1. Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial
- Author
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Howe, Emilie I, Langlo, Knut-Petter S, Terjesen, Hans Christoffer Aargaard, Røe, Cecilie, Schanke, Anne-Kristine, Søberg, Helene L, Sveen, Unni, Aas, Eline, Enehaug, Heidi, Alves, Daniele E, Klethagen, Pål, Sagstad, Kjersti, Moen, Christine M, Torsteinsbrend, Karin, Linnestad, Anne-Margrethe, Nordenmark, Tonje Haug, Rismyhr, Birte Sand, Wangen, Grete, Lu, Juan, Ponsford, Jennie, Twamley, Elizabeth W, Ugelstad, Helene, Spjelkavik, Øystein, Løvstad, Marianne, and Andelic, Nada
- Subjects
Allied Health and Rehabilitation Science ,Health Services and Systems ,Health Sciences ,Rehabilitation ,Traumatic Head and Spine Injury ,Brain Disorders ,Neurosciences ,Mind and Body ,Comparative Effectiveness Research ,Clinical Research ,Health Services ,Traumatic Brain Injury (TBI) ,Mental Health ,Physical Injury - Accidents and Adverse Effects ,Behavioral and Social Science ,Clinical Trials and Supportive Activities ,Evaluation of treatments and therapeutic interventions ,6.6 Psychological and behavioural ,Mental health ,Good Health and Well Being ,Absenteeism ,Adolescent ,Adult ,Brain Injuries ,Traumatic ,Clinical Protocols ,Cognition ,Cognitive Remediation ,Cooperative Behavior ,Efficiency ,Emotions ,Employment ,Supported ,Female ,Humans ,Interdisciplinary Communication ,Male ,Middle Aged ,Norway ,Patient Care Team ,Quality of Life ,Recovery of Function ,Rehabilitation ,Vocational ,Research Design ,Return to Work ,Sick Leave ,Time Factors ,Treatment Outcome ,Work Capacity Evaluation ,Young Adult ,Mild traumatic brain injury ,Cognitive remediation ,Supported employment ,Individual Placement and Support ,Five-Step Process ,Return to work ,Work inclusion ,Disability management ,Cardiorespiratory Medicine and Haematology ,Clinical Sciences ,Cardiovascular System & Hematology ,General & Internal Medicine ,Clinical sciences ,Epidemiology ,Health services and systems - Abstract
BackgroundA 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.Methods/designThis 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.DiscussionThe 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.Trial registrationClinicalTrials.gov, NCT03092713 . Registered on 10 March 2017.
- Published
- 2017