Interdisciplinary Interventions After mTBI

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRune Skovgaard Rasmussen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Psychoeducation

    Behavioral

    Focus on understanding mechanisms of concussion

  • Physiotherapy

    Behavioral

    Gradual training and physical exercises

  • Treatment of tinnitus and increased sound sensitivity

    Behavioral

    Treatment given individually or in groups

  • Vision training and examination

    Behavioral

    Training and examination by a neuro-optometrist

  • Sleep guidance and education

    Behavioral

    Counselling to achieve better sleep and reduce fatigue.

  • Mindfulness with a cognitive therapeutic approach

    Behavioral

    Training by certified mindfulness instructor

  • Employment-oriented intervention

    Behavioral

    The Concussion Team therapists work with a patient's employer to facilitate a gradual return to normal working hours.

  • Energy management and graded exercise

    Behavioral

    Counselling to achieve more energy and vitality.

  • Neuropsychological counseling

    Other intervention

    Talks with a neuropsychologist about mTBI sequelae.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Early intervention9 interventions
Group B: Late intervention9 interventions

Trial outcomes

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

Time frame
Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

Secondary outcomes

1

Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

Scores range from 0 to 64, low scores are best.

Time frame
Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
2

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.

Time frame
Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
3

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.

Time frame
Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention
4

European Quality of Life - 5 Dimensions

Scores range from 0 to 100, high scores are best.

Time frame
Measured at inclusion, through study completion (an average of 6 months), and after 6, 12 and 36 months of no intervention

Other outcomes

Locations

This trial has no 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: