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Prevention of Post Traumatic Stress Disorder by Early Treatment

Primary Purpose

Post-traumatic Stress Disorder

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

About this trial

This is an interventional prevention trial for Post-traumatic Stress Disorder focused on measuring Traumatic Events, Post-traumatic Stress Disorder, Treatment (psychological), Treatment (pharmacological), Prevention, SSRIs

Eligibility Criteria

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

Inclusion Criteria: Adults survivors of traumatic events Exclusion Criteria: Traumatic brain injury Lifetime psychosis Life time (prior) PTSD Medical conditions forbidding SSRIs

Sites / Locations

  • Hadassah Medical Organization Jerusalem Israel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Placebo Comparator

No Intervention

Arm Label

Prolonged Exposure (CBT)

Cognitive Therapy

SSRI (escitalopram)

Placebo

Waiting List

Arm Description

Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy

Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.

Twenty milligrams daily of escitalopram (blinded capsules)

Two concealed placebo pills resembling 10mg escitalopram tablets

Twelve weeks of waiting list no intervention group

Outcomes

Primary Outcome Measures

Post-traumatic Stress Disorder (chronic) by CAPS scores.

Secondary Outcome Measures

Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview)
Symptoms of depression as per the Beck Depression Inventory (BDI)

Full Information

First Posted
September 4, 2005
Last Updated
February 17, 2016
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00146900
Brief Title
Prevention of Post Traumatic Stress Disorder by Early Treatment
Official Title
Prevention of Post Traumatic Stress Disorder by Early Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (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
To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.
Detailed Description
Consecutive civilian trauma survivors will be contacted, by phone, within five days of admission to Hadassah University Hospital in Jerusalem and asked about their early psychological responses to the event. A short telephone interview will be administered to consenting subjects, to evaluate the presence of acute stress disorder (ASD). Subjects with ASD (full or partial) and those who so desire will be invited to clinical assessment, which will take place within the next two weeks. Survivors with significant symptoms of post-traumatic stress disorder will be randomized to five arms of twelve-week long treatment: CBT, CT, SSRI/placebo and waiting list (WL) and start treatment immediately. Subjects will be allowed to decline one form of therapy. WL subjects will start therapy 12 weeks later. All subjects who had clinical interview will be interviewed again at four and seven months - and 14 months following trauma (phone interview).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
Traumatic Events, Post-traumatic Stress Disorder, Treatment (psychological), Treatment (pharmacological), Prevention, SSRIs

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Prolonged Exposure (CBT)
Arm Type
Experimental
Arm Description
Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy
Arm Title
Cognitive Therapy
Arm Type
Active Comparator
Arm Description
Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.
Arm Title
SSRI (escitalopram)
Arm Type
Experimental
Arm Description
Twenty milligrams daily of escitalopram (blinded capsules)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two concealed placebo pills resembling 10mg escitalopram tablets
Arm Title
Waiting List
Arm Type
No Intervention
Arm Description
Twelve weeks of waiting list no intervention group
Intervention Type
Procedure
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)
Intervention Type
Procedure
Intervention Name(s)
Cognitive Therapy
Intervention Description
12 weekly 1.5 hours weekly session of cognitive therapy without exposure
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
SSRI
Intervention Description
Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance
Primary Outcome Measure Information:
Title
Post-traumatic Stress Disorder (chronic) by CAPS scores.
Time Frame
Four months, seven months, 14 moths, two years
Secondary Outcome Measure Information:
Title
Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview)
Time Frame
Four months, seven months, 14 moths, two years
Title
Symptoms of depression as per the Beck Depression Inventory (BDI)
Time Frame
Four months, seven months, 14 moths, two years

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 survivors of traumatic events Exclusion Criteria: Traumatic brain injury Lifetime psychosis Life time (prior) PTSD Medical conditions forbidding SSRIs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arieh Y Shalev, M.D.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yossi Israeli - Shalev, M.A.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
Facility Information:
Facility Name
Hadassah Medical Organization Jerusalem Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
21724790
Citation
Shalev AY, Ankri YL, Peleg T, Israeli-Shalev Y, Freedman S. Barriers to receiving early care for PTSD: results from the Jerusalem trauma outreach and prevention study. Psychiatr Serv. 2011 Jul;62(7):765-73. doi: 10.1176/ps.62.7.pss6207_0765.
Results Reference
result
PubMed Identifier
21969418
Citation
Shalev AY, Ankri Y, Israeli-Shalev Y, Peleg T, Adessky R, Freedman S. Prevention of posttraumatic stress disorder by early treatment: results from the Jerusalem Trauma Outreach And Prevention study. Arch Gen Psychiatry. 2012 Feb;69(2):166-76. doi: 10.1001/archgenpsychiatry.2011.127. Epub 2011 Oct 3.
Results Reference
result
PubMed Identifier
35141873
Citation
Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
Results Reference
derived
PubMed Identifier
32122334
Citation
van der Mei WF, Barbano AC, Ratanatharathorn A, Bryant RA, Delahanty DL, deRoon-Cassini TA, Lai BS, Lowe SR, Matsuoka YJ, Olff M, Qi W, Schnyder U, Seedat S, Kessler RC, Koenen KC, Shalev AY; International Consortium to Predict PTSD. Evaluating a screener to quantify PTSD risk using emergency care information: a proof of concept study. BMC Emerg Med. 2020 Mar 2;20(1):16. doi: 10.1186/s12873-020-00308-z. Erratum In: BMC Emerg Med. 2020 Jun 29;20(1):53.
Results Reference
derived
PubMed Identifier
27135249
Citation
Shalev AY, Ankri Y, Gilad M, Israeli-Shalev Y, Adessky R, Qian M, Freedman S. Long-term outcome of early interventions to prevent posttraumatic stress disorder. J Clin Psychiatry. 2016 May;77(5):e580-7. doi: 10.4088/JCP.15m09932.
Results Reference
derived

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Prevention of Post Traumatic Stress Disorder by Early Treatment

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