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

NCT01186315 | Completed DMC

• 3 other identifiers: Pro000117300144508144019
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Posttraumatic Stress Disorder

Keywords

Addiction; Posttraumatic Stress; substance abuse and posttraumatic stress

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Biochemical measures

  Pre Treatment, Post Treatment, Follow Up, During 10 weeks of Treatment

Study Arms (2)

Prolonged Exposure therapy

ACTIVE COMPARATOR

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

Exposure therapy + VR/ER

EXPERIMENTAL

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

Interventions

Prolonged Exposure Therapy 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.

Also known as: Exposure Therapy

Prolonged Exposure therapy

Prolonged Exposure therapy + VR/ER 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

Also known as: virtual reality, exposure therapy, CER, VR, cell-phone based computerized extinction reminder

Exposure therapy + VR/ER

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• United States Department of Defense: collaborator
• Telemedicine & Advanced Technology Research Center: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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. doi: 10.1056/NEJMoa040603.

  PMID: 15229303 BACKGROUND

• 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. doi: 10.1023/A:1024496427434.

  PMID: 9690186 BACKGROUND

• 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. doi: 10.1097/00005053-198001000-00006.

  PMID: 7351540 BACKGROUND

• 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. doi: 10.1001/archinte.167.5.476.

  PMID: 17353495 BACKGROUND

• 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. doi: 10.1016/s0740-5472(03)00106-5.

  PMID: 14629992 RESULT

• 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. doi: 10.1037/0022-006X.74.1.186.

  PMID: 16551156 RESULT

MeSH Terms

Conditions

Substance-Related Disorders; Stress Disorders, Post-Traumatic; Behavior, Addictive

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Zachary Rosenthal, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: December 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

US (1)