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

NCT06403514 | Completed

• 1 other identifier: 2024-210-NSU
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Veterans

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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. 0\. Absent: 1. Mild / subthreshold: 2. Moderate / threshold: 3. Severe / markedly elevated: 4. Extreme / incapacitating: Lower score represents lowered PTSD symptoms.

  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.

  pre-intervention, immediately after the intervention

Secondary Outcomes (2)

• The affect grid

  pre-intervention, immediately after the intervention

• The Immersive Tendency Questionnaire

  immediately after the intervention

Other Outcomes (1)

• Performance

  pre-intervention, immediately after the intervention

Study Arms (1)

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.

Other: Psychological Skills Training (PST)

Interventions

Psychological Skills Training (PST) OTHER

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

Trial

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Nova Southeastern University

Davie, Florida, 33328, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• William A Edmonds, PhD

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The design is a single-case approach with the application of range-bound changing criterion design.

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 8, 2024
• Study Start: August 16, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 26, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)