Clinical trial NCT06494319: Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
Official title: Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Trauma and Stressor Related Disorders
Traumatic Brain Injury
Keywords: veteran
Post Traumatic Stress Disorder (PTSD)
Traumatic Brain Injury
Military
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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 participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs),


Eligibility criteria: Inclusion Criteria:

* 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 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 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.

Primary outcomes:
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)
timeFrame: end of study (about 11-14 weeks after baseline)
measure: Increasing resilience as assessed by The Connor-Davidson Resilience Scale-10 (CD-RISC-10)4
timeFrame: end of study (about 11-14 weeks after baseline)
measure: Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8-item (CSQ-8)
timeFrame: 4 weeks after baseline
measure: Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8 item ( CSQ-8)
timeFrame: 8 weeks after baseline
measure: Satisfaction with care as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)
timeFrame: end of study (about 11-14 weeks after baseline)
measure: Change in average heart rate as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
timeFrame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
measure: Change in average coherence(heart rate variability) as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
timeFrame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
measure: Change in achievement score as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
timeFrame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
measure: Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)
timeFrame: 4-6 weeks(mid treatment)
measure: Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)
timeFrame: 6-8 weeks (mid treatment)
measure: Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)
timeFrame: end of treatment (11-14 weeks)
Secondary outcomes:
measure: Change in difficulty to fall sleep as assessed by the Insomnia Severity Index (ISI)
timeFrame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
measure: Change in severity of depression as assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
measure: Change in pain interference as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference scale
timeFrame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
measure: Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Intensity scale
timeFrame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
measure: Change in adaptability to stress as assessed by the Situational Adaptation to Stress Scale (SASS-HSR)
timeFrame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
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, PhD
role: PRINCIPAL_INVESTIGATOR
References: