Post Traumatic Stress DisorderNCT05751473
Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers
A study testing Prolonged Exposure for Primary Care (PE-PC) and EAP Treatment as Usual (TAU) in people with Post Traumatic Stress Disorder, run by University of Michigan at 14 sites in United States.
Trial summary
This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Prolonged Exposure for Primary Care (PE-PC) and EAP Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 14 sitesUnited States
- Study dates
- 16 May 2023to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are employees at an orginization served by a participating EAP
- Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33
- Have had psychotropic medication stability for at least 4 weeks
- Inclusion criteria for the qualitative portion of the study:
- Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder
Who cannot join
- Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
- High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: found in protocol)
- Need for detoxification
- Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment
- Currently engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).
- Patients who do not speak English will be excluded for logistical reasons.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 11 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
James Garlick, jgarlick@umich.edu
Rebecca Sripada, PhD
- Recruiting
Tanner Health System
Carrollton, Georgia, 30117
Emily Norris, PhD, LPC, CPCS, CEAP, 770-834-8327, enorris@tanner.org
- Not yet recruiting
University of Cincinati Health
Cincinnati, Ohio, 45229
Lisa Melink, MA,LPCC, 513-585-6094, lisa.melink@uchealth.com
Lisa Melink, MA,LPCC
- Active, not recruiting
Henry Ford Health System
Detroit, Michigan, 48202
- Recruiting
Detroit Fire Department
Detroit, Michigan, 48226
Lennette Wood, 313-530-2912, Woodl4116@detroitmi.gov
- Recruiting
Health Management Systems of America
Detroit, Michigan, 48226
Monique Jones, LMSW, CEAP, 800-847-7240, monique.jones@hmsanet.com
- Recruiting
Duke University Health System
Durham, North Carolina, 27705
Laurie Kovens, 919-416-1727, Laurie.kovens@duke.edu
- Recruiting
Michigan State University
East Lansing, Michigan, 48824-1037
Jon Novello, LMSW,ACSW, 517-355-4509, novelloj@msu.edu
Jon Novello, LMSW,ACSW
- Recruiting
ProMedica
Fremont, Ohio, 43420
Chris Tafelski, LPCC,CEAP, 419-291-1219 ext. 211219, Christopher.tafelski@promedica.org
Chris Tafelski, LPCC,CEAP
- Recruiting
Houston Fire Department
Houston, Texas, 77002
Leah Belsches, PsyD, 832-405-6865, leah.belsches@houstontx.gov
- Recruiting
Cope NewYork-Presbyterian
New York, New York, 10017
Randy Martin, PhD, 646-988-1763, rdm4002@med.cornell.edu
Randy Martin, PhD
- Recruiting
Rutgers Health
Piscataway, New Jersey, 08854
Susan Weinstein, 732-235-4365, sww42@ubhc.rutgers.edu
- Withdrawn
Sharp Healthcare
San Diego, California, 92129
- Active, not recruiting
West Bloomfield Fire Department
West Bloomfield, Michigan, 48322
About this study
Official title: Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs
This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs).
The central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Prolonged Exposure for Primary Care (PE-PC), EAP Treatment as Usual (TAU)
- Keywords
- Employee Assistance Programs, Frontline Healthcare Workers, Prolonged Exposure for Primary Care, First Responders
- 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.
Prolonged Exposure for Primary Care (PE-PC)Behavioural
Treatment will be given by telehealth or in person, depending on the participant preference.
Content is drawn from the Full Prolonged Exposure model and condensed so as to deliver the most efficacious components in a brief format. There will be 4-6 weekly 30-minute sessions. Treatment follows the standardized PE-PC manual and workbook. At the end of the final session, the counselor and participant will review treatment progress and either conclude treatment or refer the participant to outside mental healthcare for more intensive treatment.
Participants will complete surveys and complete homework during and following the study.
EAP Treatment as Usual (TAU)Behavioural
Treatment will be given by telehealth or in person, depending on the participant preference and current EAP practices (4-6 weeks). This will be the standard of care practice at each EAP site. Usually, this includes up to six sessions of solution focused therapy, and referrals to an established network of community providers who specialize in PTSD treatment. All PTSD care received during the study will be collected and monitored as TAU. The type of TAU used will reflect the current practice in EAPs and will not be constrained in the study design. EAP staff will monitor and record all EAP care received, including tracking no shows and cancellations. Study team members will document care received outside of the EAP (including psychiatric medications) by self-report.
Participants will complete surveys and complete homework during and following the study.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure for Primary Care | Experimental | Not described Receives: Behavioral: Prolonged Exposure for Primary Care (PE-PC) |
| EAP Treatment as Usual (TAU) | Active comparator | Employee Assistance Programs standard treatment. Receives: Behavioral: EAP Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
The PCL-5 is a 20-item self-report measure that assesses symptoms of PTSD. The self-report rating scale is 0-4 for each symptom. The minimum and maximum values are 0 and 80, with higher scores indicating worse outcome.
