Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aria Shalev, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00889005
First received: April 26, 2009
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Stress Disorder - Post-traumatic (Acute)
Other: Telephone Based Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Prevalence of Post-traumatic Stress Disorder (PTSD) three and eight months from the traumatic event [ Time Frame: Up to ten months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889005

Locations
Israel
Hadassah University Hospital
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Arieh Y Shalev, M.D. Hadassah University Hospital, Jerusalem
  More Information

No publications provided

Responsible Party: Aria Shalev, Professor of Psychiatry, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00889005     History of Changes
Other Study ID Numbers: Shalev_Phone_2009
Study First Received: April 26, 2009
Last Updated: December 3, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Post-traumatic Stress Disorder
Acute Stress Disorder
Cognitive behavioral therapy
Secondary Prevention
Anxiety disorders
Service Delivery

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014