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

The University of Texas Health Science Center, Houston20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PTSD Trauma and Stressor Related Disorders Traumatic Brain Injury

Interventions

SIT NAVIGATORBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 4 weeks after baseline

Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8 item ( CSQ-8)

Time frame: 8 weeks after baseline

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)

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

Time frame: 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

Time frame: 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.

Time frame: 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).

Time frame: 4-6 weeks(mid treatment)

Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)

Time frame: 6-8 weeks (mid treatment)

Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)

Time frame: end of treatment (11-14 weeks)

Secondary Outcomes

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

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)

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

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

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

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

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

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)

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

Time frame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts