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

Not Applicable

Completed

• Conditions: Brain Injuries, Traumatic; Cognitive Impairment
• Interventions: Behavioral: Control Group; Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)

• Registration Number: NCT03092713
• Lead Sponsor: Oslo University Hospital

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

Study Timeline

• Study Start: 2017-01-02
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-28
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control Group	Usual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team.
Cognitive Intervention and Supported Employment (CCI-SE)	Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)	Combined cognitive and vocational rehabilitation in a mixed design.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Rivermead post-concussion questionnaire	18 months	Questionnaire; The effect of the study intervention on post concussive symptoms

Trial Locations

Locations (1)

Oslo University Hospital, Dept. of physical medicine and rehabilitation; 🇳🇴 Oslo, Norway