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Completed

NCT Number: NCT03092713

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control Group

Behavioral

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

Primary outcomes

  1. Return to work

    Time frame: 18 months post injury

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

  2. Work stability

    Time frame: 18 months post injury

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

Secondary outcomes

  1. Rivermead post-concussion questionnaire

    Time frame: 18 months

    Questionnaire; The effect of the study intervention on post concussive symptoms

  2. Euro-Qol - 5D (EQ-5D)

    Time frame: 18 months

    Questionnaire; The effect of the study intervention on health-related quality-of-life throughout the follow-up period

  3. Quality of life after brain injury (Qolibri)

    Time frame: 18 months

    Questionnaire; The effect of the study intervention on disease-related quality-of-life throughout the follow-up period

Other outcomes

  1. Fatigue Severity Scale

    Time frame: 18 months

    Questionnaire; The effect of the study intervention on fatigue throughout the follow-up period

  2. Insomnia Severity Index

    Time frame: 18 months

    Questionnaire; The effect of the study intervention on sleep throughout the follow-up period

  3. Cognitive Failures Questionnaire

    Time frame: 18 months

    Questionnaire; The effect of the study intervention on self-reported cogntiive symptoms throughout the follow-up period

  4. Generalized Anxiety Disorder (GAD-7)

    Time frame: 18 months

    Questionnaire; The effect of the study intervention on anxiety throughout the follow-up period

  5. Patient Health Questionnaire (PHQ-9)

    Time frame: 18 months

    Questionnaire; The effect of the study intervention on depression throughout the follow-up period

  6. General Self-efficacy Scale

    Time frame: 18 months

    Questionnaire; The effect of the study intervention on self-efficacy throughout the follow-up period

  7. Neuropsychological functioning

    Time frame: 18 months

    Screening test battery including measures of general ability Level, attention, Processing speed, Learning and memory executive functioning, and performance validity

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Labour and Welfare Administration
  • Oslo Metropolitan University
  • Sunnaas Rehabilitation Hospital
  • The Research Council of Norway

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 28, 2017
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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