Prevention of Post Traumatic Stress Disorder by Early Treatment
Overview
- Phase
- N/A
- Intervention
- Cognitive Behavioral Therapy
- Conditions
- Post-traumatic Stress Disorder
- Sponsor
- Hadassah Medical Organization
- Enrollment
- 298
- Locations
- 1
- Primary Endpoint
- Post-traumatic Stress Disorder (chronic) by CAPS scores.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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).
Investigators
Aria Shalev
Emeritus Professor of Psychiatry
Hadassah Medical Organization
Eligibility Criteria
Inclusion Criteria
- •Adults survivors of traumatic events
Exclusion Criteria
- •Traumatic brain injury
- •Lifetime psychosis
- •Life time (prior) PTSD
- •Medical conditions forbidding SSRIs
Arms & Interventions
Prolonged Exposure (CBT)
Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy
Intervention: Cognitive Behavioral Therapy
Cognitive Therapy
Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.
Intervention: Cognitive Therapy
SSRI (escitalopram)
Twenty milligrams daily of escitalopram (blinded capsules)
Intervention: Escitalopram
Placebo
Two concealed placebo pills resembling 10mg escitalopram tablets
Intervention: Placebo
Outcomes
Primary Outcomes
Post-traumatic Stress Disorder (chronic) by CAPS scores.
Time Frame: Four months, seven months, 14 moths, two years
Secondary Outcomes
- 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)