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

Primary Purpose

Stress Disorder - Post-traumatic (Acute)

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Telephone Based Cognitive Behavioral Therapy
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Disorder - Post-traumatic (Acute) focused on measuring Post-traumatic Stress Disorder, Acute Stress Disorder, Cognitive behavioral therapy, Secondary Prevention, Anxiety disorders, Service Delivery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hadassah University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy

Waitlist control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 26, 2009
Last Updated
February 20, 2018
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00889005
Brief Title
Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
Official Title
Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorder - Post-traumatic (Acute)
Keywords
Post-traumatic Stress Disorder, Acute Stress Disorder, Cognitive behavioral therapy, Secondary Prevention, Anxiety disorders, Service Delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
Intervention Type
Other
Intervention Name(s)
Telephone Based Cognitive Behavioral Therapy
Intervention Description
Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment
Primary Outcome Measure Information:
Title
Severity of PTSD Symptoms
Description
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
Time Frame
Up to ten months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arieh Y Shalev, M.D.
Organizational Affiliation
Hadassah University Hospital, Jerusalem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

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

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