Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403514
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-04-22
Brief Title:
The Effects of a Psychoeducational Intervention on Health and Performance-based Outcomes of Veterans Diagnosed With PTSD
Sponsor:
Nova Southeastern University
Organization:
Nova Southeastern University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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 participants 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 ie 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
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 ie 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 participants 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None