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

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 Overview

• Status: Recruiting
• Conditions: PTSD; Trauma and Stressor Related Disorders; Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Stress NAVIGATOR (Mobile Health Application); Behavioral: SIT NAVIGATOR

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Jackson, PhD; Phone Number: (281) 825-9923; Email: Sarah.E.Jackson@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Sarah Jackson, PhD; Phone Number: 281-825-9923; Email: Sarah.E.Jackson@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIT NAVIGATOR plus Stress NAVIGATOR group	Behavioral: 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; Behavioral: SIT NAVIGATOR; 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.
Active Comparator: SIT NAVIGATOR only group	Behavioral: SIT NAVIGATOR; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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.	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).	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).	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).	end of treatment (11-14 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sarah Jackson, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: veteran; Military; Traumatic Brain Injury; Post Traumatic Stress Disorder (PTSD)
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Trauma and Stressor Related Disorders
• Other Study ID Numbers: HSC-MS-23-0547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No