Interdisciplinary Interventions After mTBI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychoeducation, Physiotherapy, Treatment of tinnitus and increased sound sensitivity, Vision training and examination.
- Who it may be relevant to
- Registry conditions: Concussion, Mild. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Interdisciplinary Interventions After Mild Traumatic Brain Injury
Overview
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
Detailed description
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.
Interventions
- Behavioral Psychoeducation
Focus on understanding mechanisms of concussion - Behavioral Physiotherapy
Gradual training and physical exercises - Behavioral Treatment of tinnitus and increased sound sensitivity
Treatment given individually or in groups - Behavioral Vision training and examination
Training and examination by a neuro-optometrist - Behavioral Sleep guidance and education
Counselling to achieve better sleep and reduce fatigue. - Behavioral Mindfulness with a cognitive therapeutic approach
Training by certified mindfulness instructor - Behavioral Employment-oriented intervention
The Concussion Team therapists work with a patient's employer to facilitate a gradual return to normal working hours. - Behavioral Energy management and graded exercise
Counselling to achieve more energy and vitality. - Other Neuropsychological counseling
Talks with a neuropsychologist about mTBI sequelae.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06815692 · 12292024