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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorThe University of Texas Health Science Center, Houston

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

Qualifiers

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

Treatments tested in this trial

  • Stress NAVIGATOR (Mobile Health Application)
  • SIT NAVIGATOR

Treatment groups

20 Participants
are divided into 2 treatment groups