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

NCT ID: NCT00889005

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-12-31

Brief 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.

Conditions

Stress Disorder - Post-traumatic (Acute)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral Therapy

Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.

Group Type: EXPERIMENTAL

Telephone Based Cognitive Behavioral Therapy

Intervention Type: OTHER

Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment

Waitlist control group

Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telephone Based Cognitive Behavioral Therapy

Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Aria Shalev

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arieh Y Shalev, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Hospital, Jerusalem

Locations

Hadassah University Hospital

Jerusalem, , Israel

Countries

Israel

Other Identifiers

Shalev_Phone_2009

Identifier Type: -

Identifier Source: org_study_id