Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001111965
Ethics application status
Approved
Date submitted
30/07/2020
Date registered
27/10/2020
Date last updated
31/05/2024
Date data sharing statement initially provided
27/10/2020
Date results provided
31/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and Evaluation of an Interdisciplinary Intervention for Chronic Concussion Symptoms
Scientific title
Development and Evaluation of an Interdisciplinary Intervention for Persistent Post-Concussion Symptoms in Individuals who have Experienced a Mild Traumatic Brain Injury
Secondary ID [1] 300348 0
None
Universal Trial Number (UTN)
Trial acronym
iRECOveR: Interdisciplinary Rehabilitation for Concussion Recovery
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 315963 0
Post-concussion syndrome 318860 0
traumatic brain injury 318861 0
Condition category
Condition code
Neurological 314232 314232 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 314233 314233 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 314234 314234 0 0
Physiotherapy
Injuries and Accidents 316864 316864 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. 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 be offered 8 sessions each of psychological and physiotherapy treatment over 12 weeks as required based on the initial interviews (face-to-face or Telehealth). 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. If necessary they can be spread out to fortnightly.

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 psychoeducation, activity scheduling, cognitive restructuring, anxiety management training, and sleep intervention. As part of this therapy, participants will be provided with educational materials adapted from readily available 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 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. To assess physiotherapy treatment fidelity, 10% of the sessions will be rated by an independent physiotherapist.
Intervention code [1] 316625 0
Rehabilitation
Intervention code [2] 316626 0
Behaviour
Intervention code [3] 316627 0
Treatment: Other
Comparator / control treatment
No control group. This study will be a single case series experimental design with multiple baselines. Participants' results on key outcome measures will be compared at the start of baseline, before the intervention, after the intervention and at one and two-month follow-up.

Participants will be randomised to baseline periods of 2, 4, or 6 weeks. The efficacy of the intervention for reducing post-concussion symptoms will be evaluated using a case-series design with multiple baselines,
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322621 0
Post-concussion symptoms as measured by the Rivermead Post-Concussion Symptoms questionnaire.
Timepoint [1] 322621 0
Start of baseline (T1), Baseline, End of baseline (T2), Intervention, Post-intervention (T3), 1-month follow-up (T4), and 3-month follow-up (T5).

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,

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] 379069 0
Return to activity as assessed by Goal Attainment Scaling
Timepoint [1] 379069 0
Intervention, Post-intervention (T3) and 1-month follow-up (T4)

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 one-day post-intervention,
Secondary outcome [2] 379070 0
Fatigue as assessed by the Brief Fatigue Inventory and the Fatigue Severity Scale
Timepoint [2] 379070 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,
Secondary outcome [3] 379071 0
Sleep disturbance as assessed by the Insomnia Severity Index
Timepoint [3] 379071 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,
Secondary outcome [4] 379072 0
Health related quality of life as assessed by the 36-Short form
Timepoint [4] 379072 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,
Secondary outcome [5] 379073 0
Symptoms of depression as assessed by the Depression Anxiety and Stress Scales-21
Timepoint [5] 379073 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,
Secondary outcome [6] 388258 0
Symptoms of anxiety as assessed by the Depression Anxiety and Stress Scales-21
Timepoint [6] 388258 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,
Secondary outcome [7] 388259 0
Symptoms of stress as assessed by the Depression Anxiety and Stress Scales-21
Timepoint [7] 388259 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,

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 1 month; Tator et al., 2016) assessed on the Rivermead Post-Concussion Symptoms questionnaire. Individuals must be at least four 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome measure. Systematic visual analysis of the RPQ will be conducted as per established guidelines in (Gast, D.L. and A.D. Spriggs, Visual analysis of graphic data, in Single case research methodology. 2014, Routledge. p. 176-210) incorporating both within- and between-phase analyses to evaluate trend, level, and stability of data. Planned comparisons between baseline and intervention phases will be conducted using the non-overlap method, Tau-U [Parker, R.I., et al., Combining nonoverlap and trend for single-case research: Tau-U. Behavior Therapy, 2011. 42(2): p. 284-299.]. Time series analyses will also be explored.

Secondary outcome measures. 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.). Wilcoxon signed-rank test will be used to compare secondary outcome measures (BFI, FSS, ISI, HRQOL, and DASS-21) across the four time points.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2020
Actual
22/01/2021
Date of last participant enrolment
Anticipated
30/06/2021
Actual
3/12/2021
Date of last data collection
Anticipated
1/02/2022
Actual
13/06/2022
Sample size
Target
12
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304769 0
University
Name [1] 304769 0
Monash University
Country [1] 304769 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 305083 0
None
Name [1] 305083 0
Address [1] 305083 0
Country [1] 305083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305185 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 305185 0
Ethics committee country [1] 305185 0
Australia
Date submitted for ethics approval [1] 305185 0
07/02/2020
Approval date [1] 305185 0
15/04/2020
Ethics approval number [1] 305185 0
23005

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

Contacts
Principal investigator
Name 99530 0
A/Prof Catherine Willmott
Address 99530 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 99530 0
Australia
Phone 99530 0
+61399024480
Fax 99530 0
Email 99530 0
[email protected]
Contact person for public queries
Name 99531 0
Catherine Willmott
Address 99531 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 99531 0
Australia
Phone 99531 0
+61399024480
Fax 99531 0
Email 99531 0
[email protected]
Contact person for scientific queries
Name 99532 0
Catherine Willmott
Address 99532 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 99532 0
Australia
Phone 99532 0
+61399024480
Fax 99532 0
Email 99532 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
SourceTitleYear of PublicationDOI
EmbaseInterdisciplinary Rehabilitation for Concussion Recovery (i-RECOveR): protocol of an investigator-blinded, randomised, case series with multiple baseline design to evaluate the feasibility and preliminary efficacy of a 12-week treatment for persistent post-concussion symptoms.2022https://dx.doi.org/10.1186/s40814-022-01153-6
N.B. These documents automatically identified may not have been verified by the study sponsor.