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Completed

NCT Number: NCT00146900

Prevention of Post Traumatic Stress Disorder by Early Treatment

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization Jerusalem Israel

Jerusalem, 91120, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults survivors of traumatic events

Exclusion criteria

  • Traumatic brain injury
  • Lifetime psychosis
  • Life time (prior) PTSD
  • Medical conditions forbidding SSRIs

Treatment and study plan

Cognitive Behavioral Therapy

Procedure

12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)

Cognitive Therapy

Procedure

12 weekly 1.5 hours weekly session of cognitive therapy without exposure

Escitalopram

Drug

Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg

Other names: SSRI

Placebo

Other

Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance

Primary outcomes

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

    Time frame: Four months, seven months, 14 moths, two years

Secondary outcomes

  1. Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview)

    Time frame: Four months, seven months, 14 moths, two years

  2. Symptoms of depression as per the Beck Depression Inventory (BDI)

    Time frame: Four months, seven months, 14 moths, two years

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 7, 2005
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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