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Trial registered on ANZCTR
Registration number
ACTRN12626001028392
Ethics application status
Approved
Date submitted
21/07/2026
Date registered
20/08/2026
Date last updated
20/08/2026
Date data sharing statement initially provided
20/08/2026
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluating an Integrated Trauma Treatment Program (ITTP) for Paramedic First Responders with Post Traumatic Stress Disorder (PTSD)
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Scientific title
Evaluation of the Integrated Trauma Treatment Program (ITTP) for Paramedic First Responders with Post Traumatic Stress Disorder (PTSD) symptoms: PTSD symptom severity and return-to-work outcomes
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Additional trial identifiers [1]
317921
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Post traumatic stress disorder (PTSD) symptoms
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Condition category
Condition code
Mental Health
338985
338985
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
ITTP is an intensive outpatient treatment program for post-traumatic stress in paramedic first responders that integrates four different treatments. Each of the 9 treatment days across three weeks (3 days per week, 8 hours per day, with lunch and morning break included) are held in person at the clinic at the Turner Clinics, Monash University and run by trained psychologists. Each day includes: i) individual EMDR; ii) individual Virtual Reality delivered exposure therapy; iii) group trauma-focussed psychoeducation; and iv) somatic-based therapy to support arousal regulation.
i) EMDR
EMDR is a psychotherapy treatment designed to alleviate the distress associated with traumatic memories or images. An initial assessment is conducted by a psychologist trained in EMDR to map a personalised treatment plan for each participant, with a list of the most disturbing memories to process during the ITTP delivery (highest disturbance processed first). This plan will take approximately 30 minutes. Treatment is delivered individually in nine 90-minute sessions using a structured 8-phased protocol. The psychologist supports individuals to recall the relevant distressing memory whist simultaneously focussing on an external stimulus (thereby taxing their working memory). External stimuli may involve the participant making directed eye movements, listening to audio content, responding to questions, or engaging in complex tapping patterns. EMDR 2.0 techniques may be included to intensify the level of taxation (e.g., faster eye movements, multiple distraction activities at once). Regular breaks are included to pause and reflect on the experience. The goal is a reduction in distress associated with the memory and increased access to more adaptive informed (e.g., positive self-views) to support memory resolution.
Each session will typically involve the following steps:
Review and Preparation – The psychologist will briefly review the participant’s current wellbeing, assess readiness for memory processing, and reinforce coping and emotional regulation strategies where required. Subsequent sessions will review previously processed memories.
Target Identification – A specific traumatic memory, distressing image, trigger, or related experience will be identified as the focus of the session.
Assessment – The participant will identify key aspects of the target memory, including associated thoughts, emotions, physical sensations, and the current level of distress associated with the memory.
Memory Processing – The participant will be asked to bring the memory to mind while simultaneously engaging in structured dual-attention tasks designed to support memory processing. EMDR 2.0 procedures may be incorporated, including enhanced working memory taxation strategies intended to increase processing efficiency.
Ongoing Reassessment – Throughout the processing phase, the psychologist will regularly assess changes in distress, thoughts, emotions, and physical sensations, and will guide the participant through additional processing as required.
Installation of Adaptive Beliefs – As distress reduces, attention may shift toward strengthening more adaptive and helpful beliefs associated with the memory.
Body Scan – The participant will be invited to notice any remaining physical discomfort or activation associated with the memory, with additional processing undertaken if required.
Closure and Session Debrief – The session will conclude with a review of the participant’s current emotional state, use of grounding or regulation strategies if needed, discussion of any between-session experiences that may occur and planning for the remainder of the treatment day.
Physical materials that may be used for this component include EMDR hand-held buzzers and a light bar. We may add materials to tax working memory according to EMDR 2.0 such as music or olfactory prompts including essential oils.
ii) AI-Enhanced Virtual Reality Exposure Therapy
This exposure treatment will include a combination of pre-developed Virtual Reality (VR) content and AI-generated VR scenes utilising a software program that permits personalised scenes to be developed. A library of common occupation triggers (e.g., ambulance vehicle, paramedic uniform) will be available to utilise, based on clinical appropriateness for each participant. The AI-powered software will allow clinicians and participants to generate scenes with similarity to previous traumatic jobs they attended, focussing on specific cues of distress (e.g., a crowd of people watching, a beach location) to enhance the visual exposure to personalised triggers. A list of distressing triggers will be developed for each person in the baseline assessment interview to support a personalised exposure treatment plan. This interview is approximately 30 minutes. Treatment is delivered individually in nine 60-minute sessions. Sessions begin with low-intensity, trauma-related imagery and the pacing of exposure is deliberate and responsive, with no progression unless the participant demonstrates adequate tolerance. The aim is to support gradual and repeated exposure to trauma-related memories, situations, and cues in a structured and supported way, helping to reduce distress, avoidance, and emotional reactivity over time. Participants are supported to focus on as many details as possible and describe these to the clinician as they are viewing them. Additional exposure in vivo elements such as sounds may be included to increase arousal levels. At the beginning of each session, participants will state their expected negative outcomes (e.g. ‘I won’t cope’, ‘I will scream’), which will then be reviewed at the end of the session to assess whether the outcome occurred as initially expected.
Towards the end of the session, between session activities that involve in vivo exposure will be established with the participant and recorded on a printed worksheet to reinforce the learning effects. For example, participants may develop a list of feared scenarios and make a plan to expose themselves to one or two situations such as visiting a triggering location or looking at their Ambulance Victoria uniform. It is anticipated these activities will take 30 minutes of time per week.
Each session will typically involve the following steps:
Review and Preparation – The psychologist will review the participant’s current wellbeing, discuss any between-session experiences, and confirm readiness to engage in exposure work. The rationale for the session and planned exposure activities will be reviewed.
Exposure Planning – The participant and psychologist will identify the specific trauma-related reminder, situation, environment, or memory to be targeted during the session. Exposure activities will be selected based on the participant’s individual formulation and treatment goals.
Development or Selection of VR Environment – The psychologist will select or generate immersive VR content relevant to the participant’s experiences. Content will be tailored to the participant’s needs and graded according to their readiness.
Initial Exposure and Distress Monitoring – The participant will engage with the VR environment while remaining physically seated. The psychologist will monitor emotional responses, subjective distress, and engagement throughout the session using discussion and distress ratings.
Graduated Exposure and Processing – Exposure activities may be repeated, extended, or modified as the session progresses. Participants will be encouraged to remain engaged with the feared or avoided stimulus while observing emotional, cognitive, and physical responses. The psychologist may assist participants to identify changes in distress, beliefs, avoidance behaviours, and confidence over time.
Learning and Reflection – The participant discusses observations from the exposure experience, including any changes in distress, expectations, beliefs, confidence, or perceived ability to cope with trauma-related reminders.
Session Debrief and Consolidation – The session will conclude with a review of key learning experiences, discussion of any ongoing reactions, and planning for future exposure activities where appropriate. Grounding and emotional regulation strategies may be utilised before leaving the session.
iii) Psychoeducation Group
The group psychoeducation intervention is a semi-structured group program informed by evidence-based psychoeducation and group therapy principles. There are nine 60-minute group session modules that focus on common symptoms and everyday challenges frequently experienced following trauma exposure, such as intrusive memories and flashbacks, dissociation, sleep difficulties, relationship strain, emotional distress, reduced engagement in activities, and challenges returning to meaningful routines or work. Participants are provided with information about these potential experiences and introduced to practical, evidence-based strategies that may support coping and recovery. Sessions are delivered flexibly by trained psychologists, with content selected based on the ongoing needs and interests of each group. Group discussion and reflection with other participants is encouraged to support shared learning, normalisation, and connection. The group also provides an opportunity to discuss EMDR and VR exposure therapy techniques and to review progress and additional needs of participants. Participants receive printed worksheets to develop a plan to practice content outside of sessions (e.g., activity planning, sleep hygiene planning). It is expected participants will practice and record these for approximately 30 minutes per week.
The program incorporates evidence-based strategies drawn from cognitive behavioural therapy (CBT), behavioural activation, acceptance- and values-based approaches, and psychoeducation for PTSD. Topics include understanding PTSD symptoms and recovery; anxiety, fear, avoidance, and Subjective Units of Distress (SUDS) ratings; mood, functioning, and moral injury; identification of unhelpful coping styles; sleep and physical activity; social engagement and communication; values clarification and identity; post-traumatic growth; and return-to-work planning. Practical strategies include behavioural activation (pleasant activity scheduling), sleep hygiene and behavioural sleep strategies, graded re-engagement in valued activities, values-based goal setting, communication and help-seeking skills, and personalised relapse prevention and return-to-work planning. Sessions are educational and skills-based, with participants not required to disclose details of their traumatic experiences.
