Stress, PsychologicalNCT06656780
Stress Inoculation Training (SIT): An Evidence-Based, Military Aligned Psychological Performance and Health Sustainment Prototype
A study testing SIT and DCA-FF in people with Stress, Psychological, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- SIT and DCA-FF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sarah Jackson, MFT, PhD i, 713-486-2700, Sarah.E.Jackson@uth.tmc.edu
Ronald Acierno, (713) 486-2863, Ronald.Acierno@uth.tmc.edu
About this study
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.
- Conditions
- Stress, Psychological
- Being tested
- SIT, DCA-FF
- Keywords
- Psychological health, resilience, Warfighter performance
- Medical subject headings
- Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SITBehavioural
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.
DCA-FFBehavioural
Participants will undergo 8-week Standard Firefighting Training
| Study group | Role | What they receive |
|---|---|---|
| SIT + Damage Control Assessment & Firefighting (DCA-FF) | Experimental | Not described Receives: Behavioral: SIT; Behavioral: DCA-FF |
| DCA-FF | Active comparator | Not described Receives: Behavioral: DCA-FF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
This is a is a dichotomous measure (1-successful vs. 0-unsuccessful)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: week 2
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
Measured: week 3
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start31 Aug 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Sarah Jackson, The University of Texas Health Science Center, Houston
- Investigators
- Sarah Jackson, MFT, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656780
- Sponsor's protocol ID
- HSC-MS-24-0756
- Status last verified
- Jun 2025
- First submitted
- 21 Oct 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Inoculation Training (SIT): An Evidence-Based, Military Aligned Psychological Performance and Health Sustainment Prototype
- ClinicalTrials.gov ID
- NCT06656780
- Acronym / sponsor ID
- HSC-MS-24-0756
- Conditions
- Stress, Psychological
- Keywords
- Psychological health, resilience, Warfighter performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIT + Damage Control Assessment & Firefighting (DCA-FF) | Experimental | Behavioral: SIT, Behavioral: DCA-FF |
| DCA-FF | Active comparator | Behavioral: DCA-FF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SITParticipants 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. | Behavioural | SIT + Damage Control Assessment & Firefighting (DCA-FF) |
| DCA-FFParticipants will undergo 8-week Standard Firefighting Training | Behavioural | DCA-FF, SIT + Damage Control Assessment & Firefighting (DCA-FF) |
Primary outcome
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)
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)
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)
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
16 secondary outcomes
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)
Change in mental skills as assessed by the Test of Performance Strategies (TOPS)
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
Time frame: Baseline, week 11
Change in average coherence as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment
Time frame: Baseline, week 11
Change in average heart beats per minute as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment
Time frame: Baseline, week 11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Jackson, MFT, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIT and DCA-FF in people with Stress, Psychological, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Jackson, MFT, PhD ((713) 486-2700, Sarah.E.Jackson@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.