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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Substance Use Disorders Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prolonged Exposure therapy

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.

Group Type ACTIVE_COMPARATOR

Prolonged Exposure Therapy

Intervention Type BEHAVIORAL

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.

Exposure therapy + VR/ER

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.

Group Type EXPERIMENTAL

Prolonged Exposure therapy + VR/ER

Intervention Type BEHAVIORAL

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

Interventions

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Prolonged Exposure Therapy

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.

Intervention Type BEHAVIORAL

Prolonged Exposure therapy + VR/ER

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Exposure Therapy virtual reality exposure therapy CER VR cell-phone based computerized extinction reminder

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No