Interdisciplinary Interventions After mTBI

Rune Skovgaard Rasmussen

Status: Not yet enrolling

Conditions: Concussion, Mild

Treatments: Other: Neuropsychological counseling; Behavioral: Physiotherapy; Behavioral: Energy management and graded exercise; Behavioral: Sleep guidance and education; Behavioral: Psychoeducation; Behavioral: Employment-oriented intervention; Behavioral: Treatment of tinnitus and increased sound sensitivity; Behavioral: Mindfulness with a cognitive therapeutic approach; Behavioral: Vision training and examination

Study type: Observational

Funder types: Other

Identifiers

NCT06815692

12292024

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

140 participants in 2 patient groups

Early intervention

Description:

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.

Treatment:

Behavioral: Vision training and examination

Behavioral: Mindfulness with a cognitive therapeutic approach

Behavioral: Treatment of tinnitus and increased sound sensitivity

Behavioral: Employment-oriented intervention

Behavioral: Psychoeducation

Behavioral: Sleep guidance and education

Behavioral: Energy management and graded exercise

Behavioral: Physiotherapy

Other: Neuropsychological counseling

Late intervention

Description:

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.

Treatment:

Behavioral: Vision training and examination

Behavioral: Mindfulness with a cognitive therapeutic approach

Behavioral: Treatment of tinnitus and increased sound sensitivity

Behavioral: Employment-oriented intervention

Behavioral: Psychoeducation

Behavioral: Sleep guidance and education

Behavioral: Energy management and graded exercise

Behavioral: Physiotherapy

Other: Neuropsychological counseling