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

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

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

Conditions
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Brain Injuries, Traumatic, Cognitive Impairment

Intervention / Treatment
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* Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)
* Behavioral: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with active treatment group compared to treatment as usual
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Intervention and Supported Employment (CCI-SE)<br>Combined cognitive and vocational rehabilitation in a mixed design. | Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)<br>* The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place.<br>|
| Active Comparator: Control group<br>Usual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team. | Behavioral: Control Group<br>* The Control Group receives usual assessment and treatment at Oslo University Hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work | The effect of the intervention on return to work rates throughout the follow-up period | 18 months post injury | 
| Work stability | The effect of the intervention on work stability rates throughout the follow-up period | 18 months post injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivermead post-concussion questionnaire | Questionnaire; The effect of the study intervention on post concussive symptoms | 18 months | 
| Euro-Qol - 5D (EQ-5D) | Questionnaire; The effect of the study intervention on health-related quality-of-life throughout the follow-up period | 18 months | 
| Quality of life after brain injury (Qolibri) | Questionnaire; The effect of the study intervention on disease-related quality-of-life throughout the follow-up period | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Rehabilitation, Supported employment, Mild and moderate TBI, Return to work, Randomized Controlled Trial