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

Cognitive Impairment Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092713
• Other study ID #: 2016/2038
• Status: Completed
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Dept. of physical medicine and rehabilitation	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Labour and Welfare Administration, Oslo Metropolitan University, Sunnaas Rehabilitation Hospital, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fatigue Severity Scale	Questionnaire; The effect of the study intervention on fatigue throughout the follow-up period	18 months
Other	Insomnia Severity Index	Questionnaire; The effect of the study intervention on sleep throughout the follow-up period	18 months
Other	Cognitive Failures Questionnaire	Questionnaire; The effect of the study intervention on self-reported cogntiive symptoms throughout the follow-up period	18 months
Other	Generalized Anxiety Disorder (GAD-7)	Questionnaire; The effect of the study intervention on anxiety throughout the follow-up period	18 months
Other	Patient Health Questionnaire (PHQ-9)	Questionnaire; The effect of the study intervention on depression throughout the follow-up period	18 months
Other	General Self-efficacy Scale	Questionnaire; The effect of the study intervention on self-efficacy throughout the follow-up period	18 months
Other	Neuropsychological functioning	Screening test battery including measures of general ability Level, attention, Processing speed, Learning and memory executive functioning, and performance validity	18 months
Primary	Return to work	The effect of the intervention on return to work rates throughout the follow-up period	18 months post injury
Primary	Work stability	The effect of the intervention on work stability rates throughout the follow-up period	18 months post injury
Secondary	Rivermead post-concussion questionnaire	Questionnaire; The effect of the study intervention on post concussive symptoms	18 months
Secondary	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
Secondary	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

External Links

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