PTSDNCT01760213
Brief Internet Based Treatment for PTSD
A study testing CBT delivered via Internet in people with PTSD, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The goal of the project is to overcome some of the common barriers to treatment amongst recent survivors of traumatic events, by combining the world of evidence-based intervention with that of modern Internet technology. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- CBT delivered via Internet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Aug 2015
- 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
- Exposed to a traumatic event that meets DSM Criteria (objectively could cause physical injury;
- Subjectively involves helplessness or fear);
- Aged over 18; Aged under 65;
- Hebrew speaking; Suffering from PTSD (without the time criteria i.e. less than one month of symptoms);
- Able to give informed consent.
Who cannot join
- Suffering from, or have suffered from in the past, bipolar disorder;
- Suffering from, or have suffered from in the past, psychotic disorder;
- Suffering from, or have suffered from in the past, substance abuse;
- Suffering from PTSD;
- Suffering from another Axis I anxiety disorder that requires immediate treatment;
- Currently presents as a suicide risk, requiring hospitalization.
Trial locations and contacts
1 site in 1 country.
Rena Cooper, MD contact
Sara Freedman, PhD contact
About this study
Official title: Internet Based Treatment Using Virtual Reality in the Prevention of PTSD
The goal of the project is to overcome some of the common barriers to treatment amongst recent survivors of traumatic events, by combining the world of evidence-based intervention with that of modern Internet technology. Specifically, it aims to test the feasibility and effectiveness of an Internet delivery of early-intervention trauma-focused cognitive behavioral therapy (CBT) for preventing post-traumatic stress disorder (PTSD). Over the course of the study the following objectives will be achieved:
- The development of an Internet-based Virtual Reality intervention for preventing PTSD among patients who have recently experienced a traumatic event.
- The evaluation of the feasibility of administering this intervention, and
- The evaluation of the efficacy of this Internet based intervention in the prevention of PTSD in recent trauma survivors.
- Conditions
- PTSD
- Being tested
- CBT delivered via Internet
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT delivered via InternetOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | intervention delivered via internet Receives: Other: CBT delivered via Internet |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of PTSD symptoms
the main outcome measure will be PTSD symptoms as measured by the CAPS.
Measured: 12 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Responsible party
- Sponsor
- Investigators
- Rena Cooper, MD, Principal investigator, HMOSara Freedman, PhD, Study director, Bar Ilan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760213
- Sponsor's protocol ID
- VRInternet
- Status last verified
- Dec 2012
- First submitted
- 12 Dec 2012
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Based Treatment Using Virtual Reality in the Prevention of PTSD
- ClinicalTrials.gov ID
- NCT01760213
- Acronym / sponsor ID
- VRInternet
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 4 Jan 2013 (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.
The goal of the project is to overcome some of the common barriers to treatment amongst recent survivors of traumatic events, by combining the world of evidence-based intervention with that of modern Internet technology. Specifically, it aims to test the feasibility and effectiveness of an Internet delivery of early-intervention trauma-focused cognitive behavioral therapy (CBT) for preventing post-traumatic stress disorder (PTSD). Over the course of the study the following objectives will be achieved:
- The development of an Internet-based Virtual Reality intervention for preventing PTSD among patients who have recently experienced a traumatic event.
- The evaluation of the feasibility of administering this intervention, and
- The evaluation of the efficacy of this Internet based intervention in the prevention of PTSD in recent trauma survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: CBT delivered via Internetintervention delivered via internet |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Exposed to a traumatic event that meets DSM Criteria (objectively could cause physical injury;
- Subjectively involves helplessness or fear);
- Aged over 18; Aged under 65;
- Hebrew speaking; Suffering from PTSD (without the time criteria i.e. less than one month of symptoms);
- Able to give informed consent.
Key exclusion criteria (6 listed)
- Suffering from, or have suffered from in the past, bipolar disorder;
- Suffering from, or have suffered from in the past, psychotic disorder;
- Suffering from, or have suffered from in the past, substance abuse;
- Suffering from PTSD;
- Suffering from another Axis I anxiety disorder that requires immediate treatment;
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 |
|---|---|---|
| CBT delivered via Internet | Other | Treatment |
Primary outcome
Levels of PTSD symptoms
Time frame: 12 months after end of treatment
the main outcome measure will be PTSD symptoms as measured by the CAPS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
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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.
Rena Cooper, MD contact
Sara Freedman, PhD contact
Rena Cooper, MD principal investigator
HMO
Sara Freedman, PhD study director
Bar Ilan 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 CBT delivered via Internet in people with PTSD, run by Hadassah Medical Organization at 1 site in Israel.
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 6 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: status not confirmed, as of the sponsor's last update on 23 May 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rena Cooper, MD (crena@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of PTSD symptoms (time frame: 12 months after end 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 23 May 2013.