About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
Stress NAVIGATOR (Mobile Health Application)
BehavioralParticipants will be prompted to complete their assessments each week (or upon completion of each session) via the Stress NAVIGATOR mobile health app
SIT NAVIGATOR
BehavioralParticipants 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.
Treatment groups
Trial 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
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
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
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
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
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
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
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
Sponsors and contacts
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