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.

Condition	Intervention
Post-Traumatic Stress Disorder	Procedure: Cognitive Behavioral Therapy  Procedure: Cognitive Therapy  Drug: Escitalopram

Further Study Details: 

Primary Outcomes: Post-traumatic Stress Disorder (chronic) by CAPS scores.
Secondary Outcomes: Post-traumatic Stress Disorder Symptoms per PSS-SR adn CAPS; Symptoms of depression be BDI
Expected Total Enrollment:  300

Consecutive civilian trauma survivors will be contacted, by phone, within five days of admission to Hadassah Universith 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 withing the next two weeks. Survivors with significant symptoms of post-traumatic stress disorder will be randomized to five armes 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).

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Adults survivors of traumatic events

Exclusion Criteria:

• Traumatic brain injury
• Lifetime psychosis
• Life time (prior) PTSD
• Medical conditions forbidding SSRIs

Please refer to this study by ClinicalTrials.gov identifier  NCT00146900

Arieh Y Shalev, M.D.      972 2 6777184    ashalev@cc.huji.ac.il
Sara Freedman, Ms. SC      972 2 6777184    sfreedman@pob.huji.ac.il

Israel
      Hadassah Medical Organization Jerusalem Israel, Jerusalem,  91120,  Israel; Recruiting

Study chairs or principal investigators

Arieh Y Shalev, M.D.,  Principal Investigator,  Hadassah Medical Organization   
Yossi Israeli - Shalev, M.A.,  Study Director,  Hadassah Medical Organization   

Study ID Numbers:  21-27.06.03; MH-
Last Updated:  September 6, 2005
Record first received:  September 4, 2005
ClinicalTrials.gov Identifier:  NCT00146900
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2005-09-13