Recruiting

Virtual Stress Inoculation Training

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06494319

Conditions

PTSD

Trauma and Stressor Related Disorders

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Stress NAVIGATOR (Mobile Health Application)

SIT NAVIGATOR

Study Details

Brief summary:

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

PTSD

Trauma and Stressor Related Disorders

Traumatic Brain Injury

Study ID

NCT06494319

Start date

May 28, 2024

Status verified date

Jul, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SIT NAVIGATOR plus Stress NAVIGATOR group

active comparator: SIT NAVIGATOR only group

Interventions

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.

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) ]
  • Increasing resilience as assessed by The Connor-Davidson Resilience Scale-10 (CD-RISC-10)4 [ Time Frame: end of study (about 11-14 weeks after baseline) ]
  • Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8-item (CSQ-8) [ Time Frame: 4 weeks after baseline ]
  • Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8 item ( CSQ-8) [ Time Frame: 8 weeks after baseline ]
  • Satisfaction with care as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8) [ Time Frame: end of study (about 11-14 weeks after baseline) ]
  • Change in average heart rate as assessed by the emWave Inner Balance personal biofeedback device by HeartMath [ Time Frame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks) ]
  • Change in average coherence(heart rate variability) as assessed by the emWave Inner Balance personal biofeedback device by HeartMath [ Time Frame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks) ]
  • Change in achievement score as assessed by the emWave Inner Balance personal biofeedback device by HeartMath [ Time Frame: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks) ]
  • Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8) [ Time Frame: 4-6 weeks(mid treatment) ]
  • Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8) [ Time Frame: 6-8 weeks (mid treatment) ]
  • Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8) [ Time Frame: end of treatment (11-14 weeks) ]

Central Contacts and Locations

Central contacts

Sarah Jackson, PhD

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Sarah Jackson, PhD

281-825-9923Sarah.E.Jackson@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 10, 2024

Last verified

Jul, 2024

Keywords

  • veteran
  • Post Traumatic Stress Disorder (PTSD)
  • Traumatic Brain Injury
  • Military

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-07-10.