NCT00895518

Brief Summary

This study will examine the use of prolonged exposure therapy on people who have recently experienced a trauma to prevent them from developing post-traumatic stress disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

3.8 years

First QC Date

May 7, 2009

Last Update Submit

September 7, 2016

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

  • PTSD Symptom Scale- I (PSS)

    Measured 4 and 12 weeks post-trauma

Study Arms (2)

1

NO INTERVENTION

Participants will receive assessments only.

2

EXPERIMENTAL

Participants will receive prolonged exposure therapy.

Behavioral: Prolonged Exposure (PE) Therapy

Interventions

Prolonged Exposure (PE) TherapyBEHAVIORAL

Three PE sessions lasting 1 hour each, delivered 1 week apart

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presenting to the emergency department of Emory University School of Medicine/Grady Memorial Hospital for rape in the past 72 hours
  • Meets DSM-IV diagnostic criterion A in which both of the following are present: (i) The person experienced, witnessed, or was confronted with an event or events that involved actual or threatened death or serious injury or a threat to the physical integrity of self or others (ii) The person's response involved intense fear, helplessness, or horror
  • Speaks and understands spoken English
  • Can see the assessment forms, hear instructions, and function at an emotional and intellectual level sufficient to allow accurate completion of all assessment instruments
  • No significant traumatic injuries, as determined by the physician

You may not qualify if:

  • Current or history of mania, schizophrenia, or other psychoses
  • Current (past month) prominent suicidal ideation or recent (past 3 months) parasuicidal behavior or other self-injurious behavior, such as low lethality cutting
  • Current (past month) substance dependence; people who meet criteria for current substance abuse but not dependence, or past dependence and have been in remission for at least 1 month are eligible.
  • Experienced a loss of consciousness for more than 5 minutes as a result of injuries sustained during the trauma
  • Intoxicated, altered, or highly distressed to the degree that accurate completion of the study assessments or participation in study procedures is not possible
  • Blood alcohol level above .08, determined by breathalyzer in the emergency department
  • Not alert, oriented, and coherent
  • In severe pain, active labor, or respiratory distress or hemodynamically compromised in any way

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Memorial Hospital, Emergency Department

Atlanta, Georgia, 30303, United States

Location

Related Publications (3)

  • Rothbaum BO, Kearns MC, Reiser E, Davis JS, Kerley KA, Rothbaum AO, Mercer KB, Price M, Houry D, Ressler KJ. Early intervention following trauma may mitigate genetic risk for PTSD in civilians: a pilot prospective emergency department study. J Clin Psychiatry. 2014 Dec;75(12):1380-7. doi: 10.4088/JCP.13m08715.

    PMID: 25188543DERIVED

  • Price M, Kearns M, Houry D, Rothbaum BO. Emergency department predictors of posttraumatic stress reduction for trauma-exposed individuals with and without an early intervention. J Consult Clin Psychol. 2014 Apr;82(2):336-41. doi: 10.1037/a0035537. Epub 2014 Feb 3.

    PMID: 24491070DERIVED

  • Rothbaum BO, Kearns MC, Price M, Malcoun E, Davis M, Ressler KJ, Lang D, Houry D. Early intervention may prevent the development of posttraumatic stress disorder: a randomized pilot civilian study with modified prolonged exposure. Biol Psychiatry. 2012 Dec 1;72(11):957-63. doi: 10.1016/j.biopsych.2012.06.002. Epub 2012 Jul 4.

    PMID: 22766415DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Barbara O. Rothbaum, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Psychiatry and Associate Vice Chair of Clinical Research

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

April 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

US(1)