Posttraumatic Stress DisorderNCT00229372
Prolonged Exposure Versus Treatment as Usual in Chronic Posttraumatic Stress Disorder Combat and Terror Related Patients
A study testing Prolonged Exposure (PE) therapy in people with Posttraumatic Stress Disorder, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Assessing the efficacy of Posttraumatic Stress Disorder (PE) treatment for chronic Posttraumatic Stress Disorder (PTSD) Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Prolonged Exposure (PE) therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Nov 2006to Apr 2007
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTSD
Who cannot join
- Psychotic symptoms
- Dissociation
- Drug or Alcohol dependence
Trial locations and contacts
1 site in 1 country.
About this study
Assessing the efficacy of Posttraumatic Stress Disorder (PE) treatment for chronic Posttraumatic Stress Disorder (PTSD)
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Prolonged Exposure (PE) therapy
- 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.
Prolonged Exposure (PE) therapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startNov 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Nitza Nacasch, MD, Study chair, Tel Aviv UniversityJoseph Zohar, MD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229372
- Sponsor's protocol ID
- SHEBA-02-2732-JZ-CTIL
- Status last verified
- Jan 2008
- First submitted
- 28 Sep 2005
- Last updated
- 29 Jan 2008
- Results posted
- No
Publications
Nacasch N, Foa EB, Huppert JD, Tzur D, Fostick L, Dinstein Y, Polliack M, Zohar J. Prolonged exposure therapy for combat- and terror-related posttraumatic stress disorder: a randomized control comparison with treatment as usual. J Clin Psychiatry. 2011 Sep;72(9):1174-80. doi: 10.4088/JCP.09m05682blu. Epub 2010 Nov 16.
PubMed 21208581
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Exposure Versus Treatment as Usual in Chronic Posttraumatic Stress Disorder Combat and Terror Related Patients
- ClinicalTrials.gov ID
- NCT00229372
- Acronym / sponsor ID
- SHEBA-02-2732-JZ-CTIL
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 29 Sep 2005 (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.
Assessing the efficacy of Posttraumatic Stress Disorder (PE) treatment for chronic Posttraumatic Stress Disorder (PTSD)
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PTSD
Key exclusion criteria (3 listed)
- Psychotic symptoms
- Dissociation
- Drug or Alcohol dependence
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 (PE) therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
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 29 Jan 2008.
- Derived from this study: PubMed 21208581Nacasch N, Foa EB, Huppert JD, Tzur D, Fostick L, Dinstein Y, Polliack M, Zohar J. Prolonged exposure therapy for combat- and terror-related posttraumatic stress disorder: a randomized control comparison with treatment as usual. J Clin Psychiatry. 2011 Sep;72(9):1174-80. doi: 10.4088/JCP.09m05682blu. Epub 2010 Nov 16.
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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.
Nitza Nacasch, MD study chair
Tel Aviv University
Joseph Zohar, MD principal investigator
Tel Aviv 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 (PE) therapy in people with Posttraumatic Stress Disorder, run by Sheba Medical Center 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 1 inclusion and 3 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 29 Jan 2008. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00229372, which also lists 1 linked publication.
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 29 Jan 2008.