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
Sponsor study identifier
interventional
310
1 country
1
Study Start
May 12, 2021
Actual (reported)Primary Completion
June 1, 2023
Actual (reported)Study Completion
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 9, 2021
Actual (reported)March 15, 2021
Actual (reported)May 12, 2021
Actual (reported)June 1, 2023
Actual (reported)September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
An eight-week, interdisciplinary intervention program based on principles from cognitive behavioural therapy (CBT) and gradual return to activities.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Regionshospitalet Hammel Neurocenter
Hammel, 8450, Denmark
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.
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.
Jørgen F Nielsen, Professor
Hammel Neurorehabilitation Centre and University clinic
310 participants (actual enrollment reported by the registry).
First Submitted
March 9, 2021
First Posted
March 15, 2021
Study Start
May 12, 2021
Actual (reported)A Study on the Effect of Mindfulness-based Yoga on Youth With Persistent Concussion Symptoms
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2023
Actual (reported)Study Completion
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 13, 2023
Record last verified: 2023-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: