Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
NCT Number: NCT06494319
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PTSD|Trauma and Stressor Related Disorders|Traumatic Brain Injury
Interventions: BEHAVIORAL: Stress NAVIGATOR (Mobile Health Application)|BEHAVIORAL: SIT NAVIGATOR
Sponsor: The University of Texas Health Science Center, Houston
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-28
Completion Date: 2025-06-30
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States

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),

Primary Outcome 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), 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: 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)