PTSDNCT06494319
Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
A study testing Stress NAVIGATOR (Mobile Health Application) and SIT NAVIGATOR in people with PTSD and Trauma and Stressor Related Disorders, 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 and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- PTSD, Trauma and Stressor Related Disorders, Traumatic Brain Injury
- What is being tested?
- Stress NAVIGATOR (Mobile Health Application) and SIT NAVIGATOR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sarah Jackson, PhD, 281-825-9923, Sarah.E.Jackson@uth.tmc.edu
About this study
The purpose of this study is to demonstrate the feasibility and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs),
- Being tested
- Stress NAVIGATOR (Mobile Health Application), SIT NAVIGATOR
- Keywords
- veteran, Post Traumatic Stress Disorder (PTSD), Traumatic Brain Injury, Military
- Medical subject headings
- Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress NAVIGATOR (Mobile Health Application)Behavioural
Participants will be prompted to complete their assessments each week (or upon completion of each session) via the Stress NAVIGATOR mobile health app
SIT NAVIGATORBehavioural
Participants will complete 11 self-paced virtual SIT sessions in the SIT-NAVIGATOR classroom. Participants will be asked to complete at least one session per week, in a minimum of 12 weeks and a maximum of 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SIT NAVIGATOR plus Stress NAVIGATOR group | Experimental | Not described Receives: Behavioral: Stress NAVIGATOR (Mobile Health Application); Behavioral: SIT NAVIGATOR |
| SIT NAVIGATOR only group | Active comparator | Not described Receives: Behavioral: SIT NAVIGATOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced symptoms of PTSD as assessed by the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
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
Measured: end of study (about 11-14 weeks after baseline)
Increasing resilience as assessed by The Connor-Davidson Resilience Scale-10 (CD-RISC-10)4
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
Measured: end of study (about 11-14 weeks after baseline)
Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8-item (CSQ-8)
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
Measured: 4 weeks after baseline
Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8 item ( CSQ-8)
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
Measured: 8 weeks after baseline
Satisfaction with care as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)
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
Measured: end of study (about 11-14 weeks after baseline)
Change in average heart rate as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
Heart rate is measured in beats per minute
Measured: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Change in average coherence(heart rate variability) as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
Heart rate variability is measured via a mathematical algorithm called coherence
Measured: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Change in achievement score as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
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.
Measured: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)
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).
Measured: 4-6 weeks(mid treatment)
Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)
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).
Measured: 6-8 weeks (mid treatment)
Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)
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).
Measured: end of treatment (11-14 weeks)
Secondary outcomes (5)
Change in difficulty to fall sleep as assessed by the Insomnia Severity Index (ISI)
This is a 7 item questionnaire, with a score range from 0-28, higher score indicating more insomnia
Measured: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Change in severity of depression as assessed by the Patient Health Questionnaire (PHQ-9)
9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a maximum score of 27, higher score indicating worse outcome
Measured: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Change in pain interference as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference scale
This is a 6 item questionnaire and each is scored from 1(not at all) to 5(very much) for a maximum score of 30, higher score indicating more pain interference
Measured: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Intensity scale
This is a 3 item questionnaire and each is scored from 1(had no pain) to 5(severe pain) for a maximum score of 15, higher score indicating more pain
Measured: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Change in adaptability to stress as assessed by the Situational Adaptation to Stress Scale (SASS-HSR)
This is an 18 item questionnaire and each is scored from 1( totally disagree) to 5 (agree) for a maximum score of 90, higher score indicating better outcome
Measured: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start28 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The first 10 participants will do the treatment via the canvas classroom virtually and participate in user experience interviews to improve the quality of the treatment and improve the user experience.Next, the second group of 10 participants will do the treatment with the canvas classroom aided by a mobile health application.These participants will also participate in user experience interviews to improve the quality of the treatment and improve the user experience.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Jackson, The University of Texas Health Science Center, Houston
- Investigators
- Sarah Jackson, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494319
- Sponsor's protocol ID
- HSC-MS-23-0547
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 2024
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
- ClinicalTrials.gov ID
- NCT06494319
- Acronym / sponsor ID
- HSC-MS-23-0547
- Keywords
- veteran, Post Traumatic Stress Disorder (PTSD), Traumatic Brain Injury, Military
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Jul 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 and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs),
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first 10 participants will do the treatment via the canvas classroom virtually and participate in user experience interviews to improve the quality of the treatment and improve the user experience.Next, the second group of 10 participants will do the treatment with the canvas classroom aided by a mobile health application.These participants will also participate in user experience interviews to improve the quality of the treatment and improve the user experience.
| Arm | Type | Receives |
|---|---|---|
| SIT NAVIGATOR plus Stress NAVIGATOR group | Experimental | Behavioral: Stress NAVIGATOR (Mobile Health Application), Behavioral: SIT NAVIGATOR |
| SIT NAVIGATOR only group | Active comparator | Behavioral: SIT NAVIGATOR |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 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 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).
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 |
|---|---|---|
| Stress NAVIGATOR (Mobile Health Application)Participants will be prompted to complete their assessments each week (or upon completion of each session) via the Stress NAVIGATOR mobile health app | Behavioural | SIT NAVIGATOR plus Stress NAVIGATOR group |
| SIT NAVIGATORParticipants will complete 11 self-paced virtual SIT sessions in the SIT-NAVIGATOR classroom. Participants will be asked to complete at least one session per week, in a minimum of 12 weeks and a maximum of 14 weeks. | Behavioural | SIT NAVIGATOR only group, SIT NAVIGATOR plus Stress NAVIGATOR group |
Primary outcome
Reduced symptoms of PTSD as assessed by the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
Time frame: 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)4
Time frame: end 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 HeartMath
Time frame: Baseline , 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 HeartMath
Time frame: Baseline , 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 HeartMath
Time frame: Baseline , 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
5 secondary outcomes
Change in difficulty to fall sleep as assessed by the Insomnia Severity Index (ISI)
Time frame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Change in severity of depression as assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Change in pain interference as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference scale
Time frame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Intensity scale
Time frame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Change in adaptability to stress as assessed by the Situational Adaptation to Stress Scale (SASS-HSR)
Time frame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- 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. This study is not recruiting at the moment.
Sarah Jackson, 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 Stress NAVIGATOR (Mobile Health Application) and SIT NAVIGATOR in people with PTSD and Trauma and Stressor Related Disorders, 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Jackson, PhD ((281) 825-9923, 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?
Reduced symptoms of PTSD as assessed by the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) (time frame: end of study (about 11-14 weeks after baseline)). The study lists 11 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 10 Jul 2024.