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

NCT00889005 | Completed Results

• 1 other identifier: Shalev_Phone_2009
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorder - Post-traumatic (Acute)

Keywords

Post-traumatic Stress Disorder; Acute Stress Disorder; Cognitive behavioral therapy; Secondary Prevention; Anxiety disorders; Service Delivery

Outcome Measures

Primary Outcomes (1)

• 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

  Up to ten months

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Waitlist control group

NO INTERVENTION

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

Interventions

Telephone Based Cognitive Behavioral Therapy OTHER

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

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Exposure to psychologically traumatic events
• Diagnosis of Acute Stress Disorder or Post-traumatic Stress Disorder
• Up to four weeks after trauma exposure

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Arieh Y. Shalev, M.D.
• Organization: New York Langone Medical Center Department of Psychiatry

arieh.shalev@nyumc.org

6467544782

Study Officials

• Arieh Y Shalev, M.D.

  Hadassah University Hospital, Jerusalem

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: April 26, 2009
• First Posted: April 28, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 1, 2018
• Results First Posted: November 1, 2018

Record last verified: 2018-02

Locations

IL (1)