TY - JOUR

T1 - Interdisciplinary intervention (GAIN) for adults with post-concussion symptoms

T2 - a study protocol for a stepped-wedge cluster randomised trial

AU - Næss-Schmidt, Erhard Trillingsgaard

AU - Thastum, Mille Moller

AU - Stabel, Henriette Holm

AU - Odgaard, Lene

AU - Pedersen, Asger Roer

AU - Rask, Charlotte Ulrikka

AU - Silverberg, Noah D.

AU - Schröder, Andreas

AU - Nielsen, Jørgen Feldbæk

PY - 2022/7

Y1 - 2022/7

N2 - Background: Persistent post-concussion symptoms (PCS) are associated with prolonged disability, reduced health-related quality of life and reduced workability. At present, no strong evidence for treatments for people with persistent PCS exists. Our research group developed a novel intervention, "Get going After concussIoN (GAIN)", that incorporates multiple evidence-based strategies including prescribed exercise, cognitive behavioural therapy, and gradual return to activity advice. In a previous randomised trial, GAIN provided in a hospital setting was effective in reducing symptoms in 15-30-year-olds with PCS 2-6 months post-injury. In the current study, we describe the protocol for a trial designed to test the effectiveness of GAIN in a larger municipality setting. Additionally, we test the intervention within a broader age group and evaluate a broader range of outcomes. The primary hypothesis is that participants allocated to enhanced usual care plus GAIN report a higher reduction in PCS 3 months post-intervention compared to participants allocated to enhanced usual care only.Methods: The study is a stepped-wedge cluster-randomised trial with five clusters. The 8-week interdisciplinary GAIN program will be rolled out to clusters in 3-month intervals. Power calculation yield at least 180 participants to be enrolled. Primary outcome is mean change in PCS measured by the Rivermead Post-Concussion Symptoms Questionnaire from enrolment to 3 months after end of treatment. Secondary outcomes include participation in and satisfaction with everyday activities, labour market attachment and other behavioural measures. Self-reported outcomes are measured at baseline, by end of treatment and at 3, 6, and 18 months after end of treatment. Registry-based outcomes are measured up to 36 months after concussion.Discussion: The trial will provide important information concerning the effectiveness of the GAIN intervention in a municipality setting. Furthermore, it will provide knowledge of possible barriers and facilitators that may be relevant for future implementation of GAIN in different settings.

AB - Background: Persistent post-concussion symptoms (PCS) are associated with prolonged disability, reduced health-related quality of life and reduced workability. At present, no strong evidence for treatments for people with persistent PCS exists. Our research group developed a novel intervention, "Get going After concussIoN (GAIN)", that incorporates multiple evidence-based strategies including prescribed exercise, cognitive behavioural therapy, and gradual return to activity advice. In a previous randomised trial, GAIN provided in a hospital setting was effective in reducing symptoms in 15-30-year-olds with PCS 2-6 months post-injury. In the current study, we describe the protocol for a trial designed to test the effectiveness of GAIN in a larger municipality setting. Additionally, we test the intervention within a broader age group and evaluate a broader range of outcomes. The primary hypothesis is that participants allocated to enhanced usual care plus GAIN report a higher reduction in PCS 3 months post-intervention compared to participants allocated to enhanced usual care only.Methods: The study is a stepped-wedge cluster-randomised trial with five clusters. The 8-week interdisciplinary GAIN program will be rolled out to clusters in 3-month intervals. Power calculation yield at least 180 participants to be enrolled. Primary outcome is mean change in PCS measured by the Rivermead Post-Concussion Symptoms Questionnaire from enrolment to 3 months after end of treatment. Secondary outcomes include participation in and satisfaction with everyday activities, labour market attachment and other behavioural measures. Self-reported outcomes are measured at baseline, by end of treatment and at 3, 6, and 18 months after end of treatment. Registry-based outcomes are measured up to 36 months after concussion.Discussion: The trial will provide important information concerning the effectiveness of the GAIN intervention in a municipality setting. Furthermore, it will provide knowledge of possible barriers and facilitators that may be relevant for future implementation of GAIN in different settings.

KW - Brain concussion

KW - Behavioural therapy

KW - mTBI

KW - Activities of daily living

KW - Return to work

KW - The Rivermead Post-Concussion Questionnaire

KW - TRAUMATIC BRAIN-INJURY

KW - RISK-FACTORS

KW - HEAD-INJURY

KW - QUESTIONNAIRE

KW - VALIDITY

KW - SCALE

U2 - 10.1186/s13063-022-06572-7

DO - 10.1186/s13063-022-06572-7

M3 - Journal article

C2 - 35906645

VL - 23

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 613

ER -