Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
|ClinicalTrials.gov Identifier: NCT00889005|
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : December 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorder - Post-traumatic (Acute)||Other: Telephone Based Cognitive Behavioral Therapy||Not Applicable|
Post-traumatic Stress Disorder (PTSD) is a prevalent and pervasive mental disorder. Studies have shown that there is a significant reluctance to use mental health services by trauma-exposed individuals at high risk for developing PTSD. Providing clinical services in combat or disaster zone might be difficult. Trauma-focused cognitive behavioral therapy (CBT) effectively reduces the prevalence of PTSD among recent survivors. Telephone based CBT was found to be effective in mood and anxiety disorders, but has not been tried in PTSD. Establishing the effectiveness of telephone based CBT has significant service delivery and public health implications. Preventing PTSD significantly reduces individuals' suffering and disability We will screen, by telephone, up to 1200 survivors of traumatic events, from a general hospital emergency department trauma registry list, randomize the first 240 with ASD or Acute PTSD to either early, telephone based cognitive behavioral therapy (ET_CBT) (n=120) or a no-treatment control condition (n=120). We will provide five sessions of ET-CBT to the former and compare the two groups three and eight months later.
Survivors from both groups who will continue to have PTSD at three months (after either treatment or waiting list), will receive 12 sessions of face-to-face, trauma focused CBT. A first phase of the study will consist of establishing the acceptance of ET-CBT and its main components (e.g., exposure to traumatic reminders) by survivors, and optimizing the protocol. It will involve 20 survivors and no randomization. Subsequent to that phase we will start recruiting for the main study. The study's main hypothesis is that early CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Cognitive Behavioral Therapy
Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.
Other: Telephone Based Cognitive Behavioral Therapy
Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment
No Intervention: Waitlist control group
Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
- Prevalence of Post-traumatic Stress Disorder (PTSD) three and eight months from the traumatic event [ Time Frame: Up to ten months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889005
|Hadassah University Hospital|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Arieh Y Shalev, M.D.||Hadassah University Hospital, Jerusalem|