Prevention of Post Traumatic Stress Disorder by Early Treatment

February 17, 2016 updated by: Aria Shalev, Hadassah Medical Organization
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization Jerusalem Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults survivors of traumatic events

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 4, 2005

First Submitted That Met QC Criteria

September 4, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-27.06.03-HMO-CTIL
  • MH-

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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