An interventional study of Enhanced usual care (EUC) and Get Going after concussIoN Lite in Brain Concussion, Mild Traumatic Brain Injury and Commotio Cerebri, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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:
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.
Get going After concussIonN Lite (GAIN Lite): An digital intervention to reduce impairing post-concussional mild-to-moderate symptoms in adults
Background:
Concussion, the mildest form of traumatic brain injury, is an important public health concern, affecting around 25 000 people each year in Denmark. Symptoms are associated with high societal burden due to the long-term impact on labour market attachment and increased health care usage and social welfare benefits. Evidence for effective treatment strategies is scarce, resulting in only weak recommendations for most treatment approaches, as reflected in the recently published National Guidelines for Non-Pharmacological treatment for post-concussion symptoms (PCS). Recently, the effect of a novel intervention "Get going After concussIoN" (GAIN) for people with persistent severe PCS was examined with promising results. Based on GAIN, a large research initiative (GAIN 2.0), has been established, and the present study is a part of this initiative.
Aims
Primary hypothesis:
Participants receiving GAIN Lite will 3 months after end of treatment report statistically and clinically significantly greater reduction of PCS compared to participants receiving enhanced usual care.
Methods:
The present study is a randomized controlled trial (RCT), comparing GAIN Lite to enhanced usual care. GAIN Lite is characterized as a complex intervention as described by the UK Medical Research Council (MRC) guidelines. Accordingly, GAIN Lite will be developed, feasibility-tested and evaluated before implementation into the RCT. Furthermore, the ADAPT process model outlined by Moore et al. will guide the process. During the RCT, a mixed-methods evaluation will be performed to evaluate the cost-effectiveness of GAIN Lite and to identify prerequisites for clinical implementation. Furthermore, a prospective cohort study will be performed to investigate which features of digital behaviour are related to symptom load and physical activity. The project is conducted in the Central Denmark Region and led by Hammel Neurorehabilitation Centre and University Research Clinic. One hundred people between the age of 18-60 diagnosed with a concussion at public hospitals in the Central Denmark Region will be identified from an administrative hospital register. In addition, participants can be referred to the study by general practitioners. Potential participants will approx. 2 months after the concussion receive a standardised and validated battery of questionnaires measuring PCS and daily functioning. Participants considered likely to meet the inclusion criteria will be invited to further screening for eligibility by a physician. Eligible participants will be randomised by a computer algorithm with predefined concealed random numbers to either 1) Enhanced usual care (EUC) or 2) GAIN Lite added to EUC. EUC consists of short information by a health professionel about the typical recovery process, the given reassurance about the prognosis as well as advice on adaptive illness behaviours post-concussion. GAIN Lite is a digital program that 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. The intervention begins 2-4 months after the onset of the concussion. The primary outcome is PCS measured by Rivermead Postconcussion Questionnaire (RPQ). All participants will complete self-reported measures at baseline, at end of treatment and 3 and 6 months after end of treatment. In a subgroup, an app will monitor digital behaviour on the participants' smartphones for 6 months. During the same period, participants will be frequently asked to rate their PCS. Physical activity will be assessed with thigh-worn accelerometers regarding step counts, sedentary behaviour, and sleep.
2,114 studies on the registry are indexed under Brain Injuries; 386 are open to participants now.
This study's planned enrollment of 100 is above the median of 48 across 1,332 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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: Enhanced usual care (EUC)
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.
Behavioral: Enhanced usual care (EUC) · Behavioral: Get Going after concussIoN Lite
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.
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.
Also known as: GAIN Lite, KORT OG GODT OM HJERNERYSTELSE
Rivermead Post-concussion Questionnaire (RPQ/DK)
RPQ/DK is a self-report questionaire to measure the severity of post-concussion symptoms covering physical, cognitive, and emotional symptoms with 16 sub-items and a total sum score (range 0-64, higher score define more severe status)
Time frame: 6 months: From baseline to 24 weeks after baseline
Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P/DK)
USER-P/DK is a self-report questionaire that covers aspects of participation with three separate scales: Frequency, Restrictions and Satisfaction. The restrictions scale will be used. It contains 11 sub-items that are based on whether the participant experience any limitations in daily life. A sum score from 0-100 i created. (A higher score indicates a more favorable level of participation, i.e. fewer restrictions experienced.)
