Posttraumatic Stress DisorderNCT01959620
Optimal Dose of Early Intervention to Prevent PTSD
A study testing 1-Session Exposure Therapy and 3-Session Exposure Therapy in people with Posttraumatic Stress Disorder, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- 1-Session Exposure Therapy and 3-Session Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Grady Memorial Hospital, Emergency Department
Atlanta, Georgia, 30303
About this study
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.
Read the 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
- Being tested
- 1-Session Exposure Therapy, 3-Session Exposure Therapy
- Keywords
- PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Session Exposure TherapyBehavioural
One exposure therapy session lasting one hour
3-Session Exposure TherapyBehavioural
Three exposure therapy sessions lasting one hour each, delivered one week apart
| Study group | Role | What they receive |
|---|---|---|
| Assessment only | No intervention | Participants will receive assessment only. |
| 1-session exposure intervention | Experimental | Participants will receive one session of exposure therapy. Receives: Behavioral: 1-Session Exposure Therapy |
| 3-session exposure intervention | Experimental | Participants will receive three sessions of exposure therapy. Receives: Behavioral: 3-Session Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptom Scale-I (PSS)
Measured: Measured 1, 3, 6, 12 months post-trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara O. Rothbaum, PhD, Emory University
- Investigators
- Barbara O. Rothbaum, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959620
- Sponsor's protocol ID
- IRB00063758
- Other IDs
- NARSAD 19798
- Status last verified
- Jul 2017
- First submitted
- 6 Oct 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dose of Early Intervention to Prevent PTSD
- ClinicalTrials.gov ID
- NCT01959620
- Acronym / sponsor ID
- IRB00063758
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Assessment only | No intervention | –Participants will receive assessment only. |
| 1-session exposure intervention | Experimental | Behavioral: 1-Session Exposure TherapyParticipants will receive one session of exposure therapy. |
| 3-session exposure intervention | Experimental | Behavioral: 3-Session Exposure TherapyParticipants will receive three sessions of exposure therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-Session Exposure TherapyOne exposure therapy session lasting one hour | Behavioural | 1-session exposure intervention |
| 3-Session Exposure TherapyThree exposure therapy sessions lasting one hour each, delivered one week apart | Behavioural | 3-session exposure intervention |
Primary outcome
Change in PTSD Symptom Scale-I (PSS)
Time frame: Measured 1, 3, 6, 12 months post-trauma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara O. Rothbaum, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-Session Exposure Therapy and 3-Session Exposure Therapy in people with Posttraumatic Stress Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Symptom Scale-I (PSS) (time frame: Measured 1, 3, 6, 12 months post-trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.