Substance Use DisordersNCT01186315
Post-traumatic Stress Disorder (PTSD), Addiction, and Virtual Reality
A study testing Prolonged Exposure Therapy and Prolonged Exposure therapy + VR/ER in people with Substance Use Disorders and Posttraumatic Stress Disorder, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorders, Posttraumatic Stress Disorder
- What is being tested?
- Prolonged Exposure Therapy and Prolonged Exposure therapy + VR/ER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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. At study completion, a total of 123 subjects signed consent.
Read the 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.
- Being tested
- Prolonged Exposure Therapy, Prolonged Exposure therapy + VR/ER
- Keywords
- Addiction, Posttraumatic Stress, substance abuse and posttraumatic stress
- Medical subject headings
- Substance-Related Disorders, Stress Disorders, Post-Traumatic, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure TherapyBehavioural
Also called 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/ERBehavioural
Also called virtual reality, exposure therapy, CER, VR
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Prolonged Exposure therapy + VR/ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)]
Measured: 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]
Measured: Pre Treatment, Post 10 Week Treatment, and 6 month Follow Up
Secondary outcomes (1)
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.
Measured: Pre Treatment, Post Treatment, Follow Up, During 10 weeks of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startDec 2008
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Telemedicine & Advanced Technology Research Center
- Responsible party
- Sponsor
- Investigators
- Zachary Rosenthal, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186315
- Sponsor's protocol ID
- Pro00011730
- Other IDs
- 01445, 08144019
- Status last verified
- Aug 2014
- First submitted
- 19 Aug 2010
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15229303Najavits 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.
PubMed 9690186McLellan 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.
PubMed 7351540Seal 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.
PubMed 17353495Zlotnick 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.
PubMed 14629992Koenen 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.
PubMed 16551156
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Computer-Based Intervention to Enhance Behavioral Treatments for PTSD and Addiction
- ClinicalTrials.gov ID
- NCT01186315
- Acronym / sponsor ID
- Pro00011730
- Keywords
- Addiction, Posttraumatic Stress, substance abuse and posttraumatic stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, Telemedicine & Advanced Technology Research Center
- Study start
- Dec 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure therapy | Active comparator | Behavioral: Prolonged Exposure TherapyThese 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. |
| Exposure therapy + VR/ER | Experimental | Behavioral: Prolonged Exposure therapy + VR/ERprolonged 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure TherapyAlso: Exposure TherapyThese 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. | Behavioural | Prolonged Exposure therapy |
| Prolonged Exposure therapy + VR/ERAlso: virtual reality, exposure therapy, CER, VRThe 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 | Behavioural | Exposure therapy + VR/ER |
Primary outcome
Acceptability/feasibility (e.g., retention) of the novel intervention
Time frame: 10 weeks + 6 month follow-up
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
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
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]
1 secondary outcome
Biochemical measures
Time frame: Pre Treatment, Post Treatment, Follow Up, During 10 weeks of Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
- Background: PubMed 15229303Hoge 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.
- Background: PubMed 9690186Najavits 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.
- Background: PubMed 7351540McLellan 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.
- Background: PubMed 17353495Seal 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 publication: PubMed 14629992Zlotnick 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 publication: PubMed 16551156Koenen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary Rosenthal, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure Therapy and Prolonged Exposure therapy + VR/ER in people with Substance Use Disorders and Posttraumatic Stress Disorder, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability/feasibility (e.g., retention) of the novel intervention (time frame: 10 weeks + 6 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186315, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2014.