Concussion, MildNCT06815692
Interdisciplinary Interventions After mTBI
An observational study of Concussion, Mild, run by Rune Skovgaard Rasmussen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Psychoeducation, Physiotherapy and Treatment of tinnitus and increased sound sensitivity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Interdisciplinary Interventions After Mild Traumatic Brain Injury
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
Read the 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.
- Conditions
- Concussion, Mild
- Being tested
- Psychoeducation, Physiotherapy, Treatment of tinnitus and increased sound sensitivity, Vision training and examination, Sleep guidance and education
- Keywords
- mTBI, employment, weekly working hours, quality of life, Concussion
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
Focus on understanding mechanisms of concussion
PhysiotherapyBehavioural
Gradual training and physical exercises
Treatment of tinnitus and increased sound sensitivityBehavioural
Treatment given individually or in groups
Vision training and examinationBehavioural
Training and examination by a neuro-optometrist
Sleep guidance and educationBehavioural
Counselling to achieve better sleep and reduce fatigue.
Mindfulness with a cognitive therapeutic approachBehavioural
Training by certified mindfulness instructor
Employment-oriented interventionBehavioural
The Concussion Team therapists work with a patient's employer to facilitate a gradual return to normal working hours.
Energy management and graded exerciseBehavioural
Counselling to achieve more energy and vitality.
Neuropsychological counselingOther
Talks with a neuropsychologist about mTBI sequelae.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Interventions for mTBI patients initiated within 1 to 3 months after symptoms onset:
Interventions include psychoeducation for the individual, their family, and their workplace or educational setting. Investigators initiate contact with the individual's workplace or educational setting to discuss the case and collaborate closely with both the individual and their employer/supervisor. Investigators focus on vocational rehabilitation, aiming to gradually increase the participant's work capacity, weekly working hours, and job retention. Ongoing supportive conversations are provided before and during work or study. Investigators offer counseling on cognitive and psychological aspects, with a focus on mental health.
All interventions focus on gradual progression, exposure, and rehabilitation in both personal and work life. Participants are guided in gradually increasing activities and working hours. Receives: Behavioral: Psychoeducation; Behavioral: Physiotherapy; Behavioral: Treatment of tinnitus and increased sound sensitivity; Behavioral: Vision training and examination; Behavioral: Sleep guidance and education; Behavioral: Mindfulness with a cognitive therapeutic approach; Behavioral: Employment-oriented intervention; Behavioral: Energy management and graded exercise; Other: Neuropsychological counseling | |
| Late intervention | Interventions for mTBI patients initiated at least 9 months after symptoms onset. Note that these interventions are the same as offered to the early interventions group:
Interventions include psychoeducation for the individual, their family, and their workplace or educational setting. Investigators initiate contact with the individual's workplace or educational setting to discuss the case and collaborate closely with both the individual and their employer/supervisor. Investigators focus on vocational rehabilitation, aiming to gradually increase the participant's work capacity, weekly working hours, and job retention. Ongoing supportive conversations are provided before and during work or study. Investigators offer counseling on cognitive and psychological aspects, with a focus on mental health.
All interventions focus on gradual progression, exposure, and rehabilitation in both personal and work life. Participants are guided in gradually increasing activities and working hours. Receives: Behavioral: Psychoeducation; Behavioral: Physiotherapy; Behavioral: Treatment of tinnitus and increased sound sensitivity; Behavioral: Vision training and examination; Behavioral: Sleep guidance and education; Behavioral: Mindfulness with a cognitive therapeutic approach; Behavioral: Employment-oriented intervention; Behavioral: Energy management and graded exercise; Other: Neuropsychological counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly working hours
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
Measured: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
Secondary outcomes (16)
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Scores range from 0 to 64, low scores are best.
Measured: 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).
A higher score on the WRFQ 2.0 indicates better work role functioning. Scores range from 0 to 100.
Measured: 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)
T-scores are measured, a score above 65 indicates problems. Scores range from 0 to 99.
Measured: 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
Scores range from 0 to 100, high scores are best.
Measured: 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)
Scores range from 1 to 7, high score is worst.
Measured: 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)
The total score can range from 0 to 112. A higher score indicates a greater severity of visual symptoms.
Measured: 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)
There is no strict range with clear cut-offs, normative data suggests that healthy individuals complete the test in under 60 seconds.
Measured: 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)
If symptoms are provoked, the individual rates their severity on a scale of 0 to 10 (0 = none, 10 = severe).
Measured: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
Reading test
Reading of a short article published in a newspaper. Faster reading times are best.
Measured: 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)
Scores range from 0 to 50, low scores are best.
Measured: 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)
Scores range from 1 to 7. Low scores are best.
Measured: 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)
Scores range from 0 to 10. Low scores are best.
Measured: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
Questionnaire about sound sensitivity and tinnitus
Scores range from 0 to 25, low scores are best.
Measured: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
Depression, Anxiety and Stress Scale (DASS42)
Scores range from 0 to 42, low scores are best.
Measured: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
Harvard Trauma Questionnaire (HTQ)
Scores ranged from 16 to 64. Low scores are best.
Measured: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
Generalized Anxiety Disorder Scale - 7 item (GAD-7)
Scores range from 0 to 21, low scores are best.
Measured: Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rune Skovgaard Rasmussen
- Sponsor type
- University, hospital or other
- Collaborators
- Special Education and Employment Unit (SuB) in Slagelse, part of the municipality's Center for Disability and Psychiatry, Danish Center for Concussion
- Responsible party
- Sponsor-investigator, Rune Skovgaard Rasmussen, University Hospital, Gentofte, Copenhagen
- Investigators
- Rune S Rasmussen, MSc, PhD, Study director, Special Education and Employment Unit (SuB) in SlagelseSigne E Petersson, OT, Study chair, Special Education and Employment Unit (SuB) in Slagelse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815692
- Sponsor's protocol ID
- 12292024
- Status last verified
- Aug 2025
- First submitted
- 23 Jan 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interdisciplinary Interventions After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06815692
- Acronym / sponsor ID
- 12292024
- Conditions
- Concussion, Mild
- Keywords
- mTBI, employment, weekly working hours, quality of life, Concussion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Rune Skovgaard RasmussenUniversity, hospital or other
- Collaborators
- Special Education and Employment Unit (SuB) in Slagelse, part of the municipality's Center for Disability and Psychiatry, Danish Center for Concussion
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention | – | Behavioral: Psychoeducation, Behavioral: Physiotherapy, Behavioral: Treatment of tinnitus and increased sound sensitivity, Behavioral: Vision training and examination, Behavioral: Sleep guidance and education, Behavioral: Mindfulness with a cognitive therapeutic approach, Behavioral: Employment-oriented intervention, Behavioral: Energy management and graded exercise, Other: Neuropsychological counselingInterventions for mTBI patients initiated within 1 to 3 months after symptoms onset: Interventions include psychoeducation for the individual, their family, and their workplace or educational setting. Investigators initiate contact with the individual's workplace or educational setting to discuss the case and collaborate closely with both the individual and their employer/supervisor. Investigators focus on vocational rehabilitation, aiming to gradually increase the participant's work capacity, weekly working hours, and job retention. Ongoing supportive conversations are provided before and during work or study. Investigators offer counseling on cognitive and psychological aspects, with a focus on mental health. All interventions focus on gradual progression, exposure, and rehabilitation in both personal and work life. Participants are guided in gradually increasing activities and working hours. |
| Late intervention | – | Behavioral: Psychoeducation, Behavioral: Physiotherapy, Behavioral: Treatment of tinnitus and increased sound sensitivity, Behavioral: Vision training and examination, Behavioral: Sleep guidance and education, Behavioral: Mindfulness with a cognitive therapeutic approach, Behavioral: Employment-oriented intervention, Behavioral: Energy management and graded exercise, Other: Neuropsychological counselingInterventions for mTBI patients initiated at least 9 months after symptoms onset. Note that these interventions are the same as offered to the early interventions group: Interventions include psychoeducation for the individual, their family, and their workplace or educational setting. Investigators initiate contact with the individual's workplace or educational setting to discuss the case and collaborate closely with both the individual and their employer/supervisor. Investigators focus on vocational rehabilitation, aiming to gradually increase the participant's work capacity, weekly working hours, and job retention. Ongoing supportive conversations are provided before and during work or study. Investigators offer counseling on cognitive and psychological aspects, with a focus on mental health. All interventions focus on gradual progression, exposure, and rehabilitation in both personal and work life. Participants are guided in gradually increasing activities and working hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationFocus on understanding mechanisms of concussion | Behavioural | Early intervention, Late intervention |
| PhysiotherapyGradual training and physical exercises | Behavioural | Early intervention, Late intervention |
| Treatment of tinnitus and increased sound sensitivityTreatment given individually or in groups | Behavioural | Early intervention, Late intervention |
| Vision training and examinationTraining and examination by a neuro-optometrist | Behavioural | Early intervention, Late intervention |
| Sleep guidance and educationCounselling to achieve better sleep and reduce fatigue. | Behavioural | Early intervention, Late intervention |
| Mindfulness with a cognitive therapeutic approachTraining by certified mindfulness instructor | Behavioural | Early intervention, Late intervention |
| Employment-oriented interventionThe Concussion Team therapists work with a patient's employer to facilitate a gradual return to normal working hours. | Behavioural | Early intervention, Late intervention |
| Energy management and graded exerciseCounselling to achieve more energy and vitality. | Behavioural | Early intervention, Late intervention |
| Neuropsychological counselingTalks with a neuropsychologist about mTBI sequelae. | Other | Early intervention, Late intervention |
Primary outcome
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
16 secondary outcomes
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rune S Rasmussen, MSc, PhD study director
Special Education and Employment Unit (SuB) in Slagelse
Signe E Petersson, OT study chair
Special Education and Employment Unit (SuB) in Slagelse
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Mild, run by Rune Skovgaard Rasmussen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rune S Rasmussen, MSc, PhD (28757500 ext. +45, rsras@slagelse.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.