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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06494319
Status
Recruiting
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Conditions

  • PTSD
  • Trauma and Stressor Related Disorders
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Stress NAVIGATOR (Mobile Health Application) — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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),

Key Dates

Start date
May 28, 2024
Status verified
Jul 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SIT NAVIGATOR plus Stress NAVIGATOR group
  • Active Comparator: SIT NAVIGATOR only group

Primary Outcome Measure

Reduced symptoms of PTSD as assessed by the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) [ Time Frame: end of study (about 11-14 weeks after baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Sarah Jackson, PhD
[email protected]
281-825-9923

Find similar trials in Houston, TX

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
The University of Texas Health Science Center at Houston· Houston, TX

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