Digital Program Get Going After concussion Lite to Help Adults Aged 18-60 with Mild to Moderate Post-Concussion Symptoms
Led by University of Aarhus · Updated on 2025-04-02
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to develop and evaluate a digital intervention called Get going After concussion Lite GAIN Lite for adults experiencing persistent mild-to-moderate symptoms after a concussion. The study is part of a larger initiative addressing concussion treatment in Denmark, where about 25,000 people experience concussion annually. The purpose is to test the effectiveness of GAIN Lite and to better understand how physical activity and digital behavior relate to symptom severity.
Participants will be randomly assigned to one of two groups enhanced usual care EUC or GAIN Lite plus EUC. EUC involves brief information from a health professional about typical recovery and advice on managing symptoms. GAIN Lite adds a digital program with self-guided e-learning videos and up to four hours of video or phone sessions with a therapist over eight weeks. The intervention starts 2 to 4 months after the concussion.
During the study, participants will complete questionnaires at the start, end of treatment, and at 3 and 6 months after treatment ends to measure symptoms and daily functioning. A subgroup will use an app on their smartphone for six months to monitor digital behavior and report symptoms. Physical activity will be tracked using a device worn on the thigh to measure steps, sitting time, and sleep. The main outcome is the severity of post-concussion symptoms measured by the Rivermead Postconcussion Questionnaire.
CONDITIONS
Brief Title
Get Going After concussIonN Lite
Research Team
S
Sedsel Pedersen, PhD student
I
Iris Brunner, PhD
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Hammel Neurorehabilitation Centre and University Research Clinic
Collaborating Sponsor
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
Concussion caused by head trauma with direct head contact as per Danish Consensus Report criteria
Age between 18 and 60 years at time of trauma
Total Rivermead Postconcussion Questionnaire score of 10-30 within 1 week before enrollment
Able to understand, speak, and read Danish
Living in Central Denmark Region
Identified from emergency department registers or referred by general practitioners within 2-4 months after concussion
You will not qualify if you...
Objective neurological findings or CT scan indicating neurological disease or brain damage linked to concussion
Previous concussion within last 2 years with ongoing symptoms at time of current concussion
Severe misuse of alcohol, prescription drugs, or illegal drugs
Severe psychiatric or neurological disorders that prevent participation, such as bipolar disorder, autism, psychotic disorders, or multiple sclerosis
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive either enhanced usual care, which includes information and advice from a health professional about typical recovery and adaptive illness behaviors, or the GAIN Lite digital intervention added to enhanced usual care. GAIN Lite includes self-administered e-learning videos and up to four hours of video or phone sessions with a therapist over 8 weeks.
Up to 4 video or phone sessions with a therapist during treatment
Follow-up
Duration - 6 months after treatment
Participants complete self-reported measures at the end of treatment, and at 3 and 6 months after treatment to assess symptoms and functioning. A subgroup may have digital behavior monitored via an app for 6 months and physical activity tracked with accelerometers.
Self-reported assessments at end of treatment, 3 months, and 6 months after treatment; app monitoring and physical activity assessments in a subgroup
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
A remotely delivered intervention targeting adults with persisting mild-to-moderate post-concussion symptoms (GAIN Lite): a study protocol for a parallel group randomised trial.
Sedsel Kristine Stage Pedersen, Mille Møller Thastum, Lene Odgaard...
Novel interdisciplinary intervention, GAIN, vs. enhanced usual care to reduce high levels of post-concussion symptoms in adolescents and young adults 2-6 months post-injury: A randomised trial.
Mille Moeller Thastum, Charlotte Ulrikka Rask, Erhard Trillingsgaard Næss-Schmidt...