Prevention of Post Traumatic Stress Disorder by Early Treatment

This study has been completed.
Information provided by (Responsible Party):
Aria Shalev, Hadassah Medical Organization Identifier:
First received: September 4, 2005
Last updated: February 17, 2016
Last verified: February 2016
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
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Post Traumatic Stress Disorder by Early Treatment

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Post-traumatic Stress Disorder (chronic) by CAPS scores. [ Time Frame: Four months, seven months, 14 moths, two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview) [ Time Frame: Four months, seven months, 14 moths, two years ] [ Designated as safety issue: No ]
  • Symptoms of depression as per the Beck Depression Inventory (BDI) [ Time Frame: Four months, seven months, 14 moths, two years ] [ Designated as safety issue: No ]

Enrollment: 298
Study Start Date: August 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00146900

Hadassah Medical Organization Jerusalem Israel
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Arieh Y Shalev, M.D. Hadassah Medical Organization
Study Director: Yossi Israeli - Shalev, M.A. Hadassah Medical Organization
  More Information

Responsible Party: Aria Shalev, Emeritus Professor of Psychiatry, Hadassah Medical Organization Identifier: NCT00146900     History of Changes
Other Study ID Numbers: 21-27.06.03-HMO-CTIL  MH- 
Study First Received: September 4, 2005
Last Updated: February 17, 2016
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Traumatic Events
Post-traumatic Stress Disorder
Treatment (psychological)
Treatment (pharmacological)

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Trauma and Stressor Related Disorders
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors processed this record on May 30, 2016