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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Enhanced usual care (EUC) and a behavioral approach called Get Going after concussIoN Lite for people with brain concussion, commotio cerebri, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.