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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186315
• Other study ID #: Pro00011730
• Secondary ID: 0144508144019
• Status: Completed
• Phase: N/A
• First received: August 19, 2010
• Last updated: August 19, 2014
• Start date: December 2008
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Telemedicine & Advanced Technology Research Center, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (6)

Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. — View Citation

Koenen KC, Hitsman B, Lyons MJ, Stroud L, Niaura R, McCaffery J, Goldberg J, Eisen SA, True W, Tsuang M. Posttraumatic stress disorder and late-onset smoking in the Vietnam era twin registry. J Consult Clin Psychol. 2006 Feb;74(1):186-90. — View Citation

McLellan AT, Luborsky L, Woody GE, O'Brien CP. An improved diagnostic evaluation instrument for substance abuse patients. The Addiction Severity Index. J Nerv Ment Dis. 1980 Jan;168(1):26-33. — View Citation

Najavits LM, Weiss RD, Shaw SR, Muenz LR. "Seeking safety": outcome of a new cognitive-behavioral psychotherapy for women with posttraumatic stress disorder and substance dependence. J Trauma Stress. 1998 Jul;11(3):437-56. — View Citation

Seal KH, Bertenthal D, Miner CR, Sen S, Marmar C. Bringing the war back home: mental health disorders among 103,788 US veterans returning from Iraq and Afghanistan seen at Department of Veterans Affairs facilities. Arch Intern Med. 2007 Mar 12;167(5):476-82. — View Citation

Zlotnick C, Najavits LM, Rohsenow DJ, Johnson DM. A cognitive-behavioral treatment for incarcerated women with substance abuse disorder and posttraumatic stress disorder: findings from a pilot study. J Subst Abuse Treat. 2003 Sep;25(2):99-105. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No