Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial
NCT ID: NCT03092713
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
121 participants
INTERVENTIONAL
2017-01-02
2021-06-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cognitive Intervention and Supported Employment (CCI-SE)
Combined cognitive and vocational rehabilitation in a mixed design.
Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)
The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place.
Control group
Usual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team.
Control Group
The Control Group receives usual assessment and treatment at Oslo University Hospital.
Interventions
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Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)
The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place.
Control Group
The Control Group receives usual assessment and treatment at Oslo University Hospital.
Eligibility Criteria
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Inclusion Criteria
* 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
* active substance abuse
* inability to speak and read Norwegian
18 Years
60 Years
ALL
No
Sponsors
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The Research Council of Norway
OTHER
Sunnaas Rehabilitation Hospital
OTHER
Oslo Metropolitan University
OTHER
Norwegian Labour and Welfare Administration
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Nada Andelic
MD, PhD
Principal Investigators
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Nada Andelic, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital/University of Oslo
Locations
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Oslo University Hospital, Dept. of physical medicine and rehabilitation
Oslo, , Norway
Countries
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References
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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.
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.
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.
Related Links
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Protocol paper
Baseline paper
The interim analysis paper
The intervention effect paper
Other Identifiers
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2016/2038
Identifier Type: -
Identifier Source: org_study_id