Optimal Dose of Early Intervention to Prevent PTSD

NCT ID: NCT01959620

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-12-31

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Assessment only

Participants will receive assessment only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

1-session exposure intervention

Participants will receive one session of exposure therapy.

Group Type: EXPERIMENTAL

1-Session Exposure Therapy

Intervention Type: BEHAVIORAL

One exposure therapy session lasting one hour

3-session exposure intervention

Participants will receive three sessions of exposure therapy.

Group Type: EXPERIMENTAL

3-Session Exposure Therapy

Intervention Type: BEHAVIORAL

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

Interventions

1-Session Exposure Therapy

One exposure therapy session lasting one hour

Intervention Type: BEHAVIORAL

3-Session Exposure Therapy

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Barbara O. Rothbaum, PhD

Professor in Psychiatry and Associate Vice Chair of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara O. Rothbaum, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hospital, Emergency Department

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

NARSAD 19798

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00063758

Identifier Type: -

Identifier Source: org_study_id