Brain ConcussionGAIN LiteNCT05233475
Get Going After concussIonN Lite
A study testing Get Going after concussIoN Lite in people with Brain Concussion and Mild Traumatic Brain Injury, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brain Concussion, Mild Traumatic Brain Injury, Commotio Cerebri
- What is being tested?
- Get Going after concussIoN Lite
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Feb 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri (26). The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas;
- Age 18 to 60 years at the time of the trauma;
- A total score of 10-30 on RPQ within 1 week before enrolment in the study;
- Able to understand, speak and read Danish;
- Living in Central Denmark Region;
- Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion
Who cannot join
- Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;
- Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion
- Severe misuse of alcohol, prescription drugs and/or illegal drugs
- Severe psychiatric co-morbidity (e.g. bipolar disorder, autism, psychotic disorder (life time)) or severe neurological disease (e.g. multiple sclerosis) that impedes participation in the programme.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Deb´nmark, 8450
Sedsel Pedersen, PhD studuent, +45 40171098, sedsel@hotmail.com
Iris Brunner, PhD, +45 60568195, iris.brunner@rm.dk
About this study
Official title: Get Going After concussIonN Lite (GAIN Lite): A Digital Intervention to Reduce Impairing Post-concussional Mild-to-moderate Symptoms in Adults
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.
Read more
Aims:
- 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).
- 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.
Read the detailed description
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
- To develop and test the efficacy of a digital intervention for people with persistent mild-to-moderate PCS: "Get going After concussion Lite" (GAIN Lite).
- To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load.
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.
- Being tested
- Enhanced usual care (EUC), Get Going after concussIoN Lite
- Keywords
- Brain concussion, Behavior therapy, Early intervention, Mild traumatic brain injury, Post-concussion syndrome, Rivermead post-concussion symptoms questionaire
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced usual care (EUC)Behavioural
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.
Get Going after concussIoN LiteBehavioural
Also called GAIN Lite, KORT OG GODT OM HJERNERYSTELSE
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group (EUC) | Active comparator | 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. Receives: Behavioral: Enhanced usual care (EUC) |
| Intervention Group (EUC + GAIN Lite) | Experimental | 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. Receives: Behavioral: Enhanced usual care (EUC); Behavioral: Get Going after concussIoN Lite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.)
Measured: 6 months: From baseline to 24 weeks after baseline
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 9 months: From baseline to 36 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start13 Feb 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility study, randomized controlled trial, implementation study and a prospective cohort study.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Hammel Neurorehabilitation Centre and University Research Clinic, Health Research Foundation of Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Sedsel Pedersen, PhD student, Principal investigator, Hammel Neurorehabilitation Centre and University Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233475
- Sponsor's protocol ID
- 100276
- Acronym
- GAIN Lite
- Status last verified
- May 2024
- First submitted
- 10 Jan 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen SKS, Thastum MM, Odgaard L, Naess-Schmidt ET, Pedersen CB, Nygaard C, Pallesen H, Silverberg ND, Brunner I. 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. Trials. 2024 Oct 26;25(1):720. doi: 10.1186/s13063-024-08546-3.
PubMed 39456081Thastum MM, Rask CU, Naess-Schmidt ET, Tuborgh A, Jensen JS, Svendsen SW, Nielsen JF, Schroder A. 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. EClinicalMedicine. 2019 Dec 16;17:100214. doi: 10.1016/j.eclinm.2019.11.007. eCollection 2019 Dec.
PubMed 31891145Naess-Schmidt ET, Thastum MM, Stabel HH, Odgaard L, Pedersen AR, Rask CU, Silverberg ND, Schroder A, Nielsen JF. Interdisciplinary intervention (GAIN) for adults with post-concussion symptoms: a study protocol for a stepped-wedge cluster randomised trial. Trials. 2022 Jul 29;23(1):613. doi: 10.1186/s13063-022-06572-7.
