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Randomized Controlled Trial
. 2017 Oct 17;18(1):483.
doi: 10.1186/s13063-017-2218-7.

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

Emilie I Howe  1   2 , Knut-Petter S Langlo  3   4 , Hans Christoffer Aargaard Terjesen  5 , Cecilie Røe  3   6 , Anne-Kristine Schanke  4   7 , Helene L Søberg  3   8 , Unni Sveen  3   8 , Eline Aas  9 , Heidi Enehaug  5 , Daniele E Alves  5 , Pål Klethagen  5 , Kjersti Sagstad  10 , Christine M Moen  10 , Karin Torsteinsbrend  10 , Anne-Margrethe Linnestad  7 , Tonje Haug Nordenmark  3 , Birte Sand Rismyhr  11 , Grete Wangen  8 , Juan Lu  12 , Jennie Ponsford  13 , Elizabeth W Twamley  14   15 , Helene Ugelstad  10 , Øystein Spjelkavik  5 , Marianne Løvstad  4   7 , Nada Andelic  3   16
Affiliations
Randomized Controlled Trial

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

Emilie I Howe et al. Trials. .

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.

Keywords: Cognitive remediation; Disability management; Five-Step Process; Individual Placement and Support (IPS); Mild traumatic brain injury; Return to work; Supported employment; Work inclusion.

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Conflict of interest statement

Ethical approval and consent to participate

The study has been presented to and approved by the Norwegian Regional Committee for Medical and Health Research Ethics (REK) (REK number 2016/2038). The project will be conducted according to the ethical guidelines of the Helsinki declaration. Information about the study will be presented to the patients in written and oral form. Written informed consent will be obtained, and the right to withdraw from the project at any time without any explanation necessary will be emphasized. All participants will be assigned an identification number, and all the questionnaires and datasets will be anonymized. Only the project team will have access to the document that links study identifiers with participant names.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure. CCT Compensatory Cognitive Training, HRQoL health-related quality of life, SE Supported employment
Fig. 2
Fig. 2
Flowchart for the study protocol. CCT Compensatory Cognitive Training, NAV Norwegian Labor and Welfare Service, TBI Traumatic brain injury
See this image and copyright information in PMC

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