Prevention of Post Traumatic Stress Disorder by Early Treatment

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Completed

CT.gov ID

NCT00146900

Collaborator

(none)

298

Enrollment

Location

Arms

Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Stress Disorder	Procedure: Cognitive Behavioral Therapy Procedure: Cognitive Therapy Drug: Escitalopram Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

298 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Prevention of Post Traumatic Stress Disorder by Early Treatment

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]