Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000676415
Ethics application status
Approved
Date submitted
6/02/2025
Date registered
26/06/2025
Date last updated
26/06/2025
Date data sharing statement initially provided
26/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychological and Neurobiological changes following EMDR therapy in individuals with concussion: A Pilot Study
Scientific title
Does Eye Movement Desensitisation Reprocessing (EMDR) Therapy have an effect on well-being and the brain following sport related concussion
Secondary ID [1] 313888 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 336560 0
fatigue 337052 0
problems with memory 336563 0
anxiety 336566 0
dizziness 336564 0
post concussion syndrome 336562 0
Mild traumatic brain injury (MTBI) 336561 0
depression 336565 0
problems with concentration 336681 0
headaches 336682 0
Condition category
Condition code
Mental Health 333075 333075 0 0
Depression
Injuries and Accidents 333183 333183 0 0
Other injuries and accidents
Neurological 334070 334070 0 0
Studies of the normal brain and nervous system
Mental Health 334069 334069 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 334068 334068 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eye Movement Desensitisation and Reprocessing (EMDR) is a psychological intervention based on the Adaptive Information Processing (AIP) model proposed by Shapiro (2007) that is focused on reducing trauma by altering how memories are stored in the brain. During standard treatment, the therapist will lead the client through a series of bilateral eye movements as they are recalling traumatic experiences with the aim of reducing the vividness and emotion associated with those memories (Shapiro, 2017).
For this study at initial contact the participant will be provided with participant information and consent forms. They will be asked to complete information about their history, in particular concussion and psychiatric history. The participant will then be assessed as suitable with EMDR - Recent Traumatic Episode Protocol (R-TEP). EMDR R-TEP is a comprehensive current trauma focused protocol for early intervention that incorporates and extends the existing eye movement desensitisation (EMD) and Recent Event protocols, together with additional measures for containment and safety. The EMDR R-TEP usually requires 2-4 sessions, which can optionally be conducted on successive days. For the current study, we will provide 2 sessions consisting of one single session and one follow up session.
The single session R-Tep procedure involves the participant being:
1. Assessed for suitability for treatment, referred to as phase 1
2. Taught self regulation skills with the 4 Elements protocol, referred to as phase 2
3. Asked to describe the event
4. Asked to scan the event for the worst moment and then to assess the point of disturbance
5. The point of disturbance is assessed including the negative and positive cognition, validity of cognition, subjective unit of distress, emotion and body sensation of distress, referred to as phase 3
6. The participant is asked to hold in mind the point of disturbance and bilateral stimulation is applied (e.g. eye movements), referred to as phase 4.
7. When the participant reports a reduction in distress below 2 out of 10 the participant is asked to hold in mind the positive cognition and to rate the validity of cognition until it increases to at least 6 out of 7 (with bilateral stimulation), referred to as phase 5
8. The participant is then asked to scan the event for the next point of disturbance and phase 3 to 5 are repeated until the participant reports no further point of disturbance for the event.
9. The participant is then asked to think of the entire event with the positive cognition and to assess the validity of cognition with bilateral stimulation until the validity of cognition for the entire event rises to at least 6 out of 7.
10. The participant is then asked to hold in mind the entire event with the positive cognition and to scan their body reporting any body sensations which are then processed with bilateral stimulation.
11. The session is then closed following phase 7 closure procedure.

The Second follow up review session
At the review session the participant is asked general questions about the event to determine if there remains any unresolved disturbance.


At Testing Session 1 (TS1) the R-TEP single session treatment will be delivered face to face at Swinburne University of Technology clinical rooms, in a single episode of approximately 60-90 minutes by a qualified psychologist and accredited EMDR Therapist with skills in R-TEP. There is going to be a follow-up review session, two weeks after TS1 at Testing Session 2 (TS2) for the intervention group. This makes 2 treatment sessions for the intervention group, consisting of one R-TEP treatment and one review session.

The overall duration of participation in this study involves 5 testing sessions following TS1 (intervention). The participants will be followed up at 2 weeks (TS2), 6 weeks (TS3), 3 months (TS4) and 6 months post-intervention/treatment commencement (TS5).

Fidelity to the protocol will be assessed via in session video recording by an independent EMDR consultant experienced in the R-TEP protocol.
The first 8 participant block enrolled in this trial will receive the EMDR intervention; the next 7 participant block enrolled will receive care as usual; we will alternate until we reach our sample size of 30 participants.


Intervention code [1] 330474 0
Treatment: Other
Comparator / control treatment
the control group will receive care as usual consisting of GP referral and any prescribed medication by GP, booked GP appointments
Control group
Active

Outcomes
Primary outcome [1] 341595 0
Changes in post concussion symptoms (primary outcome)
Assessment method [1] 341595 0
Assessment; Riversmead Post Concussion Symptoms Questionnaire to measure concussion symptoms
Timepoint [1] 341595 0
Intervention group TS1: baseline -before the EMDR therapy TS2: Week 2 post intervention commencement TS3: Week 6 post intervention commencement TS4: Month 3 post intervention commencement TS5: Month 6 Control group The control group will also be assessed at the equivalent time point but for them the intervention will be care as usual. TS1: at baseline (before care as usual) TS2: Week 2 post intervention commencement TS3: Week 6 post intervention commencement TS4: Month 3 post intervention commencement TS5: Month 6 post intervention commencement
Primary outcome [2] 340619 0
Changes in the brain function (primary outcome)
Assessment method [2] 340619 0
Assessment; to measure functional connectivity with resting-state (fMRI) and Magnetoencephalography (MEG ) scans
Timepoint [2] 340619 0
Intervention group TS1: Baseline-before EMDR therapy TS4: Month 3: post intervention commencement Control group The control group will also be assessed at the equivalent time point but for them the intervention will be care as usual. Ts1: before EMDR therapy TS4: Month 3: post intervention commencement
Primary outcome [3] 341767 0
changes in brain structure (composite of structural imaging methods )
Assessment method [3] 341767 0
diffusion weighted imaging (DWI) and T2 flair imaging and T1 imaging and susceptibility weighted imaging
Timepoint [3] 341767 0
Intervention group TS1: Baseline-before EMDR therapy TS4: Month 3: post intervention commencement Control group The control group will also be assessed at the equivalent time point but for them the intervention will be care as usual. Ts1: before EMDR therapy TS4: Month 3: post intervention commencement
Secondary outcome [1] 444652 0
Changes in mood (composite of Depression, Anxiety and Stress)
Assessment method [1] 444652 0
DASS21 to measure of Depression, Anxiety and Stress
Timepoint [1] 444652 0
Intervention group TS1: baseline -before the EMDR therapy TS2: Week 2 post intervention commencement TS3: Week 6 post intervention commencement TS4: Month 3 post intervention commencement TS5: Month 6 post intervention commencement Control group The control group will also be assessed at the equivalent time point but for them the intervention will be care as usual; TS1: at baseline (before care as usual) TS2: Week 2 post intervention commencement TS3: Week 6 post intervention commencement TS4: Month 3 post intervention commencement TS5: Month 6 post intervention commencement
Secondary outcome [2] 444653 0
Quality of life
Assessment method [2] 444653 0
EQ5D5L Quality of Life across 5 dimensions
Timepoint [2] 444653 0
Intervention group TS1: baseline -before the EMDR therapy TS2: Week 2 post intervention commencement TS3: Week 6 post intervention commencement TS4: Month 3 post intervention commencement TS5: Month 6 post intervention commencement Control group The control group will also be assessed at the equivalent time point but for them the intervention will be care as usual; TS1: at baseline (before care as usual) TS2: Week 2 post intervention commencement TS3: Week 6 post intervention commencement TS4: Month 3 post intervention commencement TS5: Month 6 post intervention commencement
Secondary outcome [3] 444651 0
changes in cognitive function (memory, attention and concentration will be assessed as a composite outcome
Assessment method [3] 444651 0
Assessments: WAIS (WAIS Digit Span Test, WAIS Letter Number Sequencing, WAIS Symbol Search, WAIS Verbal Fluency Test)
Timepoint [3] 444651 0
Intervention Group TS1: Baseline-before EMDR therapy TS2: Week 2 post intervention commencement TS4: Month 3: post intervention commencement Control group The control group will also be assessed at the equivalent time point but for them the intervention will be care as usual; TS1: at baseline (before care as usual) TS2: Week 2 post intervention commencement TS4: Month 3 post intervention commencement

