Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000702718
Ethics application status
Approved
Date submitted
10/05/2022
Date registered
16/05/2022
Date last updated
26/08/2022
Date data sharing statement initially provided
16/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an Interdisciplinary Intervention for Chronic Concussion Symptoms
Scientific title
Evaluation of an Interdisciplinary Intervention for Persistent Post-Concussion Symptoms in Individuals who have Experienced a Mild Traumatic Brain Injury
Secondary ID [1] 307075 0
None
Universal Trial Number (UTN)
Trial acronym
iRECOveR: Interdisciplinary Rehabilitation for Concussion Recovery
Linked study record
This study is an extension of a pilot study which used a case series design to evaluate the feasibility of the interdisciplinary intervention (ACTRN12620001111965). Protocol compliance, recruitment rates, retention rates and clinician and participant experiences from the pilot were used to inform the trial design of this phase-II randomised controlled.

Health condition
Health condition(s) or problem(s) studied:
Concussion 326231 0
Post-Concussion Syndrome 326232 0
Traumatic Brain Injury 326233 0
Condition category
Condition code
Neurological 323533 323533 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 323534 323534 0 0
Physiotherapy
Physical Medicine / Rehabilitation 323535 323535 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 323536 323536 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive intervention from a neuropsychologist, physiotherapist, and sports medicine physician. All participants will receive an initial 60-minute consultation with these clinicians. The initial consultations will take place either face-to-face or via telehealth. Following initial consultations, clinicians will meet via case conference to discuss individualised treatment plans.

Participants will then be offered weekly sessions of psychological and physiotherapy treatment across an 8 week period (face-to-face or Telehealth). Including the initial treatment session, 8 treatment sessions will be offered for each of neuropsychology and physiotherapy i.e. a total of 16 sessions of treatment will be offered. Treatment sessions will be provided in a one-on-one setting. Psychological treatment sessions will last between 60-90 minutes at a maximum of once a week. Physiotherapy treatment sessions will last for 45-60 minutes and will be at a maximum of once a week.

The psychological intervention will be oriented toward a cognitive-behavioural framework as described by Beck (1979). The intervention will use the treatment manual developed in the pilot phase of this research (ACTRN12620001111965) adapted from previous manuals developed by Ferguson and Mittenberg (1996) and Silverberg et al. (2013). The treatment manual includes psychoeducation, activity scheduling, cognitive restructuring, anxiety management training, and sleep intervention components. As part of this therapy, participants will be provided with educational materials including worksheets and handouts which were also developed in the pilot phase of this research.

Participants will also be assessed by a physiotherapist and will be provided treatment in the following domains as required: ocular, vestibular, cervical, and autonomic system functioning. Physical therapy intervention will be specific to their assessment and may comprise of vestibular rehabilitation, manual therapy, cervical strengthening and proprioceptive training and a graded exercise program. Examples of ocular retraining include convergence exercises where participants will watch a target as it moves towards them, saccadic retraining where participants quickly move their gaze between targets, and smooth pursuit training where the participant watches a moving target such as a swinging ball. Examples of vestibular rehabilitation are gaze stabilisation where participants turn their head and focus on a target (this is done to a particular speed predetermined by the physiotherapy assessing the participant), VOR cancellation exercises where participants watch a target move through space by turning their whole body, and motion sensitivity exercises such as ball skills, walking, and gaze stabilisation or VOR cancellation. Examples of cervical rehabilitation include cervical strengthening such as deep neck flexor strengthening, proprioception training with a target and a laser to rehabilitate sensory awareness of the neck, and manual work on the neck by the physiotherapist. Graded exercise is defined as exercise of the participant's choice that can be safely done for 20 minutes. Exercise will be targeted at a particular heart rate. The starting heart rate will be defined as 80% of the point of failure of the subject on the treadmill test. Heart rates will increase in line with a decrease in participant's symptoms. This will be assessed and closely monitored by the physiotherapist. Graded exercise will generally be walking, running or stationary bike, however, other modes such as swimming could be introduced if tolerated and preferred by the participant. The physiotherapist will outline an individualised treatment and home program based on the assessment.

