Psychoeducation
BehavioralFocus on understanding mechanisms of concussion
NCT Number: NCT06815692
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
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Focus on understanding mechanisms of concussion
Gradual training and physical exercises
Treatment given individually or in groups
Training and examination by a neuro-optometrist
Counselling to achieve better sleep and reduce fatigue.
Training by certified mindfulness instructor
The Concussion Team therapists work with a patient's employer to facilitate a gradual return to normal working hours.
Counselling to achieve more energy and vitality.
Talks with a neuropsychologist about mTBI sequelae.
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
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Rune Skovgaard Rasmussen
Other
Effect of Interdisciplinary Interventions After Mild Traumatic Brain Injury
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.
Published trials that share one or more normalized conditions with this study.
NCT07303933
Behavior, Brain Concussion
University Park, Pennsylvania, United States
View Trial DetailsNCT07729761
Brain Concussion, Brain Diseases
Rawalpindi, Punjab Province, Pakistan
View Trial DetailsNCT06595914
Brain Concussion, Brain Diseases
Milwaukee, Wisconsin, United States
View Trial DetailsNCT04582682
Brain Concussion, Brain Diseases
Boston, Massachusetts, United States
View Trial Details