About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Psychoeducation
BehavioralFocus on understanding mechanisms of concussion
Physiotherapy
BehavioralGradual training and physical exercises
Treatment of tinnitus and increased sound sensitivity
BehavioralTreatment given individually or in groups
Vision training and examination
BehavioralTraining and examination by a neuro-optometrist
Sleep guidance and education
BehavioralCounselling to achieve better sleep and reduce fatigue.
Mindfulness with a cognitive therapeutic approach
BehavioralTraining by certified mindfulness instructor
Employment-oriented intervention
BehavioralThe Concussion Team therapists work with a patient's employer to facilitate a gradual return to normal working hours.
Energy management and graded exercise
BehavioralCounselling to achieve more energy and vitality.
Neuropsychological counseling
Other interventionTalks with a neuropsychologist about mTBI sequelae.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Scores range from 0 to 64, low scores are best.
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.
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.
European Quality of Life - 5 Dimensions
Scores range from 0 to 100, high scores are best.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rune Skovgaard Rasmussen
Lead sponsor
University Hospital, Gentofte, Copenhagen
Sponsor institution
Special Education and Employment Unit (SuB) in Slagelse, part of the municipality's Center for Disability and Psychiatry
Collaborator
Danish Center for Concussion
Collaborator
This trial is not recruiting at the moment. You can still explore other options: