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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000612314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
27/03/2026
Date registered
Help: Date registered
18/05/2026
Date last updated
Help: Date last updated
17/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of using Virtual Reality in combination with cognitive behavioral therapy to treat driving anxiety after motor vehicle crashes
Scientific title
The effect of using Virtual Reality in combination with cognitive behavioral therapy to treat driving anxiety after motor vehicle crashes
Additional trial identifiers [1] 316893 0
Nil
Universal Trial Number (UTN)
Trial acronym
INSPIRE
Related trial records

Health condition
Health condition(s) studied:
anxiety 341302 0
fear of driving 341303 0
Condition category
Condition code
Mental Health 337373 337373 0 0
Other mental health disorders
Injuries and Accidents 337519 337519 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants randomised to the intervention group will receive an 8-week manualised Cognitive Behavioural Therapy program for driving anxiety, delivered individually by a Clinical Psychologist. Participants in both the intervention and control groups will attend one 1-hour CBT session per week for 8 weeks. The CBT component will be the same in both groups and will include psychoeducation, self-monitoring using a cognitive-behavioural emotion model, flexible thinking/cognitive restructuring, and preparation for exposure-based practice.

The exposure component of treatment will occur outside the weekly CBT sessions and will be individualised for each participant and typically be 30 minutes to 1 hour per day. During the CBT sessions, the Clinical Psychologist will work with each participant to identify their specific driving-related fears, avoidance behaviours, and treatment goals. A personalised exposure hierarchy will then be developed, ranking feared driving situations from least to most distressing using Subjective Units of Distress Scale ratings. This hierarchy will guide the participant’s between-session exposure tasks and will be reviewed and adjusted during the weekly CBT sessions according to progress, tolerance, safety, and clinical need.

The difference between groups relates to the mode of exposure practice completed between sessions. Participants in the control group will complete real-world driving exposure only. Participants in the intervention group will complete both real-world driving exposure and Virtual Reality Exposure Therapy. VRET will involve use of an immersive VR headset to complete simulated driving exposure scenarios relevant to the participant’s personalised exposure hierarchy, such as particular road types, traffic conditions, weather conditions, lighting conditions, or driving situations. VRET is intended to supplement, not replace, real-world exposure.

For participants in the intervention group who attend online sessions, the VR headset will be posted to them before the commencement of the exposure phase, with instructions for setup and use provided by the Clinical Psychologist. For participants attending in person, the VR headset will be provided at the commencement of Session 3, when the exposure phase begins. Sessions 1 and 2 will focus on psychoeducation, self-monitoring, flexible thinking, and preparation for exposure, so the headset is not required before this point.

The intervention is individualised within the manualised CBT framework. All participants receive the same core CBT program, but the specific exposure tasks are tailored to each participant’s fear profile. For example, a participant whose anxiety relates to roundabouts may complete graded exposure to roundabout scenarios, while a participant whose anxiety relates to night driving may complete exposure tasks involving low-light or night-time driving conditions. The purpose of individualisation is to ensure that exposure practice targets the participant’s own anxiety-provoking situations while maintaining consistency in the therapeutic framework.

Participants in the intervention group will also complete a prescribed home-based VRET program between weekly CBT sessions. This will involve using the VR headset at home to complete clinician-prescribed exposure scenarios based on the participant’s personalised hierarchy. The home VRET program will be conservative and will focus on scenarios that have been prepared for, or comfortably achieved, during therapist-guided planning. Participants will be asked to complete at least one home VRET exposure session per day during the exposure phase, with the exact duration and frequency adjusted by the Clinical Psychologist according to the participant’s progress, tolerance, and practical circumstances.

Adherence to the home VRET program will be monitored through an online VR/video management system, which allows the Clinical Psychologist to prescribe specific VR scenarios and review participant engagement with the assigned content. Participants may also be asked to record completion of exposure tasks and distress ratings to support review in the next weekly CBT session. Treatment fidelity will be supported through psychologist-completed checklists documenting delivery of the CBT protocol and, for the intervention group, prescription and review of VRET exposure tasks.
Intervention code [1] 333593 0
Treatment: Devices
Intervention code [2] 333594 0
Rehabilitation
Description of the comparator or control
Participants randomised to the control group will receive an 8-week manualised Cognitive Behavioural Therapy program for driving anxiety, delivered individually by a licensed and accredited Clinical Psychologist trained in CBT. Participants will attend one 1-hour session per week for 8 weeks, delivered either in person in UQ-held rooms at STARS Hospital or via telehealth, according to participant preference.

The CBT program is evidence-based and structured using a treatment manual to support consistent delivery across participants. The program includes psychoeducation about driving anxiety, self-monitoring of anxiety responses using a cognitive-behavioural emotion model, flexible thinking/cognitive restructuring to identify and modify threat-focused thoughts, and preparation for exposure-based practice. During the sessions, the Clinical Psychologist will help participants identify their specific driving-related fears, avoidance behaviours, safety behaviours, and treatment goals.

The exposure component will be individualised for each participant. A personalised exposure hierarchy will be developed, ranking feared driving situations from least to most distressing using Subjective Units of Distress Scale ratings. Participants in the control group will complete real-world driving exposure tasks between sessions only, without access to the Virtual Reality Exposure Therapy component. The exposure tasks will be reviewed and adjusted during the weekly CBT sessions according to participant progress, tolerance, safety, and clinical need.

Treatment fidelity will be supported through use of the manualised CBT protocol and psychologist-completed checklists documenting delivery of the planned CBT components.
Control group
Active

Outcomes
Primary outcome [1] 344890 0
Acceptability of the intervention
Timepoint [1] 344890 0
End of program (8 weeks from baseline)
Primary outcome [2] 345353 0
Appropriateness of the intervention
Timepoint [2] 345353 0
End of program (8 weeks from baseline)
Primary outcome [3] 345354 0
Feasibility of the intervention
Timepoint [3] 345354 0
End of program (8 weeks from baseline)
Secondary outcome [1] 459635 0
Fear of Driving
Timepoint [1] 459635 0
Baseline, 8 weeks from baseline after final therapy session, 3 months after final therapy session
Secondary outcome [2] 459636 0
Anxiety
Timepoint [2] 459636 0
Baseline, 8 weeks from baseline after final therapy session, 3 months after final therapy session
Secondary outcome [3] 459637 0
Wellbeing
Timepoint [3] 459637 0
Baseline, 8 weeks from baseline after final therapy session, 3 months after final therapy session
Secondary outcome [4] 459638 0
General Health
Timepoint [4] 459638 0
Baseline, 8 weeks from baseline after final therapy session, 3 months after final therapy session
Secondary outcome [5] 459639 0
Post Traumatic Stress
Timepoint [5] 459639 0
Baseline, 8 weeks from baseline after final therapy session, 3 months after final therapy session
Secondary outcome [6] 459640 0
Pain Disability
Timepoint [6] 459640 0
Baseline, 8 weeks from baseline after final therapy session, 3 months after final therapy session
Secondary outcome [7] 459641 0
Pain
Timepoint [7] 459641 0
Baseline, 8 weeks from baseline after final therapy session, 3 months after final therapy session
Secondary outcome [8] 459642 0
Distress
Timepoint [8] 459642 0
Each treatment (once per week for 8 weeks)
Secondary outcome [9] 459643 0
Motion sickness
Timepoint [9] 459643 0
Each treatment, once per week for 8 weeks, after therapy session
Secondary outcome [10] 459644 0
Therapeutic relationship between the participant and the treating Clinical Psychologist
Timepoint [10] 459644 0
After therapy session in week 2 and after final therapy session
Secondary outcome [11] 459645 0
Participant’s assessment of the quality of each therapy session
Timepoint [11] 459645 0
Each treatment, once per week for 8 weeks, after therapy session
Secondary outcome [12] 459646 0
Clinical result
Timepoint [12] 459646 0
End of treatment, 8 weeks from baseline after final therapy session
Secondary outcome [13] 459647 0
Participants’ views of the treatment, including perceived benefits and limitations, barriers and facilitators to participation, experience of the CBT and/or VRET components, perceived relevance to their driving anxiety, safety and comfort, and suggestions for improvement
Timepoint [13] 459647 0
End of treatment, 8 weeks from baseline after final therapy session
Secondary outcome [14] 459648 0
Adherence to exposure practice
Timepoint [14] 459648 0
End of treatment, 8 weeks from baseline after final therapy session
Secondary outcome [15] 459649 0
Safety/adverse events
Timepoint [15] 459649 0
Each treatment, once per week for 8 weeks, after therapy session
Secondary outcome [16] 466441 0
Driving Cognition
Timepoint [16] 466441 0
Baseline, 8 weeks from baseline after final therapy session, 3 months after final therapy session
Secondary outcome [17] 466442 0
Avoidance of driving and passenger situations
Timepoint [17] 466442 0
Baseline, 8 weeks from baseline after final therapy session, 3 months after final therapy session
Secondary outcome [18] 466443 0
General Depression Symptoms
Timepoint [18] 466443 0
Each treatment, once per week for 8 weeks, after therapy session

