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Behavioral Intervention

Virtual Therapy for PTSD

N/A
Recruiting
Led By Sarah Jackson, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of PTSD as measured by a Posttraumatic Symptom Checklist for DSM-5 (PCL-5) score of >33
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Awards & highlights

Summary

This trial aims to test a new way of delivering therapy for PTSD using a virtual platform, either with or without a mobile health app. The goal is to see if this therapy can help reduce PTSD symptoms

Who is the study for?
This trial is for individuals with Traumatic Brain Injury (TBI) and related stress disorders, including PTSD. Participants should be interested in a self-paced virtual therapy program to help manage their symptoms.
What is being tested?
The study tests the effectiveness of a Stress Inoculation Training (SIT) delivered virtually through a platform and an accompanying mobile app called Stress NAVIGATOR. It aims to see if these tools can reduce PTSD symptoms and increase resilience.
What are the potential side effects?
Since this trial involves virtual training and a mobile health application, there are no direct medical side effects like those from medication or surgery. However, participants may experience emotional discomfort while engaging with the material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PTSD with a PCL-5 score over 33.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not receiving any treatment more than twice a month, except for supportive care.
Select...
I am currently in therapy for trauma using CPT, PE, or EMDR methods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in achievement score as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
Change in average coherence(heart rate variability) as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
Change in average heart rate as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
+6 more
Secondary study objectives
Change in adaptability to stress as assessed by the Situational Adaptation to Stress Scale (SASS-HSR)
Change in difficulty to fall sleep as assessed by the Insomnia Severity Index (ISI)
Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Intensity scale
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SIT NAVIGATOR plus Stress NAVIGATOR groupExperimental Treatment2 Interventions
Group II: SIT NAVIGATOR only groupActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
934 Previous Clinical Trials
333,788 Total Patients Enrolled
Sarah Jackson, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
~13 spots leftby Jun 2025
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