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Not yet recruiting NCT06656780

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

No phase Interventional Stress, Psychological

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SIT, DCA-FF.
Who it may be relevant to
Registry conditions: Stress, Psychological. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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.

Interventions

  • 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 an
  • Behavioral DCA-FF
    Participants will undergo 8-week Standard Firefighting Training

Primary outcome measures

  • 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)]
  • 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)]
Secondary outcome measures (12)
  • Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric [Time frame: week 2]
  • Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric [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 [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 [Time frame: week 4]
  • Utility as assessed by the standardized self-assessment tool [Time frame: week 2]
  • Utility as assessed by the standardized self-assessment tool [Time frame: week 4]
  • Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8) [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 [Time frame: week 6]
  • 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]
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06656780 · HSC-MS-24-0756

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