2-4 participants will be enrolled at once.
iv) Somatic Group
Participants will take part in 8 group somatic (body-based) regulation sessions that aim to support nervous system regulation and recovery from trauma-related stress responses. These 60-minute sessions led by trained psychologists focus on developing practical “bottom-up” coping skills that use the body and attention systems to help manage physiological arousal. Strategies include breathing techniques, grounding and orienting exercises, gentle movement, awareness of physical sensations, and practices to support emotional regulation and present-moment awareness. The purpose of these sessions is to help participants strengthen self-regulation skills to use when faced with future work-related stressors, reduce distress associated with heightened arousal, and support participation in the ITTP program. Content is delivered using presentation slides and psychologist-led information. Participants complete in session exercises, including breathing or postural techniques and then disuses their experiences with the group. Participants receive printed worksheets to develop a plan to practice somatic skills outside of sessions. Participants will be asked to complete the worksheets and practice for approximately 30 minutes per week.
A final group session at the end of day 9 is dedicated to the end of treatment, reviewing program experience, booking in follow up assessments to be completed approximately one week later, and information around accessing additional support if needed. This session does not deliver somatic treatment content. Participants have existing care through DXC and Ambulance Victoria. At the end of the program, participants will be given an end of treatment report to share with their care team. Some participants will have existing psychologists. Options for accessing private or community-based psychologists will be provided if needed. The existing case manager will continue to support individuals and assist with any ongoing treatment needs.
2-4 participants will be enrolled per group.
There is flexibility and personalisation built into the program delivery. The group psychoeducation and somatic programs have structured modules and suggestions for delivery and group discussions; however, facilitators are encouraged to deliver these with clinical consideration of the pace and needs of each group. EMDR and VR exposure include a protocol for intervention delivery although the specific memories and avoidance criteria are assessed and tailored to each individual. Any deviations from the protocol are recorded by clinicians on a fidelity rating sheet at the end of each session, with qualitative descriptions for any changes that were made.
During the treatment phase, clinicians will enter information regarding session attendance, fidelity checks, and outcome ratings. There are clinician fidelity checklists for each of the interventions (EMDR, Virtual Reality, Somatic, Psychoeducation).
The order of interventions on each treatment day is as follows: group psychoeducation, Virtual Reality Exposure Therapy, EMDR, Somatic group. There is some flexibility for Virtual Reality Exposure Therapy and EMDR depending on clinician availability and multiple individual clients, but the day will always begin with group psychoeducation and end with group somatic therapy.
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Intervention code [1]
334765
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Rehabilitation
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Intervention code [2]
334766
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Treatment: Other
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Description of the comparator or control
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Acceptability of the program
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Assessment method [1]
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Assessed by participant responses on the Acceptability of Intervention Measure (AIM). The Acceptability of Intervention Measure (AIM) is a 4-item validated self-reported implementation measure assessing participants’ perceptions of intervention acceptability, with scale values ranging from 1 to 5. The measure evaluates the degree to which participants find the intervention appealing, approve of it, like it, and welcome it. It will be administered at post intervention and 3 months follow up.
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Timepoint [1]
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Post intervention (approximately one week post completion of treatment; primary timepoint), three month follow up post program completion
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Primary outcome [2]
346225
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Feasibility
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Assessment method [2]
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Attendance rates will be captured by researchers for each participant. Feasibility will be indicated by combined program completion (full or early completion) rates of 70% or greater. Participants may be considered an early treatment completer, prior to the full 9-day program. Early completion will be defined as clinician- and participant-agreed termination of treatment prior to the planned end of the program due to achievement of core treatment goals, including meaningful symptom reduction, reduced trauma-related distress and avoidance, and improved functional capacity. Dropout will be defined as unplanned discontinuation prior to completion or early completion without agreement that treatment goals have been met.
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Timepoint [2]
346225
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Post intervention (approximately one week post completion of treatment; primary timepoint), three month follow up post program completion
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Primary outcome [3]
346226
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PTSD symptoms
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Assessment method [3]
346226
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The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire assessing PTSD symptoms consistent with DSM-5 diagnostic criteria. Participants rate the extent to which they have been bothered by trauma-related symptoms over the past week using a 5-point Likert scale. Items are rated on a 5-point Likert scale (0–4), yielding a total score ranging from 0 to 80, with higher scores indicating greater PTSD symptom severity.
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Timepoint [3]
346226
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Baseline (within one week prior to treatment commencement), post-intervention (approximately one week post completion of treatment; primary timepoint), three month follow up post program completion
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Secondary outcome [1]
465065
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Return-to-work self-efficacy
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Assessment method [1]
465065
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Return-to-Work Self-Efficacy (RTWSE) scale. The RTWSE is a validated 11-item self-report measure that captures an individual’s confidence in their ability to meet work demands, manage workload, and communicate needs in the workplace despite ongoing symptoms. It has been widely used in populations with common mental health conditions and is predictive of return-to-work outcomes. Each item is rated on a 6-point Likert scale. A total mean score will be calculated. Given the absence of established clinical cut-offs, a change of 0.5 points on the RTWSE scale will be considered a meaningful improvement, with 1.0 points indicating a larger improvement. These thresholds are consistent with prior research examining functional changes in return-to-work confidence.
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Timepoint [1]
465065
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Baseline (at screening within one week prior to treatment commencement), post-intervention (approximately one week post completion of treatment; primary timepoint), three month follow up post program completion
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Secondary outcome [2]
465066
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The proportion of participants that commence a return-to-work plan within 3 months following completion of the program
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Assessment method [2]
465066
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Return-to-work outcomes will be accessed via both self report and via the insurer DXC, via an employment summary. These outcomes will be summarised descriptively as the proportion of participants who commence a return-to-work plan within: (a) three months following program completion; and (b) 26 weeks from claim commencement. Proportions will be reported with corresponding 95% confidence intervals to reflect uncertainty associated with the sample size. Time to return to work, defined as the number of days from program completion to return to work commencement, will be summarised using appropriate descriptive statistics, including median and interquartile range where relevant. We will further describe part time or full time RTW initiated and type of role the participant is engaged in.
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Timepoint [2]
465066
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Three month post-intervention completion follow up
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Secondary outcome [3]
465067
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The proportion of participants that commence a return-to-work plan by 26-weeks following claim commencement.
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Assessment method [3]
465067
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Data will be collected from DXC Technology (insurer) to indicate whether the participants have commenced a RTW plan.
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Timepoint [3]
465067
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26 weeks post WorkCover claim commencement
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Secondary outcome [4]
465068
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Compensation costs at 26 weeks post claim acceptance (salary)
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Assessment method [4]
465068
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Data will be collected from DXC Technology to indicate the total compensation costs for each individual. Cost outcomes will be summarised descriptively using cumulative compensation payments accrued by 26 weeks of claim commencement. Given the expected skewness of cost data, both mean and median costs will be reported, alongside measures of variability including standard deviation and interquartile range.
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Timepoint [4]
465068
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26 weeks post WorkCover claim acceptance
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Secondary outcome [5]
465069
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Participant perceptions of acceptability of the intervention.
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Assessment method [5]
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Qualitative data on intervention acceptability will be collected through semi-structured, one-on-one interviews with a member of the research team. Interviews will take approximately 10 minutes and will explore participants’ experiences and perceptions of the intervention, including its relevance, perceived benefits, satisfaction, and areas for improvement. Data will be analysed using thematic analysis. These domains are explored as part of the single qualitative outcome of intervention acceptability and are not assessed as separate outcomes or combined into a quantitative composite score. There is no treatment component to this interview.
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Timepoint [5]
465069
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Post intervention (approximately one week post program completion )
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Secondary outcome [6]
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PTSD symptoms
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Assessment method [6]
465070
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Clinician Administered PTSD Scale (CAPS-5). The CAPS-5 is a 30-item structured clinical interview that assesses the presence and severity of a categorical PTSD diagnosis according to DSM-5 criteria. Symptoms will be assessed over the past week, and items are scored from 0-4. Total scores (ranging from 0-80) will be calculated. A score reduction of 13 or greater will be used to reflect reliable change and the presence of categorical diagnosis will be reported at each timepoint. The CAPS-5 will be administered by a trained clinician (registered or provisional psychologist)
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Timepoint [6]
465070
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Baseline (within one week prior to program commencement), post-intervention (approximately one week post program completion), three month post-intervention completion follow up
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Secondary outcome [7]
465071
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Symptoms of Complex PTSD consistent with International Classification of Diseases 11 (ICD-11) Complex PTSD (CPTSD).
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Assessment method [7]
465071
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The ITQ is a self-report measure that is designed to capture symptoms of PTSD and Disturbances of Self Organisation (DSO), that may reflect a diagnosis of International Classification of Diseases 11 (ICD-11) Complex PTSD. It includes two subscales for PTSD and DSO. Dichotomous scoring will be used at baseline to describe whether a Complex PTSD diagnosis is met. Dimension scoring (ranging from 0-24 for each subscale) will be used to capture changes across time. Change scores of 6 (PTSD) and 7 (DSO) will be used to indicate meaningful improvement (Baker et al., 2025).
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Timepoint [7]
465071
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Baseline (within one week prior to program commencement), post-intervention (approximately one week post program completion), three month post-intervention completion follow up
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Secondary outcome [8]
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Disturbance in daily life because of trauma symptoms
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Assessment method [8]
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Trauma-focussed Visual Analogue Scale (T-VAS): Single item visual scale where participants rate a mark along a line to indicate their score from 0-100. The question asks how much disturbance do you feel in daily life because of your trauma symptoms?
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Timepoint [8]
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Baseline (within one week prior to program commencement), daily rating during treatment days, post-intervention (approximately one week post program completion), three month post-intervention completion follow up
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Secondary outcome [9]
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Insomnia severity
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Assessment method [9]
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Insomnia Severity Index (ISI). The Insomnia Severity Index is a 7 item self-report questionnaire designed to capture the occurrence and severity of insomnia problems over the past two weeks. Each item is scored from 0-4 . The ISI has excellent test-retest validity when administered approximately four weeks apart and is well suited to captured changes in insomnia patterns.
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Timepoint [9]
465075
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Baseline (within one week prior to program commencement), post-intervention (approximately one week post program completion), three month post-intervention completion follow up
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Secondary outcome [10]
465076
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Severity of depression
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Assessment method [10]
465076
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Patient Health Questionnaire-9 (PHQ-9) – The PHQ-9 is a 9-item self-report measure used to screen for the presence and severity of depression, with items scored from 0-3. High total scores reflect greater depressive symptom severity. The PHQ-9 is based on the DSM-5 diagnostic criteria for major depressive disorder and asks about symptoms such as low mood, fatigue, and changes in appetite over the past two weeks. The PHQ-9 has excellent internal consistency and is commonly used in primary care and mental health settings.
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Timepoint [10]
465076
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Baseline (within one week prior to program commencement), post-intervention (approximately one week post program completion), three month post-intervention completion follow up
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Secondary outcome [11]
465077
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Psychological distress
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Assessment method [11]
465077
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Clinical Outcomes in Routine Evaluation- Outcome Measure (CORE-OM). The CORE-OM is a 34 items self-reported measure to track general psychological distress over the past week and is designed to be administered during treatment to track response. Items are scored from 0-4 with higher scores indicating greater psychological distress. The measure produced a total score, and domain scores in wellbeing deficits, problems/symptoms, life functioning difficulties, and risk/harm. It is completed during assessments with a registered or provisional psychologist, who is trained to assess and respond to risk.
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Timepoint [11]
465077
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Baseline (within one week prior to program commencement), post-intervention (approximately one week post program completion), three month post-intervention completion follow up
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Secondary outcome [12]
465078
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Functional impairment across key areas of daily life
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Assessment method [12]
465078
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The Work and Social Adjustment Scale (WSAS) is a 5-item adult self-report questionnaire capturing functional impairment across key areas of daily life including work, home management, social leisure, private leisure, or close relationships. Items are scored from 0-8. This is a composite score.
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Timepoint [12]
465078
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Baseline (within one week prior to program commencement), post-intervention (approximately one week post program completion), three month post-intervention completion follow up
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Secondary outcome [13]
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Moral injury as a composite.
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Assessment method [13]
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Moral Injury Symptoms Scale – Healthcare Professionals (MISS-HP). The Moral Injury Symptoms Scale – Healthcare Professionals (MISS-HP) is a 10-item self-report measure designed to assess symptoms of moral injury in healthcare and frontline professionals. The measure assesses psychological, emotional, and existential responses to potentially morally injurious experiences, including guilt, shame, betrayal, loss of trust, difficulties with meaning and purpose, and spiritual or existential distress. Items are rated on a Likert-type scale. The MISS-HP has demonstrated good reliability and validity in healthcare populations, including physicians, nurses, and other frontline workers, and has been shown to be sensitive to clinically meaningful levels of moral distress.
