Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
NCT ID: NCT06494319
Last Updated: 2024-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-05-28
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SIT NAVIGATOR plus Stress NAVIGATOR group
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
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.
SIT NAVIGATOR only group
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
79 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Sarah Jackson
Associate Professor
Principal Investigators
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Sarah Jackson, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-23-0547
Identifier Type: -
Identifier Source: org_study_id
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