Get Going After concussIonN Lite

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.

Conditions

• Brain Concussion
• Mild Traumatic Brain Injury
• Commotio Cerebri

Interventions

BEHAVIORAL

Enhanced 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.

BEHAVIORAL

Get 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.

Sponsors & Collaborators

• Hammel Neurorehabilitation Centre and University Research Clinic

  collaborator OTHER

• Health Research Foundation of Central Denmark Region

  collaborator UNKNOWN

• University of Aarhus

  lead OTHER

Principal Investigators

• Sedsel Pedersen, PhD student · Hammel Neurorehabilitation Centre and University Research Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-13

Primary Completion

2026-09-30

Completion

2027-09-30

Countries

• Denmark

Study Locations