Optimal Dose of Early Intervention to Prevent PTSD

NCT01959620 | Completed DMC

• 2 other identifiers: IRB00063758NARSAD 19798
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Symptom Scale-I (PSS)

  Measured 1, 3, 6, 12 months post-trauma

Study Arms (3)

Assessment only

NO INTERVENTION

Participants will receive assessment only.

1-session exposure intervention

EXPERIMENTAL

Participants will receive one session of exposure therapy.

Behavioral: 1-Session Exposure Therapy

3-session exposure intervention

EXPERIMENTAL

Participants will receive three sessions of exposure therapy.

Behavioral: 3-Session Exposure Therapy

Interventions

1-Session Exposure Therapy BEHAVIORAL

One exposure therapy session lasting one hour

1-session exposure intervention

3-Session Exposure Therapy BEHAVIORAL

Three exposure therapy sessions lasting one hour each, delivered one week apart

3-session exposure intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital, Emergency Department

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Barbara O. Rothbaum, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: October 6, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)