Prevention of Post Traumatic Stress Disorder by Early Treatment
2 other identifiers
interventional
298
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 4, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFebruary 19, 2016
February 1, 2016
3.4 years
September 4, 2005
February 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-traumatic Stress Disorder (chronic) by CAPS scores.
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)
Four months, seven months, 14 moths, two years
Symptoms of depression as per the Beck Depression Inventory (BDI)
Four months, seven months, 14 moths, two years
Study Arms (5)
Prolonged Exposure (CBT)
EXPERIMENTALTwelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy
Cognitive Therapy
ACTIVE COMPARATORTwelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.
SSRI (escitalopram)
EXPERIMENTALTwenty milligrams daily of escitalopram (blinded capsules)
Placebo
PLACEBO COMPARATORTwo concealed placebo pills resembling 10mg escitalopram tablets
Waiting List
NO INTERVENTIONTwelve weeks of waiting list no intervention group
Interventions
12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)
12 weekly 1.5 hours weekly session of cognitive therapy without exposure
Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg
Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance
Eligibility Criteria
You may qualify if:
- Adults survivors of traumatic events
You may not qualify if:
- Traumatic brain injury
- Lifetime psychosis
- Life time (prior) PTSD
- Medical conditions forbidding SSRIs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization Jerusalem Israel
Jerusalem, 91120, Israel
Related Publications (6)
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.
PMID: 21724790RESULTShalev 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.
PMID: 21969418RESULTBertolini 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.
PMID: 38767196DERIVEDBertolini 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.
PMID: 35141873DERIVEDvan 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.
PMID: 32122334DERIVEDShalev 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.
PMID: 27135249DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arieh Y Shalev, M.D.
Hadassah Medical Organization
- STUDY DIRECTOR
Yossi Israeli - Shalev, M.A.
Hadassah Medical Organization
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Emeritus Professor of Psychiatry
Study Record Dates
First Submitted
September 4, 2005
First Posted
September 7, 2005
Study Start
August 1, 2004
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
February 19, 2016
Record last verified: 2016-02