Prevention of Post Traumatic Stress Disorder by Early Treatment
NCT ID: NCT00146900
Last Updated: 2016-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
298 participants
INTERVENTIONAL
2004-08-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Prolonged Exposure (CBT)
Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy
Cognitive Behavioral Therapy
12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)
Cognitive Therapy
Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.
Cognitive Therapy
12 weekly 1.5 hours weekly session of cognitive therapy without exposure
SSRI (escitalopram)
Twenty milligrams daily of escitalopram (blinded capsules)
Escitalopram
Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg
Placebo
Two concealed placebo pills resembling 10mg escitalopram tablets
Placebo
Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance
Waiting List
Twelve weeks of waiting list no intervention group
No interventions assigned to this group
Interventions
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Cognitive Behavioral Therapy
12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)
Cognitive Therapy
12 weekly 1.5 hours weekly session of cognitive therapy without exposure
Escitalopram
Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg
Placebo
Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Lifetime psychosis
* Life time (prior) PTSD
* Medical conditions forbidding SSRIs
18 Years
65 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Aria Shalev
Emeritus Professor of Psychiatry
Principal Investigators
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Arieh Y Shalev, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Yossi Israeli - Shalev, M.A.
Role: STUDY_DIRECTOR
Hadassah Medical Organization
Locations
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Hadassah Medical Organization Jerusalem Israel
Jerusalem, , Israel
Countries
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References
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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.
Shalev 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.
Bertolini 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.
Bertolini 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.
van 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.
Shalev 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.
Other Identifiers
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MH-
Identifier Type: -
Identifier Source: secondary_id
21-27.06.03-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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