The effect of the study intervention on fatigue throughout the follow-up period
Time frame: 18 months
Questionnaire; The effect of the study intervention on sleep throughout the follow-up period
Time frame: 18 months
Questionnaire; The effect of the study intervention on self-reported cogntiive symptoms throughout the follow-up period
Time frame: 18 months
Questionnaire; The effect of the study intervention on anxiety throughout the follow-up period
Time frame: 18 months
Questionnaire; The effect of the study intervention on depression throughout the follow-up period
Time frame: 18 months
Questionnaire; The effect of the study intervention on self-efficacy throughout the follow-up period
Time frame: 18 months
Screening test battery including measures of general ability Level, attention, Processing speed, Learning and memory executive functioning, and performance validity
Oslo University Hospital
Other
The Effect Evaluation of Combined Cognitive and Vocational Interventions After Mild-to-moderate Traumatic Brain Injury: a Randomized Controlled Trial and Qualitative Process Evaluation
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