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NCT Number: NCT06815692

Interdisciplinary Interventions After mTBI

The investigators aim to investigate the impact of interdisciplinary and individually tailored programs for mTBI (concussion) on quality of life and work capacity, both at the conclusion of the program and after 1 and 3 years. The investigators also want to examine whether early intervention is significant by comparing individuals who enter the program between 1 and 3 months post-concussion with those who only start the program more than 9 months post-concussion. Such a study has not been conducted before and can provide valuable insights into long-term effects and the importance of early intervention

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Key information

About this study

A concussion typically results from a trauma to the head or body and, for most people, causes symptoms that resolve within a few weeks. Approximately 25,000 individuals in Denmark experience concussions annually. However, about 8,000 to 11,000 of those affected experience prolonged symptoms such as fatigue, dizziness, headaches, pain, and cognitive impairments. These symptoms can significantly reduce quality of life and work capacity, and in some cases, become chronic. Consequently, a subset of individuals with concussions require ongoing social support even two years post-injury.

Denmark currently lacks a comprehensive national guideline for managing concussions within regional and municipal healthcare systems. As a result, individuals with concussions are often left to navigate the healthcare system on their own, leading to limited or no access to rehabilitation services. The Danish Center for Concussion and other experts have recommended the establishment of national concussion clinics.

Since 2016, the Special Education and Employment Unit (SuB) in Slagelse, part of the municipality's Center for Disability and Psychiatry, has been developing and providing concussion interventions based on national and international evidence. Participants in these programs have reported significant improvements in weekly work hours and overall quality of life. However, the long-term effects of these interventions remain unknown.

Participants are typically in great distress and need help, which is why a lack of interventions-or the delay of interventions for several months-in a control group is considered unethical. It should be noted that single-group studies, which evaluate outcomes longitudinally, are often the only possible method and can provide both interesting and reliable results. Investigators will be blinded for participants being allocated to early or late interventions.

This single-center and uncontrolled study aims to investigate the long-term impact of interdisciplinary and personalized concussion rehabilitation programs on quality of life and work capacity. Researchers will compare the outcomes of individuals who begin the program within 1-3 months post-concussion to those who start later (more than 9 months post-concussion) to determine the significance of early intervention. This research is groundbreaking as it will provide valuable insights into the long-term effects of concussions and the importance of timely interventions.

Aim: To evaluate the effectiveness of tailored concussion rehabilitation programs.

Outcomes: Changes in quality of life and work capacity. Timeframes: Immediate post-program and at 1 and 3 years. Comparison: Early vs. late intervention. Significance: The study will fill a gap in the current understanding of concussion recovery.

In essence, this study seeks to determine if a comprehensive and individualized approach to concussion rehabilitation can lead to sustained improvements in the lives of those affected, and whether starting treatment sooner is beneficial.

The investigators expect that an early intervention will result in significantly higher average weekly work hours and quality of life compared to a late intervention. The main hypothesis is that an early intervention will counteract the chronic effects and prevent worsening, including by inhibiting the development of hypersensitivity to sound and light.

The vision is to offer an intervention for concussion sufferers at the highest international level, and with this focus, it is important to know the long-term effects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults who are medically diagnosed with a concussion.
  • Adults with a connection to the labor market.
  • Participants must be able to communicate in Danish and be able to independently participate in the intervention.
  • Participants must be able to transport themsleves to and from SuB facility for their treatment sessions.
  • Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score must be at least 20, indicating a significant severity of symptoms following a concussion.

Exclusion criteria

  • Persons without medically verified concussion.
  • Person where brain injury was found at symptom onset.
  • Persons with significant cognitive dysfunction.
  • Persons who are unable to understand Danish or with communication disorders that hinder test performance.
  • Persons with terminal illness or other progressive disease.
  • Chronic use of opioids.
  • Significant abuse of alcohol or euphoriants or narcotics or other serious illnesses that may affect test results or ability/possibility of attendance.