PubMed 35906645
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Going After concussIonN Lite (GAIN Lite): A Digital Intervention to Reduce Impairing Post-concussional Mild-to-moderate Symptoms in Adults
- ClinicalTrials.gov ID
- NCT05233475
- Acronym / sponsor ID
- GAIN Lite / 100276
- Keywords
- Brain concussion, Behavior therapy, Early intervention, Mild traumatic brain injury, Post-concussion syndrome, Rivermead post-concussion symptoms questionaire
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Hammel Neurorehabilitation Centre and University Research Clinic, Health Research Foundation of Central Denmark Region
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
Detailed description
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
- To develop and test the efficacy of a digital intervention for people with persistent mild-to-moderate PCS: "Get going After concussion Lite" (GAIN Lite).
- To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Feasibility study, randomized controlled trial, implementation study and a prospective cohort study.
| Arm | Type | Receives |
|---|---|---|
| Control group (EUC) | Active comparator | 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. |
| Intervention Group (EUC + GAIN Lite) | Experimental | Behavioral: Enhanced usual care (EUC), Behavioral: Get Going after concussIoN LiteGAIN 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri (26). The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas;
- Age 18 to 60 years at the time of the trauma;
- A total score of 10-30 on RPQ within 1 week before enrolment in the study;
- Able to understand, speak and read Danish;
- Living in Central Denmark Region;
Key exclusion criteria (4 listed)
- Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;
- Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion
- Severe misuse of alcohol, prescription drugs and/or illegal drugs
- Severe psychiatric co-morbidity (e.g. bipolar disorder, autism, psychotic disorder (life time)) or severe neurological disease (e.g. multiple sclerosis) that impedes participation in the programme.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Control group (EUC), Intervention Group (EUC + GAIN Lite) |
| Get Going after concussIoN LiteAlso: GAIN Lite, KORT OG GODT OM HJERNERYSTELSEGAIN 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. | Behavioural | Intervention Group (EUC + GAIN Lite) |
Primary outcome
Rivermead Post-concussion Questionnaire (RPQ/DK)
Time frame: 6 months: From baseline to 24 weeks after baseline
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)
Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P/DK)
Time frame: 6 months: From baseline to 24 weeks after baseline
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.)
4 secondary outcomes
Brief Illness Perception Questionnaire (B-IPQ/DK)
Time frame: 3 months: From baseline to 12 weeks after baseline (End of treatment)
Behavioral Response to Illness Questionnaire (BRIQ/DK)
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)
Time frame: 9 months: From baseline to 36 weeks after baseline
Work Ability Index Short form (WAI-2)
Time frame: 9 months: From baseline to 36 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 39456081Pedersen SKS, Thastum MM, Odgaard L, Naess-Schmidt ET, Pedersen CB, Nygaard C, Pallesen H, Silverberg ND, Brunner I. 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. Trials. 2024 Oct 26;25(1):720. doi: 10.1186/s13063-024-08546-3.
- Background: PubMed 31891145Thastum MM, Rask CU, Naess-Schmidt ET, Tuborgh A, Jensen JS, Svendsen SW, Nielsen JF, Schroder A. 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. EClinicalMedicine. 2019 Dec 16;17:100214. doi: 10.1016/j.eclinm.2019.11.007. eCollection 2019 Dec.
- Background: PubMed 35906645Naess-Schmidt ET, Thastum MM, Stabel HH, Odgaard L, Pedersen AR, Rask CU, Silverberg ND, Schroder A, Nielsen JF. Interdisciplinary intervention (GAIN) for adults with post-concussion symptoms: a study protocol for a stepped-wedge cluster randomised trial. Trials. 2022 Jul 29;23(1):613. doi: 10.1186/s13063-022-06572-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sedsel Pedersen, PhD student principal investigator
Hammel Neurorehabilitation Centre and University Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Get Going after concussIoN Lite in people with Brain Concussion and Mild Traumatic Brain Injury, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sedsel Pedersen, PhD student (+45 40171098, sedped@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rivermead Post-concussion Questionnaire (RPQ/DK) (time frame: 6 months: From baseline to 24 weeks after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05233475, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.