Print

Purpose

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),

Conditions

Eligibility

Eligible Ages
Between 18 Years and 79 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
The first 10 participants will do the treatment via the canvas classroom virtually and participate in user experience interviews to improve the quality of the treatment and improve the user experience.Next, the second group of 10 participants will do the treatment with the canvas classroom aided by a mobile health application.These participants will also participate in user experience interviews to improve the quality of the treatment and improve the user experience.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Sarah Jackson, PhD
281-825-9923
Sarah.E.Jackson@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Sarah Jackson, PhD
(281) 825-9923
Sarah.E.Jackson@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.