Get Going After concussioN 2.0
GAIN2
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
1 other identifier
interventional
310
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
May 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedNovember 13, 2023
November 1, 2023
2.1 years
March 9, 2021
November 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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)
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).
Three months after end of treatment
Sumscore in the dimension 'limitations' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)
Three months after end of treatment
Sumscore in the dimension 'satisfaction with participation' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)
Three months after end of treatment
Long term sick leave defined as public assistance benefits related to illness in more than three consecutive weeks
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
Within 36 months after concussion
- +4 more secondary outcomes
Study Arms (2)
Enhanced usual care
NO INTERVENTIONParticipants 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
EXPERIMENTALAn eight-week, interdisciplinary intervention program based on principles from cognitive behavioural therapy (CBT) and gradual return to activities.
Interventions
1\) 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Sygeforsikringen danmarkcollaborator
- Hammel Neurorehabilitation Centre and University Research Cliniccollaborator
- Municipalities in Central Denmark Regioncollaborator
Study Sites (1)
Regionshospitalet Hammel Neurocenter
Hammel, 8450, Denmark
Related Publications (1)
Naess-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.
PMID: 35906645DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jørgen F Nielsen, Professor
Hammel Neurorehabilitation Centre and University clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 15, 2021
Study Start
May 12, 2021
Primary Completion
June 1, 2023
Study Completion
September 1, 2024
Last Updated
November 13, 2023
Record last verified: 2023-11