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Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial

Primary Purpose

Brain Injuries, Traumatic, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)
Control Group
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries, Traumatic focused on measuring Cognitive Rehabilitation, Supported employment, Mild and moderate TBI, Return to work, Randomized Controlled Trial

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Oslo University Hospital, Dept. of physical medicine and rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive Intervention and Supported Employment (CCI-SE)

Control group

Arm Description

Combined cognitive and vocational rehabilitation in a mixed design.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rivermead post-concussion questionnaire
Questionnaire; The effect of the study intervention on post concussive symptoms
Euro-Qol - 5D (EQ-5D)
Questionnaire; The effect of the study intervention on health-related quality-of-life throughout the follow-up period
Quality of life after brain injury (Qolibri)
Questionnaire; The effect of the study intervention on disease-related quality-of-life throughout the follow-up period

Full Information

First Posted
March 10, 2017
Last Updated
October 11, 2021
Sponsor
Oslo University Hospital
Collaborators
The Research Council of Norway, Sunnaas Rehabilitation Hospital, Oslo Metropolitan University, Norwegian Labour and Welfare Administration
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1. Study Identification

Unique Protocol Identification Number
NCT03092713
Brief Title
Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial
Official Title
The Effect Evaluation of Combined Cognitive and Vocational Interventions After Mild-to-moderate Traumatic Brain Injury: a Randomized Controlled Trial and Qualitative Process Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
The Research Council of Norway, Sunnaas Rehabilitation Hospital, Oslo Metropolitan University, Norwegian Labour and Welfare Administration

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic, Cognitive Impairment
Keywords
Cognitive Rehabilitation, Supported employment, Mild and moderate TBI, Return to work, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with active treatment group compared to treatment as usual
Masking
ParticipantOutcomes Assessor
Masking Description
Particpant are blinded to Group allocation, and all assessments are blinded to Group allocation.
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Intervention and Supported Employment (CCI-SE)
Arm Type
Active Comparator
Arm Description
Combined cognitive and vocational rehabilitation in a mixed design.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Usual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team.
Intervention Type
Behavioral
Intervention Name(s)
Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)
Intervention Description
The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
The Control Group receives usual assessment and treatment at Oslo University Hospital.
Primary Outcome Measure Information:
Title
Return to work
Description
The effect of the intervention on return to work rates throughout the follow-up period
Time Frame
18 months post injury
Title
Work stability
Description
The effect of the intervention on work stability rates throughout the follow-up period
Time Frame
18 months post injury
Secondary Outcome Measure Information:
Title
Rivermead post-concussion questionnaire
Description
Questionnaire; The effect of the study intervention on post concussive symptoms
Time Frame
18 months
Title
Euro-Qol - 5D (EQ-5D)
Description
Questionnaire; The effect of the study intervention on health-related quality-of-life throughout the follow-up period
Time Frame
18 months
Title
Quality of life after brain injury (Qolibri)
Description
Questionnaire; The effect of the study intervention on disease-related quality-of-life throughout the follow-up period
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Fatigue Severity Scale
Description
Questionnaire; The effect of the study intervention on fatigue throughout the follow-up period
Time Frame
18 months
Title
Insomnia Severity Index
Description
Questionnaire; The effect of the study intervention on sleep throughout the follow-up period
Time Frame
18 months
Title
Cognitive Failures Questionnaire
Description
Questionnaire; The effect of the study intervention on self-reported cogntiive symptoms throughout the follow-up period
Time Frame
18 months
Title
Generalized Anxiety Disorder (GAD-7)
Description
Questionnaire; The effect of the study intervention on anxiety throughout the follow-up period
Time Frame
18 months
Title
Patient Health Questionnaire (PHQ-9)
Description
Questionnaire; The effect of the study intervention on depression throughout the follow-up period
Time Frame
18 months
Title
General Self-efficacy Scale
Description
Questionnaire; The effect of the study intervention on self-efficacy throughout the follow-up period
Time Frame
18 months
Title
Neuropsychological functioning
Description
Screening test battery including measures of general ability Level, attention, Processing speed, Learning and memory executive functioning, and performance validity
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: history of severe psychiatric or neurological illness active substance abuse inability to speak and read Norwegian
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nada Andelic, MD; PhD
Organizational Affiliation
Oslo University Hospital/University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Dept. of physical medicine and rehabilitation
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35151285
Citation
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.
Results Reference
derived
PubMed Identifier
33240196
Citation
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.
Results Reference
derived
PubMed Identifier
29041954
Citation
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/29041954
Description
Protocol paper
URL
http://pubmed.ncbi.nlm.nih.gov/34314269/
Description
Baseline paper
URL
http://pubmed.ncbi.nlm.nih.gov/33240196/
Description
The interim analysis paper
URL
http://pubmed.ncbi.nlm.nih.gov/33957293/
Description
The intervention effect paper

Learn more about this trial

Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial

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