Prevention of Post Traumatic Stress Disorder by Early Treatment

H

Hadassah Medical Center

Status

Completed

Conditions

Post-traumatic Stress Disorder

Treatments

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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