Clinical trial NCT06656780: Stress Inoculation Training (SIT): An Evidence-Based, Military Aligned Psychological Performance and Health Sustainment Prototype
Official title: Stress Inoculation Training (SIT): An Evidence-Based, Military Aligned Psychological Performance and Health Sustainment Prototype
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress, Psychological
Keywords: Psychological health
resilience
Warfighter performance
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Department of Defense / Congressionally Mandated Research Program (CDMRP)
First posted: 2024-10-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Changes in perceived management of stress as assessed by the Perceived Stress Scale (PSS)
timeFrame: 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)
measure: Change in resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 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:
measure: Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric
timeFrame: week 2
measure: Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric
timeFrame: week 4
measure: level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubric
timeFrame: week 2
measure: level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubric
timeFrame: week 4
measure: Utility as assessed by the standardized self-assessment tool
timeFrame: week 2
measure: Utility as assessed by the standardized self-assessment tool
timeFrame: week 4
measure: Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: week 2
measure: Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: week 3
measure: Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: week 11(end of study)
measure: Firefighting Observational Rubrics
timeFrame: week 6
measure: Change in adaptation to stress as assessed by the Situational Adaptation to Stress Scale for Human Performance (SASS-HP)
timeFrame: Baseline, about 3 weeks from baseline, about 6 weeks form baseline
measure: Change in adaptation to stress as assessed by the Situational Adaptation to Stress Scale for Human Performance (SASS-HP)
timeFrame: about 11 weeks form baseline, end of study (about 19 weeks form baseline)
measure: Change in mental skills as assessed by the Test of Performance Strategies (TOPS)
timeFrame: Baseline, about 6 weeks form baseline, about week 11, end of study (19 weeks form baseline)
measure: Change in achievement score as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment
timeFrame: Baseline, week 11
measure: Change in average coherence as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment
timeFrame: Baseline, week 11
measure: Change in average heart beats per minute as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment
timeFrame: Baseline, week 11
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sarah Jackson, MFT, PhD
role: PRINCIPAL_INVESTIGATOR
References: