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Prevention of Post Traumatic Stress Disorder by Early Treatment

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ClinicalTrials.gov Identifier: NCT00146900
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):
Aria Shalev, Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Procedure: Cognitive Behavioral Therapy Procedure: Cognitive Therapy Drug: Escitalopram Other: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Post Traumatic Stress Disorder by Early Treatment
Study Start Date : August 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Prolonged Exposure (CBT)
Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy
Procedure: Cognitive Behavioral Therapy
12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)

Active Comparator: Cognitive Therapy
Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.
Procedure: Cognitive Therapy
12 weekly 1.5 hours weekly session of cognitive therapy without exposure

Experimental: SSRI (escitalopram)
Twenty milligrams daily of escitalopram (blinded capsules)
Drug: Escitalopram
Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg
Other Name: SSRI

Placebo Comparator: Placebo
Two concealed placebo pills resembling 10mg escitalopram tablets
Other: Placebo
Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance

No Intervention: Waiting List
Twelve weeks of waiting list no intervention group

Primary Outcome Measures :
  1. Post-traumatic Stress Disorder (chronic) by CAPS scores. [ Time Frame: Four months, seven months, 14 moths, two years ]

Secondary Outcome Measures :
  1. Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview) [ Time Frame: Four months, seven months, 14 moths, two years ]
  2. Symptoms of depression as per the Beck Depression Inventory (BDI) [ Time Frame: Four months, seven months, 14 moths, two years ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146900

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Hadassah Medical Organization Jerusalem Israel
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Arieh Y Shalev, M.D. Hadassah Medical Organization
Study Director: Yossi Israeli - Shalev, M.A. Hadassah Medical Organization
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aria Shalev, Emeritus Professor of Psychiatry, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00146900    
Other Study ID Numbers: 21-27.06.03-HMO-CTIL
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Keywords provided by Aria Shalev, Hadassah Medical Organization:
Traumatic Events
Post-traumatic Stress Disorder
Treatment (psychological)
Treatment (pharmacological)
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs