Clinical trial NCT03092713: Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial
Official title: The Effect Evaluation of Combined Cognitive and Vocational Interventions After Mild-to-moderate Traumatic Brain Injury: a Randomized Controlled Trial and Qualitative Process Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Cognitive Impairment
Keywords: Cognitive Rehabilitation
Supported employment
Mild and moderate TBI
Return to work
Randomized Controlled Trial
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Sunnaas Rehabilitation Hospital
name: Oslo Metropolitan University
name: Norwegian Labour and Welfare Administration
First posted: 2017-03-28
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with active treatment group compared to treatment as usual
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Return to work
timeFrame: 18 months post injury
measure: Work stability
timeFrame: 18 months post injury
Secondary outcomes:
measure: Rivermead post-concussion questionnaire
timeFrame: 18 months
measure: Euro-Qol - 5D (EQ-5D)
timeFrame: 18 months
measure: Quality of life after brain injury (Qolibri)
timeFrame: 18 months
Other outcomes:
measure: Fatigue Severity Scale
timeFrame: 18 months
measure: Insomnia Severity Index
timeFrame: 18 months
measure: Cognitive Failures Questionnaire
timeFrame: 18 months
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 18 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 18 months
measure: General Self-efficacy Scale
timeFrame: 18 months
measure: Neuropsychological functioning
timeFrame: 18 months
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Dept. of physical medicine and rehabilitation
Study officials:
affiliation: Oslo University Hospital/University of Oslo
name: Nada Andelic, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Howe EI, Andelic N, Fure SCR, Roe C, Soberg HL, Hellstrom T, Spjelkavik O, Enehaug H, Lu J, Ugelstad H, Lovstad M, Aas E. Cost-effectiveness analysis of combined cognitive and vocational rehabilitation in patients with mild-to-moderate TBI: results from a randomized controlled trial. BMC Health Serv Res. 2022 Feb 12;22(1):185. doi: 10.1186/s12913-022-07585-3.
citation: Howe EI, Fure SCR, Lovstad M, Enehaug H, Sagstad K, Hellstrom T, Brunborg C, Roe C, Nordenmark TH, Soberg HL, Twamley E, Lu J, Andelic N. Effectiveness of Combining Compensatory Cognitive Training and Vocational Intervention vs. Treatment as Usual on Return to Work Following Mild-to-Moderate Traumatic Brain Injury: Interim Analysis at 3 and 6 Month Follow-Up. Front Neurol. 2020 Nov 10;11:561400. doi: 10.3389/fneur.2020.561400. eCollection 2020.
citation: Howe EI, Langlo KS, Terjesen HCA, Roe C, Schanke AK, Soberg HL, Sveen U, Aas E, Enehaug H, Alves DE, Klethagen P, Sagstad K, Moen CM, Torsteinsbrend K, Linnestad AM, Nordenmark TH, Rismyhr BS, Wangen G, Lu J, Ponsford J, Twamley EW, Ugelstad H, Spjelkavik O, Lovstad M, Andelic N. Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2017 Oct 17;18(1):483. doi: 10.1186/s13063-017-2218-7.