Commotio CerebriGAIN2NCT04798885
Get Going After concussioN 2.0
A study testing GAIN 2.0 in people with Commotio Cerebri and Mild Traumatic Brain Injury, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study tests the promising results of a previous study (GAIN 1.0) in a larger RCT (GAIN 2.0) which takes place in the municipalities of Central Denmark Region where citizens live their daily lives and whose health- and social care systems support citizens who experience persisting PCS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Commotio Cerebri, Mild Traumatic Brain Injury
- What is being tested?
- GAIN 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteDenmark
- Study dates
- 12 May 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 WHO. Participants must be referred to the project within two to four months of injury.
- Age 18 to 60 years at the time of the trauma
- A RPQ score ≥20.
- Able to understand, speak and read Danish.
- Living in Central Denmark Region.
Who cannot join
- Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage.
- Previous concussion leading to persistent PCS within the last two years.
- Severe misuse of alcohol, prescription drugs and/or illegal drugs.
- Psychiatric morbidity or severe neurological disease that impedes participation in the program, i.e. Bipolar Disorder, autism, psychotic disorder (life time), multiple sclerosis etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interdisciplinary Intervention for Patients With Post-concussion Symptoms 3-6 Months Post-injury (GAIN 2.0). A Stepped Wedge Cluster Randomised Trial: Effect on Symptoms, Participation in Daily Activities, and Labour Market Attachment
The study tests the promising results of a previous study (GAIN 1.0) in a larger RCT (GAIN 2.0) which takes place in the municipalities of Central Denmark Region where citizens live their daily lives and whose health- and social care systems support citizens who experience persisting PCS.
Read the detailed description
Concussion, the mildest form of traumatic brain injury, is an important public health concern. Recent studies estimate that persistent post-concussion symptoms (PCS) are present in almost half of the affected citizens at one year post-injury. Prospective studies have demonstrated that these citizens are at risk of developing long-lasting symptoms which are associated with high societal burden due to long-term impact on labour market attachment and increased use of health care and social benefits. In Denmark, there has in recent years been an increasing awareness on societal impact and personal consequences of PCS. Accordingly, clinicians as well as social workers and therapists in the municipalities point to the gab in knowledge concerning PCS and advocate urgently for evidence-based treatment for these citizens. Recently, the research group behind this application developed a novel early intervention - "Get going After concussIoN" (GAIN 1.0) - for citizens who experience persistent PCS three to six months post-concussion. The intervention was tested in a randomized controlled trial (RCT) with promising results. However, it was delivered in a single hospital setting in which these citizens are normally not cared for. In this study the intention is to test the results of GAIN 1.0 in a larger RCT (GAIN 2.0) which takes place in the municipalities of Central Denmark Region where citizens live their daily lives and whose health- and social care systems support citizens who experience persisting PCS.
- Conditions
- Commotio Cerebri, Mild Traumatic Brain Injury
- Being tested
- GAIN 2.0
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAIN 2.0Behavioural
- three structured group sessions of two hours duration performed jointly by a neuropsychologist, an occupational therapist and a physiotherapist. Relatives are also invited. 2) Up to five weekly semi-structured individual sessions of 30 min. duration with an allocated therapist
| Study group | Role | What they receive |
|---|---|---|
| Enhanced usual care | No intervention | Participants will be informed about typical Post Concussion Symptoms and the process of typical recovery as well as given reassurance concerning the prognosis. Advice concerning the use of pain relief medication will also be provided. |
| GAIN 2.0 intervention | Experimental | An eight-week, interdisciplinary intervention program based on principles from cognitive behavioural therapy (CBT) and gradual return to activities. Receives: Behavioral: GAIN 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of at least seven in the sum score on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
RPQ is a self-report scale 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: Three months after end of treatment
Secondary outcomes (9)
Sumscore in the dimension 'time spend on daily activities' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P).
Utrecht Scale for Evaluation of Rehabilitation-Participation is a generic measurement that both objectively and subjectively measure participation in Instrumental Activities of Daily Living (IADL) such as work, voluntary work, education, family duties and responsibilities, leisure activities, transportation, communication and social activities in three dimensions. The sumscore in each dimension is converted to a 0-100 metric with higher scores meaning af better outcome.
Measured: Three months after end of treatment
Sumscore in the dimension 'limitations' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)
Utrecht Scale for Evaluation of Rehabilitation-Participation is a generic measurement that both objectively and subjectively measure participation in Instrumental Activities of Daily Living (IADL) such as work, voluntary work, education, family duties and responsibilities, leisure activities, transportation, communication and social activities in three dimensions.The sumscore in each dimension is converted to a 0-100 metric with higher scores meaning af better outcome.
Measured: Three months after end of treatment
Sumscore in the dimension 'satisfaction with participation' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)
Utrecht Scale for Evaluation of Rehabilitation-Participation is a generic measurement that both objectively and subjectively measure participation in Instrumental Activities of Daily Living (IADL) such as work, voluntary work, education, family duties and responsibilities, leisure activities, transportation, communication and social activities in three dimensions.The sumscore in each dimension is converted to a 0-100 metric with higher scores meaning af better outcome.
Measured: Three months after end of treatment
Long term sick leave defined as public assistance benefits related to illness in more than three consecutive weeks
Calculated based on weekly public assistance benefits extracted from the DREAM register
Measured: Within 12 months after concussion
Cumulated incidence proportion of participants on long term sick leave defined as receiving public assistance benefits related to illness in more than three consecutive weeks
Calculated based on weekly public assistance benefits extracted from the DREAM register
Measured: Within 36 months after concussion
Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants
Calculated based on weekly public assistance benefits extracted from the DREAM register
Measured: At 12 months after concussion
Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants
Calculated based on weekly public assistance benefits extracted from the DREAM register
Measured: At 36 months after concussion
Degree of job stability based on whether labor market contributions have been paid
Monthly measure extracted from the DREAM register
Measured: At 12 months after concussion
Degree of job stability based on whether labor market contributions have been paid
Monthly measure extracted from the DREAM register
Measured: At 36 months after concussion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start12 May 2021
- Primary completion1 Jun 2023
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Commotio CerebriStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Sygeforsikringen danmark, Hammel Neurorehabilitation Centre and University Research Clinic, Municipalities in Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Jørgen F Nielsen, Professor, Principal investigator, Hammel Neurorehabilitation Centre and University clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798885
- Sponsor's protocol ID
- GAIN 2.0
- Acronym
- GAIN2
- Status last verified
- Nov 2023
- First submitted
- 9 Mar 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hellemose LA, Thastum MM, Stabel HH, Odgaard L, Rask CU, Silverberg ND, Skandsen T, Rytter HM, Nygaard C, Eggertsen PP, Pedersen CB, Nielsen JF. Interdisciplinary intervention (GAIN) vs. enhanced usual care for reducing severe post-concussion symptoms in adults 2-4 months post-injury: a stepped wedge cluster randomised controlled trial. EClinicalMedicine. 2026 Sep 22;100:104243. doi: 10.1016/j.eclinm.2026.104243. eCollection 2026 Oct.
PubMed 42891011Naess-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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Intervention for Patients With Post-concussion Symptoms 3-6 Months Post-injury (GAIN 2.0). A Stepped Wedge Cluster Randomised Trial: Effect on Symptoms, Participation in Daily Activities, and Labour Market Attachment
- ClinicalTrials.gov ID
- NCT04798885
- Acronym / sponsor ID
- GAIN2 / GAIN 2.0
- Conditions
- Commotio Cerebri, Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Sygeforsikringen danmark, Hammel Neurorehabilitation Centre and University Research Clinic, Municipalities in Central Denmark Region
- Study start
- 12 May 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 15 Mar 2021 (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.
The study tests the promising results of a previous study (GAIN 1.0) in a larger RCT (GAIN 2.0) which takes place in the municipalities of Central Denmark Region where citizens live their daily lives and whose health- and social care systems support citizens who experience persisting PCS.
Detailed description
Concussion, the mildest form of traumatic brain injury, is an important public health concern. Recent studies estimate that persistent post-concussion symptoms (PCS) are present in almost half of the affected citizens at one year post-injury. Prospective studies have demonstrated that these citizens are at risk of developing long-lasting symptoms which are associated with high societal burden due to long-term impact on labour market attachment and increased use of health care and social benefits. In Denmark, there has in recent years been an increasing awareness on societal impact and personal consequences of PCS. Accordingly, clinicians as well as social workers and therapists in the municipalities point to the gab in knowledge concerning PCS and advocate urgently for evidence-based treatment for these citizens. Recently, the research group behind this application developed a novel early intervention - "Get going After concussIoN" (GAIN 1.0) - for citizens who experience persistent PCS three to six months post-concussion. The intervention was tested in a randomized controlled trial (RCT) with promising results. However, it was delivered in a single hospital setting in which these citizens are normally not cared for. In this study the intention is to test the results of GAIN 1.0 in a larger RCT (GAIN 2.0) which takes place in the municipalities of Central Denmark Region where citizens live their daily lives and whose health- and social care systems support citizens who experience persisting PCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care | No intervention | –Participants will be informed about typical Post Concussion Symptoms and the process of typical recovery as well as given reassurance concerning the prognosis. Advice concerning the use of pain relief medication will also be provided. |
| GAIN 2.0 intervention | Experimental | Behavioral: GAIN 2.0An eight-week, interdisciplinary intervention program based on principles from cognitive behavioural therapy (CBT) and gradual return to activities. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Concussion caused by a head trauma according to the diagnostic criteria recommended by WHO. Participants must be referred to the project within two to four months of injury.
- Age 18 to 60 years at the time of the trauma
- A RPQ score ≥20.
- 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.
- Previous concussion leading to persistent PCS within the last two years.
- Severe misuse of alcohol, prescription drugs and/or illegal drugs.
- Psychiatric morbidity or severe neurological disease that impedes participation in the program, i.e. Bipolar Disorder, autism, psychotic disorder (life time), multiple sclerosis etc.
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 |
|---|---|---|
| GAIN 2.01) three structured group sessions of two hours duration performed jointly by a neuropsychologist, an occupational therapist and a physiotherapist. Relatives are also invited. 2) Up to five weekly semi-structured individual sessions of 30 min. duration with an allocated therapist | Behavioural | GAIN 2.0 intervention |
Primary outcome
Change of at least seven in the sum score on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Time frame: Three months after end of treatment
RPQ is a self-report scale 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)
9 secondary outcomes
Sumscore in the dimension 'time spend on daily activities' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P).
Time frame: Three months after end of treatment
Sumscore in the dimension 'limitations' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)
Time frame: Three months after end of treatment
Sumscore in the dimension 'satisfaction with participation' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)
Time frame: Three months after end of treatment
Long term sick leave defined as public assistance benefits related to illness in more than three consecutive weeks
Time frame: Within 12 months after concussion
Cumulated incidence proportion of participants on long term sick leave defined as receiving public assistance benefits related to illness in more than three consecutive weeks
Time frame: Within 36 months after concussion
Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants
Time frame: At 12 months after concussion
Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants
Time frame: At 36 months after concussion
Degree of job stability based on whether labor market contributions have been paid
Time frame: At 12 months after concussion
Degree of job stability based on whether labor market contributions have been paid
Time frame: At 36 months after concussion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 42891011Hellemose LA, Thastum MM, Stabel HH, Odgaard L, Rask CU, Silverberg ND, Skandsen T, Rytter HM, Nygaard C, Eggertsen PP, Pedersen CB, Nielsen JF. Interdisciplinary intervention (GAIN) vs. enhanced usual care for reducing severe post-concussion symptoms in adults 2-4 months post-injury: a stepped wedge cluster randomised controlled trial. EClinicalMedicine. 2026 Sep 22;100:104243. doi: 10.1016/j.eclinm.2026.104243. eCollection 2026 Oct.
- Derived from this study: 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.
Related trials for Commotio Cerebri
Recruiting
Get Going After concussIonN Lite
Brain Concussion, Mild Traumatic Brain Injury
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. This study is not recruiting at the moment.
Jørgen F Nielsen, Professor principal investigator
Hammel Neurorehabilitation Centre and University 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 GAIN 2.0 in people with Commotio Cerebri 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 5 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of at least seven in the sum score on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) (time frame: Three months after end of treatment). 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 NCT04798885, which also lists 2 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 13 Nov 2023.