Interdisciplinary intervention (GAIN) for adults with post-concussion symptoms: a study protocol for a stepped-wedge cluster randomised trial

Erhard Trillingsgaard Næss-Schmidt, Mille Møller Thastum, Henriette Holm Stabel, Lene Odgaard, Asger Roer Pedersen, Charlotte Ulrikka Rask, Noah D Silverberg, Andreas Schröder, Jørgen Feldbæk Nielsen, Erhard Trillingsgaard Næss-Schmidt, Mille Møller Thastum, Henriette Holm Stabel, Lene Odgaard, Asger Roer Pedersen, Charlotte Ulrikka Rask, Noah D Silverberg, Andreas Schröder, Jørgen Feldbæk Nielsen

Abstract

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.

Trial registration: The current GAIN trial is registered in ClinicalTrials.gov (study identifier: NCT04798885 ) on 20 October 2020.

Keywords: Activities of daily living; Behavioural therapy; Brain concussion; Return to work; The Rivermead Post-Concussion Questionnaire; mTBI.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
The stepped wedge cluster randomised design. The stepped-wedge cluster randomised design with five clusters and six periods of each 3 months length. The white boxes illustrate the control condition (Enhanced Usual Care (EUC)) and the grey boxes intervention condition (EUC + Get Going After concussIoN (GAIN)). Recruitment, clinical assessment, and EUC take place 3 months period before each period illustrated in the figure. From power calculation, each box is estimated to involve a mean of 6 participants
Fig. 2
Fig. 2
Timeline. Timing and characteristics of questionnaire and treatment elements delivered in each group

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Source: PubMed

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