Stress Disorders, Post-TraumaticNCT04026373
RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
A study testing modified Prolonged Exposure and Treatment as usual in people with Stress Disorders, Post-Traumatic, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The investigators proposed to compare a modified Prolonged Exposure intervention to treatment as usual within a hospitalized injured trauma survivor sample, to determine with this intervention could prevent the development of PTSD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- modified Prolonged Exposure and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2016to 17 Oct 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive motor vehicle crash (MVC), industrial accident, and physical assault trauma survivors (i.e. victims of gunshot wounds, stab wounds), ages 18-75, to include both men and women, without evidence of serious cognitive impairment, admitted to the trauma surgery service at Froedtert Hospital beginning at the start of the funding period will be considered for recruitment.
Who cannot join
- Individuals who:
- have evidence of moderate to severe cognitive impairment secondary to trauma-related head injury,
- have self-inflicted injury,
- are more than 2 weeks post-trauma,
- do not meet the DSM-5 definition of a traumatic stressor for PTSD,
- screen positive for a current substance abuse problem ((i.e. intoxication and memory loss upon arrival or a current substance use diagnosis),
Show all 10Show fewer
- are non-English speaking,
- are not medically stable,
- cannot identify a support person to attend a session with them
- do not score a 2 or more on the 5-item PTSD subscale of the 9-item screen.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The investigators proposed to compare a modified Prolonged Exposure intervention to treatment as usual within a hospitalized injured trauma survivor sample, to determine with this intervention could prevent the development of PTSD.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- modified Prolonged Exposure, Treatment as usual
- 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.
modified Prolonged ExposureBehavioural
Treatment as usualBehavioural
May include consult to health psychology and any follow-up deemed appropriate
| Study group | Role | What they receive |
|---|---|---|
| modified Prolonged Exposure | Experimental | Not described Receives: Behavioral: modified Prolonged Exposure |
| Treatment as usual | Active comparator | Not described Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale
Total score will be examined. Range is 0 to 80, with higher scores indicating higher severity of PTSD symptoms.
Measured: Three 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 posted19 Jul 2019
- Study start8 Mar 2016
- Primary completion17 Oct 2018
- Study completion17 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadie Larsen, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026373
- Sponsor's protocol ID
- PRO00024745
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsen SE, Hunt JC, Geier T, Heyrman K, Schumann N, Brandolino A, Timmer-Murillo S, Bergner C, Larson C, deRoon-Cassini TA. A Randomized Trial of Modified Prolonged Exposure to Prevent the Development of Posttraumatic Stress Disorder in Patients Hospitalized With Traumatic Injuries. J Trauma Stress. 2021 Feb;34(1):104-115. doi: 10.1002/jts.22580. Epub 2020 Aug 17.
PubMed 33269808
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
- ClinicalTrials.gov ID
- NCT04026373
- Acronym / sponsor ID
- PRO00024745
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 19 Jul 2019 (actual)
- 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 investigators proposed to compare a modified Prolonged Exposure intervention to treatment as usual within a hospitalized injured trauma survivor sample, to determine with this intervention could prevent the development of PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified Prolonged Exposure | Experimental | Behavioral: modified Prolonged Exposure |
| Treatment as usual | Active comparator | Behavioral: Treatment as usual |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive motor vehicle crash (MVC), industrial accident, and physical assault trauma survivors (i.e. victims of gunshot wounds, stab wounds), ages 18-75, to include both men and women, without evidence of serious cognitive impairment, admitted to the trauma surgery service at Froedtert Hospital beginning at the start of the funding period will be considered for recruitment.
Key exclusion criteria (10 listed)
- Individuals who:
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 |
|---|---|---|
| modified Prolonged Exposure | Behavioural | modified Prolonged Exposure |
| Treatment as usualMay include consult to health psychology and any follow-up deemed appropriate | Behavioural | Treatment as usual |
Primary outcome
Clinician-Administered PTSD Scale
Time frame: Three months post-trauma
Total score will be examined. Range is 0 to 80, with higher scores indicating higher severity of PTSD symptoms.
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 22 Jul 2019.
- Derived from this study: PubMed 33269808Larsen SE, Hunt JC, Geier T, Heyrman K, Schumann N, Brandolino A, Timmer-Murillo S, Bergner C, Larson C, deRoon-Cassini TA. A Randomized Trial of Modified Prolonged Exposure to Prevent the Development of Posttraumatic Stress Disorder in Patients Hospitalized With Traumatic Injuries. J Trauma Stress. 2021 Feb;34(1):104-115. doi: 10.1002/jts.22580. Epub 2020 Aug 17.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified Prolonged Exposure and Treatment as usual in people with Stress Disorders, Post-Traumatic, run by Medical College of Wisconsin 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 1 inclusion and 10 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 22 Jul 2019. 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?
Clinician-Administered PTSD Scale (time frame: Three months post-trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026373, which also lists 1 linked publication.
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 22 Jul 2019.