Stress Inoculation Training (SIT): An Evidence-Based, Military Aligned Psychological Performance and Health Sustainment Prototype

The purpose of this study is to demonstrate the feasibility of augmenting existing/traditional Navy military training with the manualized SIT Core Protocol (CP) utilizing the established augmentation procedure set as measured by feasibility, utility, and satisfaction metrics (CSQ-8) and to examine the relative effectiveness of the SIT-CP by comparison to standard military training in a controlled trial examining outcomes of stress tolerance, psychological health, resilience and occupational performance in Sailors undergoing DCA Firefighting Training (pre- to post-training), while collecting implementation data.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress, Psychological
• Intervention / Treatment: Behavioral: SIT; Behavioral: DCA-FF

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Jackson, MFT, PhD; Phone Number: (713) 486-2700; Email: Sarah.E.Jackson@uth.tmc.edu
• Study Contact Backup: Name: Ronald Acierno; Phone Number: (713) 486-2863; Email: Ronald.Acierno@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Ronald Acierno; Phone Number: (713) 486-2863; Email: Ronald.Acierno@uth.tmc.edu
      • Contact: Sarah Jackson, MFT, PhD i; Phone Number: 713-486-2700; Email: Sarah.E.Jackson@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• US Navy service members on Active Duty or Reserve status
• be fluent in English.
• be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
• have access to a SmartPhone, computer, or tablet to utilize and access the virtual classroom.
• agree to undergo psychometric and operational performance testing and participate in ongoing assessments throughout the study duration.
• be willing to comply with all study procedures, able to complete all assessments independently, and available for the duration of the study (with reasonable accommodations for military operational demands as they arise).

Exclusion Criteria:

• Active suicidal ideation as assessed by the Investigator at screening or as identified during the study.
• Clinically significant history of psychotic disorder, bipolar spectrum disorder, or neurodegenerative disease/dementia as assessed by the Investigator.
• Active severe substance abuse as assessed by the investigator in accordance with The Diagnostic and Statistical Manual of Mental Illnesses (DSM-5) Substance Abuse Disorder criteria, or presence of illicit substance abuse.
• They are currently undergoing another form of treatment other than supportive therapy (>2 times per month).
• Any other condition/situation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIT + Damage Control Assessment & Firefighting (DCA-FF)	Behavioral: SIT; Participants will undergo 2 day (8 hours each) Stress Inoculation Training . This will be done in 3 steps: Step 1: focus on education about the human body and brain and shift to hands on skills practice to improve performance in stressful conditions and is designed to improve self-and-situational awareness and the ability to manipulate reactions and responses in the body on purpose to enhance performance Step 2: focuses on improving mental self-awareness and gaining skills in Mental Agility and Mental Flexibility Step 3: participants will have specific simulations and real-world opportunities to practice the skills learnt.; Behavioral: DCA-FF; Participants will undergo 8-week Standard Firefighting Training
Active Comparator: DCA-FF	Behavioral: DCA-FF; Participants will undergo 8-week Standard Firefighting Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in perceived management of stress as assessed by the Perceived Stress Scale (PSS)	This is a 10 item questionnaire and each is scored a 5 -point likert scale from 0(never) to 4(very often) for a score range of 0 to 40, higher total scores indicate higher perceived stress.	Baseline, about 3 weeks from baseline, about 6 weeks form baseline, about 11 weeks form baseline, end of study (an average of 19 weeks form baseline)
Change in resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)	This is a 25 item questionnaire and each is scored on a 5-point Likert scale ranging from 0 (Not true at all) to 4 (True nearly all the time) for a maximum score of 100 higher score indicating more resilience	Baseline, about 3 weeks from baseline, about 6 weeks form baseline, about 11 weeks form baseline, end of study (an average of 19 weeks form baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric	This is a is a dichotomous measure (1-successful vs. 0-unsuccessful)	week 2
Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric	This is a is a dichotomous measure (1-successful vs. 0-unsuccessful)	week 4
level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubric	This is scored on a likert scale from 1(low) to 5(high)	week 2
level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubric	This is scored on a likert scale from 1(low) to 5(high)	week 4
Utility as assessed by the standardized self-assessment tool	high utility is when greater than 80% of novice SIT Trainers reporting an average of >80% on standardized self-assessment rubrics of protocol Module delivery.	week 2
Utility as assessed by the standardized self-assessment tool	high utility is when greater than 80% of novice SIT Trainers reporting an average of >80% on standardized self-assessment rubrics of protocol Module delivery.	week 4
Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)	This is an 8 item questionnaire and each is scored on a 4-point Likert scale ranging from 1 (lowest satisfaction) to 4 (highest satisfaction) for a score range of 8 to 32, higher score indicating more satisfaction	week 2
Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)	This is an 8 item questionnaire and each is scored on a 4-point Likert scale ranging from 1 (lowest satisfaction) to 4 (highest satisfaction) for a score range of 8 to 32, higher score indicating more satisfaction	week 3
Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)	This is an 8 item questionnaire and each is scored on a 4-point Likert scale ranging from 1 (lowest satisfaction) to 4 (highest satisfaction) for a score range of 8 to 32, higher score indicating more satisfaction	week 11(end of study)
Firefighting Observational Rubrics	These are observational rubrics, utilized by the firefighting instructors to evaluate occupational performance of the participants on specific firefighting task	week 6
Change in adaptation to stress as assessed by the Situational Adaptation to Stress Scale for Human Performance (SASS-HP)	The premeasurement scale is a 9 item questionnaire and each is scored on a likert scale from 1(totally disagree) -5(totally agree), higher score indicates better outcome	Baseline, about 3 weeks from baseline, about 6 weeks form baseline
Change in adaptation to stress as assessed by the Situational Adaptation to Stress Scale for Human Performance (SASS-HP)	The post measurement scale is a 18 item questionnaire and each is scored on a likert scale from 1(totally disagree) -5(totally agree), higher score indicates better outcome	about 11 weeks form baseline, end of study (about 19 weeks form baseline)
Change in mental skills as assessed by the Test of Performance Strategies (TOPS)	This is a 68 item questionnaire and each is scored on a 5-point Likert scale from 1(never) to 5(always) for a maximum score of 340 , higher score indicating better outcome	Baseline, about 6 weeks form baseline, about week 11, end of study (19 weeks form baseline)
Change in achievement score as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment	Achievement score is based on an algorithm that uses variability in heart rate over time and heart beats per minute. It indicates percentage of time participant is able to relax.The score range is 0-500+. Higher score means better outcome	Baseline, week 11
Change in average coherence as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment	Coherence score is based on an algorithm that uses variability in heart rate over time and heart beats per minute. It indicates percentage of time participant is able to relax.The score range is 0-500+. Higher score means better outcome	Baseline, week 11
Change in average heart beats per minute as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment	Lower heart beats is better outcome	Baseline, week 11

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Department of Defense / Congressionally Mandated Research Program (CDMRP)
• Investigators: Principal Investigator: Sarah Jackson, MFT, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: resilience; Psychological health; Warfighter performance
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: HSC-MS-24-0756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No