Get Going After concussioN 2.0

Not Applicable

Active, not recruiting

• Conditions: Commotio Cerebri; Mild Traumatic Brain Injury
• Interventions: Behavioral: GAIN 2.0

• Registration Number: NCT04798885
• Lead Sponsor: University of Aarhus

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.

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 Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-15
• Study Start: 2021-05-12
• Primary Completion: 2023-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

1. 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.
2. Age 18 to 60 years at the time of the trauma
3. A RPQ score ≥20.
4. Able to understand, speak and read Danish.
5. Living in Central Denmark Region.

Exclusion Criteria

1. Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage.
2. Previous concussion leading to persistent PCS within the last two years.
3. Severe misuse of alcohol, prescription drugs and/or illegal drugs.
4. Psychiatric morbidity or severe neurological disease that impedes participation in the program, i.e. Bipolar Disorder, autism, psychotic disorder (life time), multiple sclerosis etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GAIN 2.0 intervention	GAIN 2.0	An eight-week, interdisciplinary intervention program based on principles from cognitive behavioural therapy (CBT) and gradual return to activities.

Primary Outcome Measures

Name	Time	Method
Change of at least seven in the sum score on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ)	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)

Secondary Outcome Measures

Name	Time	Method
Long term sick leave defined as public assistance benefits related to illness in more than three consecutive weeks	Within 12 months after concussion	Calculated based on weekly public assistance benefits extracted from the DREAM register
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	Calculated based on weekly public assistance benefits extracted from the DREAM register
Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants	At 36 months after concussion	Calculated based on weekly public assistance benefits extracted from the DREAM register
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	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.
Degree of job stability based on whether labor market contributions have been paid	At 36 months after concussion	Monthly measure extracted from the DREAM register
Sumscore in the dimension 'limitations' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)	Three months after end of treatment	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.
Sumscore in the dimension 'satisfaction with participation' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)	Three months after end of treatment	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.

Trial Locations

Locations (1)

Regionshospitalet Hammel Neurocenter; 🇩🇰 Hammel, Denmark