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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Telemedicine & Advanced Technology Research Center
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01186315
First received: August 19, 2010
Last updated: August 6, 2013
Last verified: August 2013

August 19, 2010
August 6, 2013
December 2008
October 2013   (final data collection date for primary outcome measure)
  • Acceptability/feasibility (e.g., retention) of the novel intervention [ Time Frame: 10 weeks + 6 month follow-up ] [ Designated as safety issue: No ]
    Acceptability/feasibility of exposure therapy + VR/ER will be evidenced by rates of session attendance, retention, and exit interview ratings
  • Change in PTSD symptoms [ Time Frame: Pre treatment, 10 weeks, post treatment, 6 month follow-up ] [ Designated as safety issue: No ]
    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)]
  • Change in substance use [ Time Frame: Pre Treatment, Post 10 Week Treatment, and 6 month Follow Up ] [ Designated as safety issue: No ]
    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]
Same as current
Complete list of historical versions of study NCT01186315 on ClinicalTrials.gov Archive Site
Biochemical measures [ Time Frame: Pre Treatment, Post Treatment, Follow Up, During 10 weeks of Treatment ] [ Designated as safety issue: No ]
  • 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.
Same as current
Not Provided
Not Provided
 
Post-traumatic Stress Disorder (PTSD), Addiction, and Virtual Reality
Developing a Computer-Based Intervention to Enhance Behavioral Treatments for PTSD and Addiction

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.

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 will be recruited through the Durham Veterans Affairs Medical Center (Durham VAMC). 100 participants will be enrolled (sign the consent form) in order to identify 60 who meet inclusion/exclusion criteria. Participants will be 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 will be 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 will carry cell phones, and will be randomly called three times a day via the automated server (same as the VR/ER condition). These calls will be completed for assessment only, to obtain real time self-reports of substance use and cravings (without the ER). Comprehensive assessments will be 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Substance Use Disorders
  • Posttraumatic Stress Disorder
  • Behavioral: 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.
    Other Name: Exposure Therapy
  • 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
    Other Names:
    • virtual reality
    • exposure therapy
    • CER
    • VR
    • cell-phone based computerized extinction reminder
  • Active Comparator: 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: Behavioral: Prolonged Exposure Therapy
  • Experimental: 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.
    Intervention: Behavioral: Prolonged Exposure therapy + VR/ER

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01186315
Pro00011730, 01445, 08144019
Yes
Duke University
Duke University
  • Department of Defense
  • Telemedicine & Advanced Technology Research Center
Principal Investigator: Zachary Rosenthal, PhD Duke University
Duke University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP