NCT03092713

Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial

The Effect Evaluation of Combined Cognitive and Vocational Interventions After Mild-to-moderate Traumatic Brain Injury: a Randomized Controlled Trial and Qualitative Process Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Brain Injuries, Traumatic
• Cognitive Impairment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-02
• Primary completion: 2020-12-31
• Completion: 2021-06-30
• First posted: 2017-03-28
• Last updated: 2021-10-19

Locations

1 site across 1 country: Norway