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

N/ANot Yet RecruitingNCT06656780

The University of Texas Health Science Center, Houston120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Stress, Psychological

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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)

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

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)

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: week 2

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

Time frame: week 3

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline, week 11

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts