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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

140

participants targeted

Target at P50-P75 for all trials

Timeline

57mo left

Started Jan 2026

Longer than P75 for all trials

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5 years study duration

Study Progress7%

Jan 2026Dec 2030

First Submitted

Initial submission to the registry

January 23, 2025

Completed

15 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed

11 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Expected

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

4.6 years

First QC Date

January 23, 2025

Last Update Submit

August 11, 2025

Conditions

Concussion, Mild

Keywords

mTBIemploymentweekly working hoursquality of lifeConcussion

Outcome Measures

Primary Outcomes (1)

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 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)
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).
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)
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
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)
Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
+11 more secondary outcomes

Study Arms (2)

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.

Behavioral: PsychoeducationBehavioral: PhysiotherapyBehavioral: Treatment of tinnitus and increased sound sensitivityBehavioral: Vision training and examinationBehavioral: Sleep guidance and educationBehavioral: Mindfulness with a cognitive therapeutic approachBehavioral: Employment-oriented interventionBehavioral: Energy management and graded exerciseOther: 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.