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

Not Applicable

Not yet recruiting

• Conditions: Stress, Psychological

• Registration Number: NCT06656780
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Study First Posted: 2024-10-24
• Last Update Posted: 2024-10-24
• Study Start: 2024-12-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric	week 4	This is a is a dichotomous measure (1-successful vs. 0-unsuccessful)
level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubric	week 4	This is scored on a likert scale from 1(low) to 5(high)
Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)	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
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
Utility as assessed by the standardized self-assessment tool	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.
Firefighting Observational Rubrics	week 6	These 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)	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
Change in achievement score as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment	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
Change in average coherence as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment	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
Change in average heart beats per minute as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment	Baseline, week 11	Lower heart beats is better outcome

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States