Actively Recruiting
Led by University of Aarhus · Updated on 2025-04-02
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
U
University of Aarhus
Lead Sponsor
H
Hammel Neurorehabilitation Centre and University Research Clinic
Collaborating Sponsor
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
Get Going After concussIonN Lite
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Deb´nmark, Denmark, 8450
Actively Recruiting
S
Sedsel Pedersen, PhD student
I
Iris Brunner, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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