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NCT Number: NCT06656780

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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms Personal Satisfaction Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SIT

Behavioral

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.

DCA-FF

Behavioral

Participants will undergo 8-week Standard Firefighting Training

Primary outcomes

  1. Changes in perceived management of stress as assessed by the Perceived Stress Scale (PSS)

    Time frame: 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.

  2. Change in resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: 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 outcomes

  1. Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric

    Time frame: week 2

    This is a is a dichotomous measure (1-successful vs. 0-unsuccessful)

  2. Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric

    Time frame: week 4

    This is a is a dichotomous measure (1-successful vs. 0-unsuccessful)

  3. level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubric

    Time frame: week 2

    This is scored on a likert scale from 1(low) to 5(high)

  4. level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubric

    Time frame: week 4

    This is scored on a likert scale from 1(low) to 5(high)

  5. Utility as assessed by the standardized self-assessment tool

    Time frame: week 2

    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.

  6. Utility as assessed by the standardized self-assessment tool

    Time frame: week 4

    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.

  7. Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)

    Time frame: week 2

    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

  8. Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)

    Time frame: week 3

    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

  9. Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)

    Time frame: week 11(end of study)

    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

  10. Firefighting Observational Rubrics

    Time frame: week 6

    These are observational rubrics, utilized by the firefighting instructors to evaluate occupational performance of the participants on specific firefighting task

  11. Change in adaptation to stress as assessed by the Situational Adaptation to Stress Scale for Human Performance (SASS-HP)

    Time frame: Baseline, about 3 weeks from baseline, about 6 weeks form baseline

    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

  12. Change in adaptation to stress as assessed by the Situational Adaptation to Stress Scale for Human Performance (SASS-HP)

    Time frame: about 11 weeks form baseline, end of study (about 19 weeks form baseline)

    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

  13. Change in mental skills as assessed by the Test of Performance Strategies (TOPS)

    Time frame: 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

  14. Change in achievement score as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment

    Time frame: Baseline, week 11

    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

  15. Change in average coherence as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment

    Time frame: Baseline, week 11

    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

  16. Change in average heart beats per minute as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment

    Time frame: Baseline, week 11

    Lower heart beats is better outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Ronald Acierno

CONTACT

[email protected]

(713) 486-2863

Sarah Jackson, MFT, PhD

CONTACT

[email protected]

(713) 486-2700

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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