Eligibility
Key inclusion criteria
In order to be eligible to take part in the study, participants will be required to be between ages 18 to 65, are fluent in English, have sustained a concussion within the past seven days and demonstrate cognitive capacity to provide informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants under the age of 18 and over the age of 75 will be excluded from participating in the current research. Also, individuals with a history of neurological illness, psychotic disorder, and current use of psychotropic medication will be excluded. Further the regular smoking, fear of enclosed spaces and other fMRI contra-indications (e.g., non-removable metal implants) will be screened for and be basis of exclusion during the fMRI and MEG screening procedures.

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Changes in wellbeing (mood, quality of life) are measured by completion of surveys that utilise standardised and validated measures. Changes in attention/concentration, processing speed and memory are measured by completion of WAIS subtests administered by the student researcher or Dr de Boer. The effect of the EMDR intervention will be measured by contrasting Group 1 and Group 2 across time for the outcomes of interest. Outcomes will be compared between and within groups using a mixed design analysis of variance (ANOVA) where group (either Group 1: Intervention or Group 2: Control) represent the between subjects variable and Time represents the within subjects variable. The effect of Time and Time by Group interactions will be observed and follow up analyses will be conducted as required. Partial eta squared will be used to calculate the size of the effect (eta squared of 0.01 or more indicates a small effect; eta squared of.06 or more indicates a medium effect size; eta squared of 0.14 or more indicates a large effect size (Tabachnik & Fidell, 2019). A two tailed alpha significance criterion of 0.05 will be used for all tests.

Brain Scan
Pre- processing, co registration and source space analysis of fMRI/MEG data will be conducted using MNE-Python software using standard in-house methods, while T1 data will be pre-processed using Freesurfer. Coregistration of the fMRI/MEG data to the preprocessed T1- weighted structural image (Freesurfer output) will be conducted by aligning the digitized cortical landmark points (nasion, and right and left pre-auricular points) to the structural image. The digitized head shape will then be coregistered to respective participant scalp surfaces using an iterative closest point algorithm (Gramfort et al., 2014). The forward solution will be obtained automatically, with 5 mm separation between dipole sources to obtain the gain matrix (Gramfort et al., 2014). The gain matrix will subsequently be used to obtain the inverse solution. The density of the cortical current source for event-types of interest will be calculated using the minimum norm estimate (MNE), which accounts for the superficial source bias by applying a depth-weighting scheme that is based on the source covariance matrix (Gramfort et al., 2014).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2025
Actual
Date of last participant enrolment
Anticipated
2/08/2027
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318357 0
Charities/Societies/Foundations
Name [1] 318357 0
Barbara Dicker Brain Foundation
Country [1] 318357 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Country
Australia
Secondary sponsor category [1] 320759 0
None
Name [1] 320759 0
Country [1] 320759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316988 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 316988 0
Ethics committee country [1] 316988 0
Australia
Date submitted for ethics approval [1] 316988 0
10/12/2024
Approval date [1] 316988 0
07/04/2025
Ethics approval number [1] 316988 0
20257925-21122

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 139670 0
Ms Fiona Mawson
Address 139670 0
Swinburne University of Technology, Faculty of Health Sciences, PO BOX 218, Hawthorn, Victoria, 3123
Country 139670 0
Australia
Phone 139670 0
+61 424 204 936
Email 139670 0
fmawson@swin.edu.au
Contact person for public queries
Name 139671 0
Fiona Mawson
Address 139671 0
Swinburne University of Technology, Faculty of Health Sciences, PO BOX 218, Hawthorn, Victoria, 3123
Country 139671 0
Australia
Phone 139671 0
+61 424 204 936
Email 139671 0
fmawson@swin.edu.au
Contact person for scientific queries
Name 139672 0
Laura Tirlea
Address 139672 0
Department of Biomedical, Health and Exercise Sciences|School of Health Sciences, Swinburne University of Technology Mail: H31|PO Box 218 Hawthorn| Vic 3122|
Country 139672 0
Australia
Phone 139672 0
+61 405 195 301
Email 139672 0
lauratirlea@swin.edu.au

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.