RECRUITINGINTERVENTIONAL

Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder

About This Trial

The goal of this trial is to test how augmented reality exposure therapy (ARET) may potentiate the effects of traditional exposure therapy administered to U.S. military personnel diagnosed with PTSD. 40 adult males and females over the age of 18 that have served, or are currently serving, in the U.S. military, with a current diagnosis of PTSD, will be recruited. Participants will be randomized into two groups: 20 participants will receive ARET + traditional ET, with the remaining 20 to receive traditional ET only. The main questions this trial aims to answer are: * what are the different clinical and psychosocial functioning outcomes between veterans/active-duty personnel with PTSD who receive ARET + traditional ET versus traditional ET only * what are the differences in acceptance and satisfaction of treatment, between ARET + traditional ET and the traditional ET-only group

Who May Be Eligible (Plain English)

Who May Qualify: - Adult male or female over the age of 18 that has served, or is currently serving, in the military. - Current diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview. Who Should NOT Join This Trial: - Active psychosis or dementia at screening. - Suicidal ideation with clear intent. - Concurrent enrollment in another clinical trial for PTSD or depression. - Substance use disorders - Visual impairments not allowing use of augmented reality. Visual impairments that are corrected with contact lens visual aid are not considered exclusionary as contacts can be worn under the AR headset. For patients with vision impairment that cannot wear contacts, a diopter value no stronger than -2.00 is acceptable. Exclusion criteria are limited to those factors that would negatively impact the validity of the study findings, or place participants at undue risk. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Adult male or female over the age of 18 that has served, or is currently serving, in the military. * Current diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview. Exclusion Criteria: * Active psychosis or dementia at screening. * Suicidal ideation with clear intent. * Concurrent enrollment in another clinical trial for PTSD or depression. * Substance use disorders * Visual impairments not allowing use of augmented reality. Visual impairments that are corrected with contact lens visual aid are not considered exclusionary as contacts can be worn under the AR headset. For patients with vision impairment that cannot wear contacts, a diopter value no stronger than -2.00 is acceptable. Exclusion criteria are limited to those factors that would negatively impact the validity of the study findings, or place participants at undue risk.

Treatments Being Tested

BEHAVIORAL

Traditional Exposure Therapy (ET) Treatment

Traditional exposure therapy (ET) includes the following components: (a) psychological education about trauma (sessions 1 and 2), (b) repeated in vivo exposure to trauma-related stimuli (in vivo exercises are assigned as homework during sessions 3 through 9), (c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 - 9; patients listen to session audiotapes for homework between sessions), and (d) relapse prevention strategies and further treatment planning (session 10).

BEHAVIORAL

Stepwise Augmented Reality (AR) Component with Traditional Exposure Treatment for Nonresponders

The Augmented Reality Exposure Therapy component includes the following: (a) 60-minute sessions dedicated to augmented reality exposure therapy (ARET; sessions 1-10), (b) repeated in vivo exposure to trauma-related stimuli (in vivo exercises are assigned as homework during sessions 3 through 9), and (c) relapse prevention strategies and further treatment planning (session 10). During ARET, the clinician guides participant, who is wearing augmented reality (AR) goggles, through preset scenarios during which characters mingle with each other (e.g., grocery store, social gathering), as well as custom scenarios where participant can interact with the character. Those who do not respond to treatment (i.e., responders defined as PCL score reduction of at least 12 points and final PCL score below 33) will then subsequently participate in 10 60-minute sessions of traditional exposure therapy (ET) identical to procedures described for the traditional ET arm.

Locations (1)

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, United States