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Prevention of Post Traumatic Stress Disorder by Early Treatment

Prevention of Post Traumatic Stress Disorder by Early Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00146900
Enrollment
298
Registered
2005-09-07
Start date
2004-08-31
Completion date
2008-01-31
Last updated
2016-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic Stress Disorder

Keywords

Traumatic Events, Post-traumatic Stress Disorder, Treatment (psychological), Treatment (pharmacological), Prevention, SSRIs

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.

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).

Interventions

PROCEDURECognitive Behavioral Therapy

12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)

PROCEDURECognitive Therapy

12 weekly 1.5 hours weekly session of cognitive therapy without exposure

DRUGEscitalopram

Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg

OTHERPlacebo

Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Adults survivors of traumatic events

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Post-traumatic Stress Disorder (chronic) by CAPS scores.Four months, seven months, 14 moths, two years

Secondary

MeasureTime frame
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026