Posttraumatic Stress DisorderNCT01162044
Examining an Emergency Room Intervention for the Prevention of Post Traumatic Stress Disorder (PTSD)
A study testing Computer game in people with Posttraumatic Stress Disorder, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
PTSD is a common and distressing possible outcome following exposure to a traumatic event. Recent studies show that memory processes may be central to the development of the disorder, and interrupting the consolidation of traumatic memories may prevent the disorder from developing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Computer game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2010to Sep 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-65,
- no loss of consciousness,
- ability to understand study procedures and give informed consent,
- Hebrew as first language,
- experienced a potentially traumatic event as defined in DSM (objective danger and subjective feeling of fear).
Who cannot join
- current or past psychiatric treatment,
- current or past PTSD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interrupting Traumatic Memories: An Emergency Room Intervention for the Prevention of PTSD
PTSD is a common and distressing possible outcome following exposure to a traumatic event. Recent studies show that memory processes may be central to the development of the disorder, and interrupting the consolidation of traumatic memories may prevent the disorder from developing. Specifically the use of a visual spatial task has been shown to reduce a key characteristic of PTSD, intrusions, in non-clinical populations. This study aims to administer a visual spatial task to recent trauma survivors in the Emergency Room, and compare PTSD and symptoms development in these patients as compared to a control group who did not carry out the task. The study hypothesizes that the task will result in less PTSD, lower levels of intrusions, dissociation and pain.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Computer game
- Keywords
- PTSD, prevention
- 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.
Computer gameOther
Playing with specially designed computer game while in emergency room
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Subjects will be assessed, but no active intervention given |
| Computer game | Experimental | Subjects will play with computer game while in the Emergency Room Receives: Other: Computer game |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms
PTSD status and symptoms as measured by the PSS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011 (estimated)
- Study completionSep 2011 (estimated)
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Rena Cooper, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162044
- Sponsor's protocol ID
- ER-PTSD-HMO-CTIL
- Status last verified
- Jul 2010
- First submitted
- 13 Jul 2010
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrupting Traumatic Memories: An Emergency Room Intervention for the Prevention of PTSD
- ClinicalTrials.gov ID
- NCT01162044
- Acronym / sponsor ID
- ER-PTSD-HMO-CTIL
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 14 Jul 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.
PTSD is a common and distressing possible outcome following exposure to a traumatic event. Recent studies show that memory processes may be central to the development of the disorder, and interrupting the consolidation of traumatic memories may prevent the disorder from developing. Specifically the use of a visual spatial task has been shown to reduce a key characteristic of PTSD, intrusions, in non-clinical populations. This study aims to administer a visual spatial task to recent trauma survivors in the Emergency Room, and compare PTSD and symptoms development in these patients as compared to a control group who did not carry out the task. The study hypothesizes that the task will result in less PTSD, lower levels of intrusions, dissociation and pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Subjects will be assessed, but no active intervention given |
| Computer game | Experimental | Other: Computer gameSubjects will play with computer game while in the Emergency Room |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-65,
- no loss of consciousness,
- ability to understand study procedures and give informed consent,
- Hebrew as first language,
- experienced a potentially traumatic event as defined in DSM (objective danger and subjective feeling of fear).
Key exclusion criteria (2 listed)
- current or past psychiatric treatment,
- current or past PTSD.
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 |
|---|---|---|
| Computer gamePlaying with specially designed computer game while in emergency room | Other | Computer game |
Primary outcome
PTSD symptoms
Time frame: 6 months
PTSD status and symptoms as measured by the PSS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2010.
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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 principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer game in people with Posttraumatic Stress Disorder, 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 2 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 14 Jul 2010. 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 Sara A Freedman, PhD (972544704636, sarafreedman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptoms (time frame: 6 months). 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 14 Jul 2010.