Digital intervention for post-concussion symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and test a digital intervention called 'Get Going After concussion Lite' (GAIN Lite) for adults experiencing persistent mild-to-moderate post-concussional symptoms. It will compare the efficacy of GAIN Lite against enhanced usual care in a randomized controlled trial involving 100 participants diagnosed with a concussion. The study also seeks to explore the relationship between physical activity, digital behavior, and symptom severity. Participants will be recruited from hospitals and general practitioners in the Central Denmark Region.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri (26). The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas;
2. Age 18 to 60 years at the time of the trauma;
3. A total score of 10-30 on RPQ within 1 week before enrolment in the study;
4. Able to understand, speak and read Danish;
5. Living in Central Denmark Region;
6. Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion

Exclusion Criteria:

1. Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;
2. Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion
3. Severe misuse of alcohol, prescription drugs and/or illegal drugs
4. Severe psychiatric co-morbidity (e.g. bipolar disorder, autism, psychotic disorder (life time)) or severe neurological disease (e.g. multiple sclerosis) that impedes participation in the programme.

Where it's running

• Hammel Neurorehabilitation Centre and University Research Clinic
  Hammel, Deb´nmark, Denmark Recruiting

Study contacts

• Principal investigator: Sedsel Pedersen, PhD student — Hammel Neurorehabilitation Centre and University Research Clinic
• Study coordinator: Sedsel Pedersen, PhD student
• Email: sedped@rm.dk
• Phone: +45 40171098

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.