NCT06656780

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Aug 2025Jun 2027

First Submitted

Initial submission to the registry

October 21, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

August 31, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

October 21, 2024

Last Update Submit

June 11, 2025

Conditions

Keywords

Psychological healthresilienceWarfighter performance

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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 (16)

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

    week 2

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

    week 4

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

    week 2

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

    week 4

  • Utility as assessed by the standardized self-assessment tool

    week 2

  • +11 more secondary outcomes

Study Arms (2)

SIT + Damage Control Assessment & Firefighting (DCA-FF)

EXPERIMENTAL
Behavioral: SITBehavioral: DCA-FF

DCA-FF

ACTIVE COMPARATOR
Behavioral: DCA-FF

Interventions

SITBEHAVIORAL

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.

SIT + Damage Control Assessment & Firefighting (DCA-FF)
DCA-FFBEHAVIORAL

Participants will undergo 8-week Standard Firefighting Training

DCA-FFSIT + Damage Control Assessment & Firefighting (DCA-FF)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stress, PsychologicalPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Sarah Jackson, MFT, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 24, 2024

Study Start

August 31, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations