Evidence map›Paper›PMID 35906645›Full record

ArticleTrials2022

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

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04798885 naunknown statusnot on this map

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

TypeinterventionalSponsorUniversity of AarhusRan2021 to 2024Enrolled310ConditionsCommotio Cerebri, Mild Traumatic Brain InjuryArmsGAIN 2.0
NCT05233475 narecruitingnot on this mapstarted 2023, after this paper: background citation

Get Going After concussIonN Lite (GAIN Lite): A Digital Intervention to Reduce Impairing Post-concussional Mild-to-moderate Symptoms in Adults

TypeinterventionalSponsorUniversity of AarhusRan2023 to 2027Enrolled100ConditionsBrain Concussion, Mild Traumatic Brain Injury, Commotio CerebriArmsEnhanced usual care (EUC), Get Going after concussIoN Lite
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Erhard Trillingsgaard Næss-SchmidtHammel Neurorehabilitation Centre and University Research Clinic, Health, Aarhus University, Aarhus, Denmark. erhnae@rm.dk.ORCID http://orcid.org/0000-0002-2539-0362
Mille Møller ThastumHammel Neurorehabilitation Centre and University Research Clinic, Health, Aarhus University, Aarhus, Denmark.
Henriette Holm StabelHammel Neurorehabilitation Centre and University Research Clinic, Health, Aarhus University, Aarhus, Denmark.
Lene OdgaardHammel Neurorehabilitation Centre and University Research Clinic, Health, Aarhus University, Aarhus, Denmark.
Asger Roer PedersenHammel Neurorehabilitation Centre and University Research Clinic, Health, Aarhus University, Aarhus, Denmark.
Charlotte Ulrikka RaskDepartment of Clinical Medicine, AU, Aarhus, Denmark.
Noah D SilverbergDepartment of Psychology, University of British Columbia, Vancouver, Canada.
Andreas SchröderResearch Clinic for Functional Disorders, Aarhus University Hospital, Aarhus, Denmark.
Jørgen Feldbæk NielsenHammel Neurorehabilitation Centre and University Research Clinic, Health, Aarhus University, Aarhus, Denmark.
Aarhus University · DKAarhus University Hospital · DKUniversity of British Columbia · CA

Funding

Sygesikring"danmark" 2020-0147
6 · The paper itself

Abstract

backgroundPersistent 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.

methodsThe 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 registrationThe current GAIN trial is registered in ClinicalTrials.gov (study identifier: NCT04798885 ) on 20 October 2020.

Indexed as

Brain ConcussionCognitive Behavioral TherapyAdultHumansPost-Concussion SyndromeQuality of LifeRandomized Controlled Trials as TopicSelf ReportActivities of daily livingBehavioural therapyBrain concussionmTBIReturn to workThe Rivermead Post-Concussion Questionnaire

Identifiers

PMID35906645
PMCPMC9338593
OpenAlexW4288705887

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.