We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified September 2017 by Nada Andelic, Oslo University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03092713
First Posted: March 28, 2017
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
The Research Council of Norway
Sunnaas Rehabilitation Hospital
Oslo and Akershus University College of Applied Sciences
Norwegian Labour and Welfare Administration
Information provided by (Responsible Party):
Nada Andelic, Oslo University Hospital
  Purpose

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.


Condition Intervention
Brain Injuries, Traumatic Cognitive Impairment Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment) Behavioral: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial with active treatment group compared to treatment as usual
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Particpant are blinded to Group allocation, and all assessments are blinded to Group allocation.
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nada Andelic, Oslo University Hospital:

Primary Outcome Measures:
  • Return to work [ Time Frame: 18 months post injury ]
    The effect of the intervention on return to work rates throughout the follow-up period

  • Work stability [ Time Frame: 18 months post injury ]
    The effect of the intervention on work stability rates throughout the follow-up period


Secondary Outcome Measures:
  • Rivermead post-concussion questionnaire [ Time Frame: 18 months ]
    Questionnaire; The effect of the study intervention on post concussive symptoms

  • 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

  • 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 Outcome Measures:
  • Fatigue Severity Scale [ Time Frame: 18 months ]
    Questionnaire; The effect of the study intervention on fatigue throughout the follow-up period

  • Insomnia Severity Index [ Time Frame: 18 months ]
    Questionnaire; The effect of the study intervention on sleep throughout the follow-up period

  • Cognitive Failures Questionnaire [ Time Frame: 18 months ]
    Questionnaire; The effect of the study intervention on self-reported cogntiive symptoms throughout the follow-up period

  • Generalized Anxiety Disorder (GAD-7) [ Time Frame: 18 months ]
    Questionnaire; The effect of the study intervention on anxiety throughout the follow-up period

  • Patient Health Questionnaire (PHQ-9) [ Time Frame: 18 months ]
    Questionnaire; The effect of the study intervention on depression throughout the follow-up period

  • General Self-efficacy Scale [ Time Frame: 18 months ]
    Questionnaire; The effect of the study intervention on self-efficacy throughout the follow-up period

  • 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


Estimated Enrollment: 125
Actual Study Start Date: January 2, 2017
Estimated Study Completion Date: December 31, 2021
Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092713


Contacts
Contact: Nada Andelic, MD; PhD nadand@ous-hf.no
Contact: Emilie I. Howe, Cand. Psych emihow@ous-hf.no

Locations
Norway
Oslo University Hospital, Dept. of physical medicine and rehabilitation Recruiting
Oslo, Norway, 0424
Contact: Nada Andelic, MD, PhD       nadand@ous-hf.no   
Contact: Marianne Løvstad, PhD       marianne.lovstad@sunnaas.no   
Sub-Investigator: Marianne Løvstad, PhD         
Sub-Investigator: Emilie Isager Howe, Cand.Psychol         
Sub-Investigator: Knut-Petter Langlo, Cand.Psychol         
Sub-Investigator: Øystein Spjelkavik, Cand.Sociol.         
Sub-Investigator: Hans Christoffer A Terjesen, Cand.Polit.         
Sub-Investigator: Helene Ugelstad, BA.ped.         
Sub-Investigator: Eline Aas, PhD         
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
Sunnaas Rehabilitation Hospital
Oslo and Akershus University College of Applied Sciences
Norwegian Labour and Welfare Administration
  More Information

Additional Information:
Responsible Party: Nada Andelic, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03092713     History of Changes
Other Study ID Numbers: 2016/2038
First Submitted: March 10, 2017
First Posted: March 28, 2017
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nada Andelic, Oslo University Hospital:
Cognitive Rehabilitation
Supported employment
Mild and moderate TBI
Return to work
Randomized Controlled Trial

Additional relevant MeSH terms:
Brain Injuries
Cognitive Dysfunction
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cognition Disorders
Neurocognitive Disorders
Mental Disorders