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Prolonged Exposure (PE) Treatment for Post Traumatic Stress Disorder (PTSD) 20 Minutes Versus 40 Minutes

Primary Purpose

PTSD

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Prolonged Exposure (PE) therapy
Prolonged Exposure (PE) therapy
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Post traumatic stress disorder

Eligibility Criteria

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

Inclusion Criteria: PTSD Exclusion Criteria: Psychotic symptoms Dissociation Drug or Alcohol dependence

Sites / Locations

  • Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

PSS-i

Secondary Outcome Measures

Full Information

First Posted
September 28, 2005
Last Updated
January 26, 2013
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00229307
Brief Title
Prolonged Exposure (PE) Treatment for Post Traumatic Stress Disorder (PTSD) 20 Minutes Versus 40 Minutes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparing the efficacy of 40 minutes PE treatment to 20 minutes of the same treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
Post traumatic stress disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure (PE) therapy
Intervention Description
20 minutes exposure
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure (PE) therapy
Intervention Description
40 minutes exposure
Primary Outcome Measure Information:
Title
PSS-i
Time Frame
15 weeks and 1-year follow-up

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: PTSD Exclusion Criteria: Psychotic symptoms Dissociation Drug or Alcohol dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitza Nacasch, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joseph Zohar, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Prolonged Exposure (PE) Treatment for Post Traumatic Stress Disorder (PTSD) 20 Minutes Versus 40 Minutes

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