Back to search results

Virtual Stress Inoculation Training for PTSD in Veterans

This study is developing and testing a virtual program called SIT NAVIGATOR, along with a mobile app called Stress NAVIGATOR, to help reduce symptoms of PTSD (Posttraumatic Stress Disorder) and improve resilience. Resilience is your ability to bounce back from difficult experiences. The study aims to see if this self-paced, online training can help military veterans and service members who have a PTSD diagnosis related to combat or military service in dangerous areas. To join, you must be a US Military Veteran or Service Member, aged 18-79, fluent in English, and have a specific score on a PTSD symptom checklist. The study will measure changes in your PTSD symptoms, resilience, and how satisfied you are with the care you receive.

Study design
This study plans to enroll 20 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You will complete 11 self-paced virtual SIT sessions using SIT NAVIGATOR, aiming for at least one session per week over 12 to 14 weeks. You will also use the Stress NAVIGATOR mobile app to complete weekly assessments.
Compensation
Not stated in the trial record.
Follow-up
Your PTSD symptoms and resilience will be measured at the end of the study (about 11-14 weeks after starting). Your satisfaction with care will be measured 4 weeks after starting.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06494319

Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App

UNKNOWN
NAAges 18–79InterventionalTreatment
The University of Texas Health Science Center, Houston
~20 participants
Updated 2024-07-10 on ClinicalTrials.gov
What's tested:Stress NAVIGATOR (Mobile Health Application)SIT NAVIGATOR

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduced symptoms of PTSD as assessed by the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
Measured over end of study (about 11-14 weeks after baseline)
+10 more outcomes measured

Conditions

PTSD
Trauma and Stressor Related Disorders
Traumatic Brain Injury

Explore related trials

Post-Traumatic Stress DisorderTrauma and Stressor Related DisordersTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Sarah Jackson, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Sarah Jackson, PhD
[email protected]
(281) 825-9923
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

US Military Veterans / Service Members
diagnosis of PTSD as measured by a Posttraumatic Symptom Checklist for DSM-5 (PCL-5) score of \>33
history of combat trauma and/or military service in an imminent danger pay area
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 or tablet to utilize the mobile health app and/OR access the virtual classroom.
agree to undergo psychometric 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.

Exclusion

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 DSM-5 Substance Abuse Disorder criteria, an AUDIT score \> 15, or partial Brief Addiction Monitor (BAM) indicating the presence of illicit substance use other than cannabis (\< 3 times weekly).
They are currently undergoing another form of treatment other than supportive therapy (\> 2 times per month).
Engaged in active trauma-focused therapy including Cognitive Processing Therapy (CPT)Prolonged Exposure (PE), or Eye Movement Desensitization and Reprocessing (EMDR).
Any other condition/situation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.

What this trial measures

  • Reduced symptoms of PTSD as assessed by the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)end of study (about 11-14 weeks after baseline)

    This is a 20 item questionnaire , each is scored from 0(not at all) -4( extremely)for a maximum score of 80, higher score indicating worse outcome

  • Increasing resilience as assessed by The Connor-Davidson Resilience Scale-10 (CD-RISC-10)4end of study (about 11-14 weeks after baseline)

    This is a 10 item questionnaire , each is scored from 0(not true at all) to 4(true nearly all the time) for a maximum score of 40, higher score indicating better outcome

  • Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8-item (CSQ-8)4 weeks after baseline

    This is an 8 item questionnaire , each is scored on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied,poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent). for a score range of 8-32, higher score indicating better outcome

  • Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8 item ( CSQ-8)8 weeks after baseline

    This is an 8 item questionnaire , each is scored on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied,poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent). for a score range of 8-32, higher score indicating better outcome

  • Satisfaction with care as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)end of study (about 11-14 weeks after baseline)

    This is an 8 item questionnaire , each is scored on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied,poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent). for a score range of 8-32, higher score indicating better outcome

  • Change in average heart rate as assessed by the emWave Inner Balance personal biofeedback device by HeartMathBaseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

    Heart rate is measured in beats per minute

  • Change in average coherence(heart rate variability) as assessed by the emWave Inner Balance personal biofeedback device by HeartMathBaseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

    Heart rate variability is measured via a mathematical algorithm called coherence

  • Change in achievement score as assessed by the emWave Inner Balance personal biofeedback device by HeartMathBaseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

    Achievement is measured via mathematical equation that includes coherence and heart rate variability and beats per minute over time. Higher achievement is associated with higher coherence sustained over time.

  • Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)4-6 weeks(mid treatment)

    The CSQ-8 is an 8-item measurement of global satisfaction. The range of possible scores is 8-32; higher scores indicate higher satisfaction with treatment. Items are measured on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied, poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent).

  • Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)6-8 weeks (mid treatment)

    The CSQ-8 is an 8-item measurement of global satisfaction. The range of possible scores is 8-32; higher scores indicate higher satisfaction with treatment. Items are measured on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied, poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent).

  • Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)end of treatment (11-14 weeks)

    The CSQ-8 is an 8-item measurement of global satisfaction. The range of possible scores is 8-32; higher scores indicate higher satisfaction with treatment. Items are measured on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied, poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent).