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Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial.

ABSTRACT: A considerable proportion of patients with mild to 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 are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabilitation services, the labor and welfare sector, and workplaces.This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18-60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcussive symptoms 2 months postinjury will be included in the study. A comprehensive assessment of neurocognitive function, self-reported symptoms, emotional distress, coping style, and quality of life will be performed at baseline, immediately after CCT (3 months after inclusion), following the end of SE (6 months after inclusion), and 12 months following study inclusion. The primary outcome measures are the proportion of participants who have returned to work at 12-month follow-up and length of time until RTW, in addition to work stability as well as work productivity over the first year following the intervention. Secondary outcomes include changes in self-reported symptoms, emotional and cognitive function, and quality of life. Additionally, a qualitative RTW process evaluation focused on organizational challenges at the workplace will be performed.The proposed study will combine cognitive and vocational rehabilitation and explore the efficacy of increased cross-sectoral collaboration between specialized health care services and the labor and welfare system. If the intervention proves effective, the project will describe the cost-effectiveness and utility of the program and thereby provide important information for policy makers. In addition, knowledge about the RTW process for persons with TBI and their workplaces will be provided.ClinicalTrials.gov, NCT03092713 . Registered on 10 March 2017.

SUBMITTER: Howe EI

PROVIDER: S-EPMC5645893 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial.

Howe Emilie I EI Langlo Knut-Petter S KS Terjesen Hans Christoffer Aargaard HCA Røe Cecilie C Schanke Anne-Kristine AK Søberg Helene L HL Sveen Unni U Aas Eline E Enehaug Heidi H Alves Daniele E DE Klethagen Pål P Sagstad Kjersti K Moen Christine M CM Torsteinsbrend Karin K Linnestad Anne-Margrethe AM Nordenmark Tonje Haug TH Rismyhr Birte Sand BS Wangen Grete G Lu Juan J Ponsford Jennie J Twamley Elizabeth W EW Ugelstad Helene H Spjelkavik Øystein Ø Løvstad Marianne M Andelic Nada N

Trials 20171017 1

<h4>Background</h4>A considerable proportion of patients with mild to 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 are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabil ...[more]

PMID: 29041954

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Project description:BackgroundLong-term physical, cognitive, and psychosocial problems resulting from moderate to severe traumatic brain injury (TBI) can prevent individuals from returning to preinjury lifestyles because of significant challenges with employment, leisure, and relationships. While physical activity (PA) is proposed as a cost-effective method to alleviate problems after moderate to severe TBI, there is no review to date that synthesizes the evidence for PA in the community-based context. Further, although sex- and gender-based considerations in research are considered requisite to good science, there is no review on PA and TBI that has included this explicit focus.ObjectiveThe purpose of this review is to map and synthesize the current evidence identified through a systematic search of community-based PA interventions for individuals of all ages with moderate to severe TBI and provide an overview of that evidence by asking the following research questions: (1) what are the characteristics of community-based PA programs for individuals with moderate to severe TBI, (2) what are the reported health-related outcomes and measurement tools used to evaluate them, and (3) what considerations have been given to sex and/or gender?MethodsSearches will be conducted of six academic databases for peer-reviewed articles. Two reviewers will independently screen the articles for inclusion and extract data for the analysis. The extracted data will be coded according to the Consensus on Exercise Reporting Template checklist and the Template for Intervention Description and Replication checklist to provide sufficient detail for replication.ResultsThe abstract screening was completed by two reviewers and the extracted data were analyzed. A qualitative synthesis and description of community-based PA interventions for individuals with moderate to severe TBI will be provided.ConclusionsThis scoping review will generate new knowledge from published and publicly available literature. Dissemination of the results will include activities related to knowledge transfer for community-based PA after moderate to severe TBI for future research and practice. Evidence-based recommendations, future directions, potential limitations, use of online/digital components, and the possible need for a systematic review will be discussed as well.International registered report identifier (irrid)DERR1-10.2196/24689.

Project description:BackgroundA proportion of patients with mild traumatic brain injury (mTBI) suffer long-term consequences, and the reasons behind this are still poorly understood. One factor that may affect outcomes is cognitive reserve, which is the brain's ability to maintain cognitive function despite injury. It is often assessed through educational level or premorbid IQ tests. This study aimed to explore whether there were differences in post-concussion symptoms and symptom resolution between patients with mTBI and minor orthopedic injuries one week and three months after injury. Additional aims were to explore the relationship between cognitive reserve and outcome, as well as functional connectivity according to resting state functional magnetic resonance imaging (rs-fMRI).MethodFifteen patients with mTBI and 15 controls with minor orthopedic injuries were recruited from the emergency department. Assessments, including Rivermead Post-Concussion Questionnaire (RPQ), neuropsychological testing, and rs-fMRI scans, were conducted on average 7 days (SD = 2) and 122 days (SD = 51) after injury.ResultsAt the first time point, significantly higher rates of post-concussion symptoms (U = 40.0, p = 0.003), state fatigue (U = 56.5, p = 0.014), and fatigability (U = 58.5, p = 0.025) were observed among the mTBI group than among the controls. However, after three months, only the difference in post-concussion symptoms remained significant (U = 27.0, p = 0.003). Improvement in post-concussion symptoms was found to be significantly correlated with cognitive reserve, but only in the mTBI group (Spearman's rho = -0.579, p = .038). Differences in the trajectory of recovery were also observed for fatigability between the two groups (U = 36.5, p = 0.015). Moreover, functional connectivity differences in the frontoparietal network were observed between the groups, and for mTBI patients, functional connectivity differences in an executive control network were observed over time.ConclusionThe findings of this pilot study suggest that mTBI, compared to minor orthopedic trauma, is associated to both functional connectivity changes in the brain and concussion-related symptoms. While there is improvement in these symptoms over time, a small subgroup with lower cognitive reserve appears to experience more persistent and possibly worsening symptoms over time. This, however, needs to be validated in larger studies.Trial registrationNCT05593172. Retrospectively registered.

Project description:IntroductionTraumatic brain injury (TBI) is a major public health problem, and it is estimated that 85% of TBIs are diagnosed as mild and are commonly referred to as a concussion. In adults, symptoms are expected to resolve within 10-14 days after the injury, but up to 15% of individuals continue to have symptoms beyond this period. Recent clinical recommendations suggest the use of physical activity (PA) as a therapy to manage persisting symptoms. However, the recommendations regarding PA lack clarity about important intervention parameters to help clinicians deliver the intervention. The objectives of this scoping review are thus to identify the characteristics, the measurement tools, the health-related outcomes and the reported effectiveness of PA-based interventions for adults with persisting symptoms of a mild TBI (mTBI).Methods and analysisThis scoping review protocol will follow Arksey and O'Malley's six-step iterative process enhanced by another study and will be conducted by a team of researchers and clinical experts. Five databases (MEDLINE, CINAHL, PsycINFO, SPORTDiscuss and Embase), as well as Google, will be searched using an extensive search strategy to capture relevant scientific and grey literature. Articles will be selected if they report on an intervention designed to have an impact on health-related outcomes or participation among individuals having sustained an mTBI. A data extraction form based on the Consensus on Exercise Reporting Template and the Template for Intervention Description and Replication checklists will be created. Quantitative and qualitative data will be analysed accordingly, synthesised and collated in tables.Ethics and disseminationThis scoping review generates new knowledge from published and publicly available literature; thus, an ethical approval is unnecessary to conduct this research. Dissemination of the results will involve all team members in activities aimed to facilitate knowledge uptake among TBI rehabilitation clinical experts locally, nationally and internationally.

Project description:Aims: Knowledge regarding the most effective return to work (RTW) approaches after traumatic brain injury (TBI) is lacking. This trial aimed to compare the effectiveness of a combined cognitive and vocational intervention to treatment as usual (TAU) on RTW and work stability after TBI. Methods: We performed a parallel-group randomized controlled trial (RCT) at a TBI outpatient clinic at Oslo University Hospital (OUH), Norway. Patients with a history of mild-to-moderate TBI (n = 116) aged 18-60 were randomized (1:1) by an independent investigator to receive group-based compensatory cognitive training (CCT) and supported employment (SE) (n = 60) or TAU consisting of individualized multidisciplinary treatment (n = 56). Participants were enrolled 2-3 months post-injury. The nature of the intervention prevented blinding of patients and therapists, however, outcome assessors were blinded to group allocation. The primary outcome measure was RTW at 3 and 6 months following study inclusion. Secondary outcomes were work percentage, stability, and productivity. The present study provides results from an interim analysis from the first two planned follow ups, while subsequent publications will present results up to 12 months following study inclusion. Results: Mixed effects models showed no between-group differences in the RTW proportion, work percentage, and hours worked between CCT-SE and TAU from baseline to 6 months. A significantly higher proportion of participants in CCT-SE had returned to work at 3 months when adjusting for baseline differences. The majority of participants who were employed at 3 and 6 months were stably employed. There was a statistically significant within-group improvement on RTW proportion, hours worked and work percentage in both groups. Conclusion: The results revealed no difference between CCT-SE and TAU on work-related outcomes from baseline to 6 months. However, there was a higher RTW proportion in the CCT-SE group compared to TAU at 3 months. Future publications will assess the effectiveness of CCT-SE vs. TAU up to 12 months. Clinical Trial Registration: US National Institutes of Health ClinicalTrials.gov, identifier #NCT03092713.

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Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial.

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Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial.

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