Medical management of persistent post-concussion symptoms will comprise of one consultation (same as initial consultation) with the physician which may include pharmacological management of symptoms as well as advice regarding return to activities (e.g. work, sport, school).

Treatment fidelity:
Adherence to the manualised CBT intervention will be rated by an independent psychologist who will listen to audio/video recordings of 10% of the sessions.
Intervention code [1] 323530 0
Rehabilitation
Intervention code [2] 323531 0
Behaviour
Intervention code [3] 323532 0
Treatment: Other
Comparator / control treatment
The control group is labelled as the ‘Assessment + Standard Care’ condition. Participants in this group will receive a summary report of their baseline research and physiotherapy assessments, including feedback regarding their condition and referral to their GP if required. Most individuals with mTBI’s are not admitted to hospital and receive a variable degree of medical attention (Ponsford et al., 2002). As such, the ‘Standard Care’ aspect of the control condition will encompass any health services participants chose to utilise independently. Participants in the 'Standard care + Assessment' control group will be offered the intervention upon completion of the one-month follow-up period.

Treatment fidelity:
Frequency, and type of health service utilisation will be measured for both the control and intervention groups.
Control group
Active

Outcomes
Primary outcome [1] 331292 0
Post-concussion symptoms as measured by the Rivermead Post-Concussion Symptoms questionnaire.
Timepoint [1] 331292 0
T1= Start of Baseline, Baseline, Intervention, T2 = post-intervention (primary timepoint), T3 = 1-month follow-up, T4= 2-month follow-up. Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1-week post-intervention. During baseline and intervention phases, participants will complete the Rivermead Post-Concussion Symptoms questionnaire 3 times a week via an online survey.
Secondary outcome [1] 409445 0
Return to activity as assessed by Goal Attainment Scaling
Timepoint [1] 409445 0
Intervention, Post-intervention (T2) and 1-month follow-up (T3)

GAS goals will be assessed multiple times within the intervention. GAS goals will be established in Session 2 of the psychological intervention. GAS goals will be reviewed weekly from Sessions 4-8 of the psychological intervention.

Post intervention will be defined as within 1-week post-intervention.
Secondary outcome [2] 409446 0
Fatigue as assessed by the Brief Fatigue Inventory and the Fatigue Severity Scale.
Timepoint [2] 409446 0
T1= Start of Baseline, T2 = post-intervention, T3 = 1-month follow-up, T4= 2-month follow-up. Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1-week post-intervention.
Secondary outcome [3] 409447 0
Sleep disturbance as assessed by the Insomnia Severity Index
Timepoint [3] 409447 0
T1= Start of Baseline, T2 = post-intervention, T3 = 1-month follow-up, T4= 2-month follow-up. Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1-week post-intervention.
Secondary outcome [4] 409448 0
Health related quality of life as assessed by the 36-Short form
Timepoint [4] 409448 0
T1= Start of Baseline, T2 = post-intervention, T3 = 1-month follow-up, T4= 2-month follow-up. Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1-week post-intervention.
Secondary outcome [5] 409449 0
Symptoms of anxiety as assessed by the Depression Anxiety and Stress Scales-21
Timepoint [5] 409449 0
T1= Start of Baseline, T2 = post-intervention, T3 = 1-month follow-up, T4= 2-month follow-up. Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1-week post-intervention.
Secondary outcome [6] 409450 0
Symptoms of stress as assessed by the Depression Anxiety and Stress Scales-21
Timepoint [6] 409450 0
T1= Start of Baseline, T2 = post-intervention, T3 = 1-month follow-up, T4= 2-month follow-up. Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1-week post-intervention.
Secondary outcome [7] 409451 0
Satisfaction with Social Roles and Activities assessed by the the Traumatic Brain Injury Quality-of-Life.
Timepoint [7] 409451 0
T1= Start of Baseline, T2 = post-intervention, T3 = 1-month follow-up, T4= 2-month follow-up. Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1-week post-intervention.
Secondary outcome [8] 409452 0
Health Service Utilisation assessed by collecting quantity of visits/number of times accessed for a range of health services by each participant. These health services include: medication, physiotherapy, occupational therapy, psychology, GP, paid care, unpaid care, community or social care services and hospital admissions.
Timepoint [8] 409452 0
T1= Start of Baseline, T2 = post-intervention, T3 = 1-month follow-up, T4= 2-month follow-up. Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1-week post-intervention.
Secondary outcome [9] 409453 0
The Working Alliance Inventory-Short Revised (WAI-SR) to assesses key aspects of clinician rapport.
Timepoint [9] 409453 0
Post intervention, defined as within 1-week post-intervention.

