Clinical trial NCT06403514: The Effects of a Psychoeducational Intervention on Health and Performance-based Outcomes of Veterans Diagnosed With PTSD
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Veterans
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2024-05-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The design is a single-case approach with the application of range-bound changing criterion design.
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* All veterans of the US Military
* Clinical diagnosis of PTSD
* Completed the Veterans Trust Self-Regulatory Mastery course with the Race-Simulator

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Quality of Life Scale
timeFrame: pre-intervention, immediately after the intervention
measure: The Difficulties in Emotion Regulation Scale
timeFrame: pre-intervention, immediately after the intervention
measure: Emotional Self-Efficacy
timeFrame: pre-intervention, immediately after the intervention
measure: The General Self-Efficacy Scale
timeFrame: pre-intervention, immediately after the intervention
measure: Psychological Skills Training Self-Efficacy
timeFrame: pre-intervention, immediately after the intervention
measure: The Clinician-Administered PTSD Scale
timeFrame: pre-intervention, immediately after the intervention
measure: The Trauma Symptoms Inventory-2-A
timeFrame: pre-intervention, immediately after the intervention
Secondary outcomes:
measure: The affect grid
timeFrame: pre-intervention, immediately after the intervention
measure: The Immersive Tendency Questionnaire
timeFrame: immediately after the intervention
Other outcomes:
measure: Performance
timeFrame: pre-intervention, immediately after the intervention
Locations:
city: Davie
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: William A Edmonds, PhD
role: PRINCIPAL_INVESTIGATOR
References: