NCT03092713

Brief Summary

A considerable number of patients with mild and 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 in this group are scarce. Furthermore, there have traditionally been weak collaborations among rehabilitation services in the health sector, the Labor and Welfare Administration (NAV), and the work-places. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

4 years

First QC Date

March 10, 2017

Last Update Submit

October 11, 2021

Conditions

Brain Injuries, TraumaticCognitive Impairment

Keywords

Cognitive RehabilitationSupported employmentMild and moderate TBIReturn to workRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Return to work

    The effect of the intervention on return to work rates throughout the follow-up period

    18 months post injury

  • Work stability

    The effect of the intervention on work stability rates throughout the follow-up period

    18 months post injury

Secondary Outcomes (3)

  • Rivermead post-concussion questionnaire

    18 months

  • Euro-Qol - 5D (EQ-5D)

    18 months

  • Quality of life after brain injury (Qolibri)

    18 months

Other Outcomes (7)

  • Fatigue Severity Scale

    18 months

  • Insomnia Severity Index

    18 months

  • Cognitive Failures Questionnaire

    18 months

  • +4 more other outcomes

Study Arms (2)

Cognitive Intervention and Supported Employment (CCI-SE)

ACTIVE COMPARATOR

Combined cognitive and vocational rehabilitation in a mixed design.

Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)

Control group

ACTIVE COMPARATOR

Usual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team.

Behavioral: Control Group

Interventions

Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)BEHAVIORAL

The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place.

Cognitive Intervention and Supported Employment (CCI-SE)
Control GroupBEHAVIORAL

The Control Group receives usual assessment and treatment at Oslo University Hospital.

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • reside in Oslo and Akershus counties in Norway
  • 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

You may not qualify if:

  • history of severe psychiatric or neurological illness
  • active substance abuse
  • inability to speak and read Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Dept. of physical medicine and rehabilitation

Oslo, 0424, Norway

Location

Related Publications (3)

  • 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.

    PMID: 35151285DERIVED

  • 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.

    PMID: 33240196DERIVED

  • 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.

    PMID: 29041954DERIVED

Related Links

MeSH Terms

Conditions

Brain Injuries, TraumaticCognitive DysfunctionLymphoma, Follicular

Interventions

Rehabilitation, VocationalEmployment, SupportedControl Groups

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCognition DisordersNeurocognitive DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesEmploymentSocioeconomic FactorsPopulation CharacteristicsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Nada Andelic, MD; PhD

    Oslo University Hospital/University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Particpant are blinded to Group allocation, and all assessments are blinded to Group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with active treatment group compared to treatment as usual
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 28, 2017

Study Start

January 2, 2017

Primary Completion

December 31, 2020

Study Completion

June 30, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)