Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial
Emilie I. Howe,
Knut-Petter S. Langlo,
Hans Christoffer Aargaard Terjesen,
Cecilie Røe,
Anne-Kristine Schanke,
Helene L. Søberg,
Unni Sveen,
Eline Aas,
Heidi Enehaug,
Daniele E. Alves,
Pål Klethagen,
Kjersti Sagstad,
Christine M. Moen,
Karin Torsteinsbrend,
Anne-Margrethe Linnestad,
Tonje Haug Nordenmark,
Birte Sand Rismyhr,
Grete Wangen,
Juan Lu,
Jennie Ponsford,
Elizabeth W. Twamley,
Helene Ugelstad,
Øystein Spjelkavik,
Marianne Løvstad,
Nada Andelic
Affiliations
Emilie I. Howe
Department of Physical Medicine and Rehabilitation, Oslo University Hospital
Knut-Petter S. Langlo
Department of Physical Medicine and Rehabilitation, Oslo University Hospital
Hans Christoffer Aargaard Terjesen
The Work Research Institute, Oslo and Akershus University College of Applied Science
Cecilie Røe
Department of Physical Medicine and Rehabilitation, Oslo University Hospital
Anne-Kristine Schanke
Department of Psychology, Faculty of Social Sciences, University of Oslo
Helene L. Søberg
Department of Physical Medicine and Rehabilitation, Oslo University Hospital
Unni Sveen
Department of Physical Medicine and Rehabilitation, Oslo University Hospital
Eline Aas
Department of Health Economics, Institute of Health and Society, Faculty of Medicine, University of Oslo
Heidi Enehaug
The Work Research Institute, Oslo and Akershus University College of Applied Science
Daniele E. Alves
The Work Research Institute, Oslo and Akershus University College of Applied Science
Pål Klethagen
The Work Research Institute, Oslo and Akershus University College of Applied Science
Kjersti Sagstad
Department of Vocational Rehabilitation, Norwegian Labor and Welfare Administration
Christine M. Moen
Department of Vocational Rehabilitation, Norwegian Labor and Welfare Administration
Karin Torsteinsbrend
Department of Vocational Rehabilitation, Norwegian Labor and Welfare Administration
Anne-Margrethe Linnestad
Department of Research, Sunnaas Rehabilitation Hospital
Tonje Haug Nordenmark
Department of Physical Medicine and Rehabilitation, Oslo University Hospital
Birte Sand Rismyhr
The Norwegian User Organization (Personskadeforbundet LTN)
Grete Wangen
Faculty of Health Sciences, Oslo and Akershus University College of Applied Science
Juan Lu
Department of Family Medicine and Population Health, Division of Epidemiology, Virginia Commonwealth University
Jennie Ponsford
School of Psychological Sciences and Monash Institute of Cognitive and Clinical Neurosciences, Monash University, Faculty of Medicine, Nursing and Health Sciences
Elizabeth W. Twamley
Center of Excellence for Stress and Mental Health, VA San Diego Healthcare System
Helene Ugelstad
Department of Vocational Rehabilitation, Norwegian Labor and Welfare Administration
Øystein Spjelkavik
The Work Research Institute, Oslo and Akershus University College of Applied Science
Marianne Løvstad
Department of Psychology, Faculty of Social Sciences, University of Oslo
Nada Andelic
Department of Physical Medicine and Rehabilitation, Oslo University Hospital
Abstract Background 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. Methods/design 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. Discussion 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. Trial registration ClinicalTrials.gov, NCT03092713 . Registered on 10 March 2017.