Measured: baseline to 6 months
Secondary outcomes (4)
Change in Burnout based on the Oldenburg Burnout Inventory
This is a 16-question inventory that assesses burnout. The self-report rating scale is 1-4 for each symptom.The minimum and maximum values are 16 and 64, with higher scores indicating worse outcome.
Measured: baseline to 6 months
Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH)
The WPAI-GH measures the impact of health problems on absenteeism, presenteeism, overall work performance and non-work activities using a 0 to 10 visual analog scale (VAS).
Measured: baseline to 6 months
Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9)
This is a 9-item questionnaire that participants select responses from not at all (0) to nearly every day (3), the minimum and maximum score values ranging from 0 to 27. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Measured: baseline to 6 months
Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8)
This is an 8-item questionnaire that participants complete. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start16 May 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
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 Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rebecca Sripada, University of Michigan
- Investigators
- Rebecca Sripada, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751473
- Sponsor's protocol ID
- HUM00219260
- Other IDs
- 1R01MH126693-01
- Status last verified
- Jun 2026
- First submitted
- 20 Feb 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sripada RK, Garlick J, Hemphill N, Walters HM, Ganoczy D, Kim HM, Zivin K, Nevedal AL, Avallone KM, Cigrang JA, Rauch SAM. Addressing PTSD symptoms in first responders and healthcare workers through trauma-focused treatment in Employee Assistance Programs: Protocol for a randomized controlled trial. Contemp Clin Trials. 2026 Jan;160:108174. doi: 10.1016/j.cct.2025.108174. Epub 2025 Dec 4.
PubMed 41352531
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs
- ClinicalTrials.gov ID
- NCT05751473
- Acronym / sponsor ID
- HUM00219260
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Employee Assistance Programs, Frontline Healthcare Workers, Prolonged Exposure for Primary Care, First Responders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 16 May 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 2 Mar 2023 (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.
This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs).
The central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure for Primary Care | Experimental | Behavioral: Prolonged Exposure for Primary Care (PE-PC) |
| EAP Treatment as Usual (TAU) | Active comparator | Behavioral: EAP Treatment as Usual (TAU)Employee Assistance Programs standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are employees at an orginization served by a participating EAP
- Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33
- Have had psychotropic medication stability for at least 4 weeks
- Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder
Key exclusion criteria (6 listed)
- Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
- High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: found in protocol)
- Need for detoxification
- Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment
- Currently engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).
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 |
|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC)Treatment will be given by telehealth or in person, depending on the participant preference. Content is drawn from the Full Prolonged Exposure model and condensed so as to deliver the most efficacious components in a brief format. There will be 4-6 weekly 30-minute sessions. Treatment follows the standardized PE-PC manual and workbook. At the end of the final session, the counselor and participant will review treatment progress and either conclude treatment or refer the participant to outside mental healthcare for more intensive treatment. Participants will complete surveys and complete homework during and following the study. | Behavioural | Prolonged Exposure for Primary Care |
| EAP Treatment as Usual (TAU)Treatment will be given by telehealth or in person, depending on the participant preference and current EAP practices (4-6 weeks). This will be the standard of care practice at each EAP site. Usually, this includes up to six sessions of solution focused therapy, and referrals to an established network of community providers who specialize in PTSD treatment. All PTSD care received during the study will be collected and monitored as TAU. The type of TAU used will reflect the current practice in EAPs and will not be constrained in the study design. EAP staff will monitor and record all EAP care received, including tracking no shows and cancellations. Study team members will document care received outside of the EAP (including psychiatric medications) by self-report. Participants will complete surveys and complete homework during and following the study. | Behavioural | EAP Treatment as Usual (TAU) |
Primary outcome
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
Time frame: baseline to 6 months
The PCL-5 is a 20-item self-report measure that assesses symptoms of PTSD. The self-report rating scale is 0-4 for each symptom. The minimum and maximum values are 0 and 80, with higher scores indicating worse outcome.
4 secondary outcomes
Change in Burnout based on the Oldenburg Burnout Inventory
Time frame: baseline to 6 months
Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH)
Time frame: baseline to 6 months
Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9)
Time frame: baseline to 6 months
Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8)
Time frame: baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 41352531Sripada RK, Garlick J, Hemphill N, Walters HM, Ganoczy D, Kim HM, Zivin K, Nevedal AL, Avallone KM, Cigrang JA, Rauch SAM. Addressing PTSD symptoms in first responders and healthcare workers through trauma-focused treatment in Employee Assistance Programs: Protocol for a randomized controlled trial. Contemp Clin Trials. 2026 Jan;160:108174. doi: 10.1016/j.cct.2025.108174. Epub 2025 Dec 4.
- 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.
Rebecca Sripada, PhD principal investigator
University of Michigan
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure for Primary Care (PE-PC) and EAP Treatment as Usual (TAU) in people with Post Traumatic Stress Disorder, run by University of Michigan at 14 sites 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 6 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Garlick (734-232-2663, jgarlick@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score (time frame: baseline to 6 months). 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 NCT05751473, 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 1 Jul 2026.