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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06656780
Enrollment
120
Registered
2024-10-24
Start date
2025-08-31
Completion date
2027-06-30
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Psychological

Keywords

Psychological health, resilience, Warfighter performance

Brief summary

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.

Interventions

BEHAVIORALSIT

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.

BEHAVIORALDCA-FF

Participants will undergo 8-week Standard Firefighting Training

Sponsors

Department of Defense / Congressionally Mandated Research Program (CDMRP)
CollaboratorUNKNOWN
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in perceived management of stress as assessed by the Perceived Stress Scale (PSS)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)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.
Change in resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)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)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

Secondary

MeasureTime frameDescription
Utility as assessed by the standardized self-assessment toolweek 2high utility is when greater than 80% of novice SIT Trainers reporting an average of \>80% on standardized self-assessment rubrics of protocol Module delivery.
Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)week 2This 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
Firefighting Observational Rubricsweek 6These are observational rubrics, utilized by the firefighting instructors to evaluate occupational performance of the participants on specific firefighting task
Change in adaptation to stress as assessed by the Situational Adaptation to Stress Scale for Human Performance (SASS-HP)Baseline, about 3 weeks from baseline, about 6 weeks form baselineThe 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
level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubricweek 2This is scored on a likert scale from 1(low) to 5(high)
Change in achievement score as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment AssessmentBaseline, week 11Achievement 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
Change in average coherence as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment AssessmentBaseline, week 11Coherence 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
Change in average heart beats per minute as assessed by the 10-Minute Heart Rate Variability Biofeedback assessmentBaseline, week 11Lower heart beats is better outcome
Change in mental skills as assessed by the Test of Performance Strategies (TOPS)Baseline, about 6 weeks form baseline, about week 11, end of study (19 weeks form baseline)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
Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubricweek 2This is a is a dichotomous measure (1-successful vs. 0-unsuccessful)

Countries

United States

Contacts

Primary ContactSarah Jackson, MFT, PhD
Sarah.E.Jackson@uth.tmc.edu(713) 486-2700
Backup ContactRonald Acierno
Ronald.Acierno@uth.tmc.edu(713) 486-2863

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026