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

The Effect Evaluation of Combined Cognitive and Vocational Interventions After Mild-to-moderate Traumatic Brain Injury: a Randomized Controlled Trial and Qualitative Process Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Brain Injuries, Traumatic
• Intervention / Treatment: Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment); Behavioral: Control Group

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital, Dept. of physical medicine and rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cognitive Intervention and Supported Employment (CCI-SE); Combined cognitive and vocational rehabilitation in a mixed design.	Behavioral: 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.
ACTIVE_COMPARATOR: Control group; Usual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team.	Behavioral: Control Group; The Control Group receives usual assessment and treatment at Oslo University Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rivermead post-concussion questionnaire	Questionnaire; The effect of the study intervention on post concussive symptoms	18 months
Euro-Qol - 5D (EQ-5D)	Questionnaire; The effect of the study intervention on health-related quality-of-life throughout the follow-up period	18 months
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	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Severity Scale	Questionnaire; The effect of the study intervention on fatigue throughout the follow-up period	18 months
Insomnia Severity Index	Questionnaire; The effect of the study intervention on sleep throughout the follow-up period	18 months
Cognitive Failures Questionnaire	Questionnaire; The effect of the study intervention on self-reported cogntiive symptoms throughout the follow-up period	18 months
Generalized Anxiety Disorder (GAD-7)	Questionnaire; The effect of the study intervention on anxiety throughout the follow-up period	18 months
Patient Health Questionnaire (PHQ-9)	Questionnaire; The effect of the study intervention on depression throughout the follow-up period	18 months
General Self-efficacy Scale	Questionnaire; The effect of the study intervention on self-efficacy throughout the follow-up period	18 months
Neuropsychological functioning	Screening test battery including measures of general ability Level, attention, Processing speed, Learning and memory executive functioning, and performance validity	18 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: The Research Council of Norway; Sunnaas Rehabilitation Hospital; Norwegian Labour and Welfare Administration; Oslo Metropolitan University
• Investigators: Principal Investigator: Nada Andelic, MD; PhD, Oslo University Hospital/University of Oslo

Publications and helpful links

General Publications

• 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.

Helpful Links

• Protocol paper
• Baseline paper
• The interim analysis paper
• The intervention effect paper

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2017
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (ACTUAL): March 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Cognitive Rehabilitation; Return to work; Supported employment; Mild and moderate TBI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 2016/2038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No