Treatment and study plan

Psychoeducation

Behavioral

Focus on understanding mechanisms of concussion

Physiotherapy

Behavioral

Gradual training and physical exercises

Treatment of tinnitus and increased sound sensitivity

Behavioral

Treatment given individually or in groups

Vision training and examination

Behavioral

Training and examination by a neuro-optometrist

Sleep guidance and education

Behavioral

Counselling to achieve better sleep and reduce fatigue.

Mindfulness with a cognitive therapeutic approach

Behavioral

Training by certified mindfulness instructor

Employment-oriented intervention

Behavioral

The Concussion Team therapists work with a patient's employer to facilitate a gradual return to normal working hours.

Energy management and graded exercise

Behavioral

Counselling to achieve more energy and vitality.

Neuropsychological counseling

Other

Talks with a neuropsychologist about mTBI sequelae.

Primary outcomes

  1. Weekly working hours

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Weekly working hours, measured in hours, will be assessed at baseline and after the intervention is completed. Subsequently, working hours will be assessed 1, 2, and 3 years after the intervention is completed. Follow-up will be conducted via telephone calls

Secondary outcomes

  1. Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Scores range from 0 to 64, low scores are best.

  2. Work Role Functioning Questionnaire v. 2.0 (WRFQ 2.0).

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    A higher score on the WRFQ 2.0 indicates better work role functioning. Scores range from 0 to 100.

  3. Behavioural Rating Inventory of Executive Function - Adults (BRIEF-A)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    T-scores are measured, a score above 65 indicates problems. Scores range from 0 to 99.

  4. European Quality of Life - 5 Dimensions

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Scores range from 0 to 100, high scores are best.

  5. Clinical Global Impression Scale (CGI)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Scores range from 1 to 7, high score is worst.

  6. Brain Injury Vision Symptom Survey (BIVSS)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    The total score can range from 0 to 112. A higher score indicates a greater severity of visual symptoms.

  7. King-Devick (K-D)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    There is no strict range with clear cut-offs, normative data suggests that healthy individuals complete the test in under 60 seconds.

  8. Vestibular Ocular Motor Screening (VOMS)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    If symptoms are provoked, the individual rates their severity on a scale of 0 to 10 (0 = none, 10 = severe).

  9. Reading test

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Reading of a short article published in a newspaper. Faster reading times are best.

  10. Major Depression Inventory (MDI)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Scores range from 0 to 50, low scores are best.

  11. Fatigue Severity Scale - 7 item (FSS-7)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Scores range from 1 to 7. Low scores are best.

  12. Visual Analogue Scale for Smerte (VAS)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Scores range from 0 to 10. Low scores are best.

  13. Questionnaire about sound sensitivity and tinnitus

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Scores range from 0 to 25, low scores are best.

  14. Depression, Anxiety and Stress Scale (DASS42)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Scores range from 0 to 42, low scores are best.

  15. Harvard Trauma Questionnaire (HTQ)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Scores ranged from 16 to 64. Low scores are best.

  16. Generalized Anxiety Disorder Scale - 7 item (GAD-7)

    Time frame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

    Scores range from 0 to 21, low scores are best.

Study contacts

Contact information is provided by the study sponsor or research team.

Rune S Rasmussen, MSc, PhD

CONTACT

[email protected]

28757500 ext. +45

Signe E Petersson, OT

CONTACT

[email protected]

58575715 ext. +45

Sponsors and collaborators

Lead sponsor

Rune Skovgaard Rasmussen

Other

Collaborators

  • Danish Center for Concussion
  • Special Education and Employment Unit (SuB) in Slagelse, part of the municipality's Center for Disability and Psychiatry

Registry information

Official study title

Effect of Interdisciplinary Interventions After Mild Traumatic Brain Injury

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 7, 2025
Registry last updated
Aug 12, 2025

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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