Prevention of Post Traumatic Stress Disorder by Early Treatment

Study Overview
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Brief Summary
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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
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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).

Official Title
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Prevention of Post Traumatic Stress Disorder by Early Treatment

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Procedure: Cognitive Behavioral Therapy
* Procedure: Cognitive Therapy
* Drug: Escitalopram
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults survivors of traumatic events Exclusion Criteria: Traumatic brain injury Lifetime psychosis Life time (prior) PTSD Medical conditions forbidding SSRIs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged Exposure (CBT)<br>Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy | Procedure: Cognitive Behavioral Therapy<br>* 12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)<br>|
| Active Comparator: Cognitive Therapy<br>Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders. | Procedure: Cognitive Therapy<br>* 12 weekly 1.5 hours weekly session of cognitive therapy without exposure<br>|
| Experimental: SSRI (escitalopram)<br>Twenty milligrams daily of escitalopram (blinded capsules) | Drug: Escitalopram<br>* Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg<br>* Other names: SSRI;|
| Placebo Comparator: Placebo<br>Two concealed placebo pills resembling 10mg escitalopram tablets | Other: Placebo<br>* Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance<br>|
| No Intervention: Waiting List<br>Twelve weeks of waiting list no intervention group | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Events, Post-traumatic Stress Disorder, Treatment (psychological), Treatment (pharmacological), Prevention, SSRIs