Prevention of Post Traumatic Stress Disorder by Early Treatment

Hadassah Medical Center

Status: Completed

Conditions: Post-traumatic Stress Disorder

Treatments: Procedure: Cognitive Therapy; Drug: Escitalopram; Other: Placebo; Procedure: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00146900

21-27.06.03-HMO-CTIL

MH-

Details and patient eligibility

About

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.

Full 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).

Enrollment: 298 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults survivors of traumatic events

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

298 participants in 5 patient groups, including a placebo group

Prolonged Exposure (CBT)

Experimental group

Description:

Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy

Treatment:

Procedure: Cognitive Behavioral Therapy

Cognitive Therapy

Active Comparator group

Description:

Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.

Treatment:

Procedure: Cognitive Therapy

SSRI (escitalopram)

Experimental group

Description:

Twenty milligrams daily of escitalopram (blinded capsules)

Treatment:

Drug: Escitalopram

Placebo

Placebo Comparator group

Description:

Two concealed placebo pills resembling 10mg escitalopram tablets

Treatment:

Other: Placebo

Waiting List

No Intervention group

Description:

Twelve weeks of waiting list no intervention group