Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial
NCT03092713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121
Last updated 2021-10-19
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.
Conditions
- Brain Injuries, Traumatic
- Cognitive Impairment
Interventions
- BEHAVIORAL
-
Combined 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.
- BEHAVIORAL
-
Control Group
The Control Group receives usual assessment and treatment at Oslo University Hospital.
Sponsors & Collaborators
-
The Research Council of Norway
collaborator OTHER -
Sunnaas Rehabilitation Hospital
collaborator OTHER -
Oslo Metropolitan University
collaborator OTHER -
Norwegian Labour and Welfare Administration
collaborator OTHER -
Oslo University Hospital
lead OTHER
Principal Investigators
-
Nada Andelic, MD; PhD · Oslo University Hospital/University of Oslo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-02
- Primary Completion
- 2020-12-31
- Completion
- 2021-06-30
Countries
- Norway
Study Locations
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