Prevention of Post Traumatic Stress Disorder by Early Treatment

Not Applicable

Completed

• Conditions: Post-traumatic Stress Disorder
• Interventions: Other: Placebo; Procedure: Cognitive Therapy; Procedure: Cognitive Behavioral Therapy; Drug: Escitalopram

• Registration Number: NCT00146900
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-04
• Study First Submitted QC: 2005-09-04
• Study First Posted: 2005-09-07
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

Inclusion Criteria

• Adults survivors of traumatic events

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Two concealed placebo pills resembling 10mg escitalopram tablets
Cognitive Therapy	Cognitive Therapy	Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.
Prolonged Exposure (CBT)	Cognitive Behavioral Therapy	Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy
SSRI (escitalopram)	Escitalopram	Twenty milligrams daily of escitalopram (blinded capsules)

Primary Outcome Measures

Name	Time	Method
Post-traumatic Stress Disorder (chronic) by CAPS scores.	Four months, seven months, 14 moths, two years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hadassah Medical Organization Jerusalem Israel; 🇮🇱 Jerusalem, Israel