Clinical trial NCT01186315: Post-traumatic Stress Disorder (PTSD), Addiction, and Virtual Reality
Official title: Developing a Computer-Based Intervention to Enhance Behavioral Treatments for PTSD and Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Posttraumatic Stress Disorder
Keywords: Addiction
Posttraumatic Stress
substance abuse and posttraumatic stress
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Telemedicine & Advanced Technology Research Center
First posted: 2010-08-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acceptability/feasibility (e.g., retention) of the novel intervention
timeFrame: 10 weeks + 6 month follow-up
measure: Change in PTSD symptoms
timeFrame: Pre treatment, 10 weeks, post treatment, 6 month follow-up
measure: Change in substance use
timeFrame: Pre Treatment, Post 10 Week Treatment, and 6 month Follow Up
Secondary outcomes:
measure: Biochemical measures
timeFrame: Pre Treatment, Post Treatment, Follow Up, During 10 weeks of Treatment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Zachary Rosenthal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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