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Optimal Dose of Early Intervention to Prevent PTSD

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1-Session Exposure Therapy
3-Session Exposure Therapy
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Posttraumatic Stress Disorder focused on measuring PTSD

Eligibility Criteria

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

Inclusion Criteria:

  • Presenting to the emergency department of Emory University School of Medicine/Grady Memorial Hospital for trauma 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
  • Have a memory of what happened during the trauma
  • Can see the assessment forms, hear instructions, and function at an emotional and intellectual level sufficient to allow accurate completion of all assessment instruments

Exclusion Criteria:

  • 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

Sites / Locations

  • Grady Memorial Hospital, Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Assessment only

1-session exposure intervention

3-session exposure intervention

Arm Description

Participants will receive assessment only.

Participants will receive one session of exposure therapy.

Participants will receive three sessions of exposure therapy.

Outcomes

Primary Outcome Measures

Change in PTSD Symptom Scale-I (PSS)

Secondary Outcome Measures

Full Information

First Posted
October 6, 2013
Last Updated
July 19, 2017
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT01959620
Brief Title
Optimal Dose of Early Intervention to Prevent PTSD
Official Title
Optimal Dose of Early Intervention to Prevent PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall aim of this study is to determine the optimal dose, 3-session exposure intervention versus 1-session exposure intervention compared to no treatment, for the delivery of exposure therapy in the immediate aftermath of trauma for preventing the development of posttraumatic stress disorder.
Detailed Description
The precipitant for adult posttraumatic stress disorder (PTSD) is a known event, which allows for immediate intervention and presents the potential to prevent the occurrence of this serious condition. However, there currently are no accepted interventions for the early intervention and prevention of PTSD in the immediate aftermath of trauma. This study will determine whether providing exposure therapy to people who have recently experienced trauma will significantly reduce the severity of PTSD symptoms post-trauma and if delivery of three exposure sessions will result in larger reductions in the symptoms of PTSD post-trauma than one exposure session. This study will also examine predictors for treatment response. Participation in this study will last 12 months. Participants will first undergo an evaluation session that will include an interview and questionnaires. They will then be randomly assigned to one of the following three conditions: 1-session exposure therapy, 3-session exposure therapy, or assessment only. Participants receiving 1-session exposure therapy will complete one treatment session in the emergency department (ED). Participants receiving 3-session exposure therapy will complete three weekly treatment sessions, with the first occurring in the ED. Treatment will involve reviewing memories of a recent trauma out loud with a therapist and audio-recording these discussions for review at home. All participants will undergo assessments 1, 3, 6, and 12 months after the initial evaluation session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Assessment only
Arm Type
No Intervention
Arm Description
Participants will receive assessment only.
Arm Title
1-session exposure intervention
Arm Type
Experimental
Arm Description
Participants will receive one session of exposure therapy.
Arm Title
3-session exposure intervention
Arm Type
Experimental
Arm Description
Participants will receive three sessions of exposure therapy.
Intervention Type
Behavioral
Intervention Name(s)
1-Session Exposure Therapy
Intervention Description
One exposure therapy session lasting one hour
Intervention Type
Behavioral
Intervention Name(s)
3-Session Exposure Therapy
Intervention Description
Three exposure therapy sessions lasting one hour each, delivered one week apart
Primary Outcome Measure Information:
Title
Change in PTSD Symptom Scale-I (PSS)
Time Frame
Measured 1, 3, 6, 12 months post-trauma

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: Presenting to the emergency department of Emory University School of Medicine/Grady Memorial Hospital for trauma 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 Have a memory of what happened during the trauma Can see the assessment forms, hear instructions, and function at an emotional and intellectual level sufficient to allow accurate completion of all assessment instruments Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara O. Rothbaum, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital, Emergency Department
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

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Optimal Dose of Early Intervention to Prevent PTSD

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