Prevention of Post Traumatic Stress Disorder by Early Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aria Shalev, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00146900
First received: September 4, 2005
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Post-traumatic Stress Disorder
Procedure: Cognitive Behavioral Therapy
Procedure: Cognitive Therapy
Drug: Escitalopram

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Post Traumatic Stress Disorder by Early Treatment

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Post-traumatic Stress Disorder (chronic) by CAPS scores. [ Time Frame: Four months, seven months, 14 moths, two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview) [ Time Frame: Four months, seven months, 14 moths, two years ] [ Designated as safety issue: No ]
  • Symptoms of depression as per the Beck Depression Inventory (BDI) [ Time Frame: Four months, seven months, 14 moths, two years ] [ Designated as safety issue: No ]

Enrollment: 298
Study Start Date: August 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prolonged Exposure (CBT)
Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy
Procedure: Cognitive Behavioral Therapy
Active Comparator: Cognitive Therapy
Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.
Procedure: Cognitive Therapy
Experimental: SSRI (escitalopram)
Twenty milligrams daily of escitalopram (blinded capsules)
Drug: Escitalopram
Placebo Comparator: Placebo
Two concealed placebo pills resembling 10mg escitalopram tablets
No Intervention: Waiting List
Twelve weeks of waiting list no intervention group

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults survivors of traumatic events

Exclusion Criteria:

  • Traumatic brain injury
  • Lifetime psychosis
  • Life time (prior) PTSD
  • Medical conditions forbidding SSRIs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146900

Locations
Israel
Hadassah Medical Organization Jerusalem Israel
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Arieh Y Shalev, M.D. Hadassah Medical Organization
Study Director: Yossi Israeli - Shalev, M.A. Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Aria Shalev, Emeritus Professor of Psychiatry, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00146900     History of Changes
Other Study ID Numbers: 21-27.06.03-HMO-CTIL, MH-
Study First Received: September 4, 2005
Last Updated: February 19, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Traumatic Events
Post-traumatic Stress Disorder
Treatment (psychological)
Treatment (pharmacological)
Prevention
SSRIs

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 10, 2014