NCT05233475

Brief Summary

Background: Concussion affects around 25 000 people each year in Denmark. A large research initiative (GAIN 2.0) has been established, and the current study is a part of this initiative. Aims:

  1. 1.To develop and test the efficacy of a novel intervention for people with persistent post-concussional mild-to-moderate symptoms: "Get going After concussion Lite" (GAIN Lite).
  2. 2.To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Feb 2023Sep 2027

First Submitted

Initial submission to the registry

January 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 2, 2025

Status Verified

May 1, 2024

Enrollment Period

3.6 years

First QC Date

January 10, 2022

Last Update Submit

March 28, 2025

Conditions

Brain ConcussionMild Traumatic Brain InjuryCommotio Cerebri

Keywords

Brain concussionBehavior therapyEarly interventionMild traumatic brain injuryPost-concussion syndromeRivermead post-concussion symptoms questionaire

Outcome Measures

Primary Outcomes (2)

  • Rivermead Post-concussion Questionnaire (RPQ/DK)

    RPQ/DK is a self-report questionaire 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)

    6 months: From baseline to 24 weeks after baseline

  • Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P/DK)

    USER-P/DK is a self-report questionaire that covers aspects of participation with three separate scales: Frequency, Restrictions and Satisfaction. The restrictions scale will be used. It contains 11 sub-items that are based on whether the participant experience any limitations in daily life. A sum score from 0-100 i created. (A higher score indicates a more favorable level of participation, i.e. fewer restrictions experienced.)

    6 months: From baseline to 24 weeks after baseline

Secondary Outcomes (4)

  • Brief Illness Perception Questionnaire (B-IPQ/DK)

    3 months: From baseline to 12 weeks after baseline (End of treatment)

  • Behavioral Response to Illness Questionnaire (BRIQ/DK)

    3 months: From baseline to 12 weeks after baseline (End of treatment)

  • Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P)

    9 months: From baseline to 36 weeks after baseline

  • Work Ability Index Short form (WAI-2)

    9 months: From baseline to 36 weeks after baseline

Other Outcomes (7)

  • Number of participants who receive no public assistance benefits (State education fund grants excepted)

    Six months after end of treatment

  • Number of participants who receive public assistance benefits related to illness in more than three consecutive weeks

    Six months after end of treatment

  • The degree of employment (based on whether labor market contributions have been paid)

    Six months after end of treatment

  • +4 more other outcomes

Study Arms (2)

Control group (EUC)

ACTIVE COMPARATOR

Enhanced usual care (EUC): All participants will by a health professional be shortly informed about the typical recovery process, the given reassurance about the prognosis.as well as advice on adaptive illness behaviours post-concussion.

Behavioral: Enhanced usual care (EUC)

Intervention Group (EUC + GAIN Lite)

EXPERIMENTAL

GAIN Lite: GAIN Lite in an add-on to EUC, and contains two major components: 1) self-administrated e-learning videos and 2) up to four hours video- or phone sessions with an allocated therapist (either an occupational- or a physiotherapist) during a period of 8 weeks. Health professionals provide feedback and guidance, addressing the specific aims and context of the individual.

Behavioral: Enhanced usual care (EUC)Behavioral: Get Going after concussIoN Lite

Interventions

Enhanced usual care (EUC)BEHAVIORAL

Enhanced usual care (EUC): All participants will by a health professional be shortly informed about the typical recovery process, the given reassurance about the prognosis.as well as advice on adaptive illness behaviours post-concussion.

Control group (EUC)Intervention Group (EUC + GAIN Lite)
Get Going after concussIoN LiteBEHAVIORAL

GAIN Lite: GAIN Lite in an add-on to EUC, and contains two major components: 1) self-administrated e-learning videos and 2) up to four hours video- or phone sessions with an allocated therapist (either an occupational- or a physiotherapist) during a period of 8 weeks. Health professionals provide feedback and guidance, addressing the specific aims and context of the individual.

Also known as: GAIN Lite, KORT OG GODT OM HJERNERYSTELSE
Intervention Group (EUC + GAIN Lite)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri (26). The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas;
  • Age 18 to 60 years at the time of the trauma;
  • A total score of 10-30 on RPQ within 1 week before enrolment in the study;
  • Able to understand, speak and read Danish;
  • Living in Central Denmark Region;
  • Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion

You may not qualify if:

  • Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;
  • Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion
  • Severe misuse of alcohol, prescription drugs and/or illegal drugs
  • Severe psychiatric co-morbidity (e.g. bipolar disorder, autism, psychotic disorder (life time)) or severe neurological disease (e.g. multiple sclerosis) that impedes participation in the programme.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Deb´nmark, 8450, Denmark

RECRUITING

Related Publications (3)

  • Pedersen SKS, Thastum MM, Odgaard L, Naess-Schmidt ET, Pedersen CB, Nygaard C, Pallesen H, Silverberg ND, Brunner I. A remotely delivered intervention targeting adults with persisting mild-to-moderate post-concussion symptoms (GAIN Lite): a study protocol for a parallel group randomised trial. Trials. 2024 Oct 26;25(1):720. doi: 10.1186/s13063-024-08546-3.

    PMID: 39456081BACKGROUND

  • Thastum MM, Rask CU, Naess-Schmidt ET, Tuborgh A, Jensen JS, Svendsen SW, Nielsen JF, Schroder A. Novel interdisciplinary intervention, GAIN, vs. enhanced usual care to reduce high levels of post-concussion symptoms in adolescents and young adults 2-6 months post-injury: A randomised trial. EClinicalMedicine. 2019 Dec 16;17:100214. doi: 10.1016/j.eclinm.2019.11.007. eCollection 2019 Dec.

    PMID: 31891145BACKGROUND

  • Naess-Schmidt ET, Thastum MM, Stabel HH, Odgaard L, Pedersen AR, Rask CU, Silverberg ND, Schroder A, Nielsen JF. Interdisciplinary intervention (GAIN) for adults with post-concussion symptoms: a study protocol for a stepped-wedge cluster randomised trial. Trials. 2022 Jul 29;23(1):613. doi: 10.1186/s13063-022-06572-7.

    PMID: 35906645BACKGROUND

MeSH Terms

Conditions

Brain ConcussionPost-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Sedsel Pedersen, PhD student

    Hammel Neurorehabilitation Centre and University Research Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sedsel Pedersen, PhD student

CONTACT

+45 40171098sedped@rm.dk

Iris Brunner, PhD

CONTACT

+45 60568195iris.brunner@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Both groups will recieve enhanced usual care. The care providers providing the enhanced usual care, will be blinded to group assignment. As the outcome assessor are the participants when the outcome is participant-reported outcomes, none of the outcome assessors are blinded, as it is impossible to blind the participants to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Feasibility study, randomized controlled trial, implementation study and a prospective cohort study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 10, 2022

Study Start

February 13, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

April 2, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)