Stress Disorder - Post-traumatic (Acute) Clinical Trial
Official title:
Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
Verified date | February 2018 |
Source | Hadassah Medical Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized controlled study comparing telephone-based cognitive behavioral therapy (CBT) for recent survivors of traumatic events with Acute Stress Disorder (ASD) or acute PTSD with a waitlist control group. Survivors with PTSD from both groups will receive face-to-face CBT one month from the traumatic event. The study's main hypothesis is that early telephone-based CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.
Status | Completed |
Enrollment | 139 |
Est. completion date | December 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Adults - Exposure to psychologically traumatic events - Diagnosis of Acute Stress Disorder or Post-traumatic Stress Disorder - Up to four weeks after trauma exposure Exclusion Criteria: - Chronic PTSD - Past and present psychosis, bipolar disorder, opiate or stimulants use - Medical or surgical condition that interfere with subjects ability to participate in the study or sign an informed consent - Lack of fluency in the study's main language (Hebrew) |
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah University Hospital | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of PTSD Symptoms | Clinician Administered PTSD Scale for DSM IV (CAPS IV) Score range 0-136 points Score above 40 indicate probable PTSD PTSD diagnosis inferred using DSM IV diagnostic criteria | Up to ten months |