Eligibility
Key inclusion criteria
A clinical psychologist will screen for eligibility based on history and clinical interview. Participants will be eligible for the trial if they meet the following inclusion criteria:
1. Aged 18-65 years old
2. Have a valid driver’s license
3. Self-reported driving anxiety or avoidance of driving a car for at least four weeks after a MVC
4. No or stable therapy with psychoactive medication in the last four weeks
5. Meet the criteria for specific phobia of the situational type, panic disorder, agoraphobia, social anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) or present with sub-clinical symptoms of these disorders
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants will be excluded if they have:
1. A diagnosis or evidence of Post-Traumatic Stress Disorder (PTSD)
2. Psychosis or other premorbid mental disorders or any contraindication to exposure therapy
3. Thoughts, behaviours, actions that indicate a person is considering, planning or engaging in actions that could result in their own death by suicide
4. Severe motion sickness
5. Epilepsy or seizure disorders
6. Significant uncorrected vision problems (such as severe myopia, strabismus or colour blindness)
7. Already participated in similar Immersive Virtual Reality (IVR) studies
8. Severe neck pain and are unlikely to tolerate wearing an IVR headset

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. To ensure balanced distribution of baseline driving anxiety across groups, participants will be stratified into distinct cohorts based on baseline severity scores on the Instrument for Fear of Driving (IFD), defined as Moderate Clinical Driving Fear (IFD score 11–15) or Severe Clinical Driving Fear (IFD score 16–20).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be conducted according to an a priori statistical analysis plan. Process outcomes, including eligibility, recruitment, retention, adherence, adverse events, and satisfaction, will be analysed using descriptive statistics. Qualitative interview data will be analysed using thematic analysis.

Clinical outcomes will be summarised using means, standard deviations, and 95 percent confidence intervals, where appropriate, to describe within-group and between-group change over time and to assess sensitivity to change. The primary analysis will use the per-protocol dataset, defined as randomised participants who attended at least 3 consultations and completed the primary outcome measures at 8 weeks.

Between-group differences in anxiety outcomes will be compared using linear regression modelling adjusted for baseline scores. Non-parametric equivalent tests will be used if model assumptions are not met. Similar analyses will be performed for secondary outcomes. Model assumptions will be assessed using standard diagnostic plots and methods.

An intention-to-treat analysis will be conducted as a sensitivity analysis, with multiple imputation used for missing data where appropriate. The statistical significance level will be set at a p value less than 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2026
Actual
21/07/2026
Date of last participant enrolment
Anticipated
31/03/2027
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
30
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321489 0
Government body
Name [1] 321489 0
Motor Accident Insurance Commission QLD
Country [1] 321489 0
Australia
Primary sponsor type
University
Name
The University Of Queensland
Address
Country
Australia
Secondary sponsor category [1] 324244 0
None
Name [1] 324244 0
Address [1] 324244 0
Country [1] 324244 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320023 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 320023 0
Ethics committee country [1] 320023 0
Australia
Date submitted for ethics approval [1] 320023 0
12/12/2025
Approval date [1] 320023 0
01/04/2026
Ethics approval number [1] 320023 0
2025/HE000849

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

Contacts
Principal investigator
Name 149174 0
Prof Trevor Russell
Address 149174 0
RECOVER Injury Research Centre, The University of Queensland, Level 7, Surgical Treatment and Rehabilitation Service, 296 Herston Road, Herston, QLD, 4006, Australia
Country 149174 0
Australia
Phone 149174 0
+61 432903212
Fax 149174 0
Email 149174 0
[email protected]
Contact person for public queries
Name 149175 0
Trevor Russell
Address 149175 0
RECOVER Injury Research Centre, The University of Queensland, Level 7, Surgical Treatment and Rehabilitation Service, 296 Herston Road, Herston, QLD, 4006, Australia
Country 149175 0
Australia
Phone 149175 0
+61 432903212
Fax 149175 0
Email 149175 0
[email protected]
Contact person for scientific queries
Name 149176 0
Trevor Russell
Address 149176 0
RECOVER Injury Research Centre, The University of Queensland, Level 7, Surgical Treatment and Rehabilitation Service, 296 Herston Road, Herston, QLD, 4006, Australia
Country 149176 0
Australia
Phone 149176 0
+61 432903212
Fax 149176 0
Email 149176 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.