Time frame: 6 months: From baseline to 24 weeks after baseline
Brief Illness Perception Questionnaire (B-IPQ/DK)
B-IPQ/DK consists of nine self-reported items: Eight items that covers cognitive illness, emotional representations and illness comprehensibility on a 0-to-10 response scale. (Range 0-80, higher score reflects a more negative perception). Item 9 is an open-ended response item, which asks paticipants to list the three most important causal factors in their illness. Responses to the causal item can be grouped into categories and analysed.
Time frame: 3 months: From baseline to 12 weeks after baseline (End of treatment)
Behavioral Response to Illness Questionnaire (BRIQ/DK)
BRIQ/DK is a self-report measure to assess frequency of illness behaviors, and consists of 4 subscales (19 items) on a 0-5 response scale (Range 0-95, higher scores indicate that the participant engaged in the behavior more frequently)
Time frame: 3 months: From baseline to 12 weeks after baseline (End of treatment)
Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P)
TiC-P/DK is a self-report measure designed to assess direct and indirect costs associated with mental health. Part II collects information on respondents' workplace absenteeism and/ or reduction in productivity in paid or unpaid work due to mental health illnesses in the past month.
Time frame: 9 months: From baseline to 36 weeks after baseline
Work Ability Index Short form (WAI-2)
The WAI/DK describes how capable an employee is of doing his/her job and the questionnaire consists of seven subscales referring to these aspects of work ability: Subscale 1 is used (WAI 1: current work ability compared with lifetime best)
Time frame: 9 months: From baseline to 36 weeks after baseline
Number of participants who receive no public assistance benefits (State education fund grants excepted)
Register based data on employment in the Danish Register for Evaluation of Marginalisation (DREAM). This register contains weekly information on social transfer payments for all residents of Denmark (since 1996).
Time frame: Six months after end of treatment
Number of participants who receive public assistance benefits related to illness in more than three consecutive weeks
Register based data on long term sick leave in the Danish Register for Evaluation of Marginalisation (DREAM). This register contains weekly information on social transfer payments for all residents of Denmark (since 1996).
Time frame: Six months after end of treatment
The degree of employment (based on whether labor market contributions have been paid)
Register based data job stability in the Danish Register for Evaluation of Marginalisation (DREAM). This register contains weekly information on social transfer payments for all residents of Denmark (since 1996).
Time frame: Six months after end of treatment
Continuously recording the interaction of 50 participants with their smartphones during a period of 3 months (The smart phone use will be linked to activity level and PCS)
Touchscreen data will be gathered in the background with an app (TapCounter) installed on the participants smart phones (Android users only due to system restrictions). The off-the-shelf data gathering tool available through QuantActions, Lausanne will be used. Raw smartphone taps will be converted into candidate measures for health, such as (i) Tapping speed; (ii) Typing speed; (iii) The speed of entering a passcode; (iv) The speed of finding an App icon on the home screen; (v) The number of interactions
Time frame: Three months
Continuously collecting seven days of accelerometer-assessed physical activity in 50 participants once a month for three months (The activity level will be linked to PCS and smart phone use)
Physical activity will be assessed with thigh-worn accelerometers (Axivity, Ltd, Newcastle AX3) regarding step counts, sedentary behaviour, and sleep
Time frame: Once a month for three months
Post-concussion symptoms (PCS) is measures on the Rivermead Post-concussion Questionnaire (RPQ/DK) in 50 participants once a month for three months (PCS will be linked to smart phone use and activity level)
RPQ/DK is a self-report questionaire to measure the severity of PCS covering physical, cognitive, and emotional symptoms with 16 sub-items and a total sum score (range 0-64, higher score define more severe status)
Time frame: Once a month for three months
Evaluation of the feasibility, acceptability, and tolerability of the intervention will be made during the feasibility phase. Individual, organizational, and structural aspects of clinical implementation will be evaluated at the end of the RCT
Semi-structured interviews will be used to evaluate the experiences of all involved stakeholders (participants, professionals, developers, and management).
Time frame: Before implemention into the RCT and before implementation into clinical practice
Plan to share: No
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