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

University of Oslo (UIO)

Status: Completed

Conditions: Cognitive Impairment; Brain Injuries, Traumatic

Treatments: Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment); Behavioral: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03092713

2016/2038

Details and patient eligibility

About

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.

Full description

Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954

Enrollment: 121 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 2 patient groups

Cognitive Intervention and Supported Employment (CCI-SE)

Active Comparator group

Description:

Combined cognitive and vocational rehabilitation in a mixed design.

Treatment:

Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)

Control group

Active Comparator group

Description:

Usual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team.

Treatment:

Behavioral: Control Group