Prevention of Post Traumatic Stress Disorder by Early Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aria Shalev, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00146900
First received: September 4, 2005
Last updated: February 17, 2016
Last verified: February 2016

September 4, 2005
February 17, 2016
August 2004
January 2008   (final data collection date for primary outcome measure)
Post-traumatic Stress Disorder (chronic) by CAPS scores. [ Time Frame: Four months, seven months, 14 moths, two years ] [ Designated as safety issue: No ]
Post-traumatic Stress Disorder (chronic) by CAPS scores.
Complete list of historical versions of study NCT00146900 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Post-traumatic Stress Disorder Symptoms per PSS-SR adn CAPS
  • Symptoms of depression be BDI
Not Provided
Not Provided
 
Prevention of Post Traumatic Stress Disorder by Early Treatment
Prevention of Post Traumatic Stress Disorder by Early Treatment
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.
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).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Post-traumatic Stress Disorder
  • Procedure: Cognitive Behavioral Therapy
    12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)
  • Procedure: Cognitive Therapy
    12 weekly 1.5 hours weekly session of cognitive therapy without exposure
  • Drug: Escitalopram
    Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg
    Other Name: SSRI
  • Other: Placebo
    Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance
  • Experimental: Prolonged Exposure (CBT)
    Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy
    Intervention: Procedure: Cognitive Behavioral Therapy
  • Active Comparator: Cognitive Therapy
    Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.
    Intervention: Procedure: Cognitive Therapy
  • Experimental: SSRI (escitalopram)
    Twenty milligrams daily of escitalopram (blinded capsules)
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Two concealed placebo pills resembling 10mg escitalopram tablets
    Intervention: Other: Placebo
  • No Intervention: Waiting List
    Twelve weeks of waiting list no intervention group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
298
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults survivors of traumatic events

Exclusion Criteria:

  • Traumatic brain injury
  • Lifetime psychosis
  • Life time (prior) PTSD
  • Medical conditions forbidding SSRIs
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00146900
21-27.06.03-HMO-CTIL, MH-
No
Not Provided
Not Provided
Aria Shalev, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Arieh Y Shalev, M.D. Hadassah Medical Organization
Study Director: Yossi Israeli - Shalev, M.A. Hadassah Medical Organization
Hadassah Medical Organization
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP