RecruitingNot ApplicableNCT05233475

Get Going After concussIonN Lite

Get Going After concussIonN Lite (GAIN Lite): A Digital Intervention to Reduce Impairing Post-concussional Mild-to-moderate Symptoms in Adults

Sponsor

University of Aarhus

Enrollment

100 participants

Start Date

Feb 13, 2023

Study Type

INTERVENTIONAL

Conditions

Mild Traumatic Brain Injury Brain Concussion Commotio Cerebri

Summary

Background: Concussion affects around 25 000 people each year in Denmark. A large research initiative (GAIN 2.0) has been established, and the current study is a part of this initiative. Aims: 1. To develop and test the efficacy of a novel intervention for people with persistent post-concussional mild-to-moderate symptoms: "Get going After concussion Lite" (GAIN Lite). 2. To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load. Methods: A randomized controlled trial, comparing GAIN Lite to enhanced usual care. 100 adults diagnosed with a concussion at hospitals in Central Denmark Region or referred from general practitioners will be recruited. GAIN Lite is a digital intervention, and the primary outcome is the severity of post-concussional symptoms. A prospective cohort study will be performed to investigate the association between physical activity, cognitive processing, and symptom load.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

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;
Age 18 to 60 years at the time of the trauma;
A total score of 10-30 on RPQ within 1 week before enrolment in the study;
Able to understand, speak and read Danish;
Living in Central Denmark Region;
Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion

Exclusion Criteria4

Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;
Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion
Severe misuse of alcohol, prescription drugs and/or illegal drugs
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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALEnhanced usual care (EUC)

Enhanced usual care (EUC): All participants will by a health professional be shortly informed about the typical recovery process, the given reassurance about the prognosis.as well as advice on adaptive illness behaviours post-concussion.

BEHAVIORALGet Going after concussIoN Lite

GAIN Lite: GAIN Lite in an add-on to EUC, and contains two major components: 1) self-administrated e-learning videos and 2) up to four hours video- or phone sessions with an allocated therapist (either an occupational- or a physiotherapist) during a period of 8 weeks. Health professionals provide feedback and guidance, addressing the specific aims and context of the individual.