Eligibility
Key inclusion criteria
Individuals will be included in the study if they have sustained a mild traumatic brain injury classified as having a Glasgow Coma Scale (GCS) score between 13 and 15, less than 30 minutes of loss of consciousness, and experienced less than 24 hours of post traumatic amnesia (PTA), and have persisting post-concussion symptoms (>3 post-concussion symptoms persisting for at least 2 weeks; Tator et al., 2016) assessed on the Rivermead Post-Concussion Symptoms questionnaire. Individuals must be at least two weeks post injury but less than 12 months post injury to ensure that symptoms are no longer acute but are current and persistent (Tomfohr-Madsen et al., 2019).
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current acute psychiatric condition, active substance abuse, significant neurological history, and insufficient English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization schedules will be generated by a researcher, independent of both the study and data analysis, who will notify the study co-ordinator of the participant’s treatment condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Waitlist control condition: following the end of the intervention period, those participants initially allocated to the control group will be offered the chance to partake in the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using intention-to-treat principles, differences in main outcome measure (mean RPQ severity scores) between intervention and control groups will be examined using mixed effects regression. Based on expected mean RPQ scores of 8 (SD = 5) for eligible participants, a clinically significant difference of 4 points on the RPQ (standardised mean difference of 0.5) will require 66 participants (33 in each arm) to achieve 90% power at 0.05 significance level. Mixed effects regression will also be used to compare secondary outcome measures (BFI, FSS, ISI, HRQOL, TBI-QOL and DASS-21) across the four time points. GAS goals will be descriptively explored (Perdices, M., How do you know whether your patient is getting better (or worse)? A user's guide. Brain Impairment, 2005. 6(3): p. 219-226.).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2022
Actual
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311385 0
Government body
Name [1] 311385 0
National Health and Medical Research Council
Country [1] 311385 0
Australia
Funding source category [2] 311387 0
University
Name [2] 311387 0
Monash University
Country [2] 311387 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 312776 0
None
Name [1] 312776 0
Address [1] 312776 0
Country [1] 312776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310869 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 310869 0
Ethics committee country [1] 310869 0
Australia
Date submitted for ethics approval [1] 310869 0
22/04/2022
Approval date [1] 310869 0
22/04/2022
Ethics approval number [1] 310869 0
23005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119162 0
Dr Adam McKay
Address 119162 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Faculty of Medicine, Nursing & Health Sciences
Monash University
Building 1/270 Ferntree Gully Road
Notting Hill Vic 3168
Australia
Country 119162 0
Australia
Phone 119162 0
+61 417 227 721
Fax 119162 0
Email 119162 0
[email protected]
Contact person for public queries
Name 119163 0
Adam McKay
Address 119163 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Faculty of Medicine, Nursing & Health Sciences
Monash University
Building 1/270 Ferntree Gully Road
Notting Hill Vic 3168
Australia
Country 119163 0
Australia
Phone 119163 0
+61 3 9902 4188
Fax 119163 0
Email 119163 0
[email protected]
Contact person for scientific queries
Name 119164 0
Adam Mckay
Address 119164 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Faculty of Medicine, Nursing & Health Sciences
Monash University
Building 1/270 Ferntree Gully Road
Notting Hill Vic 3168
Country 119164 0
Australia
Phone 119164 0
+61 3 9902 4188
Fax 119164 0
Email 119164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.