Clinical trial NCT06815692: Interdisciplinary Interventions After mTBI
Official title: Effect of Interdisciplinary Interventions After Mild Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Concussion, Mild
Keywords: mTBI
employment
weekly working hours
quality of life
Concussion
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Special Education and Employment Unit (SuB) in Slagelse, part of the municipality's Center for Disability and Psychiatry
name: Danish Center for Concussion
First posted: 2025-02-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two cohorts will be followed, one group of adults included between 1 and 3 months after a concussion, and another group experiencing a concussion 9 months before inclusion.

Brief summary: 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.

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.

Primary outcomes:
measure: Weekly working hours
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
Secondary outcomes:
measure: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Work Role Functioning Questionnaire v. 2.0 (WRFQ 2.0).
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Behavioural Rating Inventory of Executive Function - Adults (BRIEF-A)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: European Quality of Life - 5 Dimensions
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Clinical Global Impression Scale (CGI)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Brain Injury Vision Symptom Survey (BIVSS)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: King-Devick (K-D)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Vestibular Ocular Motor Screening (VOMS)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Reading test
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Major Depression Inventory (MDI)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Fatigue Severity Scale - 7 item (FSS-7)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Visual Analogue Scale for Smerte (VAS)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Questionnaire about sound sensitivity and tinnitus
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Depression, Anxiety and Stress Scale (DASS42)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Harvard Trauma Questionnaire (HTQ)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
measure: Generalized Anxiety Disorder Scale - 7 item (GAD-7)
timeFrame: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
Other outcomes:
Locations:
Study officials:
affiliation: Special Education and Employment Unit (SuB) in Slagelse
name: Rune S Rasmussen, MSc, PhD
role: STUDY_DIRECTOR
affiliation: Special Education and Employment Unit (SuB) in Slagelse
name: Signe E Petersson, OT
role: STUDY_CHAIR
References: