The Effects of a Psychoeducational Intervention on Health and Performance-based Outcomes of Veterans Diagnosed With PTSD

NCT ID: NCT06403514

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2025-08-26

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.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trial

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.

Group Type: EXPERIMENTAL

Psychological Skills Training (PST)

Intervention Type: OTHER

PST will include self-talk, imagery, goal-setting and arousal regulation (Biofeedback)

Interventions

Psychological Skills Training (PST)

PST will include self-talk, imagery, goal-setting and arousal regulation (Biofeedback)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

William Edmonds

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William A Edmonds, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

Nova Southeastern University

Davie, Florida, United States

Countries

United States

Other Identifiers

2024-210-NSU

Identifier Type: -

Identifier Source: org_study_id