Post Traumatic Stress DisorderNCT06403514
The Effects of a Psychoeducational Intervention on Health and Performance-based Outcomes of Veterans Diagnosed With PTSD
A study testing Psychological Skills Training (PST) in people with Post Traumatic Stress Disorder, run by Nova Southeastern University at 1 site in United States.
Trial summary
Nova Southeastern University and the Veterans trust through this line of research will strengthen community engagement and awareness for the need to recognize and provide treatment models for veterans diagnosed with PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Psychological Skills Training (PST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to 26 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All veterans of the US Military
- Clinical diagnosis of PTSD
- Completed the Veterans Trust Self-Regulatory Mastery course with the Race-Simulator
Who cannot join
- Severe/markedly elevated severity rating on the CAPS-5
- Extreme/incapacitating severity rating on the CAPS-5
- Asthma
- Emphysema
- Chronic obstructive pulmonary disease
- History of heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Experimental Examination of a Racecar-simulation Psychoeducational Intervention and the Effects on Health and Performance-based Outcomes of Veterans Diagnosed With PTSD
Nova Southeastern University and the Veterans trust through this line of research will strengthen community engagement and awareness for the need to recognize and provide treatment models for veterans diagnosed with PTSD. The goal is to improve self-regulatory mechanisms within the racecar simulated-environment with the hope it translates to real-life scenarios.
The design is a single-case approach with the application of range-bound changing criterion design. It will include elements of stress-inoculation therapy, cognitive processing therapy, optimal zones of functioning, biofeedback and psychological skills training. This particular design will allow for the collection and identification of the idiosyncratic differences between each participant which will guide how the data are collected and the tailoring of the intervention.
Read the detailed description
Initially, the participants undergo all pre-test assessments at the Neuropsychology Assessment Center prior to being deemed eligible for the experiment. Next, participants will be scheduled individually to visit the Race Lab to become acquainted with the lab and virtual environment. Basics of the research study will be explained to each participant as part of the adaptation process. This will include a brief educational lesson on the Psychological Skills Training intervention. Following the adaptation period, the participant will commence with the experimental race-car psychoeducational intervention.
Design. A single-case approach with the Range-Bound Changing Criterion design (RBCC) will used. The RBCC design is a variant of the changing criterion design used in single-subjects research to allow for the systematic shaping of behaviors in the pursuit of short- and long-term based objectives. As a result, the design adequately allows for the application of the Learning-Modification-Application Model (LMA), which is based on the premise of periodization (i.e., step-wise incremental changes as a means to improve performance through increased challenges). That is, following baseline collection, a performance range-bound criterion will be established a-priori based on the phase of the LMA model. Control is established when the participant's performance consistently matches or surpasses the criterion within the given phase of the LMA and continues to progress throughout the subsequent intervention phases as performance criteria becomes more rigorous. See Table 1 and Figure 1 for the basics of the RBCC Design.
Table 1. Range-Bound Changing Criterion Design Legend Design Notation Design Phase A Baseline B Learning C Modification D Application
Figure 1. Condensed Design Structure of the RBCC Design
Treatment Phase Design Structure
Learning: A-B-A-B-A-B-A-B-A-B-A
Modification: A-C-A-C-A-C-A-C-A-C-A
Application: A-D-A-D-A-D-A-D-A-D-A
Procedural Steps. There are three main phases of the experiment- Learning, Modification and Application. Within the Learning and Modification phases, participants will be required to complete five separate time-trials (i.e., race against the clock in the absence of other competitors), with each trial consisting of four laps. Multiple checkpoints within the race along with the finish line will allow performance times to be collected. The Application phase will also include five separate time trials, but the race will include competitors.
Throughout the experiment, the participant will be connected to physiological recording devices and data will be collected via the baseline and in-trial activities, which include heart rhythms (Beats per minute (BPM) and Heart Rate Variability - (HRV)), Electromyograph (EMG), respiration, and subjective perceptions of affect. Following each experimental phase, immersion, cognitive and somatic anxiety measures will be taken along with self-efficacy. Objective and subjective data from the trials will be reduced and Individual Zone of Optimal Functioning (IZOFs) will be determined to be utilized in the Psychological Skills Training aspect of the experiment.
Psychological Skills Training (PST). The primary focus of PST is to assist the participants in acquiring adequate self-regulatory and coping skills as a mean to increase the participants' coping repertoire.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Psychological Skills Training (PST)
- Keywords
- Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Skills Training (PST)Other
PST will include self-talk, imagery, goal-setting and arousal regulation (Biofeedback)
| Study group | Role | What they receive |
|---|---|---|
| Trial | Experimental | Psychological Skills Training (PST). The PST will include elements, both generalized and idiosyncratic, for each participant and is considered an adapted model of stress inoculation skills training protocol. The specifics will include each participant's unique optimal and poor ranges of performance (i.e., IZOFs), which will be calculated utilizing HRV, BPM, EMG, respiration and subjective affect. The participants will be introduced to their IZOFs and then taught general and specific approaches to self-regulation using elements of a mindfulness protocol for BFB in a clinical environment. A dual-monitor setup for the BFB application will be employed. Receives: Other: Psychological Skills Training (PST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quality of Life Scale
(QOLS). The QOLS is used to assess quality of life across a wide-range of clinical and non-clinical groups and is considered distinct from health status or other indicators of quality of life. Scores range from 16 to 112. Higher scores represent enhanced QOL.
Measured: pre-intervention, immediately after the intervention
The Difficulties in Emotion Regulation Scale
(DERS). The DERS is an assessment tool for gauging challenges in emotion regulation. It allows for the assessment of respondents' interactions with their emotions and generates scores across six distinct subscales. Scores range from 36 to 180. Higher scores represent enhanced self-regulatory skills.
Measured: pre-intervention, immediately after the intervention
Emotional Self-Efficacy
(ESE). ESE is designed to assess an individual's belief that he or she can appropriately respond to positive and negative environmental cues, particularly when there is little motivation to do so. Scores range from 10 to 50. Higher scores represent enhanced emotional efficacy.
Measured: pre-intervention, immediately after the intervention
The General Self-Efficacy Scale
(GSE). The GDE is a 23-item tool based on Bandura's social cognitive theory, measuring overall confidence in life activities with subscales for general (GSE) and social (SSE) self-efficacy. Higher scores predict success in various areas (e.g., vocational, educational, and military settings). Scores range from 10 to 40. Higher scores represent enhanced general efficacy.
Measured: pre-intervention, immediately after the intervention
Psychological Skills Training Self-Efficacy
(PST-SE). Each item of the Psychological Skills Training program will be represented in the PST-SE which include: Arousal Regulation, Self-Talk, Imagery, Goal Setting and Imagery. Scores range from 10 to 40. Higher scores represents enhanced PST efficacy.
Measured: pre-intervention, immediately after the intervention
The Clinician-Administered PTSD Scale
(CAPS-5). The CAPS-5 is a diagnostic interview for assessing post-traumatic stress disorder (PTSD). CAPS is a criterion measure, and it evaluates all PTSD criteria and associated features like dissociation. The results from the CAPS provides global ratings for distress, impairment, response validity, symptom severity, and improvement since the last assessment.
- Absent:
- Mild / subthreshold:
- Moderate / threshold:
- Severe / markedly elevated:
- Extreme / incapacitating:
Lower score represents lowered PTSD symptoms.
Measured: pre-intervention, immediately after the intervention
The Trauma Symptoms Inventory-2-A
(TSI-2). The TSI-2 is a self-report tool with 126 items assessing post-traumatic stress and psychological outcomes from traumatic events in adults. The tool is used to assess PTSD symptoms and broader psychological effects (i.e., well-being). Scores range from 0 to 378. Lower scores represent lowered trauma symptoms.
Measured: pre-intervention, immediately after the intervention
Secondary outcomes (2)
The affect grid
(AG). The affect grid is a 9-by-9 grid designed to measure dimensions of perceived physiological arousal and pleasure. The vertical dimension represents arousal and ranges and the horizontal dimension represents pleasure and ranges. Pleasure ranges from 1-9 and Arousal ranges from 1-9. Scores are not qualified as good or bad.
Measured: pre-intervention, immediately after the intervention
The Immersive Tendency Questionnaire
(ITQ). The ITQ is designed to assess the subjective experience of being in one place or environment, particularly in a virtual environment. Scores range from 32 to 224. Higher scores represent enhanced perceptions of immersion.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start16 Aug 2024
- Primary completion1 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The design is a single-case approach with the application of range-bound changing criterion design.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, William Edmonds, Nova Southeastern University
- Investigators
- William A Edmonds, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403514
- Sponsor's protocol ID
- 2024-210-NSU
- Status last verified
- Aug 2025
- First submitted
- 22 Apr 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Experimental Examination of a Racecar-simulation Psychoeducational Intervention and the Effects on Health and Performance-based Outcomes of Veterans Diagnosed With PTSD
- ClinicalTrials.gov ID
- NCT06403514
- Acronym / sponsor ID
- 2024-210-NSU
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nova Southeastern University and the Veterans trust through this line of research will strengthen community engagement and awareness for the need to recognize and provide treatment models for veterans diagnosed with PTSD. The goal is to improve self-regulatory mechanisms within the racecar simulated-environment with the hope it translates to real-life scenarios.
The design is a single-case approach with the application of range-bound changing criterion design. It will include elements of stress-inoculation therapy, cognitive processing therapy, optimal zones of functioning, biofeedback and psychological skills training. This particular design will allow for the collection and identification of the idiosyncratic differences between each participant which will guide how the data are collected and the tailoring of the intervention.
Detailed description
Initially, the participants undergo all pre-test assessments at the Neuropsychology Assessment Center prior to being deemed eligible for the experiment. Next, participants will be scheduled individually to visit the Race Lab to become acquainted with the lab and virtual environment. Basics of the research study will be explained to each participant as part of the adaptation process. This will include a brief educational lesson on the Psychological Skills Training intervention. Following the adaptation period, the participant will commence with the experimental race-car psychoeducational intervention.
Design. A single-case approach with the Range-Bound Changing Criterion design (RBCC) will used. The RBCC design is a variant of the changing criterion design used in single-subjects research to allow for the systematic shaping of behaviors in the pursuit of short- and long-term based objectives. As a result, the design adequately allows for the application of the Learning-Modification-Application Model (LMA), which is based on the premise of periodization (i.e., step-wise incremental changes as a means to improve performance through increased challenges). That is, following baseline collection, a performance range-bound criterion will be established a-priori based on the phase of the LMA model. Control is established when the participant's performance consistently matches or surpasses the criterion within the given phase of the LMA and continues to progress throughout the subsequent intervention phases as performance criteria becomes more rigorous. See Table 1 and Figure 1 for the basics of the RBCC Design.
Table 1. Range-Bound Changing Criterion Design Legend Design Notation Design Phase A Baseline B Learning C Modification D Application
Figure 1. Condensed Design Structure of the RBCC Design
Treatment Phase Design Structure
Learning: A-B-A-B-A-B-A-B-A-B-A
Modification: A-C-A-C-A-C-A-C-A-C-A
Application: A-D-A-D-A-D-A-D-A-D-A
Procedural Steps. There are three main phases of the experiment- Learning, Modification and Application. Within the Learning and Modification phases, participants will be required to complete five separate time-trials (i.e., race against the clock in the absence of other competitors), with each trial consisting of four laps. Multiple checkpoints within the race along with the finish line will allow performance times to be collected. The Application phase will also include five separate time trials, but the race will include competitors.
Throughout the experiment, the participant will be connected to physiological recording devices and data will be collected via the baseline and in-trial activities, which include heart rhythms (Beats per minute (BPM) and Heart Rate Variability - (HRV)), Electromyograph (EMG), respiration, and subjective perceptions of affect. Following each experimental phase, immersion, cognitive and somatic anxiety measures will be taken along with self-efficacy. Objective and subjective data from the trials will be reduced and Individual Zone of Optimal Functioning (IZOFs) will be determined to be utilized in the Psychological Skills Training aspect of the experiment.
Psychological Skills Training (PST). The primary focus of PST is to assist the participants in acquiring adequate self-regulatory and coping skills as a mean to increase the participants' coping repertoire.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The design is a single-case approach with the application of range-bound changing criterion design.
| Arm | Type | Receives |
|---|---|---|
| Trial | Experimental | Other: Psychological Skills Training (PST)Psychological Skills Training (PST). The PST will include elements, both generalized and idiosyncratic, for each participant and is considered an adapted model of stress inoculation skills training protocol. The specifics will include each participant's unique optimal and poor ranges of performance (i.e., IZOFs), which will be calculated utilizing HRV, BPM, EMG, respiration and subjective affect. The participants will be introduced to their IZOFs and then taught general and specific approaches to self-regulation using elements of a mindfulness protocol for BFB in a clinical environment. A dual-monitor setup for the BFB application will be employed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All veterans of the US Military
- Clinical diagnosis of PTSD
- Completed the Veterans Trust Self-Regulatory Mastery course with the Race-Simulator
Key exclusion criteria (6 listed)
- Severe/markedly elevated severity rating on the CAPS-5
- Extreme/incapacitating severity rating on the CAPS-5
- Asthma
- Emphysema
- Chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological Skills Training (PST)PST will include self-talk, imagery, goal-setting and arousal regulation (Biofeedback) | Other | Trial |
Primary outcome
The Quality of Life Scale
Time frame: pre-intervention, immediately after the intervention
(QOLS). The QOLS is used to assess quality of life across a wide-range of clinical and non-clinical groups and is considered distinct from health status or other indicators of quality of life. Scores range from 16 to 112. Higher scores represent enhanced QOL.
The Difficulties in Emotion Regulation Scale
Time frame: pre-intervention, immediately after the intervention
(DERS). The DERS is an assessment tool for gauging challenges in emotion regulation. It allows for the assessment of respondents' interactions with their emotions and generates scores across six distinct subscales. Scores range from 36 to 180. Higher scores represent enhanced self-regulatory skills.
Emotional Self-Efficacy
Time frame: pre-intervention, immediately after the intervention
(ESE). ESE is designed to assess an individual's belief that he or she can appropriately respond to positive and negative environmental cues, particularly when there is little motivation to do so. Scores range from 10 to 50. Higher scores represent enhanced emotional efficacy.
The General Self-Efficacy Scale
Time frame: pre-intervention, immediately after the intervention
(GSE). The GDE is a 23-item tool based on Bandura's social cognitive theory, measuring overall confidence in life activities with subscales for general (GSE) and social (SSE) self-efficacy. Higher scores predict success in various areas (e.g., vocational, educational, and military settings). Scores range from 10 to 40. Higher scores represent enhanced general efficacy.
Psychological Skills Training Self-Efficacy
Time frame: pre-intervention, immediately after the intervention
(PST-SE). Each item of the Psychological Skills Training program will be represented in the PST-SE which include: Arousal Regulation, Self-Talk, Imagery, Goal Setting and Imagery. Scores range from 10 to 40. Higher scores represents enhanced PST efficacy.
The Clinician-Administered PTSD Scale
Time frame: pre-intervention, immediately after the intervention
(CAPS-5). The CAPS-5 is a diagnostic interview for assessing post-traumatic stress disorder (PTSD). CAPS is a criterion measure, and it evaluates all PTSD criteria and associated features like dissociation. The results from the CAPS provides global ratings for distress, impairment, response validity, symptom severity, and improvement since the last assessment. 0. Absent: 1. Mild / subthreshold: 2. Moderate / threshold: 3. Severe / markedly elevated: 4. Extreme / incapacitating: Lower score represents lowered PTSD symptoms.
The Trauma Symptoms Inventory-2-A
Time frame: pre-intervention, immediately after the intervention
(TSI-2). The TSI-2 is a self-report tool with 126 items assessing post-traumatic stress and psychological outcomes from traumatic events in adults. The tool is used to assess PTSD symptoms and broader psychological effects (i.e., well-being). Scores range from 0 to 378. Lower scores represent lowered trauma symptoms.
2 secondary outcomes
The affect grid
Time frame: pre-intervention, immediately after the intervention
The Immersive Tendency Questionnaire
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William A Edmonds, PhD principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Skills Training (PST) in people with Post Traumatic Stress Disorder, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Quality of Life Scale (time frame: pre-intervention, immediately after the intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.