Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
Condition: Stress Disorder - Post-traumatic (Acute)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Telephone Based Cognitive Behavioral Therapy
Intervention type(s): Other
Intervention description(s): Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Post-traumatic Stress Disorder; Acute Stress Disorder; Cognitive behavioral therapy; Secondary Prevention; Anxiety disorders; Service Delivery