Clinical trial NCT05233475: Get Going After concussIonN Lite
Official title: Get Going After concussIonN Lite (GAIN Lite): A Digital Intervention to Reduce Impairing Post-concussional Mild-to-moderate Symptoms in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Concussion
Mild Traumatic Brain Injury
Commotio Cerebri
Keywords: Brain concussion
Behavior therapy
Early intervention
Mild traumatic brain injury
Post-concussion syndrome
Rivermead post-concussion symptoms questionaire
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Hammel Neurorehabilitation Centre and University Research Clinic
name: Health Research Foundation of Central Denmark Region
First posted: 2022-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility study, randomized controlled trial, implementation study and a prospective cohort study.
Primary purpose: TREATMENT

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. 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. To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load.

Methods:

A randomized controlled trial, comparing GAIN Lite to enhanced usual care. 100 adults diagnosed with a concussion at hospitals in Central Denmark Region or referred from general practitioners will be recruited. GAIN Lite is a digital intervention, and the primary outcome is the severity of post-concussional symptoms. A prospective cohort study will be performed to investigate the association between physical activity, cognitive processing, and symptom load.

Detailed description: Get going After concussIonN Lite (GAIN Lite): An digital intervention to reduce impairing post-concussional mild-to-moderate symptoms in adults

Background:

Concussion, the mildest form of traumatic brain injury, is an important public health concern, affecting around 25 000 people each year in Denmark. Symptoms are associated with high societal burden due to the long-term impact on labour market attachment and increased health care usage and social welfare benefits. Evidence for effective treatment strategies is scarce, resulting in only weak recommendations for most treatment approaches, as reflected in the recently published National Guidelines for Non-Pharmacological treatment for post-concussion symptoms (PCS). Recently, the effect of a novel intervention "Get going After concussIoN" (GAIN) for people with persistent severe PCS was examined with promising results. Based on GAIN, a large research initiative (GAIN 2.0), has been established, and the present study is a part of this initiative.

Aims

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

Primary hypothesis:

Participants receiving GAIN Lite will 3 months after end of treatment report statistically and clinically significantly greater reduction of PCS compared to participants receiving enhanced usual care.

Methods:

The present study is a randomized controlled trial (RCT), comparing GAIN Lite to enhanced usual care. GAIN Lite is characterized as a complex intervention as described by the UK Medical Research Council (MRC) guidelines. Accordingly, GAIN Lite will be developed, feasibility-tested and evaluated before implementation into the RCT. Furthermore, the ADAPT process model outlined by Moore et al. will guide the process. During the RCT, a mixed-methods evaluation will be performed to evaluate the cost-effectiveness of GAIN Lite and to identify prerequisites for clinical implementation. Furthermore, a prospective cohort study will be performed to investigate which features of digital behaviour are related to symptom load and physical activity. The project is conducted in the Central Denmark Region and led by Hammel Neurorehabilitation Centre and University Research Clinic. One hundred people between the age of 18-60 diagnosed with a concussion at public hospitals in the Central Denmark Region will be identified from an administrative hospital register. In addition, participants can be referred to the study by general practitioners. Potential participants will approx. 2 months after the concussion receive a standardised and validated battery of questionnaires measuring PCS and daily functioning. Participants considered likely to meet the inclusion criteria will be invited to further screening for eligibility by a physician. Eligible participants will be randomised by a computer algorithm with predefined concealed random numbers to either 1) Enhanced usual care (EUC) or 2) GAIN Lite added to EUC. EUC consists of short information by a health professionel about the typical recovery process, the given reassurance about the prognosis as well as advice on adaptive illness behaviours post-concussion. GAIN Lite is a digital program that 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. The intervention begins 2-4 months after the onset of the concussion. The primary outcome is PCS measured by Rivermead Postconcussion Questionnaire (RPQ). All participants will complete self-reported measures at baseline, at end of treatment and 3 and 6 months after end of treatment. In a subgroup, an app will monitor digital behaviour on the participants' smartphones for 6 months. During the same period, participants will be frequently asked to rate their PCS. Physical activity will be assessed with thigh-worn accelerometers regarding step counts, sedentary behaviour, and sleep.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Age 18 to 60 years at the time of the trauma;
3. A total score of 10-30 on RPQ within 1 week before enrolment in the study;
4. Able to understand, speak and read Danish;
5. Living in Central Denmark Region;
6. Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion

Exclusion Criteria:

1. Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;
2. Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion
3. Severe misuse of alcohol, prescription drugs and/or illegal drugs
4. 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.

Primary outcomes:
measure: Rivermead Post-concussion Questionnaire (RPQ/DK)
timeFrame: 6 months: From baseline to 24 weeks after baseline
measure: Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P/DK)
timeFrame: 6 months: From baseline to 24 weeks after baseline
Secondary outcomes:
measure: Brief Illness Perception Questionnaire (B-IPQ/DK)
timeFrame: 3 months: From baseline to 12 weeks after baseline (End of treatment)
measure: Behavioral Response to Illness Questionnaire (BRIQ/DK)
timeFrame: 3 months: From baseline to 12 weeks after baseline (End of treatment)
measure: Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P)
timeFrame: 9 months: From baseline to 36 weeks after baseline
measure: Work Ability Index Short form (WAI-2)
timeFrame: 9 months: From baseline to 36 weeks after baseline
Other outcomes:
measure: Number of participants who receive no public assistance benefits (State education fund grants excepted)
timeFrame: Six months after end of treatment
measure: Number of participants who receive public assistance benefits related to illness in more than three consecutive weeks
timeFrame: Six months after end of treatment
measure: The degree of employment (based on whether labor market contributions have been paid)
timeFrame: Six months after end of treatment
measure: Continuously recording the interaction of 50 participants with their smartphones during a period of 3 months (The smart phone use will be linked to activity level and PCS)
timeFrame: Three months
measure: Continuously collecting seven days of accelerometer-assessed physical activity in 50 participants once a month for three months (The activity level will be linked to PCS and smart phone use)
timeFrame: Once a month for three months
measure: Post-concussion symptoms (PCS) is measures on the Rivermead Post-concussion Questionnaire (RPQ/DK) in 50 participants once a month for three months (PCS will be linked to smart phone use and activity level)
timeFrame: Once a month for three months
measure: Evaluation of the feasibility, acceptability, and tolerability of the intervention will be made during the feasibility phase. Individual, organizational, and structural aspects of clinical implementation will be evaluated at the end of the RCT
timeFrame: Before implemention into the RCT and before implementation into clinical practice
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation Centre and University Research Clinic
state: Deb´nmark
Study officials:
affiliation: Hammel Neurorehabilitation Centre and University Research Clinic
name: Sedsel Pedersen, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.