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Timepoint [13]
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Baseline (within one week prior to program commencement), post-intervention (approximately one week post program completion), three month post-intervention completion follow up
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Secondary outcome [14]
465362
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Patient perspectives on recovery
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Assessment method [14]
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Qualitative interview assessing perspectives on recovery. This interview will be conducted by a member of the clinical team (i.e., provisional or registered psychologist). The interview will be approximately 10 minutes in total.
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Timepoint [14]
465362
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Post-intervention (approximately one week post program completion)
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Secondary outcome [15]
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Medical and like compensation costs at 26 weeks post claim acceptance
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Assessment method [15]
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Data will be collected from DXC Technology to indicate the total medical and like compensation costs for each individual. Cost outcomes will be summarised descriptively using cumulative compensation payments accrued by 26 weeks of claim commencement. Given the expected skewness of cost data, both mean and median costs will be reported, alongside measures of variability including standard deviation and interquartile range.
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Timepoint [15]
465901
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26 weeks post WorkCover claim acceptance
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Secondary outcome [16]
465902
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Patient perspectives of the perceived feasibility of the Integrated Trauma Treatment Program
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Assessment method [16]
465902
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Feasibility will be assessed through an approximately 10-minute semi-structured, one-on-one qualitative interview conducted by a clinician (provisional or registered psychologist). The interview will explore participants’ experiences of participating in the program, including perceived barriers and facilitators to participation and delivery. Data will be analysed using thematic analysis. Barriers and facilitators will be explored as part of the single qualitative outcome of perceived feasibility and will not be assessed as separate outcomes or combined into a quantitative composite score.
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Timepoint [16]
465902
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Post-intervention (approximately one week post program completion)
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Secondary outcome [17]
465903
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Patient perspectives of the perceived tolerability of the Integrated Trauma Treatment Program
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Assessment method [17]
465903
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Tolerability will be assessed through an approximately 10-minute semi-structured, one-on-one qualitative interview conducted by a clinician (provisional or registered psychologist). The interview will explore participants’ experiences of the program, including perceived burden, distress, and manageability. Data will be analysed using thematic analysis. These domains will be explored as part of the single qualitative outcome of perceived tolerability and will not be assessed as separate outcomes or combined into a quantitative composite score.
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Timepoint [17]
465903
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Post-intervention (approximately one week post program completion)
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Secondary outcome [18]
465905
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Patient perspectives on the return to work experience
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Assessment method [18]
465905
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Qualitative interview assessing perspectives on the return to work experience. This interview will be conducted by a member of the clinical team (i.e., provisional or registered psychologist). The interview will be approximately 10 minutes in total.
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Timepoint [18]
465905
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Post-intervention (approximately one week post program completion)
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Secondary outcome [19]
465906
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Participant perspectives on the Integrated Trauma Treatment Program
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Assessment method [19]
465906
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A semi-structured, one-on-one qualitative interview will be conducted by a member of the clinical team (provisional or registered psychologist) and will take approximately 10 minutes in total. The interview will explore participants’ overall experiences and perspectives on the treatment program, including suggestions for improvement. Data will be analysed using thematic analysis. This will be assessed as a single qualitative outcome and not as separate or composite outcomes.
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Timepoint [19]
465906
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Post-intervention (approximately one week post program completion)
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Secondary outcome [20]
465908
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Participant perceptions of feasibility
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Assessment method [20]
465908
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Qualitative data will be collected from participant feedback at post-intervention. Data will be analysed using thematic analysis. Coding will focus on key feasibility domains including barriers and facilitators to participation and delivery. This interview will be approximately 10 minutes and conducted by a member of the research team.
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Timepoint [20]
465908
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Post intervention (approximately one week post program completion).
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Secondary outcome [21]
465910
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Participant perceptions of the tolerability of the Integrated Trauma Treatment Program
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Assessment method [21]
465910
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Qualitative data will be collected through approximately 10-minute semi-structured, one-on-one interviews conducted by a clinician (provisional or registered psychologist) at post-intervention. Interviews will explore perceived burden, distress, and manageability of the program. Clinician reflections will also inform the qualitative analysis. Data will be analysed using thematic analysis. These domains will be explored as part of the single qualitative outcome of tolerability and will not be assessed as separate outcomes or combined into a quantitative composite score.
