An interventional study of GAIN 2.0 in Commotio Cerebri and Mild Traumatic Brain Injury, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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.
550 studies on the registry are indexed under Brain Concussion; 154 are open to participants now.
This study's enrollment of 310 is above the median of 64 across 376 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: GAIN 2.0
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
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)
Time frame: 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).
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.
Time frame: 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.
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)
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.
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
Calculated based on weekly public assistance benefits extracted from the DREAM register
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
Calculated based on weekly public assistance benefits extracted from the DREAM register
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 36 months after concussion
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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