Post-traumatic Stress DisorderNCT00146900
Prevention of Post Traumatic Stress Disorder by Early Treatment
A study testing Cognitive Behavioral Therapy, Cognitive Therapy and Escitalopram in people with Post-traumatic Stress Disorder, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Cognitive Behavioral Therapy, Cognitive Therapy and Escitalopram
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2004to Jan 2008
- 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
- Adults survivors of traumatic events
Who cannot join
- Traumatic brain injury
- Lifetime psychosis
- Life time (prior) PTSD
- Medical conditions forbidding SSRIs
Trial locations and contacts
1 site in 1 country.
About this study
To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.
Read the detailed description
Consecutive civilian trauma survivors will be contacted, by phone, within five days of admission to Hadassah University Hospital in Jerusalem and asked about their early psychological responses to the event. A short telephone interview will be administered to consenting subjects, to evaluate the presence of acute stress disorder (ASD). Subjects with ASD (full or partial) and those who so desire will be invited to clinical assessment, which will take place within the next two weeks. Survivors with significant symptoms of post-traumatic stress disorder will be randomized to five arms of twelve-week long treatment: CBT, CT, SSRI/placebo and waiting list (WL) and start treatment immediately. Subjects will be allowed to decline one form of therapy. WL subjects will start therapy 12 weeks later. All subjects who had clinical interview will be interviewed again at four and seven months - and 14 months following trauma (phone interview).
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Cognitive Behavioral Therapy, Cognitive Therapy, Escitalopram, Placebo
- Keywords
- Traumatic Events, Post-traumatic Stress Disorder, Treatment (psychological), Treatment (pharmacological), Prevention, SSRIs
- 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.
Cognitive Behavioral TherapyProcedure or surgery
12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)
Cognitive TherapyProcedure or surgery
12 weekly 1.5 hours weekly session of cognitive therapy without exposure
EscitalopramDrug
Also called SSRI
Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg
PlaceboOther
Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure (CBT) | Experimental | Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy Receives: Procedure: Cognitive Behavioral Therapy |
| Cognitive Therapy | Active comparator | Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders. Receives: Procedure: Cognitive Therapy |
| SSRI (escitalopram) | Experimental | Twenty milligrams daily of escitalopram (blinded capsules) Receives: Drug: Escitalopram |
| Placebo | Placebo comparator | Two concealed placebo pills resembling 10mg escitalopram tablets Receives: Other: Placebo |
| Waiting List | No intervention | Twelve weeks of waiting list no intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic Stress Disorder (chronic) by CAPS scores.
Measured: Four months, seven months, 14 moths, two years
Secondary outcomes (2)
Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview)
Measured: Four months, seven months, 14 moths, two years
Symptoms of depression as per the Beck Depression Inventory (BDI)
Measured: Four months, seven months, 14 moths, two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionJan 2008
- Study completionJan 2008
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 Post-traumatic 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aria Shalev, Hadassah Medical Organization
- Investigators
- Arieh Y Shalev, M.D., Principal investigator, Hadassah Medical OrganizationYossi Israeli - Shalev, M.A., Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146900
- Sponsor's protocol ID
- 21-27.06.03-HMO-CTIL
- Other IDs
- MH-
- Status last verified
- Feb 2016
- First submitted
- 4 Sep 2005
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Shalev AY, Ankri YL, Peleg T, Israeli-Shalev Y, Freedman S. Barriers to receiving early care for PTSD: results from the Jerusalem trauma outreach and prevention study. Psychiatr Serv. 2011 Jul;62(7):765-73. doi: 10.1176/ps.62.7.pss6207_0765.
PubMed 21724790Shalev AY, Ankri Y, Israeli-Shalev Y, Peleg T, Adessky R, Freedman S. Prevention of posttraumatic stress disorder by early treatment: results from the Jerusalem Trauma Outreach And Prevention study. Arch Gen Psychiatry. 2012 Feb;69(2):166-76. doi: 10.1001/archgenpsychiatry.2011.127. Epub 2011 Oct 3.
PubMed 21969418Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
PubMed 35141873van der Mei WF, Barbano AC, Ratanatharathorn A, Bryant RA, Delahanty DL, deRoon-Cassini TA, Lai BS, Lowe SR, Matsuoka YJ, Olff M, Qi W, Schnyder U, Seedat S, Kessler RC, Koenen KC, Shalev AY; International Consortium to Predict PTSD. Evaluating a screener to quantify PTSD risk using emergency care information: a proof of concept study. BMC Emerg Med. 2020 Mar 2;20(1):16. doi: 10.1186/s12873-020-00308-z.
PubMed 32122334Shalev AY, Ankri Y, Gilad M, Israeli-Shalev Y, Adessky R, Qian M, Freedman S. Long-term outcome of early interventions to prevent posttraumatic stress disorder. J Clin Psychiatry. 2016 May;77(5):e580-7. doi: 10.4088/JCP.15m09932.
PubMed 27135249
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post Traumatic Stress Disorder by Early Treatment
- ClinicalTrials.gov ID
- NCT00146900
- Acronym / sponsor ID
- 21-27.06.03-HMO-CTIL
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Traumatic Events, Post-traumatic Stress Disorder, Treatment (psychological), Treatment (pharmacological), Prevention, SSRIs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 7 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.
To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.
Detailed description
Consecutive civilian trauma survivors will be contacted, by phone, within five days of admission to Hadassah University Hospital in Jerusalem and asked about their early psychological responses to the event. A short telephone interview will be administered to consenting subjects, to evaluate the presence of acute stress disorder (ASD). Subjects with ASD (full or partial) and those who so desire will be invited to clinical assessment, which will take place within the next two weeks. Survivors with significant symptoms of post-traumatic stress disorder will be randomized to five arms of twelve-week long treatment: CBT, CT, SSRI/placebo and waiting list (WL) and start treatment immediately. Subjects will be allowed to decline one form of therapy. WL subjects will start therapy 12 weeks later. All subjects who had clinical interview will be interviewed again at four and seven months - and 14 months following trauma (phone interview).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure (CBT) | Experimental | Procedure: Cognitive Behavioral TherapyTwelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy |
| Cognitive Therapy | Active comparator | Procedure: Cognitive TherapyTwelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders. |
| SSRI (escitalopram) | Experimental | Drug: EscitalopramTwenty milligrams daily of escitalopram (blinded capsules) |
| Placebo | Placebo comparator | Other: PlaceboTwo concealed placebo pills resembling 10mg escitalopram tablets |
| Waiting List | No intervention | –Twelve weeks of waiting list no intervention group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults survivors of traumatic events
Key exclusion criteria (4 listed)
- Traumatic brain injury
- Lifetime psychosis
- Life time (prior) PTSD
- Medical conditions forbidding SSRIs
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 Therapy12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure) | Procedure or surgery | Prolonged Exposure (CBT) |
| Cognitive Therapy12 weekly 1.5 hours weekly session of cognitive therapy without exposure | Procedure or surgery | Cognitive Therapy |
| EscitalopramAlso: SSRITwelve weeks of treatment with Escitalopram at Max. daily dose of 20mg | Drug | SSRI (escitalopram) |
| PlaceboTwelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance | Other | Placebo |
Primary outcome
Post-traumatic Stress Disorder (chronic) by CAPS scores.
Time frame: Four months, seven months, 14 moths, two years
2 secondary outcomes
Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview)
Time frame: Four months, seven months, 14 moths, two years
Symptoms of depression as per the Beck Depression Inventory (BDI)
Time frame: Four months, seven months, 14 moths, two years
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 19 Feb 2016.
- Results publication: PubMed 21724790Shalev AY, Ankri YL, Peleg T, Israeli-Shalev Y, Freedman S. Barriers to receiving early care for PTSD: results from the Jerusalem trauma outreach and prevention study. Psychiatr Serv. 2011 Jul;62(7):765-73. doi: 10.1176/ps.62.7.pss6207_0765.
- Results publication: PubMed 21969418Shalev AY, Ankri Y, Israeli-Shalev Y, Peleg T, Adessky R, Freedman S. Prevention of posttraumatic stress disorder by early treatment: results from the Jerusalem Trauma Outreach And Prevention study. Arch Gen Psychiatry. 2012 Feb;69(2):166-76. doi: 10.1001/archgenpsychiatry.2011.127. Epub 2011 Oct 3.
- Derived from this study: PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
- Derived from this study: PubMed 35141873Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
- Derived from this study: PubMed 32122334van der Mei WF, Barbano AC, Ratanatharathorn A, Bryant RA, Delahanty DL, deRoon-Cassini TA, Lai BS, Lowe SR, Matsuoka YJ, Olff M, Qi W, Schnyder U, Seedat S, Kessler RC, Koenen KC, Shalev AY; International Consortium to Predict PTSD. Evaluating a screener to quantify PTSD risk using emergency care information: a proof of concept study. BMC Emerg Med. 2020 Mar 2;20(1):16. doi: 10.1186/s12873-020-00308-z.
- Derived from this study: PubMed 27135249Shalev AY, Ankri Y, Gilad M, Israeli-Shalev Y, Adessky R, Qian M, Freedman S. Long-term outcome of early interventions to prevent posttraumatic stress disorder. J Clin Psychiatry. 2016 May;77(5):e580-7. doi: 10.4088/JCP.15m09932.
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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.
Arieh Y Shalev, M.D. principal investigator
Hadassah Medical Organization
Yossi Israeli - Shalev, M.A. study director
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 Cognitive Behavioral Therapy, Cognitive Therapy and Escitalopram in people with Post-traumatic 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 1 inclusion and 4 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 19 Feb 2016. 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. Some participants in this study may receive a placebo. 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?
Post-traumatic Stress Disorder (chronic) by CAPS scores. (time frame: Four months, seven months, 14 moths, two years). 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 NCT00146900, 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 19 Feb 2016.