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Timepoint [21]
465910
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Post intervention (approximately one week post program completion)
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Secondary outcome [22]
465911
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Acceptability - willingness to recommend treatment program
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Assessment method [22]
465911
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One questionnaire item on a 5-point Likert scale asking how likely participants would be to recommend the program to a friend or family member.
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Timepoint [22]
465911
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Post intervention (approximately one week post program completion ), and three month post-intervention completion follow up
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Secondary outcome [23]
465914
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Safety of the Integrated Trauma Treatment Program
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Assessment method [23]
465914
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Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs) recorded by clinicians during the study. AEs and SAEs will be used to assess the single secondary outcome of program safety and will be interpreted against pre-specified safety thresholds.
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Timepoint [23]
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Recorded throughout the 3-week treatment program, with the total number of adverse events and serious adverse events assessed at the end of treatment.
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Secondary outcome [24]
466317
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Participant and clinician perspectives on the safety of the Integrated Trauma Treatment Program
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Assessment method [24]
466317
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Qualitative data on perceived safety will be collected from participant interviews at post-intervention and from clinician reflections. Data will be analysed using thematic analysis, with attention to any perceived or observed concerns regarding psychological or clinical safety during participation in the program.
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Timepoint [24]
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Post intervention (approximately one week post program completion)
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Eligibility
Key inclusion criteria
Participant is employed by Ambulance Victoria and has submitted a WorkSafe claim
Participants must be taking time off work
Intend to return to work within 12 months
Able to engage in an intensive in person treatment program on Tuesdays, Wednesdays and Thursdays in Notting Hill, Victoria
Have been exposed to a potentially traumatic event and are experiencing post-traumatic stress symptoms (score 31 on PCL-5)
Fluent in English
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
Have submitted a WorkSafe claim that was not accepted
Are experiencing acute suicide risk (assessed by psychologists in the project)
Have severe psychiatric comorbidity that would prohibit participation in the intensive program
Have a medical condition that would impact participation in the program (e.g., neurological conditions or physical injury without medical clearance from a GP)
Have engaged in or are planning to engage in a non-standard psychological treatment program (e.g., a different intensive program or other pilot program that is being funded by WorkSafe) following lodging their WorkSafe claim and prior to completing the 3 month follow up assessment) as this may influence treatment outcomes
Are currently engaging in or are planning to engage in concurrent similar treatment components to the ITTP (i.e., the individual must not engage in concurrent EMDR, exposure treatments, somatic interventions, or group psychoeducation) from the initial baseline assessment and until after completion of the post-intervention assessment (other individual psychological sessions are permitted)
High levels of dissociative symptoms as assessed by clinicians during the baseline clinical interview.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
18/08/2026
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Date of last participant enrolment
Anticipated
27/09/2027
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Actual
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Date of last data collection
Anticipated
23/12/2027
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Actual
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Sample size
Target
48
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Accrual to date
3
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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WorkSafe Victoria
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Address [1]
322457
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Country [1]
322457
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
325385
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Address [1]
325385
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Country [1]
325385
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
320948
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30/06/2026
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Approval date [1]
320948
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08/07/2026
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Ethics approval number [1]
320948
0
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Summary
Brief summary
This study will evaluate a new three-week (nine day) intensive outpatient trauma treatment program for paramedic first responders experiencing post-traumatic stress disorder (PTSD). The program combines established evidence-based PTSD treatments, including eye movement desensitisation and reprocessing (EMDR), virtual reality exposure therapy, body-based techniques, and group trauma education. The virtual reality component uses personalised scenarios that include work-related environments and equipment relevant to paramedics. The study aims to determine whether this integrated treatment program is acceptable and feasible to deliver, and whether it shows early benefits in reducing PTSD symptoms and improving return-to-work outcomes immediately after treatment and three months later.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Alexandra Anderson
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Address
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Turner Clinics, 1/270 Ferntree Gully Road, Notting Hill, Victoria 3168
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Country
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Australia
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Phone
152174
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+61399024546
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Alexandra Anderson
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Address
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Turner Clinics, 1/270 Ferntree Gully Road, Notting Hill, Victoria 3168
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Country
152175
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Australia
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Phone
152175
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+61399024546
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Fax
152175
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Email
152175
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[email protected]
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Contact person for scientific queries
Name
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Alexandra Anderson
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Address
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Turner Clinics, 1/270 Ferntree Gully Road, Notting Hill, Victoria 3168
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Country
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Australia
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Phone
152176
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+61399024546
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Fax
152176
0
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Email
152176
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[email protected]
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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.
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