Prevention of Post Traumatic Stress Disorder by Early Treatment

Post-traumatic Stress Disorder Clinical Trial

Official title:

Prevention of Post Traumatic Stress Disorder by Early Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146900
• Other study ID #: 21-27.06.03-HMO-CTIL
• Secondary ID: MH-
• Status: Completed
• Phase: N/A
• First received: September 4, 2005
• Last updated: February 17, 2016
• Start date: August 2004
• Est. completion date: January 2008

Study information

• Verified date: February 2016
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults survivors of traumatic events

Exclusion Criteria:

• Traumatic brain injury

• Lifetime psychosis

• Life time (prior) PTSD

• Medical conditions forbidding SSRIs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Cognitive Behavioral Therapy
12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)
• 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:
• Placebo
Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization Jerusalem Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Shalev AY, Ankri Y, Israeli-Shalev Y, Peleg T, Adessky R, Freedman S. Prevention of posttraumatic stress disorder by early treatment: results from the Jerusalem Trauma Outreach And Prevention study. Arch Gen Psychiatry. 2012 Feb;69(2):166-76. doi: 10.1001 — View Citation

Shalev AY, Ankri YL, Peleg T, Israeli-Shalev Y, Freedman S. Barriers to receiving early care for PTSD: results from the Jerusalem trauma outreach and prevention study. Psychiatr Serv. 2011 Jul;62(7):765-73. doi: 10.1176/appi.ps.62.7.765. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-traumatic Stress Disorder (chronic) by CAPS scores.		Four months, seven months, 14 moths, two years	No
Secondary	Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview)		Four months, seven months, 14 moths, two years	No
Secondary	Symptoms of depression as per the Beck Depression Inventory (BDI)		Four months, seven months, 14 moths, two years	No