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

Primary Purpose

Substance Use Disorders, Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure Therapy
Prolonged Exposure therapy + VR/ER
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Addiction, Posttraumatic Stress, substance abuse and posttraumatic stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prolonged Exposure therapy

Exposure therapy + VR/ER

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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
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)]
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]

Secondary Outcome Measures

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.

Full Information

First Posted
August 19, 2010
Last Updated
August 19, 2014
Sponsor
Duke University
Collaborators
United States Department of Defense, Telemedicine & Advanced Technology Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01186315
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
United States Department of Defense, Telemedicine & Advanced Technology Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Posttraumatic Stress Disorder
Keywords
Addiction, Posttraumatic Stress, substance abuse and posttraumatic stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged Exposure therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exposure therapy + VR/ER
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Other Intervention Name(s)
Exposure Therapy
Intervention Description
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
Intervention Name(s)
Prolonged Exposure therapy + VR/ER
Other Intervention Name(s)
virtual reality, exposure therapy, CER, VR, cell-phone based computerized extinction reminder
Intervention Description
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
Primary Outcome Measure Information:
Title
Acceptability/feasibility (e.g., retention) of the novel intervention
Description
Acceptability/feasibility of exposure therapy + VR/ER will be evidenced by rates of session attendance, retention, and exit interview ratings
Time Frame
10 weeks + 6 month follow-up
Title
Change in PTSD symptoms
Description
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)]
Time Frame
Pre treatment, 10 weeks, post treatment, 6 month follow-up
Title
Change in substance use
Description
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]
Time Frame
Pre Treatment, Post 10 Week Treatment, and 6 month Follow Up
Secondary Outcome Measure Information:
Title
Biochemical measures
Description
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.
Time Frame
Pre Treatment, Post Treatment, Follow Up, During 10 weeks of Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Rosenthal, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15229303
Citation
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.
Results Reference
background
PubMed Identifier
9690186
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. doi: 10.1023/A:1024496427434.
Results Reference
background
PubMed Identifier
7351540
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. doi: 10.1097/00005053-198001000-00006.
Results Reference
background
PubMed Identifier
17353495
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. doi: 10.1001/archinte.167.5.476.
Results Reference
background
PubMed Identifier
14629992
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. doi: 10.1016/s0740-5472(03)00106-5.
Results Reference
result
PubMed Identifier
16551156
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. doi: 10.1037/0022-006X.74.1.186.
Results Reference
result

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

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