Posttraumatic Stress DisorderNCT00656344
Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse
A study testing Cognitive behavioral treatment enhanced by virtual reality in people with Posttraumatic Stress Disorder and Substance Abuse, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study is exploring the use of an intervention designed to treat PTSD in individuals with comorbid PTSD and substance abuse resulting from the attacks of September 11 or from military service in Iraq. A cognitive behavioral treatment protocol will be used to treat PTSD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Substance Abuse
- What is being tested?
- Cognitive behavioral treatment enhanced by virtual reality
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Between the ages of 18 and 70
- Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
- Diagnosed with PTSD symptoms
- Current substance abuse disorder or history of substance abuse disorder
Who cannot join
- Presence of current organic mental disorder
- Presence or history of schizophrenia, bipolar disorder or depression with psychotic features, delusional disorder
- Active suicidal ideation, intent, or plan
- Active homicidal ideation, intent, or plan
- Use of pacemaker
- Medically unstable
- History of seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
This study is exploring the use of an intervention designed to treat PTSD in individuals with comorbid PTSD and substance abuse resulting from the attacks of September 11 or from military service in Iraq. A cognitive behavioral treatment protocol will be used to treat PTSD. The exposure component of the protocol will be enhanced with the use of virtual reality in which the client will view a virtual environment while describing their trauma.
- Conditions
- Posttraumatic Stress Disorder, Substance Abuse
- Being tested
- Cognitive behavioral treatment enhanced by virtual reality
- Keywords
- PTSD, Substance Abuse, WTC attacks, Iraq War
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral treatment enhanced by virtual realityOther
A cognitive behavioral protocol with cognitive and behavioral techniques will be used to treat symptoms. The exposure part of the treatment will be enhanced with the use of a virtual environment.
What is being measured
The primary outcome is the main question the study is designed to answer.
posttraumatic stress symptomatology
Measured: prior to treatment, during the treatment, immediately following treatment and 6 months after the completion of treatment
Secondary outcomes (1)
substance use symptomatology
Measured: prior to treatment, during treatment, immediately following treatment, and 6 months after the completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joann Difede, Weill Medical College of Cornell University
- Investigators
- JoAnn Difede, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656344
- Sponsor's protocol ID
- 9603000551
- Status last verified
- Dec 2013
- First submitted
- 7 Apr 2008
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse
- ClinicalTrials.gov ID
- NCT00656344
- Acronym / sponsor ID
- 9603000551
- Conditions
- Posttraumatic Stress Disorder, Substance Abuse
- Keywords
- PTSD, Substance Abuse, WTC attacks, Iraq War
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Apr 2008 (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.
This study is exploring the use of an intervention designed to treat PTSD in individuals with comorbid PTSD and substance abuse resulting from the attacks of September 11 or from military service in Iraq. A cognitive behavioral treatment protocol will be used to treat PTSD. The exposure component of the protocol will be enhanced with the use of virtual reality in which the client will view a virtual environment while describing their trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English-speaking
- Between the ages of 18 and 70
- Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
- Diagnosed with PTSD symptoms
- Current substance abuse disorder or history of substance abuse disorder
Key exclusion criteria (7 listed)
- Presence of current organic mental disorder
- Presence or history of schizophrenia, bipolar disorder or depression with psychotic features, delusional disorder
- Active suicidal ideation, intent, or plan
- Active homicidal ideation, intent, or plan
- Use of pacemaker
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 |
|---|---|---|
| Cognitive behavioral treatment enhanced by virtual realityA cognitive behavioral protocol with cognitive and behavioral techniques will be used to treat symptoms. The exposure part of the treatment will be enhanced with the use of a virtual environment. | Other | – |
Primary outcome
posttraumatic stress symptomatology
Time frame: prior to treatment, during the treatment, immediately following treatment and 6 months after the completion of treatment
1 secondary outcome
substance use symptomatology
Time frame: prior to treatment, during treatment, immediately following treatment, and 6 months after the completion 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 10 Dec 2013.
- Related InfoLink provided by the sponsor.
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A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
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Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
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Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
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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.
JoAnn Difede principal investigator
Weill Medical College of Cornell 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 Cognitive behavioral treatment enhanced by virtual reality in people with Posttraumatic Stress Disorder and Substance Abuse, run by Weill Medical College of Cornell 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 5 inclusion and 7 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 10 Dec 2013. 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?
posttraumatic stress symptomatology (time frame: prior to treatment, during the treatment, immediately following treatment and 6 months after the completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2013.