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Trial registered on ANZCTR


Registration number
ACTRN12625001119482p
Ethics application status
Submitted, not yet approved
Date submitted
22/09/2025
Date registered
13/10/2025
Date last updated
13/10/2025
Date data sharing statement initially provided
13/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of telehealth delivery of interdisciplinary treatment for persisting post-concussion symptoms after mild traumatic brain injury (i-RECOveR-TH): a randomised control trial
Scientific title
Evaluation of Interdisciplinary REhabilitation for COncussion Recovery via telehealth (i-RECOveR-TH): Investigating the impact on concussion symptoms in individuals who have experienced a mild traumatic brain injury in a phase II randomised control trial
Secondary ID [1] 315420 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is extending our pilot telehealth trial (ACTRN12624000924550) to evaluate treatment efficacy, and its comparative effectiveness with our existing in-person delivery (ACTRN12622000702718).

Health condition
Health condition(s) or problem(s) studied:
Concussion 338944 0
Persisting post-concussion symptoms 338945 0
Mild traumatic brain injury 338946 0
Traumatic brain injury 338947 0
Condition category
Condition code
Neurological 335236 335236 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 335237 335237 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 335238 335238 0 0
Physiotherapy
Injuries and Accidents 335239 335239 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive intervention from a neuropsychologist, physiotherapist, and sports medicine physician via telehealth. Participants will be posted equipment packs to facilitate physiotherapy treatment via telehealth, including heart rate monitor, paddle pop sticks, laminated pages with numbers and checkers, and a ruler.

All participants will receive 3 initial 60–90-minute consultations independently with a neuropsychologist, physiotherapist, and medicine physician. Telehealth will be facilitated using online video conferencing. Following initial consultations, clinicians will meet via video conference to discuss individualised treatment plans.

Participants will then be offered up to an additional 7 sessions each of neuropsychology, physiotherapy, and medical treatment as required (i.e., including initial consultations, up to 24 sessions in total across the disciplines will be available based on clinical need).

Telehealth treatment sessions will be delivered online via videoconference. 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. Participants will also be offered ongoing medical management/review/consultations as required over the 8-week program.

The psychological intervention will be oriented toward a cognitive-behavioural framework as described by Beck (1979) and will be adapted from previous manuals developed by Ferguson and Mittenberg (1996) and Silverberg et al. (2013) and will comprise of goal setting and review, psychoeducation, activity scheduling, cognitive restructuring, anxiety management training, cognitive compensation intervention and sleep intervention. As part of this therapy, participants will be provided with educational materials adapted from readily available resources (published materials such as the Mild Head Injury Bookelet; https://www.monash.edu/medicine/psych/merrc/resources) as well as provided with material specially designed for this study.

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, 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. 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, walking, and gaze stabilisation or VOR cancellation. Examples of cervical rehabilitation include cervical strengthening such as deep neck flexor strengthening, and proprioception training with a target and a laser to rehabilitate sensory awareness of the neck. 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 85% of the point of failure of the subject on Montreal Virtual Exertion 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. Equipment used throughout the assessment and rehabilitation include various targets (a paddle pop, sticky labels), balls for motion sensitivity and a heart rate monitor for tracking heart rate.

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. To assess physiotherapy treatment fidelity, 10% of the sessions will be rated by an independent physiotherapist.
Intervention code [1] 332030 0
Rehabilitation
Intervention code [2] 332031 0
Behaviour
Intervention code [3] 332032 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 neuropsychology 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. All procedures (e.g. assessment and feedback) will be done via telehealth, however if participants are receiving existing care (i.e., treatment as usual) that is in-person, they will not be asked to stop this treatment in order to participate in this study, for ethical reasons.

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] 342841 0
Post-concussion symptoms as measured by the Rivermead Post-Concussion Symptoms questionnaire.
Timepoint [1] 342841 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] 452328 0
Return to activity as assessed by Goal Attainment Scaling
Timepoint [1] 452328 0
Intervention, Post-intervention (T2). 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] 452329 0
Fatigue
Timepoint [2] 452329 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] 452330 0
Sleep disturbance as assessed by the Insomnia Severity Index
Timepoint [3] 452330 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] 452331 0
Health related quality of life as assessed by the 36-Short form
Timepoint [4] 452331 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] 452332 0
Symptoms of anxiety as assessed by the Depression Anxiety and Stress Scales-21
Timepoint [5] 452332 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] 452333 0
Fear avoidance behaviours
Timepoint [6] 452333 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4). Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion.
Secondary outcome [7] 452334 0
Telehealth Usability
Timepoint [7] 452334 0
Post-Intervention (T3) Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [8] 452335 0
Vestibular and oculomotor functioning will be assessed together as a composite outcome
Timepoint [8] 452335 0
Start of baseline (T1) and Post-intervention (T3). Start of baseline is defined as one day prior to baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [9] 452337 0
Cervical functioning
Timepoint [9] 452337 0
Start of baseline (T1) and Post-intervention (T3). Start of baseline is defined as one day prior to baseline. Post intervention will be defined as one-day post-intervention completion,
Secondary outcome [10] 452338 0
Physiological Functioning
Timepoint [10] 452338 0
Start of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4). Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion.
Secondary outcome [11] 452732 0
Fatigue
Timepoint [11] 452732 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 [12] 452733 0
Cervical functioning
Timepoint [12] 452733 0
and Flexion Rotation testStart of baseline (T1), End of baseline (T2), Post-intervention (T3), and 1-month follow-up (T4). Start of baseline is defined as one day prior to baseline. End of baseline is defined as one day post-baseline. Post intervention will be defined as one-day post-intervention completion.
Secondary outcome [13] 452734 0
Health related quality of life - to inform "cost effectiveness"
Timepoint [13] 452734 0
Baseline (T1) and end of treatment (T3)
Secondary outcome [14] 452735 0
Self-efficacy
Timepoint [14] 452735 0
Baseline (T1) and end of treatment (T3)
Secondary outcome [15] 452736 0
Economic evaluation
Timepoint [15] 452736 0
Baseline (T1) to 2-month followup (T5)

Eligibility
Key inclusion criteria
(a) aged 16 –70 years, (b) sustained mTBI classified using American Congress of Rehabilitation Medicine criteria (ACRM):(31) (c) experiencing 3 or more PCS rated 2 or more over 2 weeks on RPQ (32); (d) >two weeks post-injury, <two years post-injury, (e) sufficient English, (f) reside in a Modified Monash Model classification area 2-6 (Australian Statistical Geography Standards for Remoteness) (g) have access to computer or tablet with an Internet connection that has sufficient bandwidth for videoconferencing.
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)
Randomisation 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants recruited for telehealth treatment will be participate
2 (treatment condition) x 3 (assessment time) factorial design. Participants will be randomly allocated to either 1) i-RECOveR-TH (treatment) or 2) Assessment and Standard Care (control). Participants will be assessed (i) pre-intervention, (ii) post-intervention (primary endpoint), and at (iii) 2 months post-intervention follow-up.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat analysis will be conducted. The primary outcome will be RPQ score at post-treatment. Secondary outcomes will be (1) RPQ at 2 month follow-up, (2) GAS goal attainment scores (3) BFI fatigue (4) ISI scores (5) FSS fatigue, (6) DASS scores (5) SF-36v2 quality of life (6) Fear Avoidance scores (7) MOVE (9) VOMS (8) SPNTT (9) Flexion Rotation Test (10) Economic evaluation. Regression methods appropriate for the analysis of repeated measures data, consisting of mixed-model regression for normally distributed outcomes and or generalised estimating equations incorporating generalized models for non-normal data, will be used to model RPQ scores and other outcomes as functions of treatment (i-RECOveR-TH vs standard care control) and time point. We will model relationships of both primary and secondary outcomes with age, gender, time post-injury, IQ, baseline attention, memory, depression, anxiety, fear avoidance and psychiatric history to examine predictors of treatment response. We will also conduct a non-inferiority analysis comparing treatment response with that from our in-person delivered treatment trialled in a RCT (ACTRN12622000702718).

We will also conduct an economic evaluation which includes a cost of implementation analysis (essential for future intervention scaling), a cost-effectiveness analysis (to understand the impact of the intervention on the individual participant’s quality of life) and a social return on investment analysis (to report the social value of the intervention). Costs will be presented in $AUD 2028/29 with a time horizon aligned to the time of intervention commencement to 2-months post intervention. The cost of implementation analysis will include costs for set up, intervention, marketing and communication, and equipment for the intervention.

The social return on investment analysis will be calculated for both intervention and control groups and compared. Investment value is based on cost of implementation analysis, and return value is based on the differences between the baseline and 2-month health service utilisation, health and social care utilisation, engagement in employment, education, volunteering and leisure activities. Social return on investment is the ratio between the investment and the social return.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2026
Actual
Date of last participant enrolment
Anticipated
1/06/2029
Actual
Date of last data collection
Anticipated
10/08/2029
Actual
Sample size
Target
143
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 320002 0
Government body
Name [1] 320002 0
National Health and Medical Research Council (NHMRC)
Country [1] 320002 0
Australia
Funding source category [2] 320003 0
University
Name [2] 320003 0
Monash University
Country [2] 320003 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 322546 0
None
Name [1] 322546 0
Address [1] 322546 0
Country [1] 322546 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318543 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 318543 0
Ethics committee country [1] 318543 0
Australia
Date submitted for ethics approval [1] 318543 0
23/09/2025
Approval date [1] 318543 0
Ethics approval number [1] 318543 0

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

Contacts
Principal investigator
Name 144526 0
Prof Jennie Ponsford
Address 144526 0
Monash University, 18 Innovation Walk Clayton campus VIC 3800
Country 144526 0
Australia
Phone 144526 0
+61 3 9905 1552
Fax 144526 0
Email 144526 0
[email protected]
Contact person for public queries
Name 144527 0
Stephanie Antonopoulos
Address 144527 0
Monash-Epworth Rehabilitation Research Centre School of Psychological Sciences 185-187 Hoddle Street Richmond, VIC 3121 Australia
Country 144527 0
Australia
Phone 144527 0
+61 406776088
Fax 144527 0
Email 144527 0
[email protected]
Contact person for scientific queries
Name 144528 0
Stephanie Antonopoulos
Address 144528 0
Monash-Epworth Rehabilitation Research Centre School of Psychological Sciences 185-187 Hoddle Street Richmond, VIC 3121 Australia
Country 144528 0
Australia
Phone 144528 0
+61 406776088
Fax 144528 0
Email 144528 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.