Post-traumatic Stress Disorder (PTSD), Addiction, and Virtual Reality

Study Overview
=================
Brief Summary
-----------------
Eligible veterans, National Guardsmen & Reservists with post-traumatic stress disorder (PTSD) and problems with addiction will be randomly assigned to one of two treatment conditions. All participants will undergo exposure therapy, a gold standard behavioral treatment for PTSD for 10 weeks. In addition to exposure therapy, some participants will be randomly assigned to receive (1) virtual reality (VR)-based exposure to cues for marijuana, cocaine, heroin, cigarette, and/or alcohol use, and (2) cellular phone-based reminders of learning (extinction reminders, or, ERs) to VR exposure (available 24 hours per day/7 days per week) to high-risk contexts for drug use. The main hypothesis is that those participants who receive exposure therapy + VR/ERs will demonstrate less substance use and lower PTSD symptoms during treatment, at post-treatment, and at follow-up than those participants who only receive exposure therapy. At study completion, a total of 123 subjects signed consent.

Detailed Description
-----------------
Veterans, National Guardsmen, & Reservists with post-traumatic stress disorder (PTSD) and problems with addiction need a wider array of treatment options than what is currently available. The present project offers the promise of a complementary approach that uses computer-based interventions to augment exposure therapy for veterans with both PTSD and use alcohol, nicotine and/or other substances. If this new intervention is found to be efficacious in the present project, it would provide an alternative to standard treatment for a growing number of veterans who are at risk for lifetime problems with PTSD and addiction, but who may be unwilling to begin usual psychotherapy. This direct way of training new behavior in the clinic and extending learning into the real world is missing in treatments for many medical and psychiatric conditions. As such, the impact of this project could extend into treatment of a wide variety of other chronic conditions for which more powerful new treatments are needed. Veterans will be recruited from the Durham Veterans Affairs Medical Center (Durham VAMC) and local community. Participants (N = 60) meeting full criteria for current diagnoses of both PTSD and at least one SUD were to be recruited through the Durham Veterans Affairs Medical Center (Durham VAMC). 100 participants were to be enrolled (sign the consent form) in order to identify 60 who meet inclusion/exclusion criteria. Actually 123 subjects signed consent and 38 subjects are considered ITT (intent to treat-met inclusion/exclusion criteria, randomized and showed to their first therapy session). Participants were randomly assigned to one of two treatment conditions-exposure therapy alone or exposure therapy + virtual reality (VR)-based exposure to cues for marijuana, cocaine, heroin, cigarette, and/or alcohol use, and (2) cellular phone-based reminders of learning (extinction reminders, or, ERs) to VR exposure. Matching between treatment groups was based on age, gender, severity of PTSD and substance use. In addition, to control for differential dropout and other changes in treatment due to cell phone use in the VR/ER condition, participants in the control condition also carried cell phones, and were randomly called three times a day via the automated server (same as the VR/ER condition). These calls were completed for assessment only, to obtain real time self-reports of substance use and cravings (without the ER). Comprehensive assessments were conducted at pre-treatment, 10 weeks (post-treatment), and at a 6-month follow-up. The goals of this project are to examine the acceptability and feasibility of the complementary treatment and evaluate the effects of the complementary intervention on PTSD and substance use.

Official Title
-----------------
Developing a Computer-Based Intervention to Enhance Behavioral Treatments for PTSD and Addiction

Conditions
-----------------
Substance Use Disorders, Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Prolonged Exposure Therapy
* Behavioral: Prolonged Exposure therapy + VR/ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets SCID-I criteria for PTSD; criterion A stressor must be deployment related, and substance dependence; primary substance of dependence is cocaine, heroin, alcohol, cigarettes, or marijuana Must be a Veteran Consents to outpatient treatment for PTSD and drug addiction Exclusion Criteria: Full criteria met for current manic episode or psychotic disorder through using SCID-I interviews Pregnant at time of treatment IQ less than 70; unable to give consent; can not read current and chronic absence of shelter impending jail/prison for more than three weeks Court order to treatment, court order to treatment or to jail, or agency order to treatment or loss of child custody (due to inability to freely drop-out of treatment) Refuses to discontinue current mental health or drug abuse behavioral treatment (i.e., psychotherapy) or random assignment Suicide attempt or self-harm in the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prolonged Exposure therapy<br>These treatments include repeated exposure to intrusive trauma-related memories in a safe and structured manner designed to reduce emotional arousal and facilitate processing of trauma-related memories. | Behavioral: Prolonged Exposure Therapy<br>* These treatments include repeated exposure to intrusive trauma-related memories in a safe and structured manner designed to reduce emotional arousal and facilitate processing of trauma-related memories.<br>* Other names: Exposure Therapy;|
| Experimental: Exposure therapy + VR/ER<br>prolonged exposure therapy plus virtual reality (VR) based cue exposure/extinction software and cellular phone-based computerized extinction reminder (CER) technology for use in high-risk situations outside treatment sessions. | Behavioral: Prolonged Exposure therapy + VR/ER<br>* The therapy includes repeated exposure to intrusive trauma-related memories in a safe and structured manner designed to reduce emotional arousal and facilitate processing of trauma-related memories and adding in virtual reality (VR)-based exposure to cues for marijuana, cocaine, heroin, cigarette, and/or alcohol use & CER used outside treatment sessions in response to VR exposure (available 24 hours per day/7 days per week) to high-risk contexts for drug use<br>* Other names: cell-phone based computerized extinction reminder;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability/feasibility (e.g., retention) of the novel intervention | Acceptability/feasibility of exposure therapy + VR/ER will be evidenced by rates of session attendance, retention, and exit interview ratings | 10 weeks + 6 month follow-up | 
| Change in PTSD symptoms | Self-report measures of PTSD symptoms [e.g. The Davidson Trauma Scale (DTS)]and interview measures [e.g. Structured interview for DSM-IV, Axis I (SCID-I), Clinician Administered PTSD Scale (CAPS)] | Pre treatment, 10 weeks, post treatment, 6 month follow-up | 
| Change in substance use | Self report measures of substance use: (e.g. Fagerström Test for Nicotine Dependence, Smoking Effects Questionnaire, Alcohol Craving Questionnaire, Heroin Craving Questionnaire, Cocaine Craving Questionnaire) and Interview Measures: [e.g. Structured Clinical Interview for DSM-IV, Axis I (SCID-I); Addiction Severity Index (ASI); Time Line Follow-back Assessment Method] | Pre Treatment, Post 10 Week Treatment, and 6 month Follow Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical measures | Urinalysis testing is done using the Biosite Diagnostics Triage Meter Plus within 24 hours for cocaine, marijuana, opiates, amphetamines, and benzodiazepines. Will be thrice weekly during 10 weeks of treatment. Breathalyzer is done Pre Treatment, Post Treatment, Follow Up and before sessions during treatment. | Pre Treatment, Post Treatment, Follow Up, During 10 weeks of Treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Addiction, Posttraumatic Stress, substance abuse and posttraumatic stress